‘Smart pill’ company etectRx and Pear Therapeutics form CNS partnership

etectRx, Inc., a digital health company, has entered into an agreement with Pear Therapeutics, Inc., a prescription digital therapeutics (PDTs) provider.

The objective: develop up to two product candidates in the central nervous system (CNS) sector that combine PDTs and adherence sensors. The companies say that this partnership is the first to explore the use of digital pill solutions with PDTs.

etectRx’s ingestible sensor, the ID-Cap System

etectRx’s FDA-cleared ID-Cap System, a digital pill system that the company says is accurate and flexible, enhances adherence to oral medication and helps to improve patient outcomes. Specifically, FDA cleared ID-Cap System as an ingestible event marker, which has the ability to guide digital and non-digital therapeutic interventions. Once swallowed, its ID-Tag uses etectRx’s proprietary communications technology to transmit a very low power digital message from within the patient’s stomach.

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Thermo Fisher acquires Novasep’s viral vector manufacturing business

Thermo Fisher Scientific Inc. and Groupe Novasep SAS, a services and technologies supplier for the life sciences industry, announced that Thermo Fisher has acquired Henogen S.A., Novasep’s viral vector manufacturing business in Belgium, for approximately €725 million (about $876 million) in cash.

Henogen S.A. will be part of Thermo Fisher’s pharma services business within the laboratory products and services segment.

Between its two locations in Seneffe and Gosselies, Belgium, the business offers contract manufacturing services for both vaccines and therapies to biotech companies and large biopharma customers via approximately 75,347 square feet of capacity. The business’ estimated 2020 revenue was €80 million (approximately $97 million).

Thermo Fisher previously announced plans to construct a 67,000-sq.-ft. plasmid DNA manufacturing facility in Carlsbad, CA last month.

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Amalgam Rx acquires CDS business

Amalgam Rx, Inc., which specializes in digital therapeutics and patient support, has acquired Avhana Health, a clinical decision support (CDS) company with tools that are directly integrated into the electronic health record (EHR) workflow, for an undisclosed amount. The software as a service (SaaS)-based CDS tool allows for two-way interactions within the EHR and can help enhance provider workflow. Amalgam Rx says that it will expand Avhana’s CDS features to various therapeutic areas, with the goal of making doctors’ daily processes a bit smoother.

Doctors use Avhana Health’s services in an effort to support adherence to clinical quality guidelines—the aforementioned tool has been implemented in more than 150 provider groups and reportedly recognizes over $120 million a year in cost savings.

The deal marks Amalgam Rx’s first ever acquisition.

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CareMetx gains pair of investments

CareMetx, a technology-enabled hub services company whose goal is to improve patient access to specialty medications; General Atlantic, a global growth equity firm; and The Vistria Group, a private investment firm, have formed a strategic partnership.

Although terms of the deal were not disclosed, General Atlantic will become the majority owner of CareMetx. The Vistria Group, an existing majority shareholder in CareMetx since 2017, will keep its significant position in the company by reinvesting through Vistria Fund III, LP. Further, Marty Nesbitt, co-CEO of The Vistria Group, will be CareMetx’s chairman.

CareMetx represents pharma and biotech companies, and looks to assist patients and providers with piloting reimbursement challenges. The plan is to continue designing solutions that can help lower the financial cost of patients’ therapy.

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EVOQ Therapeutics inks autoimmune partnership

EVOQ Therapeutics has signed a license and collaboration contract with Amgen around the discovery and development of novel drugs for autoimmune disorders.

Under the terms of the agreement, Amgen and EVOQ will team up when it comes to preclinical development, while Amgen will be responsible for clinical development and commercialization. In exchange for exclusive rights to certain autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million, as well as pay royalties on sales of resulting therapies.

Amgen specializes in treating autoimmune disorders, with a résumé featuring Otezla and Enbrel, along with biosimilar products, such as AMGEVITA (a biosimilar to Humira) and AVSOLA (a biosimilar to Remicade). Michigan-based EVOQ Therapeutics is developing technology focused on the activation of dendritic cells. The two companies will work together to use dendritic cells to develop immune tolerance.

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Sanofi expands immunotherapy portfolio

Sanofi has acquired Kymab, a biopharma immunotherapy company. Under the deal’s terms, the drug manufacturer will purchase Kymab for an upfront payment of approximately $1.1 billion and up to an additional $350 million for completion of specific milestones.

Sanofi will have full global rights to KY1005, a fully human monoclonal antibody that has a novel mechanism of action. KY1005 binds to OX40-ligand and has the potential to combat various immune-mediated diseases and inflammatory disorders.

Paul Hudson, Sanofi’s CEO, notes that this addition further establishes the company’s interest in fighting immune-related illnesses.

“The Kymab acquisition adds KY1005 to our dynamic pipeline, a potential first-in-class treatment for a range of immune and inflammatory diseases. The novel mechanism of action may provide treatment for patients with suboptimal responses to available therapies,” he said. “We understand from our ongoing work in debilitating immunological diseases how critical it is to find the right treatment for each patient. We look forward to rapidly developing this investigational medicine.”

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BioNTech raises vaccine distribution goal to 2 billion doses

BioNTech SE, Pfizer’s vaccine development partner, has boosted the 2021 delivery target for its Covid-19 vaccine to 2 billion doses, an increase from its previous projection of 1.3 billion, due to the addition of new production lines and as more doses can be extracted per vial, according to a Reuters report.

The company mentioned yesterday—in a presentation for the virtual JP Morgan healthcare conference—that a new manufacturing site in Marburg, Germany, acquired from Novartis in September, could help increase annual capacity by up to 750 million doses when it becomes operational by the end of February. Special syringes known as low dead space syringes allow for extraction of six vaccine doses from a standard vial, instead of the usual five, which can avoid wasting unused liquid left in a syringe, Reuters notes.

BioNTech mentioned that this would result in 1 billion people getting the designated two-dose regimen, the report says.

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Liveo’s blister films hit Argentinian market

Liveo Research and Plásticos DISE SA have entered into a strategic partnership to provide Argentinian pharmaceutical manufacturers and contract packagers with Liveo’s blister film portfolio. DISE’s local pharma business unit in Córdoba, Argentina, provides access to Liveo’s blister films while maintaining Liveo’s standards. As a result of the collaboration, Argentinian customers will be able to shorten the supply cycle and expedite the import process, the companies say.

Grand View Research notes that global pharmaceutical packaging market revenue is projected to grow to $188.8 billion, with a compound annual growth rate (CAGR) of 10.8%, from 2020-2027. More specifically, within the Argentinian pharma blister packaging sector, Research and Markets anticipate a 7.5% CAGR, from 2019-2024.

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Kuehne+Nagel will distribute Moderna’s vaccine

Moderna and Kuehne+Nagel have reached an international supply chain arrangement to provide distribution and storage of Moderna’s Covid-19 mRNA vaccine. The news comes after the vaccine was granted conditional market authorization (CMA) by the European Commission last week.

The arrangement includes distribution and warehousing of the vaccine from Kuehne+Nagel’s Europe-based pharma hub. The logistics company will use its network of more than 230 operations worldwide to distribute the vaccine via road and air. In Europe, the company operates its own fleet of over 200 dedicated pharma transport vehicles—besides this region, distribution will also be to Asia, the Middle East and parts of the Americas. At all stages of transport and storage, product temperature will remain at the required -20°C (-4°F).

Kuehne+Nagel has also signed partnerships with officials in various countries for local storage and last-mile distribution, including in Germany’s most populous state, North Rhine-Westphalia.

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Abzena reveals plans for new biologics cGMP site

Due to an increase in customer demand for commercial scale 2000L single use bioreactors across various therapeutic sectors, Abzena will add a sixth global site that will expand current good manufacturing practice (cGMP) manufacturing capacity for mammalian biologics, the life sciences group says.

Construction of the site is expected to begin mid-2022.

The new facility will be in the US and will be home to Phase III and commercial manufacturing. A phased approach to construction will initially allow four modular suites, with each suite including up to two 2000L bioreactors, followed by the addition of two further 2000L suites.

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Catalent agrees to sell Blow-Fill-Seal business

SK Capital Partners LP, a private equity firm that focuses on the specialty materials, chemicals and pharma sectors, has signed an agreement to acquire the Blow-Fill-Seal (BFS) sterile contract development and manufacturing business from Catalent Pharma Solutions, LLC.

The deal is expected to close in April 2021, which is when the contract development and manufacturing organization (CDMO) will function as an independent company.

The BFS business’ primary focus is clinical to commercial stage formulation and manufacturing. It is catered toward an international, blue-chip customer base with products that use its BFS sterile manufacturing capabilities and formulation know-how in small molecule, biologics, macromolecules and potent compounds.

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Bayer and CureVac team up on potential vaccine

Bayer has signed an agreement with CureVac N.V., a biopharma company that manufactures medication based on messenger ribonucleic acid (mRNA). Per the deal, Bayer will help with development, supply and territory operations of CureVac’s Covid-19 vaccine candidate, CVnCoV.

As of Dec. 14, the vaccine has been in Phase IIb/III.

Bayer will offer its perspective in areas including clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance.

CureVac will be the marketing authorization (MA) holder for the product, while Bayer will support CureVac with country operations in the EU and other markets. Bayer also holds options to become MA holder in markets outside of Europe. The companies plan to work together on enabling CureVac to supply hundreds of millions of CVnCoV doses internationally, if approvals are granted.

In November 2020, CureVac announced that it would expand up its European manufacturing network, working with Wacker and Fareva, among others.

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Fujifilm to invest over $2B in US CDMO site

In an effort to speed up the growth of its biopharma contract development and manufacturing organization (CDMO), Fujifilm Corporation will invest over $2 billion to build a new large-scale cell culture production site in the US. This news comes only two days after the company announced a $40 million investment toward the construction of a Boston-area, advanced therapy facility that will manufacture viral vectors.

Fujifilm Diosynth Biotechnologies, a Fujifilm subsidiary with locations in the US, UK and Denmark, will be in charge of the new facility. The new location, which has not been named yet, is scheduled to begin operations in the spring of 2025, and will be constructed near a current Fujifilm site.

It is expected to offer large-scale cell culture manufacturing of bulk drug substances with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add further 24 x 20,000L bioreactors based on market demand. Besides manufacturing drug substances, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services.

Fujifilm has been actively seek investment opportunities to further develop its offerings across its Bio CDMO sites—most recently, in June 2020, the company put $928 million towards Fujifilm Diosynth Biotechnologies’ Hillerød, Denmark site, as part of its initiative to double large-scale cell culture manufacturing capacity and add commercial scale drug production capabilities.

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New IATA air freight data released

November data for global air freight markets showed that freight volumes improved over October, but remain low when compared to 2019, according to the latest numbers from the International Air Transport Association (IATA). Capacity remains limited, due to the loss of available belly cargo space, as passenger aircrafts are at a standstill.

Global demand, measured in cargo tonne-kilometers (CTKs), was down 6.6% from last year’s November numbers (-7.7% for international operations). This was consistent with the 6.2% year-on-year drop in October. However, the year-on-year decline is skewed, as November 2019 saw an increase in demand from the US-China trade war.

Global capacity, which is measured in available cargo tonne-kilometers (ACTKs), shrank by 20% in November (‑21.3% for international operations) compared to 2019, making it almost three times larger than the contraction in demand. The capacity issues can be attributed to a 53% decrease in belly capacity. This has been partially offset by a 20% boost in freighter capacity.

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AmerisourceBergen acquires Walgreens’ Alliance Healthcare for $6.5B

Nearly three years after Pharmaceutical Commerce began reporting on what was only a rumor at the time (albeit details were reversed), drug wholesaler AmerisourceBergen Corp. (ABC) will be purchasing the majority of Walgreens Boots Alliance (WBA)’s Alliance Healthcare businesses for approximately $6.5 billion, consisting of $6.275 billion in cash and 2 million shares of ABC common stock.

ABC’s acquisition of Alliance Healthcare, Walgreens said in a release, will provide even stronger support for pharmacies and pharmacists on an international level, while also providing integrated solutions for drug manufacturers. WBA will be able to increase its effort toward growing its retail pharmacy businesses by bringing more healthcare offerings to patients and customers.

The two companies are also extending and expanding their commercial agreements—their US distribution agreement will be extended by three years until 2029, while their partnership will now include a commitment to pursue more sourcing and distribution leads. Alliance Healthcare UK will remain WBA’s distribution partner until 2031.

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European Commission approves Moderna vaccine

After Moderna recently said it would increase its global supply of its Covid-19 vaccine, today, the EU’s executive commission—formally known as the European Commission—has officially granted conditional market authorization (CMA) for the vaccine. The news comes after the European Medicines Agency (EMA) recommended its authorization earlier in the day.

From a distribution standpoint, this greenlights the move of 160 million doses that are expected to be delivered to the EU between Q1 and Q3.

Pfizer and BioNTech SE, whose vaccine had previously been granted CMA in December, reached a deal to supply the EU with an additional 100 million doses this year, bringing the total to 300 million. And yesterday, Bloomberg reported that there are now talks to acquire up to 300 million additional doses, though nothing has been finalized yet.

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Moderna raises vaccine supply estimate

Moderna said it will increase supply of its Covid-19 vaccine, from its original base-case global production estimate of 500 million to at least 600 million doses for 2021. The company stated that it is continuing to invest and hire staff to build up to potentially 1 billion doses for the year.

Domestically, Moderna said it expects about 100 million doses to be available in the US by the end of Q1, with 200 million available by the end of Q2. The biotech reported that approximately 18 million doses have been supplied to the US government to date. Its vaccine received emergency use authorization from the FDA on Dec. 18 for individuals 18 years or age and older.

The news comes after Pfizer and BioNTech SE announced a second agreement before the holidays with the US government to supply an additional 100 million doses of their vaccine from production facilities in North America, bringing the total number of expected delivered doses to 200 million.

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Angelini Pharma acquires Swiss CNS company for up to $960M

Angelini Pharma, an international pharma company that is part of the Angelini Group, has acquired Swiss-based biopharma Arvelle Therapeutics, which focuses on advancing treatments for patients suffering from CNS disorders. The deal is valued at up to $960 million, in an all-cash transaction. Per the agreement, $610 million will be initially paid out. Later on, once Arvelle’s cenobamate—an FDA-approved anti-seizure drug for the treatment of partial-onset (focal-onset) seizures in adults, which is available under the brand name XCOPRI CV—reaches revenue targets, the remaining $350 million will be paid.

Angelini Pharma, headquartered in Rome, will own the exclusive license to commercialize cenobamate in not only the EU but other countries in the European Economic Area (EEA) as well. Angelini plans to launch cenobamate after it receives approval from the European Medicines Agency (EMA), which is expected to come later this year.

It should also be noted that SK Biopharmaceuticals, a pharma company that is listed on the Korea Stock Exchange, has agreed to sell its 12% stake in Arvelle to Angelini Pharma. SK Biopharmaceuticals will still be eligible to receive all payments that were referenced by the license agreement signed between Arvelle and SK in February 2019. Revenue share payments due to Arvelle shareholders will be assumed by Angelini Pharma.

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Cold-chain support for drive-thru vaccine clinics

As healthcare workers and residents of long-term care facilities in the US start receiving their first dose of the Covid-19 vaccine, Creche Innovations, a medical device company, alongside a Covid-19 vaccine focus group consisting of physicians, nurses and pharmacists from across the country, have developed the Pandemic Mobile Command Center (PMCC) with built-in MicroCool Refrigeration to help maintain the vaccine cold chain. MicroCool reportedly works with any digital data logger (DDL) that an entity wants to use.

According to Creche, the PMCC will help retail pharmacies, hospitals and satellite/temporary/off-site locations with starting and maintaining drive-thru vaccination clinics that follow the Centers for Disease Control and Prevention (CDC)’s best practices.

The PMCC allows for Covid-19 vaccination providers that are a part of the CDC’s US Covid-19 Vaccination Program to:

  • Preserve cold-chain conditions at all times, in accordance with the emergency use authorization (EUA)/vaccine packet insert and CDC guidelines
  • Constantly keep track of the MicroCool Refrigerator temperature using a DDL of their choosing
  • Ensure proper vaccine and supply inventory before the start of each vaccination clinic day
  • Have immediate access to all necessary Covid-19 ancillary supplies

Creche began PMCC production in Q4 2020 and plans to launch in the US and Canada this month.

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Pfizer to supply US with 100 million more doses of vaccine

Pfizer and development partner BioNTech SE announced a second agreement with the US government to supply an additional 100 million doses of the companies’ Covid-19 vaccine from production facilities in North America. This agreement brings the total number of doses to be delivered to the US to 200 million. The companies expect to deliver the full 200 million doses to Operation Warp Speed (OWS) by July 31, 2021. Consistent with the original agreement announced in July, the US government will pay $1.95 billion for the additional 100 million doses.

Under the terms of the second agreement, Pfizer and Germany-based BioNTech will deliver at least 70 million of the additional doses by June 30, 2021, with the remaining 30 million doses to be delivered no later than July 31. The US also has the option to acquire up to an additional 400 million doses. 

According to the companies’ joint release, eligible US residents will continue to receive the vaccine for free, consistent with the government’s commitment to providing free access for Covid vaccines and according to CDC Advisory Committee on Immunization Practices (ACIP) recommendations for the vaccine’s phased rollout.  

The Pfizer-BioNTech vaccine has not been approved or licensed by the FDA, but has been authorized for emergency use by the agency for individuals 16 years of age and older.

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Qatar Airways Cargo earns CEIV pharma certification

Qatar Airways Cargo has been awarded the International Air Transport Association (IATA)’s Center of Excellence for Independent Validators (CEIV) certification in pharma logistics, the company announced. CEIV Pharma is an industry-wide standard that addresses the segment’s need for more safety, security, compliance and efficiency.

The certification encompasses Qatar Airways Cargo’s operations, its quality management system and supplier management processes in Doha, Qatar’s capital city. The company also received the certification for its pharma handling and warehouse at Hamad International Airport in Qatar, along with its climate control center, which contains two temperature-controlled zones operating at both 2-8°C (35.6-46.4°F) and 15-25°C (59-77°F), with a capacity to hold up to 156 ULDs (unit load devices) at a time.

Alongside Kuehne+Nagel, the airline is currently part of the “1 million kilos” charitable initiative, in which they are donating air freight services to UNICEF to help combat Covid-19.

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Taysha Gene Therapies to open new cGMP facility

Taysha Gene Therapies, Inc., which focused on developing adeno-associated virus (AAV)-based gene therapies for the treatment of monogenic diseases, has entered into a lease agreement for an approximately 187,000-sq.-ft. current Good Manufacturing Practices (cGMP) manufacturing facility in Durham, NC. The company will invest $75 million and create an estimated 200 jobs over two and a half years.

Multiple production suites are expected to be completed by 2023, and will allow production that is compliant with FDA guidelines. The facility will feature 2,000 liters of capacity—additional reinforcements aside from Taysha’s existing manufacturing agreements with UT Southwestern’s gene therapy program and Catalent—and will be designed to support all aspects of scalable manufacturing of gene therapy material to meet both clinical and commercial demand.

The company plans on having four open investigational new drug (IND) applications in 2021.

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Honeywell purchases software company for $1.3B

Technology giant Honeywell has agreed to acquire Sparta Systems for $1.3 billion in an all-cash deal, which is expected to close by the end of Q1 2021. Sparta Systems is a provider of enterprise quality management software (QMS)—including its own software as a service (SaaS) platform—for the life sciences industry.

Honeywell plans to leverage the Sparta portfolio to introduce new, integrated products, such as QMS offerings, for life sciences and other segments, particularly through the company’s TrackWise Digital and QualityWise.ai software. In turn, executives say, this will increase access for Honeywell’s pharma and biologics customers to higher-quality products in the form of new therapies, faster time to market, better business and patient outcomes, and regulatory compliance.

Honeywell says it will continue to develop TrackWise Digital QMS by implementing artificial intelligence and machine-learning features that augment human decision-making.

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LSBio bolsters antibody tech portfolio

LSBio, a supplier of antibodies and life science research reagents, has acquired Absolute Antibody, Ltd. and its sister company Kerafast. Terms of the deal were not disclosed.

Specifically, LSBio provides immunohistochemistry (IHC)-validated reagent antibodies and offerings to academic, pharma and biotech researchers. With more than 750,000 reagent antibodies, assay kits, proteins and biochemicals, the company’s purchase of Absolute Antibody and Kerafast further expands its product portfolio by adding an assortment of additional reagents and antibody services.

Absolute Antibody specializes in recombinant antibody technology, offering antibody sequencing, engineering and recombinant production as custom services, along with recombinant antibodies and Fc-fusion proteins, designed into new formats. In 2018, it merged with Kerafast Inc., a company that enables access to unique laboratory-made reagents, to extend the availability of recombinant antibodies.

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Aceto adds chemical supply presence in the US

Aceto, a virtual manufacturer of specialty materials for the life sciences and advanced technology end markets, has acquired New York-based IsleChem. The latter’s specializations include chemical manufacturing, contract research and development, analytical services, and technical and support services. Founded in 1947, Aceto distributes over 1,100 chemical compounds used principally by the pharmaceutical, nutraceutical, agricultural, and specialty chemical industries.

The company says its deal with IsleChem is a part of its strategy for long-term growth. By adding manufacturing expertise in the US, Aceto boosts its global supply network that is mainly focused in India and China. Agreements like these, CEO Gilles Cottier said, have become increasingly important amid the coronavirus crisis.

“The Covid pandemic has reinforced that access to a diverse, secure supply chain and dependable manufacturing is essential to business continuity,” he said. “This acquisition adds manufacturing and R&D capabilities to enhance Aceto’s already robust supply network. IsleChem is poised for facility expansion to service growing market demand, allowing the combined company to support more of our customers’ needs, from development through to commercialization and full-scale production.”

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Syneos Health acquires Illingworth Research Group

Syneos Health, a biopharma solutions organization, has acquired Illingworth Research Group, a clinical research home health services provider.

 

Illingworth’s specialization is in-home and on-site research nursing services (including mobile research nursing) for clinical trials. The company works with biopharma and medical device companies supporting studies in more than 46 countries. The current pandemic has further accelerated the demand for these types of offerings. Illingworth also provides complementary patient-focused contract research organization (CRO) services aimed at decreasing patient and site burden, and has experience across Phase I–IV studies in therapeutic segments such as oncology, respiratory, rare disease and pediatrics. The deal adds additional capabilities to Syneos’s decentralized clinical trial solutions. 

 

Illingworth will maintain its brand name, but will operate as a part of Syneos Health.

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Eversana and Experic form life sciences collaboration

Eversana and Experic, a contract manufacturing organization (CMO) and pharmaceutical supply service company, announced a partnership to enhance clinical development, manufacturing, launch planning and commercialization efforts for life sciences companies.

Per the deal, Experic’s clinical and commercial scale manufacturing and packaging services will be available within Eversana’s platform, which is currently under contract to manage multiple product launches across various therapeutic fields. In 2021, the services will assist in the commercialization of new products or to revitalize the market position and performance of existing branded therapies.

According to the companies, clients will have greater access to end-to-end outsourced services and contracting to improve patient experiences. Eversana’s integrated or stand-alone pharma services intersect multiple areas, ranging from global pricing to patient support.

Experic supports every phase of a product’s life cycle from clinical to commercial scale, across multiple dosing and packaging formats, including capsule filling, powder and pellet dosing (including dry powder inhalation, or DPI), autoinjectors and pen assemblies.

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IATA makes case that aviation employees be deemed essential for vaccination

The International Air Transport Association (IATA) asked governments to acknowledge that employees in the aviation sector be considered essential workers during the Covid-19 vaccine campaign, once healthcare workers and vulnerable groups have been protected.

Alexandre de Juniac, IATA’s director general and CEO, is not calling for governments to change priorities, but rather to consider the role that those in the aviation industry play in the global supply chain.

“We are not asking for aviation workers to be on top of the list, but we need governments to ensure that transportation workers are considered as essential when vaccine roll-out plans are developed,” he said. “The transportation of the Covid-19 vaccines has already begun, and as calculations show, it will require the equivalent of 8,000 Boeing 747 freighter aircraft for global distribution. It is therefore essential that we have the qualified workforce in place to ensure a functioning logistics chain.”

IATA’s 76th Annual General Meeting (AGM) recently adopted a resolution speaking to this effect.

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Thermo Fisher to build plasmid DNA manufacturing facility

Thermo Fisher Scientific announced the construction of a new current good manufacturing practice (cGMP) plasmid DNA manufacturing facility in Carlsbad, CA. The 67,000-sq.-ft. site—which is expected to be completed in the first half of 2021—will expand the company’s clinical and commercial capabilities for cGMP plasmid DNA as a raw material to develop cell and gene-based therapies, including cancer treatments, along with mRNA vaccines.

In addition, the site will be able to produce large-scale plasmid DNA as a main drug substance for DNA therapies.

The new building—one that will add approximately 150 jobs over the next year—furthers the company’s investment in cell and gene therapy services. This includes viral vector services in Cambridge, Lexington and Plainville, MA, and Alachua, FL; a new cell therapy manufacturing facility in Princeton, NJ; and coming January 2021, a cryocenter in Weil am Rhein, Germany, for delivering specialized cryogenic and cold-chain supply chain services.

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Pelican BioThermal unveils ‘School of Cool’

Pelican BioThermal introduced School of Cool, an online learning platform that’s goal is to help customers and distributors build proficiency in temperature-controlled packaging technology. The new training program provides on-demand, self-service training at a time when instruction has taken a virtual shift, while demand for these types of packaging options continues to increase.

School of Cool is used to develop and provide content for various industries, such as pharma, healthcare, biotech and general business. The first four training modules the company offers include:

  • What is Temperature Controlled Packaging? – Introduces new and potential customers to the temperature-controlled packaging industry and the mechanical properties of insulation.
  • Types of Temperature Controlled Packaging – Explains the types of temperature-controlled packaging and optimal use case for each, including payload capacities and temperature ranges.
  • Phase Change Material – Brings attention to the types of phase change materials and how they maintain designated temperature ranges throughout the entire product transport.
  • Phase Change Material Conditioning – Covers how to prepare temperature-controlled packaging coolants for use before pack out.

Plans to add more lessons are in the works, including those that address product temperature ranges, parcels versus pallets, dry ice shippers and Pelican BioThermal’s new NanoCool push-button cooling technology, which was part of an acquisition the company made early this year.

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EQT makes $2.1B bid to purchase Recipharm

Private equity firm EQT AB has made an offer to acquire Recipharm AB, a contract development and manufacturing organization (CDMO), for $2.1 billion, EQT announced. The offer is expected to be made public on or around Dec. 17.

As Bloomberg reported, Sweden-based EQT has already secured ownership of about 25.7% of the shares and 74.3% of the votes in Recipharm via its chairman, Lars Backsell, and Thomas Eldered, its CEO.

The firm will be offering shareholders $26.24 in cash per share, the report stated.

Other reports noted that Recipharm recently signed a preliminary deal with Moderna Inc to fill and seal the packaging for the biotech’s mRNA Covid-19 vaccine.

Recipharm signed a letter of intent with Moderna to help “formulate, fill and finish” its Covid-19 vaccine, as an FDA advisory board prepares to meet on Thursday  to discuss Moderna’s request for emergency use authorization (EUA).

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DeltaTrak says its equipment fulfills Covid-19 vaccine requirements

DeltaTrak rolled out vaccine temperature-monitoring products that are compatible with the three temperature profiles necessary for the transport, storage and handling of Covid-19 vaccines, the company says. These consist of certified alarm thermometers, digital data loggers (DDLs) and real-time monitors (RTL) for vaccines stored in refrigerators, freezers, ultra-low temperature (ULT) freezers, and thermal shippers.

DeltaTrak’s three-in-one vaccine monitors can be used for vaccines that need customized temperature management profiles, such as Pfizer’s (-70°C, -94 °F), Moderna’s (-20°C, -4 °F) and AstraZeneca-Oxford University’s (2-8°C, 35.6-46.4 °F).

The FlashTrak cloud platform enables access to reports and sharing with hospitals, clinics, pharmacies, third-party logistics providers (3PLs) or health departments. The platform also allows users to customize settings for cargo security, temperature alerts, location and arrival and departure status using geofence and API integration.

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CCT involved in OWS’s vaccine distribution efforts

Cold Chain Technologies (CCT) was a supplier of specialty thermal packaging for the storage and transfer of Covid-19 vaccines in support of the US government’s Operation Warp Speed (OWS) distribution plan.

Although no two scenarios are alike, Ranjeet Banerjee, the company’s CEO, notes that CCT’s experience in similar situations, such as H1N1, have helped from a logistical standpoint.

“Our company is prepared, ready and able to leverage both our deep experience of delivering for past pandemics and the expanded capacity we have been building since the COVID-19 pandemic began to meet the temperature-sensitive requirements of the vaccine—with the industry’s broadest portfolio of single-use and reusable systems for parcel and pallet shipments,” he said.

CCT opened a new 255,000 sq.-ft. cold-chain facility in Lebanon, TN, last month.

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HDA foundation captures specialty Rx distributor trends

New data released by the Healthcare Distribution Alliance (HDA) Research Foundation points to the supply chain efficiencies generated by HDA-member specialty drug distributors. According to the latest edition of Specialty Pharmaceutical Distribution: Facts, Figures and Trends, specialty distributors serve as an important link between 176 manufacturers and more than 49,000 provider ship-to points for administration or dispensing to patients. In citing data from IQVIA, HDA noted that the specialty pharma market reached $426 billion in 2019.

Independent physician-owned and -operated clinics make up the biggest customer segment (about 18,000), followed by hospitals, retail pharmacies and specialty pharmacies. As in years past, oncology products accounted for the highest shipping volume, at 52% of specialty distributors’ weighted average sales, followed by products in the inflammatory/autoimmune, supportive care, ophthalmology and hemophilia/bleeding disorder groups.

The primary data are gathered through a survey of HDA specialty distributors who have recorded yearly sales greater than $1 billion for the 2019 fiscal year; they also have combined average gross specialty sales of $23 billion. The Covid-19 response is not reflected in this particular publication.

Among the 2019 highlights:

  • On average, specialty distributors received more than 4,500 orders daily. Each distribution center typically picked nearly 7,300 lines daily, with an average of 2.8 lines per order.
  • Distributors achieved a 98.8% order fill rate on average and delivered 1.4 days after receiving an order. The typical turnaround time from courier pickup to delivery to the dispenser was 18.3 hours.
  • A majority of distributors (75%) reported using temperature-monitoring devices to track shipments of specialty pharmaceuticals at various points in the supply chain. The same amount believe that overall cold-chain compliance and temperature monitoring are becoming increasingly important.

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Schreiner MediPharm joins tracking standardization consortium

Schreiner MediPharm, a German specialty label developer, has joined DoseID, the US-based industry association launched in August that works to standardize the use of RFID tags in healthcare. The company is focused closely on this technology—in fact, it augmented its Cap-Lock tamper-evident specialty label with an RFID inlay in October.

DoseID’s goal is to monitor the performance of RFID-tagged drug products as they move through the pharma supply chain. The products are tracked across all hardware and software systems—from the manufacturer, through the distributor, to the hospital and ultimately, the patient.

Pharmaceuticals can be tracked by serializing medications, containers and devices, but the RFID tags need perform well in hospital and healthcare IT systems—otherwise, the products won’t be able to be tracked from start to finish.

The unit level serialization supported by DoseID exceeds the requirements set forth by the Drug Supply Chain Security Act (DSCSA). To ensure adherence to the standards established by the consortium and conformity with the requirements of pharmaceutical manufacturers, compounding pharmacies, pharmacy automation services providers and manufacturers of RFID inlays and tags, a special RFID tag certification also is awarded after third-party testing.

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Mobile pharmacy looks to enhance medicine management

Kit Check, a provider of automated and medication management solutions, launched its Mobile Pharmacy, which is now available to hospitals and health systems. According to the company, the platform enables hospital pharmacists and staff to manage, track and stock medication inventories appropriately.

The cart consists of an RFID-enabled scanning station, along with a tablet-accessible dashboard that helps with inventory organization. The goal is for the cart to limit stocking time—Kit Check says it does so by 30-50%—and to issue medication efficiently. The Mobile Pharmacy integrates with existing hospital and health system technology, the company states.

 

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High Court rules that states can regulate PBMs

The US Supreme Court today issued its ruling in Rutledge v. Pharmaceutical Care Management Association (PCMA)deciding if community pharmacies  are protected  from abusive payment practices.

The unanimous (8-0) decision ruled in favor of the interests of community pharmacies’ favor, who have been fighting for several years to regulate pharmacy benefit managers (PBMs)—the middlemen that manage prescription drug benefits for health insurers, Medicare Part D drug plans and large employers.

Specifically, the Court investigated the degree to which the federal Employee Retirement Income Security Act of 1974 (ERISA), which controls private employee benefit plans, prevents states from regulating the amount that PBM pay pharmacies to distribute Rx drugs that are covered by an employer-sponsored health plan.

The ruling is a win for 45 states, led by Arkansas, who now have more authority to protect local businesses and their patients from PBM overreach. Scott J. Knoer, executive vice president and CEO of the American Pharmacists Association, said the Supreme Court decision restores a proper distribution of power that both independent pharmacies and customers were looking for.

“For years,” he stated, “PBMs have threatened the sacrosanct relationship between pharmacists and their patients, and have never been forced to answer to any authority for their actions. This opinion redresses that imbalance and returns the power to protect the interests of patients to the states and other local authorities, where it belongs.”

During oral argument, a published report by USA Today noted that several justices expressed concern that state interference in the Rx drug marketplace might subject PBMs to dozens of state laws—something the Employee Retirement Income Security Act of 1974 (ERISA)  was meant to preclude.

In shared comments provided to Pharmaceutical Commerce, attorney Benjamin Conley, a partner with the employment law firm Seyfarth, believes the ruling “creates a potential roadmap for states to influence ERISA plans without running afoul of ERISA’s preemption provisions.”

“The Court found that while the Arkansas law at issue could certainly influence plan costs and create plan operational inefficiencies, it did not mandate any particular structure, nor did it impact central plan administrative operations,” he added. “As such, the Court opined that extending preemption would create a potentially limitless barrier to state regulations.”

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Carrier Pods to help tackle Covid-19 vaccine storage demands

SeaCube Containers LLC acquired 200 Carrier Pods monitored by Sensitech to help combat the projected need for refrigerated storage capacity and cargo visibility in support of Covid-19 vaccine distribution.

Carrier Pods temporary storage unit. Credit: Carrier Transicold

As previously reported by Pharmaceutical Commerce, the systems offer deep-frozen container refrigeration with telematics, data analytics and most recently, remote cargo monitoring capabilities. Both Carrier and Sensitech are part of Carrier Global Corp., which offers building and cold chain solutions.

With Carrier Pods monitored by Sensitech, container refrigeration units deliver temperature control within +/- 0.25 ºC (32.45 ºF, 31.55 ºF) and temperatures down to -40 ºC (-40 ºF), while their monitoring devices are able to track readings down to dry ice conditions of -95 ºC (-139 ºF). Sensitech noted the devices’ simple mobility, which allows them to easily relocate, whether it be to meet changing capacity demands or go to temporary vaccine administration locations.

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Real Endpoints aims to simplify drug contracting process

Real Endpoints (RE), an advisory and analytics firm focused on market access within the pharma industry, has launched RE Marketplace, a platform the company says will boost the efficiency and reach of value-based contracting for drugs for rare and orphan disease, providing significant benefits for patients, payers and manufacturers.

The founding members consist of four regional health plans, representing nearly 2.5 million beneficiaries. More plans are expected to join in the coming months.

Through value-based contracts, the platform accelerates the availability of rare-disease drugs to millions of members in mid-sized and smaller health plans who otherwise may not normally have access to these products.

Further, RE Marketplace provides each plan access to value-based agreements through a single contract for all participating biotech drugs, while biopharma manufacturers have contracted access to previously hard-to-reach plan members.

Using the medical and pharmacy claims data from the RE Marketplace member health plans, Real Endpoints and its academic partner, the University of Colorado Anschutz Medical Campus, will be responsible for performing all of the analytics and financial reconciliation, using a secure, HIPAA-compliant system that has already been tried and used in various deals.

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Latest IATA numbers suggest a mixed bag for air cargo

October data for global air freight markets showed that air cargo demand is improving, but at a slower speed than September, according to the International Air Transport Association (IATA)’s latest data. It also remains below previous year levels.

Global demand, measured in cargo tonne-kilometers (CTKs), was 6.2% below previous-year levels in October (-7.5% for international operations). That is an improvement from the 7.8% year-on-year drop recorded in September. However, the pace of recovery in October was slower than in September, with month-on-month demand growing 4.1% (1.1% for international).

Similar to September, global capacity—measured in available cargo tonne-kilometers (ACTKs)—was also a concern this time around, shrinking by 22.6% in October (‑24.8% for international operations) compared to the year before. That is almost four times larger than the contraction in demand, illustrating the continuing and severe capacity issue.

North American and African carriers reported year-on-year gains in demand (+6.2% and +2.2% respectively), while all other regions remained in the negative, versus October 2019.

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Tjoapack invests $12M in Netherlands facility

Tjoapack, a contract packaging organization (CPO) for the pharma industry, has invested $12.1 million into its packaging and supply chain facility in Etten-Leur, Netherlands over the next two years.

The location will expand from approximately 90,417 sq. ft. to about 123,785 sq. ft. in size, adding eight new production lines to double capacity for primary packaging for oral solids to over four billion tablets per year. Further, the company’s team is expected to double with the hiring of 100 employees.

Other than the growth in production capacity, Tjoapack said it will be “investing heavily” in both its warehousing and cold chain capabilities to meet the increased customer demand for the company’s logistics services.

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Vaccine storage & packaging market to balloon to $43.8B

The global vaccine storage and packaging market is projected to jump to $43.8 billion by 2027, according to a new study published by Polaris Market Research.

The market is also expecting a compound annual growth rate (CAGR) of 10.4% from 2020 to 2027. Technological advancements in the storage and packaging of medicines, a climb in the number of pharma retailers and an increase in the prevalence of infectious diseases are projected to drive demand for the worldwide market.

The Covid-19 pandemic has caused a rise in research studies for the development of a vaccine to prevent and cure the disease, as well as demand for reliable storage and packaging solutions to store these vaccines—doses such as Pfizer’s that use synthetic mRNA to activate the immune system against the virus have to be stored at -70 ºC (-94 ºF).

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DoKaSch and Air Europa expand pharma product capabilities

DoKaSch Temperature Solutions and Air Europa have signed a master rental agreement for the use of DoKaScho’s temperature-controlled Opticooler packaging solution. The partnership opens up new direct routes between Europe and Latin America, giving forwarders and pharma producers additional transport options.

DoKaSch’s Opticooler RAP container. Credit: DoKaSch Temperature Solutions

DoKaSch’s airfreight container comes in two sizes: there is the RKN version that holds 1.5 Euro pallets (one CP1 pallet), while the RAP version—which United Cargo utilized last April—offers space for up to five Euro pallets (four CP1 pallets). The Opticooler is capable of keeping the desired temperature level between 2 and 8 ºC (35.6 and 46.4 ºF) at all times, regardless of the surrounding climate. It is equipped with batteries and only requires a power socket for charging.

Air Europa, an airline based in Spain’s capital city of Madrid, offers flights within Europe, to Africa and the Americas. At the moment, it is providing direct flights with wide-body aircrafts from Madrid to 21 destinations in Latin America.

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Bayer launches cell and gene therapy platform

Germany-based Bayer AG recently launched a cell and gene therapy (C&GT) platform within its pharmaceuticals division.

Stefan Oelrich, a member of the company’s Board of Management and president of the pharma division, says that with the rapid growth of C&GT, Bayer believes the time is now to competitively establish itself in this field. A challenge that Bayer is ready for, he says.

“This is a defining moment for Bayer. Cell and gene therapies are leading innovation in healthcare, and it is our goal to be at the forefront of this revolution in science,” Oelrich stated.  “This will complement our existing C&GT pipeline, which already includes five advanced assets with at least three investigational new drugs annually for the next years.“

As part of the pharma division, the C&GT platform will merge several functions, providing support across the entire value chain for the R&D of C&GTs. This includes expertise in research and preclinical development, CMC (chemistry, manufacturing and controls), clinical development, commercial, strategy implementation and project management.

Bayer focuses on selected areas of C&GT, such as stem cell therapies, gene augmentation, gene editing and allogeneic cell therapies. In 2019, it acquired BlueRock Therapeutics, and a deal with Asklepios Biopharmaceutical closed on Dec. 1 of this year. These initial partners are starting to enroll in Bayer’s C&GT platform.

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Latest HDA Factbook outlines supply chain trends

Data published yesterday by the Healthcare Distribution Alliance (HDA) Research Foundation revealed that in 2019, approximately 93% of all US pharma sales were completed through HDA-member traditional pharmaceutical distributors. As reported in the 91st Edition HDA Factbook, total distributor sales were $519 billion.

The Factbook is based on surveys collected at the corporate level of HDA traditional distributor member companies with yearly sales greater than $1 billion, along with secondary data included from healthcare and governmental organizations. The data reflect distribution industry performance metrics and overall supply chain management trends for the 2019 operating year; it should be noted that this edition does not reflect the effects of Covid-19 on supply chain operations.

Prescription drugs accounted for about $420 billion of distributors’ overall pharmaceutical sales, representing a nearly 6% growth over 2018—distributors worked with more than 1,400 manufacturer suppliers.

Among the other findings:

  • On a typical business day, each traditional distribution center picked more than 105,000 SKUs and processed about 4,000 orders.
  • The average total amount of SKUs that distributors held in inventory was 45,645; prescription medicines represented 76% of total lines picked, with non-prescription drugs (health and personal care products, general merchandise and durable medical equipment and home healthcare) making up the remaining 24%.
  • Forty percent of distributors are currently using EPCIS 1.2—a GS1 standard that allows partners to gather content about supply chain events—for serialized data exchange (a requirement for 2023 Drug Supply Chain Security Act interoperability), with 60% reporting they plan to do so in the next 12 months.

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Eversana reaches predictive intelligence agreement

Eversana, a provider of global commercial services to the life sciences industry, and ArisGlobal, a drug development software company, have officially reached a partnership that Eversana says will “digitally transform end-to-end pharmacovigilance services, leading to safer, more effective healthcare for patients worldwide.”

Per the agreement, Eversana will use ArisGlobal’s LifeSphere cloud platform for clinical and commercial product safety management, which includes intelligent automation and machine-learning-enhanced adverse event case processing—the commercial services company began onboarding clients to the platform last month and plans to continuing doing so into next year.

The technology adds real-time predictive intelligence to Eversana’s drug safety repertoire, including the capability to process and analyze data to recommend appropriate products to patients. It will also help clients determine safe options when it comes to therapeutics.

This latest announcement comes after Eversana reached data deals with both Symphony Health and Compile back in November.

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World Courier opens new sites in Asia, Africa

World Courier’s new Kenya office. Credit: World Courier

World Courier, a specialty logistics company, opened a new clinical and commercial storage depot in Istanbul, Turkey, along with a new office in Nairobi, Kenya.

Given the city’s large population and location in the Eastern-Europe-Middle East-North African triangle, the company’s Turkey depot will serve as a clinical and commercial storage facility. It offers the advantage of allowing sponsors to utilize in-country depot storage, as opposed to direct-to-site shipments, which the company says can help mitigate any temperature deviation issues.

The opening of the new Kenya office comes at a time when governments across the globe are planning for the rollout of Covid-19 vaccines and formulating distribution plans in regions, such as Sub-Saharan Africa that may have limited logistics infrastructure (internet, cargo facilities, roads)—high temperatures and lack of rainfall are also concerns. World Courier notes that the GxP (good practice)-compliant location is conveniently near the Nairobi airport—with enough fridge and freezer capacity for packaging—and should help strengthen local supply chains.

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Bora Pharmaceuticals finalizes acquisition of GSK facility

Bora Pharmaceuticals Co., Ltd has officially acquired GlaxoSmithKline’s Mississauga, Ontario (Canada) facility in a minimum five-year supply agreement. The deal is part of a long-term growth strategy that has seen Bora, a contract development and manufacturing organization (CDMO), complete three M&As in the past five years.

Bora Pharmaceuticals’ Mississauga facility. Credit: Bora Pharmaceuticals

Originally announced in March, the Canadian location is the company’s first manufacturing facility in North America, which will now be home to its North American headquarters. This also marks the Bora’s second site on the continent, after opening a US office in Delaware in 2019.

With this deal, Bora is able to diversify its range of dosage forms—the new flagship location provides the company with greater production capabilities, which, executives say, will not only help strengthen Canada’s medicines supply chain, but will allow Bora to make 50 different products to 100 international markets. It also plans to bring additional employees aboard its technical and operational team.

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CarepathRx nabs managerial control of UPMC infusion unit

CarepathRx, a pharmacy management company, has partnered with the University of Pittsburgh Medical Center (UPMC)’s Chartwell subsidiary in a deal that executives say will expand patient access to specialty pharmacy and home infusion capabilities. Per the $400 million agreement, CarepathRx will acquire the management services organization responsible for the operational and strategic management of Chartwell, while UPMC becomes a strategic investor in CarepathRx. The deal is expected to close within the next 30 days.

By prioritizing the most vulnerable patients—many of which are undergoing specialty and infusion therapies—CarepathRx’s goal is to overcome the hurdles that may come with traditional pharmacy care and medication management. CarepathRx works closely with an array of members within the healthcare field, such as health systems, community physicians, home health agencies and payers, providing services to more than 600 hospitals nationwide.

The deal is a positive for all parties involved, says Leslie Davis, senior vice president of UPMC, and executive vice president and COO of its health services division, noting that the center is continually searching for ways to get involved with new care delivery models, including in the pharmacy sector.

“Health systems nationwide are looking for new ways of delivering care beyond the walls of the hospital to drive better clinical outcomes at lower costs,” she mentioned. “Chartwell’s agreement with CarepathRx will allow other health systems to benefit from the pharmacy model that UPMC has created, while delivering even better care and service for our patients and health plan members.”

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CSafe Global unveils an innovative look into shipment GPS

CSafe Global, a provider of powered, temperature-controlled air-freight containers for pharmaceuticals has officially launched the company’s real-time shipment visibility platform and technology, which was built by Cloudleaf, Inc. in collaboration with CSafe operations.

CSafe customer shipment visibility dashboard. Credit: CSafe Global

The company began adding new location and condition-tracking sensors to its active RKN and RAP containers, which, according to Tom Weir, CSafe’s COO, have received FAA approval for tracking device integration.

The program provides alerts and notifications directly to customers via email, text or in the platform itself regarding the following information:

  • Cargo temperature outside set parameters
  • Door open events
  • Ambient temperature change outside set parameters
  • Shock event
  • Tilt event
  • Ambient pressure changes outside set parameters
  • Ambient humidity changes outside set parameters
  • Route deviations or delays

CSafe customers who use this new program will also receive other standard benefits, such as the ability to request and manage leases, monitor shipments in real-time and access historical shipments.

Earlier this year, CSafe nearly tripled the size of its San Juan, PR container station.

 

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Targeting Middle East logistics, companies demonstrate vaccine proactivity

As part of the “1 million kilos” charitable initiative, Kuehne+Nagel and Qatar Airways Cargo have donated air freight services to UNICEF to help combat Covid-19.

Members of the Hope Consortium. Credit: the Hope Consortium

The “1 million kilos” initiative is part of the larger sustainability “We Qare” project of Qatar Airways Cargo, in which the airline is donating one million kilos (2.2 million pounds) of freight for humanitarian aid including medical supplies, such as protective equipment, until the end of 2020. The one million kilos are allocated to freight forwarders to give to charities of their choice.

In other parts of the Middle East, the city of Abu Dhabi (United Arab Emirates) is also facilitating coronavirus vaccine distribution efforts by launching the Hope Consortium, whose mission is to tackle all supply chain-related concerns related to coronavirus vaccines: transport, demand planning, sourcing, training, digital technology infrastructure and assisting with availability. The group is expected to be able to handle over six billion vaccine doses (single or multi doses) in cold and ultra-cold conditions in 2021, which will increase to over three times more doses by the end of next year.

Distribution of the treatments, which will be stored in Abu Dhabi Ports Company warehouses, will be carried out by Etihad Cargo, the first Middle Eastern carrier to gain IATA’s Center of Excellence for Independent Validators (CEIV) certification for pharmaceutical logistics; the company provides end-to-end thermal shipping, and on behalf of Abu Dhabi’s Department of Health, transported five million vaccines this past month.

Other consortium members consist of the aforementioned Abu Dhabi Ports Group, Rafed, the healthcare purchasing piece of Abu Dhabi-based ADQ, and SkyCell, which creates temperature-controlled containers for the pharma industry, including hybrid ones. The technology is constantly tracking conditions to make sure that inoculations are protected. With insulation and cooling technology, the containers are able to maintain a steady climate for an average of 202 hours (8.4 days) and self-recharge automatically in a cooling chamber or reefer truck. The Switzerland-based manufacturer will have a regional service and manufacturing location in Abu Dhabi.

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Supply chain management giant doubles down on Covid fight

In response to the challenge associated with the storage and transportation of cold chain products, including frozen vaccines for Covid-19, UPS Healthcare, which continued major expansion this summer, can now create up to 1,200 pounds of dry ice per hour in its US facilities. That output is in line with manufacturer storage requirements. UPS will also make dry ice accessible for US and Canadian hospitals, clinics and other points of care that need dry ice to store vaccines locally on premises.

Stirling ULT25 NEU. Credit: UPS

Together with Stirling Ultracold, UPS is also unveiling portable ultra-low temperature (ULT) freezers—including the Stirling ULT25 and the more compact SU105—which can store vaccines at temperatures from -20°C to -80°C (-4 °F to -112 °F). Both will be dispensed in smaller locations that will be using freezer storage for extended periods.

Dusty Tenney, Stirling’s CEO, who has been outspoken about the effort required to distribute ULT-mandated vaccines for Covid-19, commented: This program will help ensure vaccines remain effective next year, and for years to come, as future vaccines and biologics are developed to keep the world healthy and safe.”

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Partnership links immunotherapy and AI

Building on a business relationship that was established in 2019, BioNTech SE and InstaDeep Ltd have struck a multi-year partnership that, companies say, will employ the most up-to-date developments in artificial intelligence (AI) and machine learning (ML) technology to develop novel immunotherapies, including vaccines, for cancers and infectious diseases, such as Covid-19.

As part of the collaboration, the companies will form a joint AI Innovation Lab in both London and Mainz, Germany, to advance various plans surrounding drug discovery and design, protein engineering, manufacturing and supply chain optimization. The lab will combine InstaDeep’s expertise in AI, ML and digitalization alongside BioNTech’s immunotherapy knowledge.

The alliance will emphasize three areas:

  • Original drug design: BioNTech is advancing mRNA-based vaccines (most notably with Pfizer, as they work towardsa coronavirus vaccine) and therapeutics, and will use InstaDeep’s DeepChain protein design platform to design new mRNA sequences for protein targets, including for its RiboMab and RiboCytokine platforms, which use mRNA to encode antibodies and cytokines in vivo.
  • Innovative analytics: Both companies plan to receive insights from public and proprietary meta datasets, along with anonymized patient data through the use of ML and edge analytics.
  • Manufacturing and supply chain optimization: BioNTech will use AI and ML applications to further expand upon manufacturing and supply chain processes.

Ugur Sahin, MD, CEO and co-founder of BioNTech, sees this as an ideal time to further grow in the immunotherapy market through opportunities in advanced digitalization.

“We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” he explained. “This collaboration will expand our digital capabilities and optimize our operations across the value chain. We look forward to working with InstaDeep to advance the next wave of innovation in the field.”

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Med device task guide for UK conformity post-Brexit

As the medical device industry prepares to enforce new rules post-Brexit, Maetrics, a global life sciences consulting firm, unveiled a 10-task guide that consolidates the requirements of the new UK government and suggests areas that manufacturers should focus on. This includes information relevant to the UK Conformity Assessment certification (UKCA mark), a symbol that the UK government says covers most goods that previously required the CE (Conformité Européenne) marking, which could be found on many products in the European Economic Area (EEA).

CE mar

CE marking in the UK post-Brexit. Credit: Maetrics

Manufacturers, who are working diligently to stay within the rules laid out by both the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), need to also be mindful of the fact that businesses that have products on the UK market will need to follow the rules presented under this new leadership. It’s worth noting that that these companies have additional time—the EU MDR date has been pushed to May 2021.

For efficiency purposes, one of the initial priorities for impacted companies will be to track the commonalities between these EU and UK regulations. They should monitor developments as the situation progresses.

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CCT dedicates new facility to dispensing Covid-19 vaccine

Cold Chain Technologies (CCT), a company that is no stranger to innovation, has opened up a new location in Lebanon, TN, a 255,000 sq.-ft. cold chain facility that’s main priority will be Covid-19 vaccine distribution.

The space contains Koolit refrigerant manufacturing and work cells for CCT’s KoolTemp EcoFlex (CCT’s reusable thermal packaging solution), with the capability to support the coronavirus’s temperature-sensitive supply chain stipulations.

With 50-plus years of operation, CCT’s CEO, Ranjeet Banerjee, contends the company is up to the tall order that lies ahead, and scaling up to meet critical needs during Covid-19. “Our longstanding history and partnerships through previous pandemics, coupled with our deep engineering and testing lab capabilities, position us to tackle this Covid challenge,” he said. “Our packaging solutions will help ensure the integrity of these vaccines during transit and enable the safe delivery of vaccinations.”

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DHL further propels investment in San Juan facility

DHL Global Forwarding is growing its 72,000 sq.-ft. certified life science station in San Juan, Puerto Rico by investing over $650,000 in further cold storage space and technology for the life sciences and healthcare sector. This comes after previously announcing its $70 million US life sciences investment earlier this year, and the completion of a $1.6 million Indianapolis facility.

When it comes to working with Puerto Rico—which has been looking to fill a US supply chain gap—relations date back to 2016, when DHL funded over $1 million to reaching a tenfold upsurge in its temperature control area capacity. The latest announcement expands on that goal.

Among the various highlights, the mail service’s new project will consist of:

  • Construction of a new deep-frozen cool room with a temperature range of -18.0 to -30.0 °C, which allows for pre-conditioning of passive containers, blankets, boxes and PCM units, while still providing full ability to provide product delivery.
  • Additional 2-8 °C storage, a temperature controlled cross docking area and ample space for the control of RAP containers, which can each fit four US-size pallets.
  • Supplementary loading and unloading services for containers under the controlled ambient temperature (15-25°C & 2-8°C).

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Pharma tech developer increases UNC Health’s footprint

Arxium, a provider of automation, workflow and inventory management solutions who over three years ago added upgraded software to its RIVA pharmacy-compounding system, has completed a multi-year process that expands and integrates the UNC Health Shared Services Center, UNC Hospitals and Rex Hospital.

UNC Health utilizes RxWorks Pro, a supply management application which during Covid-19, has been helpful in providing available quantity on hand (QOH) information. It lets the informatics department remotely access RxWorks, enabling the health system to share QOH data for specific medications, such as remdesivir. The app’s virtual location feature helps manage Covid-related medication stock across all UNC facilities and provides real-time tracking and optimization of locations that experience the most demand.

Dr. Niels Erik Hansen, president and CEO of Arxium, observes that the battle against Covid-19 has been a difficult one, but it has reminded everyone of the need for logistical organization and the value of backlog analysis.

“ … While COVID presented unforeseen challenges,” he said, “it demonstrated a renewed importance of inventory management due to supply chain disruptions and other issues. As such, our mobile application has served as a timely solution for efficiently managing UNC’s Covid-related supplies.”

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Pharma Logistics and ConsortiEX join forces to foster supply chains

Pharma Logistics, a service provider operating out of its new Illinois-based reverse-distribution center, and ConsortiEX, a health care pharmacy IT company in Wisconsin, launched a strategic collaboration program, whose aim is to improve inventory efficiency and patient safety, reduce cost, manage cash flow and compliance for their customers.

Highlights of the program include:

  • ConsortiEX’s Drug Supply Chain Security Act (DSCSA) compliance takes responsibility for a majority of the work necessary, helping provide a lower cost.
  • Pharma Logistics’ reverse distribution service not only speeds up the process of returning generated credits—it also keeps labor costs for managing those returns at a minimum.
  • ConsortiEX’s services look to provide the most effective way of detecting suspicious drugs, so that these products do not reach the patients.
  • If saleable, unsaleable and recalled drugs need to be returned, Pharma Logistics works to simplify the credit recovery process.

Customers working with both companies will be able to use funds from Pharma Logistics to pay for ConsortiEX resources. And down the road, the organizations plan on assisting their mutual clients by managing drug recalls, optimizing inventory levels and limiting waste by keeping track of items that are close to expiring.

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Conduent, Experian Health partner on Rx and patient assistance

Conduent Incorporated, a patient support company, has reached a commercial agreement with Experian Health, a data aggregator that provides revenue cycle management products involving patient engagement, access and collections.

The deal allows Conduent’s IntelliHealth program to connect with Experian’s consumer data and electronic income verification tool. The combination, companies say, can help speed up prescription drug assistance approvals and shorten prescription fulfillment and time to therapy.

With Conduent’s experience with patient assistance programs (PAPs) and Experian’s Patient Financial Clearance tool, the alliance is projected to simplify access to free Rx drug assistance that could benefit up 28 million Americans with no or limited healthcare coverage, and more than 12.6 million that are reported to be jobless by the Bureau of Labor Statistics.

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Payer harmony for Lilly’s Covid mAb?

Eli Lilly’s investigational monoclonal antibody (mAb) bamlanivimab, which recently was issued emergency use authorization (EUA) by the FDA for Covid-19, is unlikely to face payer pushback, despite its broad label, GlobalData reports.

The data and analytics company notes that drug prices have been closely examined during the Covid-19 pandemic, but, citing feedback from EUA experts, given bamlanivimab’s potential benefit in curtailing hospitalizations, it and other mAbs under FDA review may offer pricing value. Manasi Vaidya of GlobalData said, “If bamlanivimab and other similar monoclonal antibodies can reduce hospitalization risk, they could be prevent [ing] anxiety and loss of income that would have resulted otherwise, and thus be cost-effective.”

Earlier this month, FDA granted bamlanivimab EUA to treat mild-to-moderate Covid-19 patients who are at high risk for progressing to severe infection and/or hospitalization. Specifically, this includes adults 65 years or older, and/or those with certain chronic medical conditions. Lilly will be supplying 300,000 vials of 700 mg bamlanivimab at a cost of $1,250 per vial.

Vaidya points out that distribution channels are different today from pre-pandemic times and uncertainty on demand coupled with specialized manufacturing requirements for mAbs could create their own barriers to access.

“Unlike situations where payers may require additional documentation or restrict use to a narrower patient population for a newly approved biologic, with COVID-19, a physician determination for bamlanivimab’s need may be adequate for coverage,” she said.

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Analysts: Global API market to reach $306B by 2027

According to a recent report by Polaris Market Research, the worldwide active pharmaceutical ingredient (API) market valuation is projected to reach $306.1 billion by  2027. An increase in occurrences of chronic ailments such as cardiovascular diseases (CVDs), arthritis and diabetes, along with growing prevalence of infectious diseases such as influenza, hepatitis and Covid-19, are boosting the demand for drugs and medications across the globe. The growing elderly segment is also a contributor.

The global API market includes monoclonal antibodies (mAbs), cytokines, immunoglobulin, insulin, blood factors, peptide hormones, peptide antibiotics, small molecule antibiotics, vaccines and highly potent active APIs, among other areas.

Experts note as well that factors such drug side-effects, high capital investment requirements, along with government regulations and policies, could potentially hinder the growth of the API market between now and 2027.

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New IATA recommendations outline coronavirus vaccine distribution plan

The International Air Transport Association (IATA), which previously noted that month-on-month global demand for air cargo in September increased 3.7% over August numbers, recently released logistics supply chain guidance to help make sure that the air cargo industry is ready to support the handling, transportation and distribution of a Covid-19 vaccine.

Produced with the backing of various partners, such as the International Civil Aviation Organization (ICAO), International Federation of Freight Forwarders Associations (FIATA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Pan American Health Organization (PAHO), UK Civil Aviation Authority, World Bank, World Customs Organization (WCO) and World Trade Organization (WTO), IATA’s Guidance for Vaccine and Pharmaceutical Logistics and Distribution consists of myriad international standards and guidelines related to the transport of vaccines, being revised as frequently as information is made available.

The association, as reported by AviationPros, references several notable obstacles, including:

  • The availability of temperature-controlled storage facilities, including alternatives when these are not accessible.
  • Defining the roles and responsibilities of everyone involved in vaccine distribution, such as government authorities and non-governmental organizations (NGOs).
  • Industry readiness for vaccine distribution, which includes: capacity and connectivity; facilities and infrastructure (availability of the proper temperature-controlled facilities and equipment and staff trained to handle time- and temperature-sensitive vaccines); border management (receiving proper clearance and landing permits) and security.

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Amazon moves full-bore into pharmacy space

In its biggest move yet in the tech giant’s steadily building but aggressive entrance into healthcare and the lucrative pharmacy market, Amazon today officially launched two new ways to help customers purchase their prescription medications. One is the unveiling of Amazon Pharmacy, which allows customers to complete an entire pharmacy transaction on their desktop or mobile device; all that’s required is the Amazon app and a prescription from a licensed healthcare provider. With a secure pharmacy profile, customers can add insurance information, manage prescriptions and choose payment options, all before checking out. Prime members, Amazon says, will receive unlimited, free two-day delivery on Rx orders included with their membership.

The other new offering involves savings for those without healthcare insurance. Prime members will have access to deals on medications at Amazon Pharmacy if choosing to purchase without coverage, as well as at over 50,000 other participating pharmacies nationwide. The Amazon Prime prescription savings benefit can reportedly save members up to 80% off generic drugs and 40% off brand-name medications when paying without insurance. Prime members will have access to their Rx savings at checkout.

Today’s moves follow other notable pharmacy plays by Amazon in the last couple years. In 2018, the company acquired mail-order pharmacy PillPack, now part of Amazon Pharmacy. It will continue to assist customers with chronic health conditions who are taking multiple daily medications. PillPack service provides pre-sorted dose packaging for everyday dispensing, In August, Horizon Healthcare Services and its pharmacy benefit manager, Prime Therapeutics, partnered with Amazon on offering Horizon members an integrated pharmacy experience with PillPack.

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Catalent-cell therapy manufacturer deal now complete

Following an agreement Pharmaceutical Commerce originally reported being reached in late October, Catalent Pharma Solutions, Inc. has officially completed its acquisition of Bone Therapeutics’ manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS), for $14.2 million USD ($12 million EUR). With the transaction closing, SCTS’ manufacturing infrastructure and production operating teams are now part of Catalent’s Cell & Gene Therapy division.

Alongside this deal, Bone Therapeutics and Catalent also entered into associated supply agreements, which state that the purchased manufacturing entity will continue to service the production of ALLOB, Bone Therapeutics’ allogeneic cell therapy product, for Bone Therapeutics and its partners. This will grant the company access to Catalent’s network of clinical and commercial manufacturing facilities.

The partnership will allow Bone Therapeutics to focus its strategy on product development from its MSC (mesenchymal stromal cell) platform of cell and gene therapeutic targets for orthopedics, among other indications.

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CCA debuts change management matrix

With a potential inoculation on the horizon, the Cool Chain Association (CCA) has launched a Covid-19 Distribution Change Management Matrix. Its objective: supporting airports with their coronavirus vaccine logistics plans.

As noted by AviationPros, the matrix examines adherence to temperature requirements, packaging, forecast and quantity and timeframe across different stages in a vaccine’s journey through an airport—this is different than the initiative launched by Worldwide Flight Services (WFS), known as “Project Coldstream,” which determines how to efficiently transport large volumes of Covid-19 vaccines.

CCA will look to share the matrix with members for them to fill out. From there, the information will be combined to assist the supply chain in determining focal points, such as training needs, safety and security, as well as supplier and risk management.

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Antares Vision Strengthens Traceability Position

Italian multinational Antares Vision, which offers customized inspection and track-and-trace systems, has been selected by the French judicial authority as the winner of the tender for the purchase—directly or indirectly through its subsidiaries—of the assets of the French company Adents High Tech International, which is in liquidation. The closing will occur within two months for $1.8 million USD (1.5 million EUR), paid in cash.

Mainly focused on the pharmaceutical sector, Adents offers traceability and serialization software that can be used for the data management and exchange between companies and regulatory authorities (level 5). It also offers single-tenant and multi-tenant cloud services.

The deal lets Antares Vision multiply its software capabilities that are able to track and trace the end-to-end supply chain, which will allow for greater transparency among members across the industry. Both companies have verification router service (VRS) offerings.

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UK’s Envision lands launch expert Two Labs

Envision Pharma Group, a UK-based scientific communications company, has acquired Two Labs, a strategic consulting and commercialization provider with a footprint in the US pharma domestic market. Two Labs is known for helping pharma companies develop and execute customized launch strategies for products, a process that may include selecting a third-party logistics provider (3PL).

Howard Miller, CEO, Two Labs, noted, “We are delighted to be joining the Envision family and taking Two Labs to the next logical step in its successful journey to date. With Envision’s global footprint and Two Labs’ market-leading US footprint, we have a unique opportunity to enrich our client partnerships with more connected services across the launch continuum.”

He pointed as well to a “compelling” cultural fit between the two organizations.

Envision’s acquisition of Two Labs follows the recent announcement of GHO Capital’s increased investment in the company and management support for its continued expansion. Since its inception in 2001, Envision has produced solid organic growth, while also providing medical affairs strategy, medical communications, and its iEnvision technology.

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Vibalogics backs Boston virotherapy facility

Vibalogics, a global contract development and manufacturing organization (CDMO) that specializes in the production of oncolytic viruses, viral vector vaccines and viral vector gene therapy products, has initiated the first step of its planned $150 million investment in a late-phase clinical and commercial virotherapy manufacturing facility near Boston, MA. The three-year investment plan includes building out a 110,000 sq.-ft. location, which the company expects to be operational by the second half of 2021.

It will contain modern technology and allow for a notable capacity increase, such as 2000L scale bioreactors and additional fill-finish capabilities.

According to Vibalogics CEO Tom Hochuli, the facility will create 100 jobs initially, and 250 positions over the next four years.

The CDMO was recently selected by J&J’s Janssen Pharmaceutical Companies as one of its manufacturing partners for its investigational Covid-19 vaccine candidate. The European Commission had previously approved an advance purchase agreement in which Janssen would supply 200 million doses of the vaccine following approval or authorization from regulators.

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Pfizer’s Covid-19 vaccine could present cold-chain concerns

In news reported by Reuters on Tuesday, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus indicated that it hopes to have a Covid-19 vaccine by end of 2020 and that Pfizer’s experimental candidate is “a very promising one.”

However, vaccines such as Pfizer’s that use synthetic mRNA to activate the immune system against the virus have to be stored at -70 ºC (-94 ºF) or below, which could be more complicated in places with warmer climates, such as Africa and Asia, where the proper equipment to handle these temperatures may not be up to par, the report notes.

From a logistical standpoint, this also raises the question of how the product will be safely transported, as recent surveys indicate that the air cargo industry feels unprepared for such a challenge. However, that does not necessarily signify that a cold chain cannot still formulate a successful plan to meet the forthcoming demands.

Pfizer, which will be coordinating its own vaccine distribution, made headlines earlier this week after revealing that its vaccine, jointly developed with BioNTech SE, was over 90% effective, according to the first set of interim data from a large-scale clinical trial.

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J. Knipper completes acquisition of Eagle Pharmacy

J. Knipper and Company, Inc., a supplier of pharma healthcare marketing services, and its affiliates (including its three-year-old specialty pharmacy, KnippeRx), have finalized the acquisition of Eagle Pharmacy, LLC, a full-service, direct-to-patient (DTP) pharmacy. KnippeRx and Eagle Pharmacy are approved to ship and dispense prescription medications throughout the US, the District of Columbia and US territories.

Florida-based Eagle Pharmacy adds operational automation and scalability to KnippeRx’s résumé, while simultaneously offering clients separation of customer pharmacy solutions under one partner. According to J. Knipper, over 90% of enrollments completed by Eagle result in a shipment, while clean orders are processed and shipped in less than one business day. Operations are currently at 25% capacity, but Eagle Pharmacy reaches approximately 200,000 patients a month, supporting more than 50 customized drug programs.

KnippeRx, a provider of patient assistance program (PAP) services, has seen rapid expansion, adding brand name, DTP programs to its pharma client offerings, among pursuing other avenues for evolution.

J. Knipper previously underwent an ownership change in October 2019 after 33 years as a family business.

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Descartes expands last-mile delivery presence

Descartes Systems Group, a supply chain software firm that offers its technology to the pharmaceutical space, has purchased ShipTrack, a Canada-based provider of e-commerce final-mile (last-mile) solutions for $19 million.

ShipTrack offers cloud-based mobile resource management and shipment tracking solutions. These tools are able to assist users with automating dispatch, updates on shipment status and estimated time of arrival (ETA); they also remove the need for paper-based delivery. ShipTrack notes that its platform is a fit for the medical courier market—one component of the growing last-mile delivery market, which reports estimate to reach about $6.2 billion by 2025.

Shawn Winter, co-founder of ShipTrack and now the vice president of mobility solutions at Descartes, alluded to the obstacles surrounding high demand that are often faced by last-mile delivery services, saying that “The challenge for today’s final-mile carriers is how to handle increasing volumes alongside rising consumer expectations for delivery choice and real-time information. Our platform helps final-mile carriers meet that challenge head-on with powerful workflows across delivery processes and the ability to expose information to consumers in real-time.”

He says the deal merges ShipTrack’s final mile know-how with Descartes’ ability to improve routes.

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Eversana inks pair of commercial data deals

Eversana, a provider of global commercial services to the life sciences industry, has solidified partnerships with a pair of comprehensive data and infrastructure companies, Symphony Health and Compile. The deals establish what Eversana calls the industry’s “first single, streamlined claims, formulary and physician dataset.”

Eversana and Symphony Health, a PRA Health Sciences company, reached a multi-year agreement that will provide access to claims and electronic medical records data for more than 300 million patients.

The company’s partnership with Compile, Eversana says, will help continue to incorporate physician information to drive market access and healthcare professional (HCP) participation. By combining public and government figures with privately licensed medical and pharmacy claims, Compile forms a record database on every practitioner, facility, health system and event that takes place in the US healthcare market.

The datasets from Symphony and Compile will feed into ACTICS by Eversana, a data-mastering platform and cloud-based infrastructure. In the coming month, Eversana plans to announce a third partnership to include formulary content.

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September air freight experiences growth

Month-on-month global demand for air cargo in September increased 3.7% over August numbers, according to the most recent data from the International Air Transport Association (IATA). However, demand, which is measured in cargo tonne-kilometers (CTKs), was actually 8% below September 2019’s numbers, but an amount that is still a step above the 12.1% year-on-year drop recorded in August.

Alexandre de Juniac, IATA’s director general and CEO, noted the industry struggles but approached it with a glass-half-full mentality, stating  that “Air cargo volumes are down on 2019, but they are a world apart from the extreme difficulties in the passenger business. For air cargo, 92% of the business is still there, whereas about 90% of international passenger traffic has disappeared. Favorable indicators for the peak year-end season will support the continued recovery in demand.”

The association’s CEO also referenced the ongoing challenge that capacity poses during the coronavirus pandemic, as carriers will need to modify schedules to mirror the decrease in demand.

The aforementioned global capacity, measured via available CTKs, shrank by 25.2% for the month of September and 28% for international operations, compared to 2019. That makes it almost three times greater than the contraction in demand.

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UK schedule for Covid vaccine delivery falls behind

Per a report by Reuters, the timetable for delivery of the Oxford University/AstraZeneca Covid-19 vaccine candidate (AZD1222, ChAdOx1 nCoV-19) has slipped. UK vaccine chief Kate Bingham, according to the report, said that Britain will receive just four million doses of the shot this year. As this Lancet article and a separate Reuters report explain, the vaccine is made from a weakened version of a common cold virus that causes infections in chimpanzees—the chimpanzee cold virus has been genetically modified to include the genetic sequence of the  spike protein, which SARS-CoV-2, the novel coronavirus that causes COVID-19, travels on to enter human cells. 

In May, Britain agreed to take 100 million doses of the vaccine, with 30 million doses originally estimated for delivery by September, after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that clinical trials of the vaccine candidate were safe to continue. Across the pond, the FDA authorized a trial restart in late October. The exact timing for delivery is uncertain at this point, as it depends on infection numbers.

Bingham, Reuters reports, said that the vaccine was being made initially in bulk (drug substance) but could not yet be transferred into vials until more certainties of the timing of late-stage trial data delivery. She added that once the vaccine is put in vials, the clock for shelf life—and how soon one can use the product—begins.

AZ, in a written statement to Reuters, indicated it was making progress to start supplying hundreds of millions of doses on a rolling basis once it receives regulatory approvals. The Oxford/AZ candidate is likely to be among the first vaccines from big pharma to be submitted for governmental authorization.

For an overall look at the regulatory picture for Covid-19 vaccines, read Pharmaceutical Commerce‘s chat with Dr. Ash Ramzan of Woodley BioReg Ltd.

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New application streamlines serialization techniques

TraceLink, a Massachusetts-based digital platform company for the life science supply chain, officially introduced Serialized Product Intelligence, a new cloud application that uses serialization data to simplify the process of managing data across companies’ operations. The software provider previously set the table for this program last year after introducing its Digital Network Platform (DNP), which allows users to “rapidly design and deploy network orchestration and analytics applications, enabling patient-centric orchestration.”

According to TraceLink, biopharma companies can proactively monitor serialized operations, identify supply chain issues early, avoid costly delays and maintain timely product delivery to market. It could serve, TraceLink contends, as a first step in building a foundation for using more advanced technologies to predict and prevent critical business issues from occurring.

Serialized Product Intelligence is a fully automated, self-service analytics application, built on TraceLink’s Opus DNP, which the company says is the only such platform designed to support the development of multi-enterprise business applications for the pharma industry.

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Pact struck around thin-film freezing tech for Covid-targeted mAbs

TFF Pharmaceuticals, Inc., a clinical-stage biopharma that recently increased its cGMP capabilities, and Augmenta Bioworks, Inc., a biotech that uses immune profiling technologies for medicinal purposes, have entered into a joint development and collaboration agreement to develop products incorporating Augmenta’s human-derived monoclonal antibodies (mAbs) for potential Covid-19 therapeutics. Previously, in June, the companies struck a feasibility and material transfer agreement under which Augmenta supplied various mAb product materials to TFF for compatibility and feasibility testing.

Per the most recent agreement, both companies will collaborate to develop one or more commercial therapeutics based on, derived from and/or incorporating Augmenta’s human mAbs to potentially treat patients with Covid-19. These products will be developed using TFF’s thin-film freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to patients’ lungs.

Further, the agreement includes the development of formulations suitable for parenteral administration, where the thin-film freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling. TFF will also have the option to develop two additional Augmenta mAbs for indications other than Covid-19.

Robert O. Williams III, PhD, division head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery and inventor of TFF’s thin-film freezing technology, said a challenge of mAbs is in their delivery via injection, which does not reach directly to the initial site of infection—the deep lung area. “Liquid injections are also subject to all the attendant difficulties of cold chain handling and storage, potentially limiting their use to only areas in the developed world,” noted Williams.

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Pfizer to coordinate its own coronavirus vaccine distribution

According to a published report by FreightWaves, pharma giant Pfizer will manage the distribution of its Covid-19 vaccine on its own instead of through the US government’s designated coordinator, McKesson. In July, the US government reached a contractual agreement with Pfizer to deliver 100 million initial doses once its vaccine is approved, along with an option for an additional 500 million doses. Pfizer’s vaccine must be kept at minus 75 ºC (-109.3 ºF) to maintain its effectiveness, FreightWaves notes.

Officials, according to the report, said they expect to provide safety data from Pfizer’s final-stage clinical trials to FDA by the third week of November and, subsequently, apply for an emergency use authorization if all goes well, But there is also skepticism, the report says, concerning whether the US has enough medical-grade freezers at the point of use for vaccines requiring storage at ultra-cold temperatures.

“The responsibility for determining how many deep-freeze machines exist at healthcare facilities has fallen on states because there is no central inventory,” FreightWave’s Eric Kulisch writes. He notes that uncertainty about the cold-chain capabilities of transportation providers and vaccine administration facilities resulted in Pfizer developing a special cooler, or “thermal shipper,” with real-time GPS and thermal monitoring that can maintain deep-freeze vaccine storage for 10 days if left unopened. Kulisch reports that the shipping container is “about the size of a small suitcase” and uses dry ice to maintain recommended storage temperatures.

In mid-August, as reported here, the Centers for Disease Control and Prevention (CDC) designated Irving, TX-based McKesson as the “centralized” distributor of future Covid-19 vaccines. Pharma manufacturers will ship approved vaccines to McKesson distribution centers, which, in turn, will disperse to hospitals, nursing homes, and other points of care.

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New HDA Research Foundation survey points to positivity for pharma supply chain

A survey released yesterday by the Healthcare Distribution Alliance (HDA) Research Foundation suggests that, overall, the pharmaceutical supply chain continues to make steady progress to comply with the 2013 Drug Supply Chain Security Act (DSCSA).

Back in April, the FDA made a DSCSA announcement that would help expedite drug deliveries from suppliers to where they were needed by suspending some distributor requirements; however, some implementation priorities have shifted amid the initial industry response to the Covid-19 pandemic.

HDA’s new “Serialization Readiness Survey  determines the current preparedness of manufacturers and distributors to meet DSCSA requirements, when distributors can expect to begin receiving serialized product, as well as perceptions of dispenser readiness. Survey responses were collected prior to FDA’s announcement of additional enforcement discretion related to certain DSCSA dispenser and wholesale distributor requirements. The agency is now permitting until Nov. 27, 2023, for compliance.

Data reflect the survey responses of 57 manufacturers—including 14 of the 2018 top 20 pharmaceutical manufacturers by sales and nine of the top 20 manufacturers by prescriptions dispensed as listed by IQVIA—and 21 distributors. Among the findings:

  • Nearly half of manufacturers and distributors note challenges with the requirement for industry to process serialized saleable returns. Covid-19 was cited as a reason for this response, as gaining entry to company facilities has impacted the ability to train employees and implement systems as planned.
  • Approximately 5% of distributors believe that their dispenser customers understand what is required of them for overall DSCSA compliance. Moreover, nearly two-thirds (62%) of wholesale distributors report dispenser knowledge of DSCSA requirements varies considerably among pharmacy industry segments.
  • About 21% of manufacturers plan to send serialized data with 100% of products in 2020, a decrease from last year’s survey. While a majority anticipate sending 100% of data with shipped product by 2023, when it is legally required, 32% plan to first send data between 2020 and 2021, resulting in more than half of manufacturers sending data for at least some products by the end of next year.
  • Collectively, manufacturers and distributors cited collaborating with trading partners, governance, differing legal interpretations of the DSCSA and establishing standards as priorities as the industry moves toward 2023 interoperability.

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Sonoco ThermoSafe strengthens presence in ULD sector

Sonoco ThermoSafe, a temperature assurance packaging company, and AirBridge Cargo Airlines have signed a master lease agreement to offer Sonoco ThermoSafe’s new Pegasus unit load device (ULD) bulk temperature-controlled container directly to its customers.

The Pegasus ULD. Credit: Sonoco ThermoSafe

This comes after the Pegasus ULD creator reached a development and manufacturing partnership with AeroTuf last year. The device uses AeroTuf’s patented Aerotherm composite material technology.

Pegasus ULD is also the first passive bulk temperature-controlled container approved for pharmaceutical use. Its FAA clearance, Sonoco ThermoSafe says, allows the device to speed through existing international ground handling and customs processes at the lowest possible cost.

With the composite-material engineering, Pegasus offers a lighter solution that is described as “substantially more damage resistant than traditional metal containers.” It also contains a fully integrated, FAA-approved telemetry system. The system, the company says, provides real-time, cloud-based data on payload and ambient temperature and environmental factors, synchronized with GPS location.

AirBridgeCargo Airlines, part of Volga-Dnepr Group, is the largest Russian cargo airline. It operates scheduled cargo services on routes between Russia, Asia, Europe and North America.

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Key certification for cargo company’s Covid vaccine preparations

FCS Frankfurt Cargo Services was recently granted EU good distribution practice (GDP) certification for medical products for human use—a key step in the company’s goal to expand its pharmaceutical logistics activities and ramp up preparations to handle sensitive Covid-19 vaccine consignments.

This designation comes on the heels of FCS concluding its International Air Transport Association (IATA) Center of Excellence for Independent Validators (CEIV) certification—one that airport hubs consisting of air cargo carriers, ground handlers and freight forwarders operating at the hub are able to receive collectively.

FCS Frankfurt Cargo Services in Frankfurt, Germany. Credit: FCS Frankfurt Cargo Services

Unlike CEIV certification, which relates exclusively to airfreight, GDP certification stands alone. It involves checking the quality of the distribution chain for medical goods and ensuring that they are intact, from from the producer to the end customer, according to EU standards.

A subsidiary of Worldwide Flight Services (WFS), an airfreight handling company, FCS and its GDP certification fit into the “Project Coldstream” initiative recently launched by WFS, which focuses on coordinating worldwide transportation of large delivery quantities of vaccines to fight Covid-19. According to the IATA, the industry expects these deliveries to amount to the largest volume of airfreight involving a single item ever transported.

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Aphena Pharma completes $7M expansion

Aphena Pharma Solutions Inc., an organization providing contract manufacturing and packaging services for the biologics, pharmaceutical, consumer health and medical device markets, completed its $7 million facility expansion and renovation in Easton, MD. The newly renovated, 30,000-square-foot facility and three large, high-end blending suites are open for new pharmaceutical business. Aphena’s Maryland campus supports liquids, creams, gels and suspensions.

Aphena Pharma’s Easton, MD facility. Credit: Aphena Pharma Solutions Inc.

Housed in three new blending suites are two new Feldmeier 1,000-gallon mixing tanks and a sister 100-gallon tank, which offer center agitation mixing and dual alternate directional side sweeps for scale-up and registration batches. In addition, the tanks are jacketed for heat and chilling, and are pressurized for powder mixing.

“Adding these tanks and new capabilities will allow Aphena to increase capacity levels and handle 90% of the liquid-based pharmaceutical products on the market today,” said Eric Allen, Aphena’s EVP of sales. “The smaller 100-gallon tank is 1/10 scale, making submission batches easy to scale per FDA  guidelines.”

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Onfleet raises $14M in Series A funding for last-mile delivery services

Onfleet, a provider of last-mile delivery management software, has raised $14 million in Series A funding to meet rising customer demand.

According to the San Francisco-based company, it added hundreds of new customers this year and has doubled its year-over-year overall delivery volume, as COVID-19 has rapidly accelerated retail’s transition to online, delivery-centric models. The company says it has powered more than 80 million deliveries to over 90 countries for clients including several pharmacies. This investment round brings Onfleet’s total funding raised to $20 million since inception.

The company’s routing and dispatch platform allows for real-time communications and delivery management. Particularly amid the continuing global COVID-19 pandemic, there has been increasing attention paid to last-mile logistics in the pharma supply chain, and the use of new technology to expand care access in remote areas.

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Survey: Technology and drug pricing clarity key to industry recovery

Proposed moves aimed at gaining ‘most-favored nation’ drug pricing so that Medicare pays the same drug prices as other developed countries would face significant barriers to implementation, according to results of a survey released this week by Model N, Inc., a technology provider for many large pharma companies.

Model N fielded its survey to more than 100 pharmaceutical and medtech professionals in July 2020 in order to understand more about key financial concerns, public-facing issues associated with drug pricing, attitudes around technology, and to gauge the industry’s response to the global coronavirus pandemic.

Results indicated that a program requiring an overhaul of today’s complex system of incentives and rebates, as well as initiatives designed to address the technological and regulatory constraints under which the industry currently operates, would face an uphill battle.

Some 86 percent of the respondents believe there is a disconnect between pharmaceutical companies and the general public when it comes to the perception of drug pricing. The top reason cited (76 percent) was a lack of understanding of the complexity behind how a drug is paid for and how it gets to patients.

Other reasons cited by survey respondents include pricing disparity and international pricing differences (46 percent) and government regulations (46 percent).

Pharmaceutical and medtech executives also have concerns over revenue issues, with the survey showing that government regulations, as well as pricing and rebates, are the top concerns for solving revenue problems, at 41 percent each. While only 9 percent said Covid-19 has not impacted their revenue this year, 46 percent reported that it has impacted their revenue by delaying the process of bringing new products to market.

There is awareness that technology is key to solving the issues, as some 67 percent believe their companies need to invest more in technology to solve their financial and revenue management challenges.

In addition, the executives seem open to exploring new approaches to resolving revenue concerns, while at the same time addressing public concerns about drug prices. They cite better management of government regulations (26 percent), as well as pricing and contract compliance (25 percent), as two key opportunities for fixing pricing issues and avoiding ‘leaving money on the table.’ Assistance with value-based pricing is another area where industry professionals think technology can offer a useful assist, at 44 percent.

When polled about a broader, post-pandemic recovery, 76 percent of respondents report they have been satisfied with the industry’s response to Covid-19. Some 49 percent emphasized recovering from Covid-19 as their top priority, while 45 percent said eliminating system or process inefficiencies was their biggest priority for the remainder of 2020.

Overall, 40 percent said technology will be a key enabler in helping their firms recover from Covid-19. In terms of corporate planning, 55 percent of respondents report that current or new product launches are the top priority for the remainder of this year.

Model N offers visibility, insight and control for complex commercial operations and compliance, along with cloud revenue management technology in order to automate pricing, incentive and contract decisions. It serves such major pharmaceutical, medical technology, semiconductor and high-tech companies as Johnson & Johnson, AstraZeneca, Stryker, Seagate Technology, Broadcom and Microchip Technology.

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Schreiner MediPharm equips Cap-Lock security label with RFID technology

Schreiner MediPharm, a Germany-based provider of functional labels for the healthcare industry, has augmented its Cap-Lock tamper-evident specialty label with an RFID inlay.

Cap-Lock label now equipped with RFID inlay. (Credit: Schreiner MediPharm)

Developed to expand digitization initiatives at hospitals, the label-and-cap security concept for prefilled syringes now enables automated inventory and supply chain management, as well as digital first-opening indication. In doing so, the new Cap-Lock plus RFID offers product authentication and enhanced patient safety.

Equipping syringes containing liquid medications with RFID labels poses a challenge, as both the container material and the composition of the liquid may impair reading of a UHF RFID label. Flag labels protruding from the container are frequently used for this purpose; however, these typically require additional space, are prone to being torn off and must be applied manually.

With the enhanced Cap-Lock, the RFID chip is integrated within the label, which wraps around the syringe body and cap adapter and, once opened, provides irreversible tamper evidence due to an integrated perforation.

The RFID inlay is located in the upper part of the label at the level of the cap. It mostly sits outside the liquid-filled area and enables long-range reading. The label can be automatically processed as part of the primary container’s normal labeling workflow, according to the company.

Schreiner MediPharm’s US facility is located in Blauvelt, NY.

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Stevanato to expedite delivery of visual inspection systems to Catalent sites

Stevanato Group has expanded its collaboration with Catalent to include delivery of advanced visual inspection systems to help with potential Covid-19 pandemic programs, biologics and sterile injectable products.

Under the expanded arrangement, Catalent has ordered Plus 400 LKD automatic and PWL semi-automatic visual inspection machines from Stevanato and will install the equipment at its sites in Bloomington, IN and Anagni, Italy.

Plus 400 LKD inspection machine.
(Images courtesy of Stevanato Group)

The move is intended to support various customer and quality assurance programs through the use of advanced technologies to inspect biologics and sterile injectables, maximizing the detection rate while keeping false rejections low.

Privately held Stevanato Group said it plans to speed delivery of the high precision and high throughput equipment to the Catalent manufacturing operations.

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Catalent to acquire cell therapy manufacturing facility in Belgium

Catalent has signed an agreement with Bone Therapeutics to acquire its cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA, including all of its assets located in Gosselies, Belgium. The transaction is expected to close in November.

The Skeletal Cell Therapy Support manufacturing facility in Gosselies, Belgium. (Image courtesy of Catalent)

Under the terms of the agreement, Catalent will purchase the shares of Skeletal Cell Therapy Support, currently held by Bone Therapeutics, which owns and operates a purpose-built CGxP facility of approximately 41,000 square feet, including its related quality control and product development laboratories, warehouse, grade C and B cleanrooms and equipment, as well as land for further development.

Catalent will undertake the manufacturing of clinical material for Bone Therapeutics’ drug, ALLOB, an allogeneic osteoblastic cell therapy product, derived from ex vivo cultured bone marrow cells.

The Bone Therapeutics subsidiary and its facility, which is next to Catalent’s existing cell therapy site, will allow Catalent to expand its cell therapy capabilities and advanced clinical and commercial supply. Catalent is continuing work on a 60,000-square-foot commercial-scale production and fill-finish facility in Gosselies, which is scheduled to be completed by the end of 2021.

As part of the acquisition, manufacturing employees located in Gosselies and employed by Skeletal Cell Therapy Support are expected to remain with that entity and become part of the Catalent workforce, and Bone Therapeutics will continue to focus on its pipeline of products for orthopedics and bone diseases.

In addition to the expansion in Gosselies, validation of Catalent’s new 32,000-square-foot cell therapy development facility in Houston, TX is underway and scheduled to be completed by the end of this year.

Bone Therapeutics has a diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Catalent, based in Somerset, NJ, provides delivery technologies, development, and manufacturing services for drugs, biologics, cell and gene therapies, and consumer health products. Catalent employs approximately 14,000 workers, including roughly 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated more than $3 billion in annual revenue.

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US biopharmaceutical supply chain resilient and effective during early Covid-19 response

A new report published by the Healthcare Distribution Alliance (HDA) Research Foundation and Deloitte Consulting LLP found that during the first 90 days of the Covid-19 pandemic, the biopharmaceutical finished goods industry adapted and adjusted to deliver medicines safely and efficiently to patients with only minimal disruptions.

In the report titled, The First 90 Days: US Biopharmaceutical Finished Goods Supply Chain Response to Covid-19, pharmaceutical distributors, manufacturers and other stakeholders in the biopharmaceutical supply chain leveraged their relationships and prior emergency response experience to get medicines safely delivered to patients.

Distributors closely collaborated with manufacturers and hospitals, pharmacies, providers and other partners to anticipate changes in demand, respond to evolving patient needs and mitigate disruptions.

Findings showed:

  • The supply chain was able to balance increased demand through avoidance of single sourcing, supply risk monitoring, communication and data transparency, and proactive inventory management.
  • Distributors promptly set up individual allocation programs to manage inventory of the most in-demand products in an equitable way, which helped contain the shortages initially observed of critical care drugs used to treat Covid-19 patients in ICUs.
  • While drug shortages as measured by the Food and Drug Administration (FDA) increased during the first 90 days, there were few significant disruptions (actual and purported) beyond Covid-19 therapeutics. At least 83 percent of drugs that were reported in shortage to the FDA had a second-line or alternative treatment available.
  • The pharmaceutical supply chain was able to adapt to accommodate changes to the channels through which patients acquired their prescriptions.
  • The biopharmaceutical industry invested substantially in developing capabilities to curb the pandemic’s short- and long-term challenges, including speeding to market coronavirus testing, therapeutics and vaccine candidates, while also supporting communities through in-kind donations.
  • By leveraging their emergency response capabilities, supply chain stakeholders were able to promptly put in place business continuity plans that preserved the health and safety of frontline employees with minimal disruption to their operations.

Additionally, Deloitte’s social sentiment assessment, which monitored and analyzed consumers’ online comments about perceived supply disruptions shows that consumer sentiment for the biopharmaceutical industry improved during the first 90 days of the pandemic, indicating that consumers had a positive perception of the industry’s performance in managing the early challenges of Covid-19.

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors—the link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

The First 90 Days: US Biopharmaceutical Finished Goods Supply Chain Response to Covid-19 received support from several sponsors, including Cardinal Health, CuraScript SD, Novartis Pharmaceuticals, Endo International’s PAR Pharmaceutical, KeySource, Ascend Laboratories, IQVIA and Upsher-Smith Laboratories.

The report is available as a complimentary download through the HDA website.

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Carrier Pods in combo with Sensitech provide new mobile cold storage option

New Carrier Pods monitored by Sensitech combine refrigeration technology and cargo monitoring capabilities to help address the challenges of Covid-19 vaccine distribution. Carrier and Sensitech both are part of Carrier Global Corp., a worldwide provider of building and cold chain options.

The monitored pods are available in configurations that comply with Good Distribution Practice guidelines for pharmaceutical products and address stringent regulatory temperature verification requirements for vaccines.

The Sensitech technology can monitor a wide range of temperatures, including dry ice conditions. The combination of container refrigeration and Sensitech’s advanced monitoring offers deep-freeze cooling, real-time telematics, data analytics and product visibility, according to the companies.

Carrier’s recently announced Lynx digital platform is expected to provide added connectivity by the end of the year. Additionally, the mobility of the Carrier Pods provides pharmaceutical companies, distribution centers, retailers and vaccine administrators with flexibility to move vaccine storage to other locations.

“Maintaining the temperature integrity of vaccines is critical,” said Kartik Kumar, vice president and general manager, Global Container Refrigeration, Carrier. “For greater visibility, customers can remotely monitor the conditions of the container and cargo around the clock.”

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Trebor Rx to begin production of TPE respirator masks in Canada

Trebor Rx, a new venture in Canada, is launching PRO+ Dual Respirator masks, a patent-pending mask made of thermoplastic elastomer (TPE) that can provide more than 300 hours of usage and replace hundreds of disposable masks, according to the company.

The PRO+ Dual Respirator masks (Image credit: CNW Group/Trebor Rx Corp.)

The respirator body is 95 percent recyclable, washable and sterilizable. It is designed to be used across various sectors, including healthcare, dental, mining, construction and military.

This breather technology uses disposable N95 filters, and the company claims it can filter both inhaled and exhaled air, providing protection against the spread of contaminated particles for both the user and the surrounding environment.

The PRO+ Dual Respirator claims a 98 percent effectiveness protecting against Covid-19, other viruses and bacteria, and was tested and certified under EU-GMP, the EN1827, EN149, EN142 respiratory protection standards, and BFE ASTM F2101-19 protocols to evaluate bacterial filtration efficiency.

Production is slated to begin in Collingwood, Ontario with expansion to a larger facility planned for a late 2020 opening. The company forecasts Canadian domestic production capacity of more than 500,000 masks per week.

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New alliance formed to serve biopharmaceutical and life sciences

Rapid Reshore & Development (RR&D), an alliance of three specialized firms working together to provide professional services for the life sciences and biopharmaceutical industries, has formed to address logistical challenges facing companies developing drugs, vaccines and medical devices.

The three firms—Facility Logix, EwingCole and Biggins Lacy Shapiro & Co.—intend to maximize efficiency, minimize risk and facilitate speed-to-market. The alliance represents a shift from transaction-driven service models to a holistic focus on client needs, integrating an interdisciplinary team customized for a variety of individual projects.

“Our rapidly changing world created a multitude of challenges and opportunities across all industries,” said Jared Loos, PE, AIA, EwingCole’s CEO. “However, few face logistical obstacles like the life sciences and manufacturing sectors, including biopharmaceuticals, medical devices, medical equipment and their respective supply chains. Our goal was to create an alliance that can collaboratively and succinctly support their needs from start to finish.”

Life sciences and biopharmaceutical companies are pivoting to increase efficiency and capacity in record time, which requires quicker decision-making, identifying talent, retooling facilities, increasing capacity and shoring up resources.

According to its launch announcement, RR&D is approaching the speed-to-market process by aligning and accelerating all steps, including: Up-front planning and programming; scenario development and analysis; due diligence of talent market; new facility consideration and comparative costs; early conceptual designs; competitive real estate procurement, and full design/engineering and project management.

In related news, RR&D was selected this week by BrainStorm Cell Therapeutics Inc., a developer of autologous adult stem cell therapeutics, to expedite site selection and design services for a new manufacturing facility for NurOwn, a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis and multiple sclerosis. RR&D will provide project management services throughout the project’s lifecycle.

BrainStorm, which recently signed an agreement with Catalent Pharma Solutions to manufacture NurOwn at a scale large enough to meet potential commercial needs, intends to use the proposed 50,000-square-foot facility primarily for cell therapy production.

The facility is expected to contain manufacturing suites, complementary support and infrastructure, and the ability to expand the facility to 100,000 square feet to anticipate future programmatic needs.

Facility Logix, which specializes in the biotech industry, delivers new building solutions, enabling biotech companies to produce or house healthcare products. The company provides owners’ representation, facilities planning, move and transition, as well as project and operational management implementation.

EwingCole, in practice for nearly 60 years, is a fully integrated architecture, engineering, interior design and planning firm with more than 400 professionals located in several US cities.

Biggins Lacy Shapiro & Co. features a multi-disciplinary team—attorneys, project finance and tax professionals, planners and engineers—for complex projects and portfolios through site selection, incentives and customized energy needs. Over the years, the firm has advised numerous pharmaceutical, gene therapy, biotechnology and consumer health companies.

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TFF Pharmaceuticals expands its cGMP manufacturing capabilities

TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has expanded its engagement with contract manufacturing organization (CMO) Experic, LLC to install its patented thin film freezing (TFF) processing line and associated capabilities at the CMO’s cGMP facility in Cranbury, NJ.

Installation of the custom-designed equipment is expected to be completed in early Q2 2021. It will increase TFF’s manufacturing capacity, as well as provide a third cGMP manufacturing location for the company.

The thin film freezing platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung.

“This expansion of our manufacturing operations at Experic gives us the capability and capacity to develop and produce additional products currently in assessment with pharmaceutical company partners,” said Glenn Mattes, president and CEO of TFF Pharmaceuticals.

He added that Experic’s domain expertise in dry powder inhalation products and downstream encapsulation technology rounds out the specialized manufacturing requirements of TFF’s dry powder inhalation therapies.

Experic supports product life cycle from clinical to commercial scale, across a range of dosing and packaging formats, including capsule filling, powder and pellet dosing (including DPI), and autoinjectors and pen assemblies. 

TFF Pharmaceuticals is focused on developing and commercializing drug products based on its TFF technology platform.

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West Pharma’s vial to IV bag admixture device cleared by FDA for drug transfer

West Pharmaceutical Services, Inc. has received FDA 510(k) clearance of its Vial2Bag Advanced 20mm Admixture Device, which enables reconstitution and transfer of a drug between a vial and an IV bag.

The needle-free device is suited for immediate use and can optimize pharmacy cleanroom time, while assisting in standardizing admixture systems to maximize the efficiency of point-of-care nursing and can be an effective solution for meeting USP <797> compounding requirements, according to the company.

Key features include:

  • Design: The device has a dual channel design to provide dedicated fluid pathways into and out of the IV bag and a vial spike design that improves the connection to the drug vial. Needle-free operation meets OSHA and NAPPSI sharps prevention guidance.
  • Patient Care: It provides a solution for just-in-time IV medication preparation, improving timeliness at point of care.
  • Waste Reduction: Universal compatibility with all manufacturers’ IV bags up to 250mL and is suitable for use with liquid and powder medications with standard 20mm closure vials, leading to reduced drug and IV fluid waste.

West Pharmaceutical Services is a manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Headquartered in Exton, PA, the company serves customers from locations in North and South America, Europe, Asia and Australia.

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Envirotainer adds four new RAP e2 stations in the US

Envirotainer, a global provider of temperature-controlled air freight equipment and technology for pharmaceuticals, is increasing its RAP e2 network capacity in the US by 57 percent.

The four new RAP e2 stations in New York, Miami, Philadelphia and Seattle will increase the capacity to securely ship both Covid-19 vaccines as well as all other medicines that require high-quality temperature-controlled packaging solutions.

Secure cold chain services for the pharmaceutical supply chain.
(Image credit: Envirotainer)

The move will help bring the active temperature-controlled unit closer to the manufacturing hubs of the company’s pharmaceutical customers, according to Eddy Cojulun, chief sales officer at Envirotainer.

“In light of upcoming Covid-19 vaccine shipments and the expected demand surge that it will bring, having the right solution readily available will significantly reduce the time-to-market for these life-saving vaccines once they are ready for global distribution,” Cojulun said.

Envirotainer’s strategy is to expand capabilities across the globe to meet the upcoming demand. In addition, the company says it will be positioned to handle other forthcoming temperature-sensitive shipments that require a 2-8°C or -20°C controlled environment.

The company has been expanding its commercial offerings in the US over the past decade investing in both service delivery and operational capabilities, with a focus on an agile network model. The addition of JFK, MIA, PHL and SEA will bring the total number of RAP e2 stations for the mainland US to 11 along with one in Puerto Rico.

The other RAP e2 stations are located in northern New Jersey, Atlanta, Chicago, Indianapolis, Dallas/Fort Worth, Los Angeles, San Francisco and San Juan.

Envirotainer provides a total of 41 RAP e2 stations across the world, servicing cold-chain requirements. The four new US stations are commercially ready to receive bookings starting this week, according to the company.

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CSafe expands further into Latin America

CSafe Global, provider of temperature-controlled containers for the transport of pharmaceuticals, has opened a new hub operation in Mexico City, the second largest pharmaceutical market in Latin America after Brazil.

Mexico City (Image courtesy of CSafe Global)

“We are thrilled to add our second facility in Latin America in 2020,” said Tom Weir, chief operating officer at CSafe. “The market growth has been tremendous across the region and we expect to see more development as the pharma supply chain begins to diversify their operations to better manage demand in a pandemic or any other situation that comes in the future.”

The company has contracted with AAACESA to make air cargo units available at its Mexico City International Airport facility. Through the arrangement, CSafe will gain access to 7,000 square-feet of space to store its RKN and RAP containers.

Dayton, OH-based CSafe Global with a presence in 150 countries provides end-to-end thermal shipping for pharmaceutical and life science industries worldwide.

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New business options aim to ease clinical budget headaches

Strategikon Pharma is expanding its Clinical Maestro business operations platform for biopharmaceutical participants with two new offerings, a full-service model and an operator model. The company provides a Software as a Service (SaaS) product license for clinical trial RFP planning and budgeting, which includes implementation and training.

The Clinical Maestro cloud-based platform enables participants in clinical trials—sponsor companies, vendors and service providers—to plan studies, model and manage clinical contracts and outsourcing in a systematic way.

Clinical trial pipelines have been disrupted by delays and changes to trial designs due to the pandemic, increasing the use of remote technologies and tasks, according to the company. Sponsors may find themselves swamped with budgeting and planning, while short on time or resources.

A new ‘operator’ model consists of assigning trained experts to assist, or directly operate Clinical Maestro to expedite the output delivery. The model is geared towards biopharmaceutical sponsors who operate at high speed and may not have the trained staff available or the time to run clinical plans, budgets or RFPs in the cloud-based platform. In such cases, Strategikon will work remotely to deliver the outputs required.

The ‘full service’ model, optimized for small biotechnology companies with limited resources and a small pipeline, performs the analysis on Strategikon’s internal system and provides the sponsor with a baseline budget and alternative scenarios, depending upon the sponsor’s requirement. The option allows the sponsor to develop a budget and scenarios without investing in software licensing and personnel training.

Strategikon Pharma, developer of the Clinical Maestro service, is headquartered in San Rafael, CA.

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Reflect Scientific awarded patent for low temperature bulk shipping system

Reflect Scientific, Inc. has been awarded a patent for a cryogenic modular shipping unit that can uniformly maintain its payload at temperatures as low as -90°C, making it suited for cold chain management of biologics including Covid-19 vaccines.

The cryogenic system provides a capability of short or long duration bulk shipping and may also be used for long-term storage.

Low-temperature shipping system for high-value vaccines and biologicals. (Image credit: Reflect Scientific, Inc.)

The commercially available Cryometrix S-90 shipping system eliminates managing loads of dry ice, waiting hours for the temperature to saturate the shipping container, and having little to no control over product temperature during shipping.

It bundles Reflect Scientific’s upright liquid nitrogen freezer technology with an onboard liquid nitrogen tank and power supply. The user can ship up to 33.5 cubic feet of product (or 70,000 vials) at a controlled temperature between +20°C down to -90°C with a uniformity of ± 3°C.

The S-90 features temperature and data logging that can be accessed through the touch screen or downloaded to a computer. Security issues are mitigated with three security levels and up to 30 users. It can control who opens the freezer, changes the temperature set-point and changes the settings.

Each Cryometrix shipping system is customizable to meet individual shipping needs, including for vaccines and biologics, whether used for cross country shipping at -90°C or for short trips, according to the company.

Reflect Scientific, based in Orem, UT, develops and markets proprietary technologies in cryogenic cooling for the biotechnology, pharmaceutical, medical and transportation markets.

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LaunchWorks makes FDA list of approved viral transport media vendors

LaunchWorks, a contract development and manufacturing organization (CDMO) serving the life sciences market, has been approved to manufacture and distribute viral transport media (VTM), in accordance with Section IV.B of the FDA’s Covid-19 transport media policy.

(Image credit: LaunchWorks)

The VTM, a new addition to the company’s products and services, is available in the form of bulk tubes, large volume containers and a specimen kit, which will include a tube of sterile LaunchWorks VTM, a biohazard bag and an absorbent bag. Additional options include nylon-flocked NP swab, barcode or QP-coded labels, patient card and a UN 3373 return box.

As an FDA-registered ISO 13485 certified company, LaunchWorks is a division of Integreon Global, which has supported the CDMO’s expansion in molecular diagnostics with the additions of new service offerings, including embarking on an automation program. Recently, a significant portion of the company’s efforts have involved the response to the Covid-19 crisis, and the development of VTM.

Integreon Global includes four companies: LaunchWorks, Cryopak, DDL and NexKemia. Each company offers unique critical supply chain components, including cold chain temperature monitoring options, packaging, product and materials testing, contract manufacturing and EPS resin manufacturing.

The LaunchWorks service suite ranges from package design to formulation, filling and fulfillment.

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BioSpecifics to be acquired by Endo Pharmaceuticals

Endo International plc will acquire BioSpecifics Technologies Corp. in an all cash transaction totaling an estimated $658 million in equity value. The transaction was unanimously approved by the boards of both companies and is expected to close during the current quarter.

Under the terms of the agreement, Endo, through a wholly owned subsidiary, will commence an all-cash tender offer for all outstanding shares of BioSpecifics common stock at a price of $88.50 per share.

The closing of the tender offer will be subject to a number of conditions, including that a majority of BioSpecifics’ shares are tendered in the tender offer, the expiration of the waiting period under antitrust laws and other customary closing conditions.

Following completion of the tender offer, Endo’s acquisition subsidiary will be merged into BioSpecifics, with any remaining shares of BioSpecifics common stock to be cancelled and converted into the right to receive consideration of $88.50. The merger agreement includes a remedy of specific performance and is not subject to a financing condition.

BioSpecifics Technologies Corp., based in Wilmington, DE, is a commercial-stage biopharmaceutical company. Endo International plc is a specialty pharmaceutical company with global headquarters in Dublin, Ireland and US headquarters in Malvern, PA.

Centerview Partners LLC acted as the exclusive financial advisor to BioSpecifics and Morgan, Lewis & Bockius LLP is serving as legal counsel.

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HFAP joins ACHC in move that streamlines accreditation and certification services

The Accreditation Commission for Health Care (ACHC) and Healthcare Facilities Accreditation Program (HFAP) are joining to form a single company providing accreditation and certification services to providers.

Under the October 19 merger agreement between ACHC and Accreditation Association for Hospitals/Health Systems (AAHHS)—HFAP’s parent company—HFAP will operate as a brand within ACHC.

Formally approved by the Centers for Medicare & Medicaid Services (CMS), the move streamlines services for existing customers and organizations and marks the first time that two accrediting operations with deeming authority from CMS have merged.

“Together, the combined services of ACHC and HFAP open possibilities for healthcare providers, affording them more choices and greater ease in meeting the accreditation and certification needs of their organizations,” said José Domingos, president and CEO of ACHC, in a statement following the merger announcement.

ACHC has CMS deeming authority for home health, hospice, renal dialysis, home infusion therapy and DMEPOS—durable medical equipment, prosthetics, orthotics and supplies. It also is a deeming authority for specialty pharmacies.

The expanded ACHC now adds HFAP programs with CMS deeming authority for hospitals, ambulatory surgery centers, clinical laboratories and critical access hospitals. The merged group broadens the routes to certification for pharmacies, as HFAP overlaps to some degree in the case of compounding pharmacies.

Part of that overlap has to do with a number of the HFAP-accredited hospitals that operate their own compounding pharmacies, thus making it a logical step for HFAP to offer the additional service, Marci Ramahi, CAE, director of Accreditation/Certification Operations, explained a couple of years ago. Ramahi noted at the time that freestanding compounding pharmacies were also candidates, with certification consisting of a review of documentation, interviews and site visits by surveyors.

Additional HFAP offerings—such as accreditation programs for ambulatory specialty care (office-based surgery), non-deemed accreditation and specialty certification for four levels of stroke care, laser and lithotripsy services, inpatient and outpatient joint replacement and wound care—will expand and complement the ACHC portfolio, which also includes programs for ambulatory care, behavioral health, pharmacy, private duty and sleep.

The transition is expected to be seamless, the organizations say, adding the merger does not affect accreditation cycles for either ACHC or HFAP customers. Current accreditation and/or certification status, account managers and processes also are not expected to change. In addition, the merger does not require current HFAP customers to undergo an initial survey.

Still separate following the merger of the two big accreditation services is URAC, a nonprofit organization based in Washington, DC, which was founded in 1990 as a third-party quality validator, including for specialty pharmacies. Payers and manufacturers look for URAC accreditation as part of choosing which pharmacies to work with in specialty pharmaceutical distribution and dispensing.

URAC’s accreditation standards look closely at how pharmacies document their internal practices, and there is an emphasis on proper cold chain practices to ensure that temperature-sensitive specialty pharmaceuticals are being handled safely.

ACHC, a nonprofit organization, was formed in 1986. Its staff members are expected to remain in Cary, NC. HFAP, founded in 1945, is a not-for-profit accreditation program with staff located in both Cary and Chicago.

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AGC Biologics shifts leadership structure at US and Copenhagen sites

AGC Biologics, a biopharmaceutical contract development and manufacturing organization (CDMO), has announced leadership changes at its US and Copenhagen, Denmark operations. The changes became effective October 15.

Jeffrey D. Mowery, formerly general manager of the Copenhagen site, joins the global executive team at the company’s headquarters in Seattle as senior vice president of US operations. 

Mowery, with more than 20 years of experience in small molecule, biologic and cell and gene therapy production and technology transfer, will oversee AGC’s new Boulder, CO facility rollout and progress at its expanding Seattle site.

Andrea C. Porchia was promoted to succeed Mowery in the Denmark facility as general manager and site head for Copenhagen. She previously served in a variety of roles ranging from project director and business development representative to global head of project management.

She has more than two decades of research and process experience and will have a critical focus on project management and customer service, according to AGC.

AGC Biologics, with more than 1,400 employees worldwide, focuses on all phases of development through to commercialization, with expertise in process development, formulation, and analytical testing. Its global service network maintains US locations in Seattle and Boulder, as well as operations in Denmark, Italy, Germany and Japan.

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SkyBitz and Coretex enter strategic alliance to integrate reefer and trailer tracking

IoT telematics company SkyBitz and fleet logistics technology provider Coretex are partnering to provide pharmaceutical, food and other customers with improved safety and quality assurance through visibility into the status of loads during transportation.

The move combines Coretex’s sensor-based reefer technology and cloud-based software platform with SkyBitz’s trailer tracking technology for both powered and non-powered asset tracking.

Users can access and manage both reefer device data and trailer tracking data via one connected platform, enabling greater insight, a more transparent view of their entire cold chain operation, and better decision making, according to the companies.

It also allows users to keep assets on the road for longer periods, monitoring them with advanced temperature tracking capabilities.

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UNICEF to stockpile more than a half billion syringes by year end

In anticipation of forthcoming Covid-19 vaccine approvals, the United Nations Children’s Fund (UNICEF) announced plans to stockpile 520 million syringes in its warehouses, part of a larger plan to have a billion syringes ready for use through 2021 in order to guarantee initial supply and help ensure that syringes arrive before vaccines are distributed.

To make sure that vaccines are transported and stored at the right temperature, UNICEF, along with the World Health Organization (WHO), is also mapping out existing cold chain equipment and storage capacity in both the private and public sectors, and preparing necessary guidance for countries to receive vaccines.

“We are doing everything we can to deliver these essential supplies efficiently, effectively and at the right temperature, as we already do so well all over the world,” said Henrietta Fore, UNICEF executive director.

Prior to the Covid-19 pandemic and with support from the global vaccine alliance Gavi and in partnership with WHO, UNICEF has been upgrading the existing cold chain equipment across health facilities in countries to ensure that vaccines remain safe and effective throughout their journey.

Since 2017, more than 40,000 cold-chain fridges, including solar fridges, have been installed across health facilities, mostly in Africa, and solar technologies are being promoted in many countries to help maintain supply chains, according to the agency.

In South Sudan, the least electrified country in the world, where temperatures frequently exceed 40°C, more than 700 health facilities have been equipped by UNICEF with solar-powered fridges—about 50 percent of all facilities in that nation.

UNICEF says the Covid-19 vaccination efforts will be on top of the 620 million syringes the agency intends to purchase for vaccination programs against other diseases such as measles and typhoid.

“By the end of the year, we will already have over half a billion syringes pre-positioned where they can be deployed quickly and cost effectively,” said Fore. “That’s enough syringes to wrap around the world one and a half times.”

UNICEF is also buying five million safety boxes, each capable of carrying 100 syringes, so that used syringes and needles can be disposed of in a safe manner by personnel at health facilities, reducing the risk of needle stick injuries and blood borne diseases.

The agency, originally known as the United Nations International Children’s Emergency Fund, was created by the UN General Assembly on December 11, 1946, to provide emergency food and healthcare to children and mothers in countries that had been devastated by World War II. Its mandate was later extended to address such long-term needs in all developing countries, dropping the words ‘international’ and ‘emergency’ from the name in 1953, but retaining the original UNICEF acronym.

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UK importers/exporters warned to take immediate action as Brexit nears

Many businesses trading abroad ‘are in the dark’ about what they should be doing to prepare financially for the Brexit January 1, 2021 deadline, according to feedback received by Hamilton Court FX, a UK-based consulting firm that provides foreign exchange (FX) transactional advice and delivery.

Importers and exporters, including those in pharmaceuticals, shipping, logistics, insurance and other businesses are worried about the government’s failure to provide clear detail sooner to guide them through UK and European Union bureaucracy.

With eight out of 10 businesses still ‘sitting-on-the-fence’ and waiting for detailed government advice on the changes to the way they import/export goods and pay for them, the consulting group warns that it is imperative that they act now with proactive methods of hedging their currency needs so market fluctuations don’t eat into their profits.

“We have been receiving feedback from our clients for a year or more on their frustration with government over Brexit advice,” Mark Palmer, chief operating officer of Hamilton Court FX, said. “There is little available and no one to speak to. There is no one-size-fits-all answer here, which is why businesses need to speak to someone. All their issues are different and there are less than 80 days to go.”

Last week the British government sent an email to businesses with links to its website that purport to offer advice on dealing with the changes brought on by operating outside of the UK post-Brexit, the consultancy noted.

“The portal offers us no tangible advice that hasn’t already been covered externally and by comparison misses a lot of key elements of consideration,” Palmer said, adding that the firm is countering ‘Brexit fatigue’ by offering the following advice to help companies implement active strategies to ensure that they’ll know where they stand with foreign exchange, including:

Check

  • What implications a large delay in receipt or delivery of inventory will have on cashflows and any underlying foreign exchange contracts allocated to them.
  • Whether a 10 percent move up or down in the value of the British pound will leave them having to pay extra collateral against hedging contracts.
  • The types of hedges being used: Are there more suitable methods?
  • Whether businesses in their supply chain are protecting themselves against financial exchange risk and if they would suffer as a result of any adverse effects they experience.
  • The small print.

Change

  • A non-responsive banking relationship.
  • Terms with suppliers – are they able to get some payment flexibility if required, rather than breach any strict terms that don’t make a Brexit

Go

  • Speak to people in the industry. What are they doing?
  • Act on the information they’ve got and avoid procrastination.
  • Get on top of the variables that they are in control of to reduce other distractions.

The firm also offered some alternative FX strategies instead of waiting:

  • Start small, hedge 50 percent of what they would regularly. This lowers the potential risk, while only giving up some of the potential upside.
  • Change the product mix. Something that is happening at scale already.

Hamilton Court FX added suggestions that businesses should consider with their FX product mix: A lower potential obligation; structures that allow for upside flexibility or that can deliver a level of outperformance vs. vanilla products if their risk tolerance allows for it; trades with low or zero chance of margin call, and working with an expert to tailor a trade that aligns with the company’s market view, while still delivering the level of protection required.

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Digi unit meets expected CDC monitoring guidelines for Covid-19 vaccines

The SmartSense division of Digi International announced this week that its monitoring services meet expected guidelines from the U.S. Centers for Disease Control and Prevention (CDC) for handling Covid-19 vaccines and that its solutions will support the entire vaccine cold chain from manufacturers to end-point providers.

At present, SmartSense technologies collect more than 10 million sensor readings per day in 28,000 retail pharmacy locations and their supporting distribution centers.

The CDC is expected to mandate continuous temperature monitoring for pharmacies to receive and distribute forthcoming Covid-19 vaccines. To meet the requirement, SmartSense provides automated wireless-monitoring and task-management tools that ensure the product remains at the proper temperature and that workers handle the inventory correctly.

With many vaccine candidates requiring frozen transportation and storage, the division reports that it can support such conditions without upgrades or hardware changes, and that its sensors can monitor the ultra-cold conditions required for vaccine delivery.

“Our pharmacy customers have already entrusted us to protect more than $2 billion in refrigerated inventory,” said Kevin C. Riley, president of SmartSense. “In addition, we’re also working with hospitals, clinics and transportation companies that use our technology for similar applications.

Digi International is a global provider of business and mission-critical Internet of Things (IoT) connectivity products and resources. Boston-based SmartSense, Digi’s IOT Solutions division, serves more than 2,000 organizations in 75 countries, including at Walmart, CVS Health, SpaceX, Apple, Coca Cola, McDonald’s and the US Department of State, according to the company website.

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TurboFil introduces module for automated syringe filling and assembly

TurboFil Packaging Machines LLC, a company specializing in design and development of liquid filling and assembly machines, has introduced a module offering automated, simplified production for a range of syringe formats.

TurboFil’s SimpliFil Syringe Filling & Assembly System

Employing a setup that fills syringes via ceramic piston, peristaltic pump or direct draw from a reservoir bag, the company’s SimpliFil Syringe Filling & Assembly System is suitable for small to medium batches.

The new machine’s signature feature is a walking beam indexing configuration, which provides intuitive operation and simplified, recipe-based changeover. For heightened precision, the company’s TipFil technology allows syringes of all types to be filled through the tip—a step-saving aspect that eliminates the need to insert plungers post-filling.

The SimpliFil system is capable of filling up to 36 syringes per minute, and can handle syringes with tips outfitted for press-on caps and luer caps, as well as various safety caps recently incorporated for many oral syringes, according to TurboFil.

For post-capping marking applications, an optional labeler is available that can wrap syringes with pre-printed labels or, for medications requiring variable marking, print individual labels per uploaded input. An automatic syringe loading system also is available, as is a volume and vision system for fill and label matching verification.

For preventative maintenance and diminished downtime, remote diagnostics can be performed via ethernet communications, and verification sensors monitor all production stages.

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DataLase launches functional masterbatch additive for plastics integration

DataLase, a photonic printing specialist, has developed a masterbatch additive suitable for a range of plastics for pharmaceutical, medical and other industries.

The additive addresses challenges faced by production and manufacturing companies with product coding applications, such as printing expiration dates and lot numbers.

Launched under the company’s VAReLase Pigment Solutions banner, the additive is integrated directly into the masterbatch in pellet form to provide consistent quality, contrast and permanent black coding.

The additive works with standard CO₂ scribing lasers to provide sustainability benefits in production environments by eliminating labels, consumables and waste from the coding and marking process, according to the company, which adds that it also can help streamline supply chains through a reduction in packaging.

Since the additive already is integrated into the extruded plastic, it provides SKU traceability through permanent tamper-proof anti-counterfeit coding, and can be printed anywhere on the packaging, the company reports.

DataLase is based in Cheshire, UK. Distributor partners include SunChemical, Hubergroup and UVitec.

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Medical Knowledge Group acquires life sciences market research firm

Medical Knowledge Group, LLC, a marketing and technology-oriented service for companies in the biopharmaceutical industry, has acquired research and consulting firm Magnolia Innovation.

Founded in 2013, Magnolia focuses exclusively on life sciences to help build, launch and redefine biopharmaceutical brands by leveraging market insights and business strategies. The firm is based in Hoboken, NJ.

“Magnolia Innovation’s strength in market research complements our robust data analytics capabilities,” said Leon Behar, CEO of Medical Knowledge Group. He added that, through the acquisition, his company plans to expand its capabilities across the drug commercialization process.

New York-based Medical Knowledge Group provides biopharmaceutical companies with network-mapping analytics, patient-finding analytics and multi-channel marketing services. It partners with biopharmaceutical companies and niche biotech firms to maximize the commercial potential of their brands.

In January, Medical Knowledge Group was acquired by private equity firm Court Square Capital Partners.

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Drone deliveries of cold chain medicines begin in rural North Carolina

Volansi, Inc., an on-demand aerial delivery service for time-critical shipments, has begun delivering cold chain medicines from Merck’s Wilson, N.C. manufacturing site to Vidant Healthplex-Wilson, a medical center operated by Vidant Health and serving rural portions of the state.

Initial flights in the project resulted in the first drone delivery of temperature-controlled medicines within the U.S., according to Volansi. The move represents the first part of a three-phase project to learn about drone technology’s role and ability to improve access to healthcare.

Pilot program may help establish new supply chain option. (Image courtesy of Volansi, Inc.)

“We’ve seen the world’s supply chain strained like never before from the impact of Coronavirus,” said Hannan Parvizian, CEO and co-founder of Volansi. “There’s now an accelerated need for rapid advancements in supply chain technology, especially in healthcare. Drone delivery is one solution to getting critical supplies where they are needed, at the moment they are needed most.”

The project utilizes Volansi’s VOLY C10, an all-electric drone capable of carrying 10-pounds of cargo to locations up to 50 miles away. The VOLY C10’s vertical take-off and landing (VTOL) system allows it to deliver fragile cargo with a ‘soft touch’ automated release once the drone has landed at the delivery location.

The VTOL system requires minimal infrastructure to operate and also is capable of delivering such items as temperature trackers and shipping confirmation on returning flights.

“As a healthcare leader, Merck is very supportive of collaborations using new technologies to explore how one day we could help better serve the healthcare community,” said Craig Kennedy, senior VP, global supply chain management, at Merck, which is known as MSD outside the U.S. and Canada. “Our existing distribution system is strong, and this pilot helps us explore new innovative delivery options that would complement our existing supply chain capabilities.”

Volansi is working with the Federal Aviation Administration’s (FAA) Unmanned Aircraft System Integration Pilot Program and the North Carolina Department of Transportation to ensure that its deliveries are made safely and in accordance with state and federal guidelines.

For phases two and three of the project, Volansi said it plans to seek additional approval from the FAA to provide deliveries in other locations, enabling a flexible, on-demand and responsive supply of critical medicines.

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Etihad Cargo to utilize latest CSafe high-performing containers for flights

Etihad Cargo has approved the use of CSafe Global’s high-performing container, the CSafe RAP, across its global fleet of wide-body and freighter aircraft. CSafe Global provides end-to-end thermal shipping for the pharmaceutical and life science industries with a presence in more than 150 countries.

(Images courtesy of Etihad Cargo and CSafe Global)

The CSafe RAP uses new heating and compressor-driven cooling technologies, along with advanced VIP insulation, to maintain constant payload temperatures even at extreme ambient temperatures spanning from -30°C to +54°C – reportedly the broadest operating range in the industry.

Its large payload compartment of 6.68 cubic meters (235.902 cubic feet) accommodates up to four standard U.S. pallets or five standard Euro pallets. With an extended battery run time of more than 120 hours, the CSafe RAP provides temperature integrity and product viability through to destination, including on extended journeys.

Etihad Cargo recently reinforced its pharmaceutical logistics capabilities with the launch of PharmaLife, a specialized pharma and healthcare service that comprises both active and passive containers and associated ground services. It was the first carrier in the Middle East to receive the IATA’s Center of Excellence for Independent Validators (CEIV) certification in pharmaceutical logistics.

“We are confident as market demands become stronger for vaccines and clinical trials that we are ready to offer quality along with enough capacity to our customers,” said Fabrice Panza, global cold chain manager at Etihad Cargo.

Etihad Cargo, the cargo and logistics arm of the Etihad Aviation Group, has been a long-time partner with CSafe Global and provides a number of closed cold-chain solutions, including the CSafe RAP and CSafe RKN. Sale and leasing options for the containers are available through Etihad Cargo.

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BioLife division gets $2.7m cold chain and storage contract for Covid-19 vaccines

BioLife Solutions, Inc.’s recently acquired SciSafe division has been awarded a two-year contract estimated at $2.7 million from an unnamed ‘large pharmaceutical company’ for cold chain management and storage of Covid-19 vaccines.

SciSafe, a provider of biological materials storage founded in 2010, maintains four cGMP-compliant facilities located in New Jersey, Massachusetts and Utah, with an expansion plan focused on the cell and gene therapy clusters located around the world.

While BioLife leadership did not name the pharmaceutical company in the $2.7 million agreement, the company last month reported that SciSafe customers include several Top Five global pharmaceutical companies.

In an interview published last week with Seattle’s Pugent Sound Business Journal, BioLife CEO Mike Rice said the company’s storage technology would not be used for transport of the Covid-19 vaccine, but declined to add further details about the newly signed contract.

BioLife is a developer and supplier of bioproduction tools and services for cell and gene therapies. SciSafe, acquired in September, is expected to contribute approximately $9 million in incremental revenue in 2021, according to BioLife.

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Covectra introduces suite of services for comprehensive serialization and traceability

Covectra has launched a suite of serialization and track & trace engineering, integration and consulting options to complement its products and services, allowing businesses to address supply chain challenges, optimize technology products and implement new processes quickly and cost effectively.

Technical help in serialization is available across a broad set of industries including pharmaceutical and life sciences for implementation of smart strategies that provide visibility and full traceability along the digital supply chain. It also assists in the customizing, implementation and integration of technology needed to optimize resources and ensure the supply chain’s integrity.

“Our customers are struggling as the growing threat of counterfeit products from drugs, cosmetics to tobacco floods their markets, and puts their brands at risk,” said Steve Wood, Covectra’s CEO. “Also, their resources are being drained by constantly changing regulations and they need to focus on their business requirements.”

Support offered for serialization services includes:

  • Requirements, compliance and implementation plans
  • Line selection criteria and installation planning
  • Equipment analysis and selection
  • Serialization-ERP integration
  • Vendor assessment and selection
  • Technology assessment

Covectra provides serialization, track & trace, and authentication technologies to secure and manage products across the entire supply chain extending to the unit dose level. The company also can provide a user requirements study for serialization and other engineering functions, printing and vision system planning and Level 4 integration.

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IntegriChain launches advanced analytics to improve forecasting and accrual processes

IntegriChain, a Philadelphia-based data and managed services company, has introduced GTN Analytics, a service for life sciences manufacturers to improve visibility to the market access datasets that power the accuracy of accruals and forecasting processes, delivers best practices reports and metrics, and offers visualizations of gross-to-net, or GTN, trends.

The new service is complementary to IntegriChain’s GTN Accruals and GTN Forecasts services that integrate financial data with channel and patient data, including national demand, third-party logistics, specialty pharmacy, specialty distribution and rebate data. “Business strategy in life sciences is often stymied because of the inability to connect the impact of channel, contracting, and pricing decisions on net profitability and demand realization,” said Josh Halpern, IntegriChain co-founder and EVP of product and strategy.

According to the company, GTN Analytics improves accuracy and predictability of accruals and forecasts through the following key components:

  • Data on demand reduces the risk of gross-to-net accrual mistakes and improves overall contract decision making by providing finance and market access teams a consistent way to visualize, extract and integrate data into existing workflows. It allows analytics to quickly access self-service data, including ad hoc analysis, pre-built reports and dashboards, on-demand data exports, and an application programming interface for business intelligence tools.
  • GTN Reporting allows manufacturers to evaluate key gross-to-net metrics and trends with web-based data visualization and analysis tools. Visualizations align with industry best practices, including product profit and loss statements as well as actual and forecast variance analysis, and provide insights into the effectiveness of contract decision making using datasets from across traditional silos.

GTN Analytics is available to all current IntegriChain GTN customers and demos are being scheduled for other interested parties.

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LabVantage to supply lab information management system to Walter Reed unit

The Walter Reed Army Institute of Research has awarded LabVantage Solutions, Inc. a contract to supply its LabVantage Pharma laboratory information management system (LIMS) to support Covid-19 and other vaccine production programs at the institute’s pilot bioproduction facility.

The web-based system provides out-of-the box workflows and functionality to manage pharmaceutical manufacturing, including batch management, stability testing, consumables management, environmental monitoring, barcode label printing, and instrument calibration, certification and maintenance.

Its pre-validated and pre-configured system reduces deployment time and costs compared to traditional LIMS, according to the company.

LabVantage, headquartered in Somerset, NJ with offices around the globe, provides such services as system installation and setup, individualized methods and specifications, and personnel training.

The Walter Reed Army Institute of Research, dating back to 1893, works alongside civilian researchers, medical professionals and military personnel to develop and test products that ultimately will reduce the impact of dangerous and debilitating diseases. It has developed many vaccines and drugs in use today by military and civilian medicine around the world.

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Air transport groups find ‘a concerning lack of readiness’ for Covid-19 vaccine logistics

The International Air Cargo Association (TIACA) and Pharma.Aero, a cross-industry consortium focused on reliable end-to-end air transportation for pharmaceutical shippers, this week sounded an alarm over the current state of air cargo readiness for upcoming Covid-19 vaccine transportation.

The two organizations recently surveyed airlines, freight forwarders, ground handlers, airport operators and solution providers to gauge their preparedness to handle the global logistics effort to distribute the upcoming vaccines.

While the vast majority of respondents have begun preparations to handle, store, transport and deliver the future Covid-19 vaccines, only 28 percent of them feel well prepared to do so at this time.

On that basis, TIACA and Pharma.Aero this week issued a call for “urgent industry collaboration” to address what they termed “a concerning lack” of readiness.

“We as an industry are as strong as our weakest link,” said Emir Pineda, member of TIACA’s board and co-lead of the joint Sunrays project initiated in August to help the air cargo industry get ready for the transportation of the Covid-19 vaccines.

“To move the needle on industry readiness, we need to ensure everyone is engaged and informed,” Pineda said. “Only with a strong and transparent dialogue between pharmaceutical and air cargo sectors, governments, non-governmental organizations and healthcare institutions can we overcome these challenges.”

Areas of immediate priority, according to the two air transport groups, require a focus on industry collaboration between the pharma and air cargo sectors; improving visibility and transparency; building adequate capabilities; getting support from regulators to speed up the process and remove cumbersome procedures, and receiving help from international organizations and donors to ensure that no country is left behind.

Such coordinated action would provide the maximum air cargo preparedness required to meet shippers’ needs and expectations for speed, security, reliability and transparency.

To strengthen industry collaboration, the survey sponsors called for vaccine manufacturers to involve all of their air cargo logistics providers, including airports and ground handlers, as early as possible.

TIACA and Pharma.Aero also called on air cargo stakeholders to map existing capabilities at each location and make the information available; secure dry ice, active containers, trained staff and cold chain space availability early in the process, and to start making any necessary infrastructure investment decisions.

To improve visibility, they suggested that the use of tracking and monitoring devices should be encouraged and the approval process for their safe use in flight should begin ASAP, along with the accelerated rollout of digital solutions and data sharing platforms.

As for removing barriers, TIACA and Pharma.Aero suggest that governments, customs authorities and border agencies should be ready to facilitate and expedite all Covid-19-related goods, and that international organizations, NGOs and donors should support cold chain capacity building efforts in the least-developed countries to ensure that no one is left behind in the upcoming global immunization campaign.

“We are still at early stages of industry preparation for the transportation of Covid-19 vaccines and there are still a lot of unknowns,” said Nathan De Valck, chairman of Pharma.Aero’s board and member of the Sunrays project. “Getting the equation right requires us to work together now.”

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Momentive Technologies and Stevanato Group collaborate on vials packaging

Momentive Technologies and Stevanato Group agreed to supply Momentive’s Pur Q fused quartz vials in Stevanato’s EZ-fill packaging format.

The Pur Q vials are ultra-high-purity fused quartz vials available for pharmaceutical packaging. The EZ-fill secondary packaging provides a fully integrated, ready-to-use option for aseptic fill-finish operations.

Pur Q fused quartz vials. (Image courtesy of Momentive Technologies)

Combined, the move is expected to help biopharmaceutical companies improve the reliability and speed of drug development and production of medications via highly stable primary packaging and an efficient secondary packaging method.

Made from 99.995 percent pure silicon dioxide (SiO2), the Pur Q fused quartz vials have an inert, nonreactive surface that virtually eliminates risk of interaction with packaged drug formulations.

“Due to the vials’ highly inert properties, biopharmaceutical companies will be able to confidently take the container out of the equation when assessing the viability of formulations, helping to accelerate the development of increasingly complex and sensitive biologic drug formulations,” said Robert Koch, global commercial director at Momentive Technologies.

The EZ-fill secondary packaging is designed to mitigate the risk of breakage, cosmetic issues and particulate generation during fill-finish operations. The packaging stores vials safely in a tray, or nest and tub configuration for efficient filling, while minimizing glass-to-glass contact.

EZ-fill packaging stores vials in tray or nest and tub configuration. (Image courtesy of Stevanato Group)

Momentive Technologies, headquartered in Strongsville, Ohio, employs more than 700 workers and maintains seven manufacturing locations in the U.S., Germany, Japan and China. Formerly a division of Momentive Performance Materials, the business became a separate stand-alone entity in January.

Privately owned Stevanato Group, based in Piombino Dese, Italy, is a designer and producer of glass primary packaging for the pharmaceutical industry. In September, the company launched a Technology Excellence Center in Boston to support biopharma companies from early phase development through to commercialization, helping them overcome container-closure system hurdles.

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Authentix acquires Bibliotheca anticounterfeiting unit

Authentix, Inc., an authentication and information service based in Addison, TX, has acquired the Traceless Authentication Group from Bibliotheca, Inc. a library systems company serving libraries worldwide.

Rochester, NY–based Traceless delivers anticounterfeiting and diversion control options to customers in the global pharmaceuticals, spirits, and apparel industries. The acquisition includes the company’s complete portfolio of patented covert marking solutions as well as its own enterprise cloud-based digital track and trace software technology.

Product lines acquired include Traceless Ultra, Traceless Pro and Traceless Anti-Diversion covert marking systems that can be integrated into existing product production.

“Traceless brings an extensive capability in the worldwide digital tracking of products and consumer-level product marketing, both of which integrate well with our growth strategy,” said Kevin McKenna, CEO of Authentix.

In addition to the U.S., Authentix has offices in the United Kingdom, Saudi Arabia and Africa. MHT Partners, L.P. acted as financial advisor to Authentix in the transaction.

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Balaxi Ventures renamed to better reflect its core focus on pharma

India’s Ministry of Corporate Affairs has granted formal approval to Balaxi Ventures Ltd to change the company’s name to Balaxi Pharmaceuticals Ltd. The move received shareholder okay last month at the company’s annual general meeting.

Hyderabad, India-based Balaxi supplies “frontier” markets in Angola, Guatemala and the Dominican Republic with branded, generic and over-the-counter medicines that address multiple therapeutic segments. The products are procured from World Health Organization GMP-certified contract manufacturers based in India, China and Portugal.

“Considering our focus on pharma business, it is only apt that the company’s name reflects our brand proposition,” Ashish Maheshwari, managing director, commented regarding the name change.

The company maintains an on-ground presence with 38 warehouses and a distribution network featuring a fleet of company-owned vehicles. It reports that it currently is building a branded fast-moving-consumer-goods (FMCG) business to complement its pharmaceutical operations while taking advantage of its established on-ground infrastructure and channel relationships.

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IQVIA: Biosimilars on track to reduce drug costs by $100b over next five years

Biosimilar medicine availability and use are growing and on track to reduce drug costs by $100 billion over the next five years, according to a new report from the IQVIA Institute for Human Data Science.

The development and approvals of biosimilars have been accelerating in the U.S. over the past two years, bringing a total of 33 approvals across 13 molecules through the 2020 second quarter. Only 22 of these have launched thus far due to legal challenges and commercial agreements.

An additional 108 biosimilars are in development across 22 other molecules and will potentially reach the U.S. market within the next 10 years.

“Contrary to some predictions, biosimilars are not a failed concept; they are in fact becoming a growing part of affordable treatment options available to payers, physicians and patients,” said Murray Aitken, IQVIA senior vice president and executive director of the institute. “It is our estimate that biosimilars could reach $80 billion in aggregate sales over the next five years, including $16 billion to $36 billion in 2024.”

Recent biosimilar launches of bevacizumab, trastuzumab and rituximab are set to reach nearly 60 percent volume share by the end of their second year on the market, significantly higher and faster than prior biosimilars.

The growing willingness by stakeholders across the U.S. to adopt biosimilars is confounded by an extreme heterogeneity across provider groups where biosimilar usage ranges from 0 percent to 100 percent, according to IQVIA.

The differences reflect contracting approaches by manufacturers and providers, and prescriber willingness to adopt biosimilars including the associated issues with changing patient treatment protocols.

Key highlights of the report include:

  • Savings enabled by the presence of biosimilars are modeled to exceed $100 billion in aggregate over the next five years, though volume and price dynamics remain volatile and significant uncertainty remains.
  • Price declines for biosimilars significantly vary but are in line with prior IQVIA assumptions of roughly 30 percent discounts. Higher discounts have occurred for many biosimilars, and an increase in the average discount is possible in the future. (IQVIA reported on the overall effects of discounting on pricing in the pharmaceutical sector in its Global Medicine Spending and Usage Trends report released in March.)
  • The introduction of biosimilars in some cases has triggered 2 percent to 4 percent incremental demand for the molecules, bringing biologic treatments to more patients.
  • Patients benefit from the use of biosimilars in the form of lower out-of-pocket costs, depending on their insurance plan design.
  • In the case of insulins, patients with Medicare Part D and commercial insurance are saving an average of about $18 and $13 per prescription, respectively, when using a biosimilar insulin.
  • Patients who are typically responsible for 20 percent of Medicare Part B costs are benefiting from the lower average sales price of $500 to $1,900 for a standard course of treatment for the three most recently launched biosimilars.
  • Large pharmaceutical companies, often with existing innovative biologic portfolios, lead the marketing of biosimilars, while the smaller companies that are developing biosimilars are likely to license products to the larger companies for marketing.

The study was produced independently without industry or government funding, according to IQVIA. The full version of the report, including a detailed description of the methodology, is available from the institute.

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Abzena invests $60 million to expand cGMP manufacturing capacity

Abzena, a contract provider of integrated services for biologics and bioconjugates, has invested $60 million into a new facility for late phase and commercial current good manufacturing practice (cGMP) production.

The new 50,000 square foot ‘Lusk’ facility at the company’s site in San Diego houses a process development laboratory and two new cGMP manufacturing cleanrooms for 500L and 2,000L scale in Sartorius single use bioreactors. The facility also houses a good manufacturing practice warehouse and analytical development and quality control laboratories.

The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects, according to Abzena.

“Until now our other San Diego site has been focused primarily on development and manufacture of Phase I and II clinical trial materials,” saidMatt LeClair, senior VP, who added that the expansion will allow the company to provide project integration as customers move into Phase III and ultimately commercial manufacture.

The new facility, which received its manufacturing license from the California Food and Drug Branch, has added 125 new positions within the company.

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Mapi Pharma earmarks space for vaccine production facility

Mapi Pharma Ltd., a late clinical stage biopharmaceutical company, plans to dedicate production capacity at its Jerusalem Har-Hotzim manufacturing facility for upcoming Covid-19 vaccines destined for Israel, the European Union and other potential locations.

The company’s GMP facility is audited by the Israeli Ministry of Health, with approvals that are mutually recognized by the EU, thus exempting Israeli manufacturers from the requirement to perform laboratory tests on shipments heading to Europe.

Mapi has invested more than $100 million to expand its Jerusalem fill & finish facility, a unit that originally was established by Johnson & Johnson to supply J&J’s own needs of sterile products. Mapi now is adding a new line for sterile filling and finishing of liquids and powders for injections.

“We are making available our production capacity, as well as our cold chain and storage capacities, for the delivery of vaccines to Israel and EU,” Ehud Marom, chairman and CEO of Mapi, said in a statement. “By making our manufacturing capacity available, we hope to assist in the quick deployment of vaccines once they are approved by the heath authorities.”

Mapi is headquartered in Israel, with R&D operations in Israel and China, an active pharmaceutical ingredient production facility in the Neot-Hovav Eco Industrial Park near Beer Sheva, Israel, and an aseptic manufacturing and fill & finish facility in Jerusalem.

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‘Green’ new reefer trailer being tested for pollution-free shipping of biologics

Reflect Scientific, Inc., a provider of products and services for the biotechnology, pharmaceutical and transportation industries, has been testing an electric-powered heavy-duty truck to potentially replace the diesel-powered tractor trailers that currently are in use for the movement of goods requiring controlled temperatures.

Cryometrix 53-foot reefer trailer (Credit: Reflect Scientific, Inc. via GlobeNewswire)

The Cryometrix CB-40 TRU is a pollution-free refrigeration alternative to diesel-powered systems, according to the company, which added that system weight is comparable to diesel units and can be retrofitted into existing trailers. The CB-40 uses a patented self-contained liquid nitrogen cooling system to achieve consistent temperature control with few moving parts.

The new 53-foot reefer trailer offers a temperature setpoint control that can be adjusted to match payload requirements that potentially could be used for shipping of biologics such as upcoming Covid-19 vaccines.

Demonstration runs conducted from Salt Lake City to Los Angeles and Denver reportedly were successful with the 525-mile Denver run going through varied outside air temperatures and multiple stops for unloading while maintaining internal temperature at -15°F.

Reflect Scientific, based in Orem, Utah, develops and markets proprietary technologies in cryogenic cooling for the biotechnology, pharmaceutical, medical and transportation markets.

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Omnicell rebrands unit with mission to raise quality at lower cost for providers and payers

Omnicell, Inc. is rebranding its Population Health Solutions division into EnlivenHealth, a unit dedicated to enabling retail pharmacies and health plans to improve patient outcomes while reducing costs through software-as-a-service technology.

The newly named division serves nearly 30,000 retail pharmacies across the country, delivering patient engagement and personalized communications tools to pharmacists.

Technology services offered include medication synchronization designed to align prescription refills to a single date each month, communications programs that help pharmacies and health plans streamline workflow and create personalized patient care, and at the same time support patient satisfaction and retention.

“The mission of EnlivenHealth is fundamentally about bending the quality and cost curve for healthcare providers and payers,” according to Randall Lipps, chairman, president, CEO and founder of Omnicell. He added that the company’s vision aims to leverage data intelligence, and drive workflow automation, digitization and optimization.

Other EnlivenHealth services include medication therapy management, interactive voice response, patient adherence, opioid mitigation and tailored population health programs.

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International logistics firm takes steps to build supply chain visibility and resiliency

Chicago-based project44, a supply chain visibility and logistics service, announced a series of new capabilities offering enhanced collaboration, automation and predictive insights to help shippers drive performance, productivity and customer experience.

In the pharmaceutical and biotech sectors the company provides a range of temperature control services, predictive tracking, secure data flow, collaboration, rapid carrier onboarding and accelerated ROI, according to the company.

Transportation and shipping types served by project44 include air, rail, ocean, truckload, less-than-truckload, final-mile and other modes in more than 120 countries.

“With increasing demands for agility, the world’s leading brands are looking for a new level of real-time collaboration, automation and predictive insights,” said Jett McCandless, founder and CEO of project44. “Our new capabilities can help them make faster, more effective decisions and, as a result, build more resilient supply chains.”

The newly launched capabilities include:

  • Improved carrier collaboration: Transportation carriers now have access to a carrier-centric interface that visualizes current and historical shipment data along with benchmarks broken down by lane. Shared real-time access to tracked shipments and analytics enables a more collaborative relationship that improves service levels, reduces costs and empowers more efficient exception management.
  • Increased pre- and post-shipment workflow automation and orchestration: Organizations can automate and orchestrate truckload and less-than-truckload tender as well as dispatch and digital document retrieval processes, including electronic bill of lading and proof of delivery in North America and Europe.
  • Harness multimodal data to unlock predictive insights: Deeper predictive and exception management capabilities are provided to proactively manage multimodal shipments. Real-time condition monitoring with configurable notifications ensures regulatory compliance and significantly improves cold chain visibility on temperature-sensitive shipments for pharmaceutical, food and beverage and consumer packaged goods companies.
  • Gain order and inventory level visibility: Enhanced order and inventory visibility improves operational efficiency, on-time delivery and proactive decision-making by providing a single view of associated SKUs, orders and shipments, while also predicting risk using a predictive health scoring algorithm.

Life sciences companies using project44 services include AbbVie, Bayer, the Alcon unit of Novartis, pharmacy chain Walgreens and medical equipment company ResMed, according to the project44 website.

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MilliporeSigma making headway on new membrane production plant

Progress continues on MilliporeSigma’s new $165-million membrane production plant in Darmstadt, Germany, part of an overall $1.2 billion global headquarters investment that Merck KGaA announced last year.

New membrane production plant. (Image courtesy of MilliporeSigma)

The membranes are critical components in Millipore Express aseptic filters that help ensure the sterility of biological drug products.

“This investment increases our membrane manufacturing capacity and allows for more supply chain diversification,” Chris Ross, interim CEO of MilliporeSigma, said as the company held a topping-out program for the new manufacturing facility this week.

Construction began in March and is expected to be completed in 2022, followed by production process validation and commercialization. The new four-story membrane plant will incorporate immersion membrane casting equipment, quality control laboratories and offices, and add about 55 new jobs, according to the company.

Millipore Express membranes manufactured at the new Darmstadt facility will be processed into filters for pharmaceutical production at MilliporeSigma’s existing device center in Jaffrey, New Hampshire.

The life science business of Germany-based Merck KGaA, which operates as MilliporeSigma in the U.S. and Canada, has some 22,000 employees and 59 manufacturing sites worldwide with products focused on scientific discovery, biomanufacturing and testing services.

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New line of thermal packaging hits the market

Packaging Technology Group, Inc., a provider of thermal packaging for the biopharmaceutical and life sciences sector, has initiated a new line of off-the-shelf pre-qualified shippers, including an eco-friendly alternative.

As pharmaceutical manufacturers race to respond to the global health crisis with a vaccine, the need to protect any potential vaccine’s temperature tolerance remains a priority. The World Health Organization reports that up to 50 percent of vaccines are wasted each year, often due to inadequate temperature control in the supply chain.

The new off-the-shelf line includes small, medium and large shippers that all maintain a temperature profile of 2-8°C for 48 to 96 hours. Each shipper has a qualified design to perform in the summer and winter seasons.

The pre-qualified products are offered in four different insulating materials, including expanded polystyrene, cellulose, vacuum insulated panels and polyurethane.

The shippers in the cellulose line are 100 percent curbside recyclable and certified re-pulpable, so the entire box can be disposed of in a standard recycling bin. In addition, Packaging Technology reports that, to date, it has helped save roughly 400,000 pounds of expanded polystyrene from landfills.

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J&J and Europe agree on Janssen Covid-19 vaccine candidate, subject to regulatory okay

The European Commission (EC), acting on behalf of the European Union (EU) member states, has approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its Covid-19 vaccine candidate following approval or authorization from regulators.

The member states also have the option to secure up to 200 million additional doses, according to an announcement issued today by Johnson & Johnson.

The investigational Covid-19 vaccine leverages Janssen’s AdVac technology that was used to develop Janssen’s EC-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates.

The Covid-19 vaccine, if successful, is estimated at launch to remain stable for two years at -20°C and at least three months at 2-8°C, according to a September 23 company release that noted, “This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.”

The Covid-19 contract follows the conclusion of exploratory talks with the EC. The company said it is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to make its vaccine candidate accessible globally, provided the vaccine has a good safety profile, is efficacious and receives approval or authorization from regulators.

Separate to the agreement with the EC, Johnson & Johnson also announced plans to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower income countries, with delivery beginning mid next year following required regulatory acceptance.

The company is evaluating a single-dose regimen in its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) that started in September. A second Phase 3 study with a two-dose regimen is planned to start later this year.

Johnson & Johnson previously announced it has been scaling up its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year.

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Carrier cold chain initiative targets growing vaccine demand

Carrier Global Corp., a provider of cold chain assets and intelligence, has launched a program designed to help meet the rapidly evolving cold chain demands for advanced refrigeration technology to protect medicines, vaccines and food.

“The times we live in have increased the importance of cold chain resiliency and accelerated the need for more connected solutions from origination to delivery,” said David Appel, refrigeration president at Carrier.

The new Healthy, Safe, Sustainable Cold Chain Program focuses on four key health-related areas:

  • Medicine and food security measures that address refrigeration technology challenges from production to patient and farm to fork
  • Ensuring safety during temperature-controlled vaccine distribution
  • Employing digital technology to connect and enhance cold chain visibility and intelligence end-to-end
  • Reducing loss, waste and environmental impact across the cold chain

The company’s refrigeration technology monitors the safe transport of perishable medicine and food to support supply chain flexibility and product safety.

Carrier’s installed base includes 1.2 million transport refrigeration units, 50,000-plus commercial refrigeration installations and cargo monitoring capabilities for theft prevention, thermal mapping and logistics optimization.

Palm Beach Gardens, Florida-based Carrier offers heating, ventilating, HVAC, and air conditioning, refrigeration, fire, security and building automation technologies.

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Sandoz launches its first RFID-tagged critical injectable medicines

Sandoz Inc.’s first two injectable medicines featuring Radio Frequency Identification (RFID) tags will become available to U.S. hospitals beginning this month through a collaborative effort with automated medication management company Kit Check, Inc.

The medicines include Anectine 200 mg/10mL and Rocuronium 50mg/5mL and 10mg/5mL (paralytics to relax muscles during surgery or other medical procedures). The companies announced that additional Sandoz medicines are expected to be made available to Kit Check’s hospital partners through early 2021.

“Several products included in our collaboration with Kit Check are important hospital medicines that physicians rely on for immediate treatment of critically ill patients,” Carol Lynch, Sandoz president, said in a statement. “This aligns with our strategy to supplement our ongoing work through disruptive channels to ensure a reliable supply of high-quality injectable medicines makes it to hospital patients who need them.”

The move is intended to help hospital pharmacies reduce risk and better support patient treatment in hospitals by providing real-time inventory reports, timely tracking of expiration of products and recalls, and aid in automatic replenishment of supplies long-term, according to the companies.

Kit Check supplies RFID-based medication inventory tracking and automated tray processing at more than 500 hospitals in the U.S. and Canada. The tags are applied to vials, syringes, bags and other medication packages and supplies in trays and kits, and used to track each medication that passes through hospital pharmacies.

Both Sandoz and Kit Check are members of the newly formed industry consortium DoseID, launched in August 2020 to ensure standardization and interoperability of RFID in the pharmaceutical supply chain.

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Continuity Pharma scores $1.5 million development grant

The Defense Advanced Research Project Agency (DARPA) has selected Indiana-based Continuity Pharma, a Purdue University-affiliated company, to receive a $1.5 million grant to develop continuous manufacturing technology.

The COVID-19 pandemic has created supply chain gaps in critical drug products, especially those needed for the most critical patients in intensive care units across the country.

DARPA established a competitive review process to award grant funding to companies presenting advanced manufacturing technologies. Grant specifics include development funding over the next 24 months, with additional funding for commercialization in the subsequent 12 months.

Continuity Pharma’s mission is to apply new continuous manufacturing capabilities to reshore generic drug products to the U.S., with specific focus on drugs in short supply. The company is working with Purdue Research Foundation to secure additional lab space in Purdue Research Park, West Lafayette, IN.

DARPA, located is Arlington, VA, has approximately 210 government employees, including some 100 program managers, in six technical offices. With a fiscal year 2020 budget of $3.45 billion, the agency oversees roughly 250 research and development programs through a series of contracts, grants and other agreements.

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Cryoport completes MVE and CryoPDP acquisitions

Cryoport, Inc. has completed the acquisitions of MVE Biological Solutions, a global supplier of manufactured vacuum insulated products and cryogenic freezer systems, and CryoPDP, a provider of temperature-controlled logistics for the clinical research, pharmaceutical and cell and gene therapy markets.

In 2019, MVE generated revenue of approximately $84 million and CryoPDP generated approximately $47 million of revenue. With the closings, Cryoport’s annual revenue run rate is more than $160 million and both acquisitions are expected to be immediately accretive to earnings.

These two acquisitions strengthen Cryoport’s ability to support the growing need for integrated temperature-controlled supply chain requirements in life sciences, and expand its client coverage in the global cell and gene therapy market.

With the MVE deal, Cryoport also completed its previously announced private placement issuance of $25 million of common stock and $250 million of newly designated Series C convertible preferred stock to funds affiliated with The Blackstone Group Inc.

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Aktana touts a next-generation form of AI for commercial interactions

Aktana has had significant success in recent years in winning over pharma companies who want to add AI power to their salesforce automation tools; half of the top 20 pharma companies currently use its systems. Now, the company is introducing a next-generation version, branded as the Contextual Intelligence Engine, and claiming that better recommendations for sales and marketing actions will come out of this engine.

Commercial life sciences AI, generally, relies on gathering as wide a variety of data points as possible on the activities and intentions of healthcare professionals, such as the conferences they attend, the peer relationships they have, their prescribing activities and the like. When all goes well, this data, analyzed by the right algorithms, should produce recommendations and projections on next steps sales and marketing teams should take.

According to Aktana CEO Dave Ehrlich, this process is now being enhanced by providing more capacity for salespeople and marketers to add their own expertise to the analysis; Aktana customers can also add their own computer algorithms to those offered by the company. Another feature is “explainable” AI—having the system so set up that the rationale for a recommendation is made clear. (Many AI systems suffer from a “black box” problem—results come out of the analysis, but it’s unclear why that result was chosen).

The end result of this process, says Ehrlich, should be sales reps receiving more relevant recommendations; marketers enabled to execute marketing plans more accurately, and medical science liaisons being better prepared to address HCP concerns.

 

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Drug importation from Canada steps closer to realization

It’s taken nine months, but the Trump administration has delivered on one of its politically popular proposals: drug importation from Canada. HHS issued a Final Rule (soon to be published in the Federal Register), “Importation of Prescription Drugs,” [Docket No. FDA-2019-N-5711], scheduled to go into effect after 60 days. The original proposed rule appeared last December.

In the interim, HHS and FDA received some 1,200 comments on the rule, but appears to be much as originally proposed. For now, states and territories (and later, wholesalers or individual pharmacists) can sponsor a Section 804 Importation Program (SIP), managed by the sponsor and overseen by FDA. The Sponsor will select an Importer who will deal with a Foreign Seller (in Canada). The Foreign Seller is to be registered both with Health Canada and with FDA; the Importer is to be a US entity. Those three parties will work together to ensure that only drugs licensed to be sold in Canada and that meet FDA requirements, and are tested for quality by either the manufacturer or the Importer, will be allowed into the US and prescribed to patients.

President Trump touted the program as part of an “America First Health Plan” in a speech in North Carolina on Sept. 25. “This will be a game changer for American seniors. And by allowing you to do this through Canada, we’re doing it very, very quickly. So it goes very fast. And the new rule goes into effect as of today,” he said, but as is often the case with his pronouncements, that isn’t quite true, if only for the 60-day provision.

According to Kaiser Health News, Florida is primed to go forward, and has a request for contractors already in place. Other states—Colorado, Maine, New Hampshire, New Mexico and Vermont—also intend to start programs.

The HHS Final Rule addresses a key obstacle of previous federal efforts to permit importation—that the Secretary of Health needs to certify the safety and cost savings of such a program—by essentially asserting both those points. It’s left to states, the Sponsors, to collect the necessary documentation; as to cost savings, the rule simply sidesteps the matter, saying “We are unable to estimate the cost savings from this final rule because we lack information about the likely size and scope of SIPs, the specific eligible prescription drugs that may be imported, the degree to which these imported drugs will be less expensive than nonimported drugs available in the United States, and which eligible prescription drugs are produced by U.S.-based drug manufacturers.”

For now, drug importation is a two-year test, to be evaluated after that for its savings. Besides the heavy documentation, testing and relabeling rules, the plan also faces a lack of interest from Health Canada (Canada’s population is one-tenth that of the US, and they are already worried about some drug shortages), and the potential litigation from the US pharma industry.

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Etihad Cargo offers a dedicated life sciences logistics service, PharmaLife

Etihad Cargo has launched the PharmaLife service, comprising both active and passive cargo containers and associated ground services. The company is not new to pharma logistics; a previous service was called TempCheck. It also touts its first-in-class status as the first Middle Eastern carrier to earn the CEIV Pharma certification from the International Air Transport Assn. (IATA).

The coming Covid-19 vaccine delivery flood was a factor in the launch. “The pandemic prompted a reassessment of our top-level services to ensure we can address the specific requirements for shipping high volumes of in-demand product in very short timescales,” explained Andre Blech, head of operations & service delivery at Etihad Cargo. “To avoid last-minute pressure once a vaccine is approved, we have established a dedicated Covid-19 vaccines workforce composed of a steering committee and a working group to manage all anticipated elements.”

Etihad Cargo has 54 stations globally, including Abu Dhabi, Barcelona, Chicago, Paris, Dubai, Frankfurt, Hyderabad, London, Milan, Melbourne, Mumbai, Shanghai, Singapore, and Sydney. A dedicated pharma handling facility in Abu Dhabi is currently being refurbished, among other upgrades in the network.

As part of the role out, Etihad Cargo is currently reviewing the refurbishment of a dedicated pharmaceutical handling facility to accommodate increased capacity at its hub in Abu Dhabi, as well as further thermal covers, and enhanced capabilities at origin stations based on pharma trade lanes and specific requests.

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Digital pills, aka ‘ingestible sensors’, are at a crossroads

EtecctRx, one of a handful of companies pursuing what has variously been called “digital medicine,” “digital pills” and “ingestible sensors,” has appointed Valerie Sullivan, an executive experienced in patient support functions, and is going forward with its IDCap technology for monitoring patients taking oral drugs.

Meanwhile, over the summer, a dramatic confrontation has played out among investors in Proteus Digital Health, one of the pioneering firms of this technology. Having reached a market capitalization of $1.5 billion at one point (and absorbing some $420 million of investor funds), a bankruptcy judge approved the sale of the company to Otsuka Pharmaceuticals, one of its investors (and customers), for all of $15 million. Other investors, including Novartis, had contended the price was a fire sale and that the company’s 600-some patents were worth considerably more, but the bankruptcy judge disagreed.

EtectRx’s Sullivan says that in contrast to Proteus and other companies in the digital pill arena, her company’s focus is almost exclusively on patient adherence, in both clinical trials and commercial brands. “This pandemic era we’re in has ramped up interest in telehealth generally,” she says. “The remote patient monitoring that ID-Cap enables can reduce clinical trial costs, eliminate non-adherence among patients and allow for real-time intervention with them.” Once the EtectRx capsule is swallowed, a signal of that event is received (via a wearable reader that transmits to a smartphone) by a clinician within six minutes.

EtectRx has four NIH-sponsored trials running or about to start up, involving HIV treatment or prevention and a variety of shorter- and longer-term adherence studies. Looking ahead, Sullivan says that a strong opportunity should exist for oral oncology drugs, which can have highly specific treatment regimens.

There are other ingestible sensor developers, including implantable drug delivery mechanisms or diagnostic medical devices, each with a goal to provide signals while analyzing patient response. Otsuka’s interest in Proteus has been based on Abilify-MyCite (aripiprazole tablets with sensor), for various mental-health conditions. Meanwhile, adherence continues to be a problem across the board for pharma, with getting and keeping patients on therapy still a significant factor in healthcare despite years of efforts to counter noncompliance.

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Cryoport acquires CryoPDP for specialized temperature-controlled shipping

Cryoport, whose business a few years ago was mostly around providing metal containers (dewars) for cryogenic shipping of life sciences materials, has now become a global player with a focus on the rapidly evolving cell and gene therapy (CGT) field. It opened a service center in the Netherlands in 2019 along with a European-based partnership. Now that globalization has jumped ahead with the acquisition of CryoPDP, a Paris-based provider that mirrors Cryoport’s offerings of containers and packaging, logistics and courier services, and clinical trials support.

The transaction is valued at €49 million (subject to closing conditions); CryoPDP had revenues of €42 million in 2019 (about $50 million). CryoPDP has 220 employees, operating in 22 facilities in 12 countries. According to a press release, it has handled over 300,000 shipments for life sciences over the past 25 years. Part of the company was originally a subsidiary of Air Liquide, the industrial gases producer; Air Liquide sold the business to a Paris-based private-equity firm, HIvest Capital, last spring, who has now turned the company over to Cryoport.

“Our acquisition of CryoPDP is an important milestone in carrying out Cryoport’s strategy to further entrench and strengthen our global footprint and support capabilities for the entire life sciences industry,” said Jerrell Shelton, Cryoport CEO, in a statement. “CryoPDP is especially strong in EMEA and APAC, where it enjoys a strong reputation as a valued specialist logistics provider to CROs, the pharmaceutical industry, and the life sciences clinical research community.”

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Addressing shortfalls in sickle cell specialized care access

Directors of the top sickle cell disease (SCD) programs in the US recently published the first set of recommendations for establishing SCD centers aimed at improving access to care for adults living with the debilitating, lifelong blood disease. The recommendations, which resulted from a study done in preparation for an American Society of Hematology (ASH) workshop in 2019, outline the essential components that must be in place to establish an adult SCD treatment center.

SCD patients in the US often lack access to comprehensive care to manage their condition, help them prevent emergency department visits, and avoid serious complications.

The recommendations, published in Blood Advances, codify the required components of establishing SCD adult care centers. These requirements include:

  • Multidisciplinary, team-based, evidence-guided care that is coordinated throughout the institution
  • The SCD center as the recognized authority for managing SCD within the institution
  • A physician lead who is considered an SCD specialist
  • One or more social workers, a patient coordinator, and dedicated nursing staff
  • The ability to offer acute and chronic pain management, transfusion, and access to specialists

The paper makes recommendations for additional important, but not required, personnel such as clinic managers, behavioral health staff and psychologists, physical and occupational therapists, and pharmacists. Altogether, the recommendations define comprehensive care for SCD as team-based, holistic, and tailored to the unique needs of individuals with this condition.

SCD is the most common inherited red blood cell disorder in the US, affecting an estimated 100,000 people. According to the Centers for Disease Control and Prevention, SCD affects one out of every 365 Black or African American births and one out of every 16,300 Hispanic American births. Individuals with SCD suffer from acute pain episodes and chronic pain, and may be affected by an array of other organ complications, which can cause disability or even death.

Since the universal adoption of newborn screening in the US in 2006, care for children living with SCD has improved. However, their access to appropriate, quality care often suffers in the transition to adulthood because of a shortage of specialized providers (adult patients are reportedly more likely to receive care in community hospitals, where SCD-specific experience is less common) and gaps in coordination among the various primary care physicians and specialists who might treat a patient with this disease. Other barriers to specialized care for adults with SCD include those related to health insurance cost and coverage, socioeconomic status, and co-existing conditions.

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US Covid-19 vaccine distribution will start with McKesson

Saying it is “expanding an existing partnership with the Centers for Disease Control,” the Irving, TX firm has announced its designation as the “centralized” distributor of future Covid-19 vaccines. “We are honored that the U.S. government has asked McKesson to play a key role in the effort to distribute COVID-19 vaccines,” said CEO Brian Tyler in a statement.

In all likelihood, multiple other distributors will be involved as well, possibly as vaccines are cross-docked from McKesson facilities to those of other distributors. That is the pattern for the seasonal flu vaccine, where nearly 200 million dosages move rapidly into hospitals, clinics, retail pharmacies and public health facilities each year. One complication of the Covid-19 process is that some or all of the vaccines will require refrigerated (or possibly deep frozen) storage and transport—it depends on which vaccines ultimately are cleared for administration.

McKesson has been the lead distributor of the CDC’s Vaccines for Children Program (VFC), based on a competitive 2016 contract award. VFC provides vaccines for Medicaid and other underinsured children.

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2020 Inc. 5000 lists 10 specialty pharmacies

A privately held pharmacy benefit manager, RxAdvance, has the No. 1 spot among 10 specialty pharmacies listed in this year’s Inc. 5000 (see table). With publication of the Inc. 5000, readers get a view of some of the elements of privately-held companies, whose financials are usually not apparent. RxAdvance’s news release does reveal that the company’s overall revenue is $2 billion—and given that its three-year growth rate is 1,071%, that is quite an achievement.

Inc 5000 specialty pharmaciesOverall, however, the Inc. 5000 data indicates a slowing of the growth among specialty pharmacies, which has been meteoric over the past decade. PantherRx—which is still showing dramatic, 391% growth—is now No. 1,154 on the list; it entered the Inc. 5000 in 2016 at No. 9 on the list. (Granted, revenue growth gets harder as revenues mount, but its 2016 three-year growth rate was over 13,000%.)

It is important to note that the Inc. 5000 data is not a measure of overall specialty pharmacy (let alone specialty pharmaceutical) trends; the industry is dominated by big, publicly held companies like CVS Health or Cigna-Express Scripts. The past year is also notable for the exit of Diplomat Pharmacy, which grew phenomenally during the 2010s, went public, then stumbled and was acquired by Optum earlier this year.

According to Inc. magazine, publisher, the rankings are based on percentage revenue growth when comparing 2016 and 2019. To qualify, companies must have been founded and generating revenue by March 31, 2016. They had to be U.S.-based, privately held, for profit, and independent—not subsidiaries or divisions of other companies—as of December 31, 2019. The full listing is available here.

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Weekly Roundup: Horizon, Prime Therapeutics partner with Amazon’s PillPack

To make it easier for members to fill and manage multiple prescriptions, Horizon Healthcare Services and its pharmacy benefit manager, Prime Therapeutics, now offer members an integrated pharmacy experience with PillPack by Amazon Pharmacy. Under the partnership, Horizon will provide its members simplified PillPack sign-up, choice of multi-dose packages or traditional medicine bottles, and estimated out-of-pocket cost information to help members make informed Rx choices.

The integrated process, companies said, will ensure a member’s necessary information is safely and securely transferred to PillPack.. This saves time and effort as members avoid reentering (or potentially mistyping) their insurance details, demographic information, or medicine lists.

According to Prime Therapeutics and Horizon, more than 33 million Americans take five or more medications daily, making it crucial to avoid missed doses due to drug cost uncertainty, unclear directions, or inability to go to the pharmacy.

Horizon members, through this arrangement, can choose PillPack as their pharmacy from their health plan’s web portal. They can decide how and when medicines arrive. PillPack’s pre-sorted packets—that can include both Rx and over-the-counter medicines—can be delivered monthly, directly to their door, or Horizon members can opt to receive  90-day supplies of their prescriptions.

J.D. Power releases 2020 U.S. Pharmacy Study

Those pharmacist consultation kiosks, exam rooms, and walk-in vaccination sites popping up in neighborhood pharmacies across the country are not a coincidence. They are part of a concerted effort by the nation’s major pharmacy chains to become the center of gravity for consumer healthcare. According to the J.D. Power 2020 U.S. Pharmacy Study, released on Wednesday, the strategy is working, with pharmacy expansion into primary care driving significant increases in both satisfaction and consumer spending.

The study reports nearly half (48%) of retail pharmacy customers have used at least one health and wellness-oriented service provided by their pharmacy this year, up 5% points from 2019. Overall customer satisfaction with the retail pharmacy is 26 points higher (on a 1,000-point scale) among customers who use health and wellness services vs. those who have not.

Also included in the study were yearly rankings of pharmaceutical providers by customer satisfaction. Good Neighbor Pharmacy ranked highest among brick-and-mortar chain drug store pharmacies for a fourth consecutive year. Sam’s Club topped the list  among brick-and-mortar mass merchandiser pharmacies for a fifth straight year. And Wegmans ranked highest among brick-and-mortar supermarket pharmacies for a third year in a row. Humana Pharmacy scored the highest in the mail order segment for a third straight year as well.

The 2020 study is based on responses from 13,378 pharmacy customers who filled a Rx during the three months prior to the survey period of September 2019 to May 2020.

Marken launches new cell and gene control center

Marken has opened a dedicated cell and gene control center in North Carolina, built on the same property as its corporate headquarters. The facility offers full visibility of all complex cell and gene shipments anywhere in the world. Marken’s center will closely monitor every shipment for these highly complex therapies, monitoring weather, flight delays, and other potential risks to inform critical-path decisions. The space also includes a gallery for customer tours and training purposes.

The new control center is Marken’s latest investment in this segment. The company has six designated Centers of Excellence for cell and gene logistics across the US, Europe, and Asia, adding to its global network of liquid nitrogen storage facilities.

Rx-360 expands pharmaceutical-based audit program

 Rx-360, an international pharmaceutical consortium dedicated to supply chain integrity and patient safety, announced the expansion of its audit program this week, including adding new audit partners, an expanded audit checklist menu, and the integration of remote auditing into the program.

Regarding the latter, COVID-19 has changed the global environment, and auditing needs have evolved. Rx-360 is now offering remote audits to assist the pharma industry in meeting and maintaining quality standards.

This year, Rx-360 added audit checklists for supply chain security and single-use systems. For the last several years, the company has focused efforts on the Joint Audit Model. This program allows for industry manufacturers to confidentially join and sponsor an audit. In return, they minimize their audit costs through co-sponsorships as well as participating in the member-only credit program. In 2020, Rx-360 added the ability for pharmaceutical suppliers to not just sponsor audits, but also promote sole sponsorships.

Rx-360 is partnering with ASC Associates Ltd, blue inspection body GmbH, BSI, and SQA Services to help support its Rx-360 Audit Program.

Report: Compounding pharmacies market to reach $14 billion by 2026

A new research report by Global Market Insights estimates that the valuation for the compounding pharmacies market will cross $14 billion by 2026. The rising demand for compounding pharmacies due to drug shortages and preference for personalized medicines will accelerate the overall business progression, the report predicts.

Customized medicines can offer better health outcomes to patients, particularly infants, senior citizens, and individuals allergic to certain ingredients in commercial medicine. Moreover, compounding allows the provider to request for drugs to be prepared according to patient’ specific needs for effective care. Compounding pharmacies can combine drugs into a single pill, reducing the dosage frequency.

 

– News assembled from published wire reports

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IQVIA productizes its Ada machine intelligence in orchestrated salesforce management

In 2017, IQVIA announced its Orchestrated Customer Engagement (OCE), a new salesforce-automation solution to manage the pharma sales process. The emphasis then was on being able to coordinate multiple parties—sales reps, medical science liaisons, marketing services and more—to streamline the process and achieve better results.

At the time, an in-house technology called Ada machine learning was mentioned as an available resource to the process. Now, that resource, along with OCE itself, has been productized as OCE Optimizer.

According to IQVIA, OCE Optimizer leverages IQVIA’s Ada machine learning algorithms to draw intelligent insights from varied information sources, including healthcare organization affiliations, call reports and access changes. With a detailed and current profile of every HCP, commercial teams then use OCE Optimizer to make on-demand course corrections to field alignments, segments and targets, and omnichannel engagement plans using visual tools and what-if scenarios for complex territory alignments.

“What is truly exciting about Optimizer is the potential it has to consolidate and simplify complicated commercial activities like re-aligning territories and products, customer segmentation and generating engagement plans,” says Manish Goel, VP and GM, customer engagement. “Ada helps power the intelligence in OCE Optimizer to assess and optimize the alignments, identify new targets/segments and adapt multi-channel engagement plans in near real time to quickly respond to the changing business environment.”

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Sonoco ThermoSafe will sponsor an industry-wide cold-chain blockchain

For several years now, various players around the logistics of temperature-senstive pharmaceuticals have looked into blockchain technology, and some have adopted blockchain-like features in their data-handling systems. Now, one of the leading providers of cold-chain packaging—Sonoco ThermoSafe—is plunging in with both feet. The company has partnered with IBM to set up what will be called the PharmaPortal platform, and the stated goal is to develop a vendor-neutral to “to trace assets across many different supply chain participants, record a single version of the truth on all events generated on a package’s journey, integrate this data with that of other businesses across an industry-scale network, and provide access controls to help ensure each data owner maintains control over who can access it on the network,” according to Sonoco.

IBM has invested heavily in blockchain for the past several years, mostly involving HyperLedger Fabric, one of the version of blockchain that supports “smart contracts” (a way to have self-acting files or documents that could, for example, complete a sales transaction when the correct data has been provided). Around 2017, it announced the IBM Food Trust, which now has over 200 member organizations that share data on the provenance, quality and status of food products in a supply chain.

Paul Chang, global industry lead for blockchain at IBM, says that the company’s “production scale” developmentof blockchain, enables a relatively fast ramp-up of capabilities, including cryptography for protected messaging, permissioning of participants and other services. A built-in feature of IBM’s implementation is GS1-standardized messages, such as GLN (Global Location Number) and EPCIS, a framework to record supply chain events. (Pharma supply chain managers involved in compliance with the Drug Supply Chain Security Act will recognize the value of these GS1 standards, which are state-of-the-art in that application.)

Unlike IBM Food Trust, however, Sonoco ThermoSafe is setting up PharmaPortal to be governed separately from IBM; according to Christopher Day, director, marketing and innovation at Sonoco ThermoSafe, PharmaPortal will eventually be governed by its members. In blockchain-speak, Sonoco is the “convener” of what will become a “permissioned network” (meaning that only credentialed organizations can be members).
Data is the product

Sonoco’s PharmaPortal, as innovative as it promises to be, is only one of many approaches to cold chain tracking. Longtime US and international standards have required pharma cold-chain shipments to be monitored, even in transit from one location to another; now blockchain promises to make this data sharable to trading partners In recent months, two companies, va-Q-tec and SkyCell, whose products partially overlap with Sonoco Thermosafe’s, have ongoing blockchain-related projects. Among logistics providers (for all countries and industries) there is a Blockchain in Transit project. Meanwhile, a variety of telecom solution providers are offering systems and software to manufacturers to collect their own shipment’s operation and performance, in some cases duplicating the data collected by the container provider or by the freight forwarder. If the interoperability issues common in tracking the identity of drug shipments (DSCSA compliance) is any indication, the industry is heading for multiple blockchains an multiple interoperability issues..

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Trump directives to rearrange drug pricing land with a thud

On July 24, President Trump held a ceremony to sign four executive orders affecting drug pricing, distribution and reimbursement, but commentary was nearly immediate that the orders would have little near-term effect, amounting, as one industry expert put it, to “political theatre” in the runup to the fall election.

One of the orders, “Access to Affordable Life-saving Medications,” may make a near-term difference to some people, some of the time, for two drugs: insulin and epinephrine pens. The order requires Federally Qualified Health Centers (FQHCs—a small subset of the providers who run 340b discount programs) to pass their reduced pricing for those drugs on to low-income, uninsured patients. It’s a gesture to address the situations where the rapidly growing 340b program generates savings for healthcare providers (generally, hospital pharmacies), but only indirectly for indigent patients.

Another executive order, “Lowering Prices for Patients by Eliminating Kickbacks to Middlemen,” is a new effort to revive a failed attempt to ensure that the rebates collected by pharmaceutical benefit managers (PBMs) flow through to the prices that patients pay. This idea was floated in Trump’s 2018 “Blueprint to Lower Drug Prices,” but a year later the rebate-reform portion was dropped. PBMs like managing rebate programs, and payers like getting some of the rebate money returned to them, ostensibly to lower insurance premiums. The executive order instructs HHS to develop new rebate policies for Medicare; that process can take months to years before becoming effective.

The importation idea—again
A third order, “Increasing Drug Importation to Lower Prices,” brings up another Blueprint idea that has been kicking around Washington for many years. This time, Trump is pushing for HHS to begin “facilitating” waivers on the importation prohibition—something several states have initiated as well. The order also specifies bringing in insulin “upon a finding by the Secretary that it is required for emergency medical care”—presumably at a lower cost.

Importation (also known as “reimportation”) would allow drugs from other countries (usually, the target is Canada) to be brought into the US without direct FDA oversight. FDA did issue a Notice of Proposed Rulemaking on this in December 2019, but nothing has happened since the comment period closed.

The White House ceremony included Florida’s Governor Ron DeSantis, where that state passed a law a year ago to begin an importation program. As of June 30, the state’s Dept. of Health issued a solicitation for a vendor to manage the program, and a vendor selection will occur in mid-December.

The fourth order was only hinted at by Trump, who said it is on hold for a month pending pharma industry response. Yet another idea floated in the Blueprint, it will establish some form of reference pricing, whereby US Medicare or Medicaid drug prices will be mandated or negotiated based on some non-US pricing regimen. In the past, this was described as a basket of various international prices but for now the details are up in the air.

There is an official transcript of Trump’s remarks as he signed these orders, and it’s a breathtaking ramble through facts, factoids and fabrications. “We strongly defended Medicare and Social Security, and we will always protect — and we have been protecting, and we always will — protect Republicans” is arguably the most eye-popping statement. Nearly all the press reports about the executive orders ignored Trump’s statements—wisely so—but there’s considerable entertainment value in the commentary of what ought to be significant actions on US drug policy.

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Prioritizing cold chain sustainability

According to results from a newly released cold chain sustainability survey, the biopharma industry is increasing its pace to prioritize sustainability in business and operational strategies. Nearly half of all respondents in the survey, produced by Pelican BioThermal, indicate that their existing practice had always factored sustainability into cold chain purchasing decisions.

Overall, the survey uncovered three key trends. The first is that although 66% of organizations rate sustainability as very important, valuing sustainability hasn’t yet translated into widespread action. More than half of respondents—53%–reported their companies don’t currently use sustainable or green initiatives in their companies. But organizations expressed a desire to work with companies that help them advance their sustainability goals, ultimately moving sustainability from valuable to actionable.

In 2015, the United Nations and its member countries created Sustainable Development Goals (SDGs) to guide the world on a sustainable path to 2030. With mounting pressures to improve sustainability, including from consumers and corporate stakeholders, biopharma companies are actively looking for ways to preserve the planet, reduce waste, and strengthen their brands.

The second trend speaks to how cold chain partners can help advance biopharma’s sustainability goals and how life sciences companies seek to partner with like-minded organizations. More than half of biopharmas indicate that it’s very important to choose cold chain packaging options that advance their organization’s sustainability.

Additionally, 64% inquire about sustainability when performing audits of suppliers and 52% reported that they, too, were audited for sustainability by vendors supplying their organizations.

The final trend reveals that recyclability and lower emissions matter. Greater focus is being put on how cold chain packaging is constructed, with increasingly high value placed on cold chain packaging that is recyclable or can more easily enter the waste stream. Nearly half of the survey respondents (48%) said they always look for packaging with these characteristics.

Likewise, the industry tends to lean toward lighter, more energy efficient shippers that reduce carbon emissions for temperature-sensitive pharma products being shipped by air. Fifty-six percent, according to the survey, already use these shippers and 81% are likely to use energy-efficient packaging in the future.

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Speed-date with the DSCSA pilot project sponsors

Bells didn’t exactly ring out when the organizations conducting pilot projects addressing the Drug Supply Chain Security Act (DSCSA) filed their reports with FDA. That agency had picked 20 companies or groups to evaluate a range of technical and business issues for DSCSA compliance, which has a 2023 deadline for completion. Some of the 20 made their reports public as early as February; others announced theirs in June, and some have not published anything.

Now, the Partnership for DSCSA Governance (PDG)—the creation of which, strangely, was one of the pilot projects—is holding a webinar on July 23-24 for the sponsors to present their findings. The webinar will be somewhat like speed dating: each presentation (18 of the 20 have signed on) will have an 18-minute slot. Some of the already-public FDA filings are 40+-page reports, so there will be some fast talking to make the presentations.

When FDA announced the program, it said that it “will end after the pilot projects are completed and FDA issues a final program report,” but that report is still in the works.

Industry slogs ahead

The pilot program was something written into the original 2013 DSCSA law, and there have been regulatory deadlines to be met since 2015. Currently, much of the US focus is on the requirement that wholesalers who receive product returns (usually, overstock from pharmacies) need to validate those returns with the original manufacturer before sending the product back into commercial distribution. The Healthcare Distribution Alliance had estimated that these “saleable returns” constitute 2-3% of total pharmaceutical inventory—a not-insignificant quantity, worth billions of dollars.

Wholesalers, and their solution providers, have been busy setting up “Verification Router Services” (VRSs) to accommodate the data-storage and messaging requirements for saleable returns validation. The original deadline for meeting the DSCSA requirement was November 2019, but that was pushed a year out. Now, because of the pandemic, industry insiders are concerned that the distribution network will be unable to meet a November 2020 deadline. 

Registration for the webinar is accessible at: https://info.leavittpartners.com/dscsa-pilot-program-round-robin

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DHL Supply Chain boosts its US life sciences investment by $70 million

Having committed $150 million to life sciences resources in the US in 2019, DHL Supply Chain is upping its ante with a new round of investment, totaling $70 million. Expansions are planned at Las Vegas, Memphis and Indianapolis, plus two other undisclosed locations; total 2-8°C storage capacity is rising from 12,000 pallets to 15,000, and overall storage capacity is rising by 1 million sq. ft. Additionally, the company is investing in more automation and IT, including expanded e-commerce capabilities and robotic devices on the warehouse floor.

One of the drivers of the current round of expansion, says David Kopstein, VP of Life Sciences & Healthcare, DHL Supply Chain North America, is that manufacturers are expanding their inventories of both ingredients and finished product, necessitating more storage capacity at logistics providers. DHL Life Sciences includes pharma, med devices and OTC products; recently the company also announced a 10-year relationship with Siemens Healthineeers, providers of medical imaging equipment, diagnostics and other products, for sales and service.

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Walgreens takes another stab at retail clinics with VillageMD partnership

Only last year, Walgreens Boots Alliance (WBA), was partially exiting the retail clinic business, giving up some 160 self-administered clinics while maintaining about 200 clinics operated by others in Walgreens pharmacy locations. Now, it has announced a $1-billion equity and growth investment in VillageMD, an operator of full-service clinics, with a goal of adding 500-700 sites co-located with Walgreens pharmacies.

VillageMD currently operates around 1,000 clinics in the metro areas of nine states: Texas, Arizona, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan and New Hampshire. WBA says that 50% of the future locations will be in Medically Underserved Areas/Populations, a designation of HHS. VillageMD’s model is to provide primary care (it has 2,800 physicians in its network) as well as telehealth and at-home services, with the promise of more economical care and higher adherence to therapy.

The retail clinic model, when aligned with a pharmacy store, has been a compelling idea for the better part of a decade, but the results to date have been mixed. According to press reports, the number of retail clinics has topped out at around 2,000; roughly half of those are CVSHealth Minute Clinics. The idea has been that more prescriptions will be filled, and more foot traffic through the pharmacy floor, occurs when patients have just seen a healthcare provider who works adjacently. These days, urgent-care clinics (generally, not co-located with a pharmacy) and the outpatient services of large health systems, are competing for the same patient opportunity.

There is potential for the retail clinic model to offer a new or at least different distribution channel for pharma, in that devices (such as automated injectors), drugs and patient assistance can all be provided while physicians are involved. How significant this will be remains to be seen.

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Kalderos’ 340b management tools will broaden with new funding

Kalderos, a Chicago analytics company, attracted new attention a year ago as it garnered a round of funding and won business from 7 of the top 15 pharma companies to help them manage their interactions with providers over the 340b program. That program, which represented $30 billion in 2019 drug revenue according to DrugChannels.net, enables hospital pharmacies to take significant discounts on drug purchases, ostensibly to provide lower-cost drugs to indigent patients—but the allocation of those funds is at the discretion of the hospital. The sales were up 23% from the year before and have tripled since 2014.

Kalderos’ position in this isn’t to restrict or control 340b sales on behalf of its pharma clients, but rather to enable them to efficiently allocate 340b discounts against other government discount programs—Medicaid, Medicare Part D and some commercial plans. Properly allocating discounts has saved pharma clients $100 million to date (the company launched in 2016), says Jeremy Docken, CEO and co-founder. (Most of these savings come from drugs that received duplicate discounts from state Medicaid programs; also, it’s worth noting that some discounts generate additional price reductions under Average Manufacturers Price [AMP] rules.)

Recently, Kalderos garnered an additional $28 million in Series B funding from Bain Capital Ventures and Mercato Partners. With the additional funding, says Docken, Kalderos is already building out data services for payers and providers, in addition to manufacturers. Transparency and “preventive drug discount management” among all the parties is the goal, he says and ultimately “to further streamline the interactions between participants in the healthcare ecosystem.”

For sure, revenue management and resolving multiple conflicting discount programs will be helpful to all parties involved. The larger question, of course, is whether those parties want to continue the current regulatory setup; the dissatisfaction of manufacturers with the open-endedness of the current 340b setup is growing.

On the horizon, Docken says Kalderos will get involved in patient copay and voucher programs, and perhaps manage them on behalf of pharma. Managing value-based contracting is another potential application. “The ultimate goal is to get discounts to the patients where they are most needed,” he says.

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Clinical trial data-gathering for Covid-19: new technology, new collaborations

So many research projects are underway for vaccines or therapies for SARS-CoV-2 that there are concerns over getting suitable trial patients; it seems foreordained that there will be duplicative efforts and perhaps contradictory findings. A further complication, much commented on in the research arena for trials generally, is that travel and movement restrictions have made conventional clinical-trial practices extremely difficult: patients can’t, or won’t expose themselves to the risks of going to a clinic or hospital as part of a trial protocol.

The research community, and the vendors that serve it, have responded to these difficulties. One notable action comes from TransCelerate, the eight-year-old consortium of leading biopharma companies to pool research efforts. In 2017, TransCelerate had launched DataCelerate, a “cloud-based data sharing platform that allows for deidentified, anonymized pre-clinical and clinical data types to be requested and voluntarily shared.” Now, that platform is being opened to non-TransCelerate members; according to the group, eligible companies or research agencies “with proven human therapeutic clinical research, development and commercialization experience, who can properly manage data privacy and security, in alignment with both current TransCelerate Member Companies’ best practices and regulatory requirements” are eligible to participate.

According to Accenture, which provides the underlying technology to DataCelerate via its AIP+ analytics platform, “In other therapeutic areas, data shared via DataCelerate has already been used to reduce the number of patients in clinical trials, improve trial design, assess safety signals, increase knowledge of disease and treatments and improve the understanding of global patient populations.”

TranCelerate currently has 20 member companies, and is coordinating more than 30 initiatives to improve pharmaceutical research management.

Oracle expands data collection
To its Clinical One clinical-trial management system, Oracle Health Sciences has now added Clinical One Data Collection, which the company says “collects data from any source – forms, wearable sensors, patient apps, electronic health records (EHR), labs – and harmonizes it in a single place.” Earlier, the company also announced additional Clinical One services: its Clinical One Randomization and Supplies Management Cloud Service, which it says reduces the time required for study set up from nearly two months to just a few days. The company notes that Clinical One is already in use in trials focusing on Covid-19 vaccines and treatments.

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