Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant

Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. 

Further, Birinapant also complements the anti-tumor activity of the immune system. Thus, the drug appears to be a promising therapeutic agent in treating different forms of cancer in combination with other drugs. IGM-8444 is another drug that is currently being tested in a phase I dose-escalation study in patients with solid and hematologic malignancies by IGM Biosciences. It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year. 

As per the terms and conditions of the agreement, Medivir is eligible to receive an upfront payment of USD 1 million, followed by an additional USD 1.5 million after Birinapant successfully becomes a part of the Phase I trials. Medivir is also eligible to receive milestone payments up to a total of approximately USD 350 million, plus tiered royalties up to mid-teens on net sales upon the commercial approval of the drug. 

AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences 

AvantGen has announced the licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. It is a panel of high-affinity human monoclonal antibody clones, which binds to two distinct epitopes on the receptor-binding domain of the SARS-CoV-2 spike protein, thereby blocking the spike protein from interacting with ACE2. This eventually averts virus-induced cell-killing, also known as cytopathic effect.

Under the licensing agreement, IGM Biosciences receives the rights to convert the antibody clones into IgA or IgM format for further development for the treatment of COVID-19. While AvantGen received an upfront payment and is eligible to receive milestone and royalty payments.

The companies believe that their candidate in its original IgG format has shown potent neutralization activity in in vitro assays and in an in vivo animal model. This will have an advantage over the multiple vaccines that have been getting EUA, which are not suitable for immunocompromised patients. 

BeiGene, Novartis partner to develop cancer drug Tislelizumab, an Anti-PD-1 Antibody 

BeiGene has announced the collaboration with Novartis Pharma AG to develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. 

Already in markets in China, BeiGene’s Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved for classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. 

The duo will jointly develop the therapy, conducting clinical trials globally. BeiGene is eligible to receive an upfront cash payment of USD 650 million, up to USD 1.3 billion upon achieving regulatory milestones, USD 250 million for sales milestones, and royalties on future sales of tislelizumab in the licensed territory. At the same time, Novartis will take care of regulatory submissions after a transition period and for commercialization upon regulatory approvals. Besides, BeiGene has an option to co-detail the product in North America, which will be funded in part by Novartis.

Valo Raises USD 190 Million in Series B Financing and Unveils Select Therapeutic Programs

Valo has announced the closing of a USD 190 million Series B financing and unveiled select therapeutic programs. The company is creating a new systemic approach for drug discovery and development. The proceeds from Series B will continue to support the discovery and development of therapeutic programs that the company is undertaking. Further, Valo plans to use the sum to advance its proprietary Opal Computational Platform and its build working capital. 

The company plans to combine its unique human-centric dataset (over 125-million patient-years) with its Opal Computational PlatformTM with an aim to leverage machine learning and patient data for the facilitated and speedy development of products at clinical stages. Some of the key preclinical programs that Valo proudly owns include NAMPT, PARP1, USP28, and HDAC3. 

The financing was led by The Public Sector Pension Investment Board (PSP Investments), along with Valo’s existing major investors, including Flagship Pioneering and several new institutional investors, including Invus Public Equities, HBM Healthcare Investments, Atinum Investment, and Mirae Asset Capital.  

Bluebird spins off to two companies, cleaving off its gene therapy, and cancer units

Bluebird bio recently announced its plans to split its genetic disease and oncology businesses. The company has decided to prioritize its severe genetic disease unit and form its oncology business into a new company.

The decision came after the company struggled to commercialize its gene therapies, and as a result, its stocks continue to stumble down. Recently, bluebird bio decided against filing for USFDA approval for its gene therapy for sickle cell disease (SCD) for at least a minimum of 2 years. 

Another of its therapy, bb1111, a LentiGlobin treatment for SCD, was building its submission on promising data from Group C pf the HGB-206 study. The company and the agency had reached an agreement on a path to transition to commercial manufacturing using an analytical comparability strategy, including a suspension-based lentiviral vector (sLVV).

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ViewPoints Interview: Neoleukin’s Daniel-Adriano Silva Shares Insight on Novel Protein Designed to Treat or Block SARS-COV-2

In a recent interview with PharmaShots Daniel-Adriano Silva, PhD, Co-founder and Vice President Head of Research at Neoleukin shared the significance and promise of the findings published in Science and discuss the details of its De Novo Protein Design

Shots:

  • NL-CVX1 (CTC-445.2d) demonstrated the ability to prevent infection of multiple human cell lines in vitro and to protect hamsters from serious consequences of SARS-CoV-2 infection
  • NL-CVX1 is designed to mimic the natural human ACE2 receptor. By doing so, it is designed to be resistant to viral mutation
  • De novo protein design begins computationally, where we identify the structure of the molecule we are trying to build and its interaction with the biological target

.

Tuba: Can we have an insight into Neoleukin’s research published in “Science”?

Daniel: The publication describes the potential of Neoleukin’s de novo protein design platform. In less than three months, our team was able to create novel molecules designed to treat or prevent infection by the virus that causes COVID-19, SARS-CoV-2. Specifically, it details the creation of de novo protein decoys that were designed to bind the SARS-CoV-2 spike protein with high affinity and prevent its association with the viral receptor hACE2, which is required for infection.

Our lead molecule, NL-CVX1 (CTC-445.2d), demonstrated the ability to prevent infection of multiple human cell lines in vitro and to protect hamsters from serious consequences of SARS-CoV-2 infection. Additionally, prophylactic intranasal administration of NL-CVX1 led to survival of all hamsters challenged with a lethal dose of SARS-CoV-2.

The full article “De novo design of potent and resilient hACE2 decoys to neutralize SARS-CoV-2”  can be accessed from the publications page of our website here.

Tuba: Tell us more about De Novo Protein Design?

Source: Neoleukin

Daniel: De novo protein design is a fundamentally different way to think about drug discovery.  Most traditional biologics are created by taking natural proteins and modifying them. De novo protein design begins computationally, where we identify the structure of the molecule we are trying to build and its interaction with the biological target.  These computational designs are then further refined and taken into the lab to be tested to evaluate whether the molecule demonstrates the desired properties.

This new way of protein engineering, called protein design, allows us to design proteins to have specific biologic activities and properties that provide potentially superior benefit over native proteins. Neoleukin Therapeutics is pioneering the application of de novo protein design to the development of therapeutic molecules.

Tuba: Discuss the potential of NL-CVX1 in protecting against SARS-CoV-2 infection?

Daniel: NL-CVX1 is designed to mimic the natural human ACE2 receptor.  By doing so, it is designed to be resistant to viral mutation.

In addition, NL-CVX1 is designed to be stable and could potentially be administered by intranasal spray or inhalation to prevent and treat infection in the lungs and upper airways by SARS-CoV-2.

Tuba: What can we learn about the potential of de novo protein design based on your experience in the development of NL-CVX1?

Daniel: NL-CVX1 was developed in less than three months from concept to preclinical validation. As such, we believe it represents the fastest development of a therapeutic de novo protein.  This rapid timeline demonstrates the potential of our de novo protein design platform to address a wide array of important biological problems.

Tuba: When can we expect NL-CVX1 (CTC-445.2d) to enter into clinical studies?

Daniel: We are currently evaluating the possibility of advancing this molecule to clinical trials in humans, as well as potential strategic partnership opportunities.

Tuba: Can we have a review on NeoLeukin’s lead program, NL-201 which is the world’s first computationally-designed de novo protein therapeutic?

Source: Neoleukin

Daniel: Our first program, NL-201, is a de novo receptor agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at very low doses with minimal impact on immunosuppressive regulatory T cells. Treatment with NL-201 in animal models was well-tolerated and induced durable, anti-tumor immunity.  Additionally, minimal immunogenicity was reported following five weekly doses of NL-201 in non-human primates.

Our corporate update released on November 9, 2020 announced that we remain focused on our efforts to submit an Investigational New Drug (IND) application for NL-201 during the fourth quarter of 2020 and that we do not expect a delay in the submission of our IND due to COVID-19 but acknowledge the potential exists for this timing to be impacted. In addition, we have submitted a Clinical Trial Notification (CTN) application for NL-201 in Australia. The planned first-in-human clinical trials for NL-201 will test intravenous, monotherapy in patients with advanced solid tumors to determine the safety and tolerability of various dosing regimens.

Tuba: . Are you planning to collaborate with academia and industry to explore new applications of Neoleukins’ technology in other therapy areas or indications?

Daniel: De novo protein design is in its infancy, and we would welcome the opportunity to collaborate with academia and industry partners to move this technology forward.  We are focused on developing drugs in the oncology and autoimmune space.  However, given the potentially broad application of the technology, we would be open to exploring collaborations and other research efforts to design other molecules in areas outside oncology and autoimmune disease as well. 

While we are initially focused on establishing single agent activity for NL-201 in cancer, we recognize there may be an opportunity to combine NL-201 with other therapies such as checkpoint inhibitors, cell therapy, antibodies and other agents. 

About Daniel-Adriano Silva:

Daniel-Adriano Silva is aCo-founder and Vice President Head of Research at Neoleukin and is a leader in the fields of protein folding, structure, dynamics, and function and is the primary architect of the Neoleukin Platform.

Related Post: ViewPoints Interview: Kezar’s Noreen Henig Shares Insight on Therapeutic Potential of KZR-616

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Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Shots:

  • Roche has launched Elecsys SARS-CoV-2 Ag test as an aid in the diagnosis of SARS-CoV-2 infections, in the markets accepting the CE Mark. Additionally, Roche has also filed a EUA to the US FDA
  • The test showed 94.5% sensitivity across 200 PCR confirmed symptomatic individuals & 99.9% specificity across 2747 PCR negative symptomatic & screening individuals in clinical studies. The company plans to ramp up production to have a double-digit million number of tests/ month, in early 2021
  • The test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx & oropharynx. The test is the latest addition to Roche’s COVID-19 portfolio

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Business Standard

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UK groups get £12m funding for COVID-19 monitoring software

Researchers at the Wellcome Sanger Institute in the UK are working on software to monitor the genome of SARS-CoV-2 coronavirus in the hope of spotting changes that could affect the fight against COVID-19.

Backed by £12.2 million in UK government funding, Wellcome Sanger and the COVID-19 Genomics UK (COG-UK) Consortium intend to develop a real-time nationwide surveillance system that could identify mutations in the virus.

Wellcome Sanger will use the funding to develop the software to capture genomic information digitally, and pair it up with data from the UK public health agencies and the NHS and Trace programme.

The hope is that monitoring will allow health authorities to quickly identify mutations that might allow the virus to sidestep diagnostics, vaccines and drug therapies, for example, and guide the development of counter measures.

It will also allow linking of viral sequencing patterns with host genomics, immunology, clinical outcomes and risk factors, according to the consortium.

With the second wave of COVID-19 infections now gathering pace, and vaccines on the brink of being made available, genomic data will be critical to determine whether the virus evolves to escape them.

Since the first whole-genome sequence of SARS-CoV-2 was shared online on 11 January, scientists around the world have been sequencing the virus to spot genomic changes that will allow outbreaks to be tracked and controlled.

The effort could also help local authorities respond to outbreaks more quickly, according to researchers, and could become particularly important in allowing international travel to return to some degree of normality.

Specific lineages of virus can be identified from around the world, and that makes it possible to detect lines of transmission by comparing the genetic sequences of virus samples.

Sequencing also allows scientists to monitor key viral characteristics like transmission and disease severity, according to COG-UK director Prof Sharon Peacock from the University of Cambridge.

Since March, COG-UK has published more than 100,000 SARS-CoV-2 genomes, making up over 45% of the global total, an effort that it says has not been achieved previously for any pathogen, anywhere in the world.

The genomic data already generated by the COG-UK network – which includes Wellcome Sanger – has already “provided important scientific insights into the spread and evolution of the virus, at local, regional, national and international scales,” says the consortium.

Earlier this year, Swiss medical data specialist Sophia Genetics launched data mining tools to help researchers examine how the genome of SARS-CoV-2 changes over time, and combine that data with patients’ clinical and genetic information.

Tech company NVIDIA has also made its Parabricks genome-sequencing software available at no charge to researchers sequencing the coronavirus and the genomes of those suffering from COVID-19.

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Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Shots:

  • Qiagen has initiated the commercialization of the portable digital QIAreach SARS-CoV-2 antigen test in the US that can be used by laboratories to detect active infections in 2-15mins.
  • The test provides a higher throughput testing for SARS-CoV-2 antigen by processing up to 8 tests/ hub. The digital results do not need subjective interpretation and enable Ab tests to run simultaneously with Ag tests
  • QIAreach SARS-CoV-2 Ag test is a fast, digital, and easy to use a test that utilizes sensitive nanoparticle technology and is developed in partnership with Ellume. The company anticipate receiving CE-IVD registration for the EU and other markets by the end of 2020

Click here­ to­ read full press release/ article | Ref: Qiagen | Image: Holland One

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Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data

The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.

FDA issues Covid-19 vaccine guidance as White House reportedly relents

The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots:

  • The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process to facilitate the final MAA
  • BNT162b2 vaccinated participants showed a favorable breadth of epitopes recognized in T-cell responses specific to SARS-CoV-2 spike antigen & BNT162b2 demonstrated concurrent induction of high magnitude CD4+ & CD8+ T cell responses which are TH-1 dominant against RBD and remainder of full spike glycoprotein
  • BNT162b2 vaccine candidate (BioNTech’s proprietary mRNA technology and supported by Pfizer) encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S). It is currently being evaluated in an ongoing P-III study with ~37,000 participants enrolled and 28,000 having received their second vaccination at >120 clinical sites worldwide including the US, Brazil, South Africa, and Argentina

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: King’s College London

The post BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2 first appeared on PharmaShots.

Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial

While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.

Gilead takes over distribution of Covid-19 antiviral drug from federal government

The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.

Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data

The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.

AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19

The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar to that of Regeneron and Roche with their drug, REGN-COV2.

Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting

The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.

Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US

Shots:

  • Qiagen reports the launch of the Access Anti-SARS-CoV-2 Total test that runs on a portable device and provides accurate results on Total Ig Abs (IgA, IgM, IgG) in 10mins. The device can process up to 8 samples simultaneously or up to 32 tests/hour
  • The test was developed in collaboration with Ellume, following the US FDA’s EUA submission. The companies plan to launch it in the US in Aug’2020 while anticipates the CE-IVD marking in the EU with the initiation of commercialization in other markets in coming weeks
  • The test is performed on eHub & eStick system provides rapid qualitative serological in-vitro detection of total antibodies to SARS-CoV-2 in plasma & serum and has demonstrated 100% sensitivity & specificity

Click here ­to­ read full press release/ article | Ref: Qiagen | Image: Fierce Biotech

Related News: Qiagen Launches QIAseq SARS-CoV-2 Primer Panel for Tracking COVID-19 Mutations and Strains

Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend

The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science and data alone – may have played a role.

Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19

Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.

UK doctors call for tighter rules on coronavirus antibody tests

Doctors have called for rules to be tightened on coronavirus antibody tests in the UK amid fears that false readings could put the public at risk.

It’s not even known for sure that having antibodies against the SARS-CoV-2 coronavirus confers immunity.

But with many other diseases the presence of specific antibodies indicates that the body can quickly fight off an infection in healthy individuals.

No antibody test has been officially approved for at-home use in the UK, but many different kits are available.

The BBC reported that the Royal College of Pathologists has written to UK health secretary Matt Hancock calling for tougher rules on the tests, saying they could “mislead the public and put individuals at risk”.

The doctors said the tests should not be used without professional support, must give accurate results and be “properly readable”.

The Medicines and Healthcare products Regulatory Agency told the BBC it had “worked collaboratively with cross government agencies at pace to prevent non-compliant antibody test kits being placed into the UK market.”

But Royal College of Pathologists president Jo Martin said: “Currently, if you buy a test on the internet or you buy it in certain boutiques or shops, we can’t guarantee that the quality of that is of an appropriate standard.

“We can’t guarantee that the result will be easy to interpret or that it will not be misleading.”

An analysis seen by the BBC’s Newsnight programme found that in 41 tests sold to the public in the UK, almost a third provided incomplete and inaccurate information.

While a number claimed to offer “peace of mind” just 10% had documents available to support their claims according to academics from the universities of Birmingham and Warwick.

Lead researcher Jon Deeks, professor of biostatistics at the University of Birmingham, said the antibody tests should be subject to the same level of regulatory screening as medical devices and drugs.

He said: “If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing.”

A Department of Health spokesperson said tough action is being taken against those who market bogus antibody tests, with “a number” of arrests and 47,000 tests seized.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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ViewPoints: COVID-19 Vaccine Distribution the Next Supply Chain Frontier

An overview of various aspects of the supply chain that would be crucial in the production and distribution of COVID-19 Vaccine. Write to us at [email protected] if you want a PDF copy of this report.

Over the past seven months, the global pandemic caused by the spread of SARS-CoV-2, the virus that leads to coronavirus disease (COVID-19), has impacted the global economy and people’s lives tremendously. A number of countries and companies have concentrated their resources to produce a vaccine for COVID-19 and considering the present scenario, one can be hopeful to have a vaccine available soon. However, finding the vaccine is just the first step. Other critical steps that every government should be thinking about in relation to their national vaccine strategy are product integrity and safety, public education, and the actual distribution program itself.

Product integrity and safety tests that assure the vaccine is safe to use, communication programs that inspire public confidence, and a robust supply chain management strategy that anticipates local demand efficiently which will deliver a vaccination program that the general population is willing to participate in. Since the sense of urgency is critical, governments all over the world should start planning based on these important enablers. Without this planning, the goal of having a confident and vaccinated population ready to return to “normality” and participating fully in the economy will not become a reality.

On Tuesday 11th of August, Vladimir Putin announced the first vaccine to the world, named Sputnik V. With this announcement the race to get a working vaccine to people all over the world has heated up further between key players all over the world eager to cash in on this opportunity for financial and political reasons. One thing is clear, whichever vaccine makes it to commercialization the supply chain will play an integral part in the upstream manufacturing supply chain and the downstream distribution.

Some of the key contenders for the Covid-19 vaccine are:

 

Demand for the Vaccine

Many experts around the world are expecting the introduction of these vaccines to cause major challenges to global supply chains in manufacturing, transportation, and distribution as companies scramble to meet demand from countries all over the world. The demand for this vaccine will be at a historic high. Never in the world before has there been a situation where a vaccine needs to go out to the whole world at the same time. With a global population of more than 8 billion people, this will be more than a mammoth undertaking.

Image source: Canva

Upstream Manufacturing Supply Chain

To get to making a vaccine, there are several manufacturing steps that need to be taken which although invisible to most people are critical in the time path to a final drug product. These include making and testing the API product which forms the active ingredient of the drug. Making the actual drug itself (drug substance), the filling process involved in turning the bulk drug substance into usable vials or syringes for vaccination. The other needed parts related to the syringe itself, the needle, the vial, the cap, the label, etc. The last step is the actual final labeling and packaging of the vials into the finished product. In the pharmaceutical industry, all these manufacturing steps are usually performed at different factories often across different countries in the world. Synchronizing these production steps and the availability of all the components, the ingredients, and manufacturing capacity, as well as the logistics between the various factories all, create potential bottlenecks and risks.

Procurement of Vaccines – Access Rights  

Image source: Business Standard

Governments around the world are competing to get first access to available vaccines. They are faced with critical questions around which vaccine brand to back now to secure access to large quantities to be able to start domestic immunization programs. Backing a vaccine and paying upfront for access and guaranteeing certain quantities of doses whilst there is no advance guarantee the vaccine will work is a large financial and political risk only the richer countries are able to make. The US, clusters of countries in Europe, and some other richer nations are making these types of advanced access agreements with key manufacturers. These funds help finance the manufacturing work already started whilst the vaccines are still being developed and tested for approval.

Although it is good that some of the richer nations have stepped up to help pre-finance these vaccine programs it presents a real moral dilemma once the vaccines are approved in terms of which countries get first access rights and which ones do not. Given the share volume of vaccines that need to be produced to cover the whole global population the difference between being a “first mover” country versus a “last mover” could be as long as 3-5 years.

In other words, countries with more money will buy priority access to vaccine programs whilst emerging countries will not be able to do so financially. It will mean that as the world moves out of the COVID-19 lockdown phase, clusters of countries can do so more easily than others. It will create a further disparity between regions around the world economically which potentially poses new socio-economic and (geo) political risks.

Downstream Supply Chain

Image source: CNBC

Once a vaccine has been produced it is ready to be shipped under heavily regulated and temperature-controlled conditions to countries around the world. Many industry experts predict this enormous logistics task will lead to huge capacity problems for airlines and logistics companies. Laurent Foetisch, Supply Chain Management Consultant as Supply Chain Operations with more than 35 years of pharmaceutical manufacturing and logistics experience argues differently. “It is not possible to produce the quantities of vaccines needed all at once. Typically, vaccines are produced in batches of around 100,000 – 150’000 vials/syringes based on a daily production cycle. Even if multiple filling lines are used across various manufacturing locations it is not possible to produce all the vaccines immediately at these numbers in millions for everyone”.

This also means that the “big bang” launch theory of a vaccine might not be as big as many predict. It would mean that availability of vaccines for distribution is spread over a longer time frame which from a capacity perspective is less complicated to manage by logistics companies and airlines. Rather than a “bulk” shipment program, it could well turn more into a “Just in Time” shipment program feeding into domestic immunization programs.

However, there are other factors to think about as the first batches of vaccines are released and shipped. Eelco Dijkstra, Managing Partner at Europhia Consulting points out that ensuring product security across the entire supply chain will be vital. Not just in terms of establishing and using validated temperature-controlled transport and storage solutions but also in terms of risks such as the product being “highjacked” and/or “counterfeited” by organized crime as the product is transported across multiple countries.

National Vaccination Program – The Final Mile Distribution

Image source: Medical Express

 The two major challenges of the government-run vaccination program on a national level would be in public education and in the distribution program itself. To make any vaccination program successful, it is vital to plan on how to educate the end community to ensure that the public is fully aware prepared to take the vaccination timely and efficiently.

Talking about the distribution strategy, the key questions that need to be addressed include how to best manage any vaccination program. The biggest first question for governments to address is whether a vaccine will be made mandatory for the whole population or be voluntary? Who will receive vaccination first? Vulnerable groups first such as people with a medical condition or the elderly? Will governments use hospitals throughout the country for people to come to and get vaccinated or will government look to use more points of vaccination such as medical clinics including private ones?

In some countries it will make sense to use existing COVID-19 infrastructure such as dedicated clinics and testing centers already in place. In some cases, it might make sense to set up “mobile” vaccine units which come to elderly homes, local community centres and schools.

Vaccines are pharmaceutical drugs and will need tight temperature and security control during storage and transportation. Given the share size of any vaccination program based on population size, it will run into the millions of vaccinations for which an end to end distribution model will need to be designed, tested, and executed in a very short period of time. Therefore, the timing for the planning for such a distribution model cannot start soon enough. For any vaccination program to be successful, the distribution part will be critical. Therefore, any national distribution plan linked to a country’s vaccination program will need to involve partnerships between government and private companies in logistics and distribution to plan and execute. We are already working with several governments on these initiatives providing input on strategic and tactical elements of such distribution plans.

Disclaimer: The opinions are based on the author’s own experience and understanding of the dynamics within the sector.

Europhia Consulting is an international management consulting company specialized in the logistics and supply chain industry in the life sciences sector. We operate global assignments for our clients.

Supply Chain Operations SA, based in Switzerland, is a specialized healthcare supply chain consultancy firm created in 2011 to serve the biopharmaceutical and Medtech industry.

We bring more than 120 years of end-to-end supply chain expertise to our valued customers. Both companies work together on strategic assignments for clients globally. We do not pretend to have been able to capture all challenges and all insights and have deliberately focused this strategy paper on some of the key challenges we see based on our work with clients within the industry.

For any questions or comments about this strategy paper please do not hesitate to reach out to us.

Eelco Dijkstra

Eelco Dijkstra of Europhia Consulting has worked in supply chain and consultancy for over 25 years and in recent years has focused his expertise on the global pharmaceutical sector. He as worked a number of years for TNT Express and Kuehne & Nagel and in recent years managed his own consultancy practice. 
Mobile: +31 624661688 
Email: [email protected] 
Website: www.europhia.com  

Laurent Foetisch

Laurent Foetisch of Supply Chain Operations has extensive experience as a supply chain executive responsible for managing a global biopharmaceutical company in Switzerland for more than 20 years. In 2007 Laurent managed the supply chain integration between Merck and Serono with the responsibility to create one central supply chain structure using common processes and tools. Since 2011, Laurent runs its own supply chain boutique consulting firm named Supply Chain Operations SA. 
Mobile: +41 792052332 
Email: [email protected] 
Website: www.supplychainoperations.ch

Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns

The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.

Could AI avert a future coronavirus pandemic?

Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses?

This is a question that a consortium of European pharma companies hopes to answer as it aims to rapidly develop new therapies to combat the pandemic.

The Corona Accelerated R&D in Europe (CARE) has been hastily set up by Europe’s Innovative Medicines Initiative (IMI), focusing on tackling the pandemic that has wreaked so much havoc across the world this year.

The consortium aims to rapidly develop drugs to fight SARS-CoV-2 and find virus neutralising antibodies.

But also included in the 77.7 million euro project funded by European Union cash and European pharma companies is a work stream that aims to find drugs that work against coronavirus strains that may emerge in the future.

The UK-based artificial intelligence (AI) drug discovery firm Exscientia is heavily involved in this project and is using its technology to screen existing small molecules to see if they could be used against the coronavirus class that causes diseases such as SARS, MERS and COVID-19.

Exscientia is finishing off work already done on the SARS-CoV-2 virus to identify the targets that could be used – but chief operating officer Dave Hallett told pharmaphorum in an interview that the likely lines of attack are already well known.

The trick is to look for proteins that are used across all coronavirus types and tend not to vary much from one virus species to another.

Hallett said that the targets being explored are the proteins involved in viral replication – the protease, the RNA polymerase, the papain-lie protease and elements of the “Spike” protein that allows the virus to infect cells.

He said: “If you could find a small molecule now that had SARS, MERS, and COVID-19 activity there is a reasonable chance it could have activity against another beta-coronavirus in the future.”

The work will involve using AI to screen a library of 12,500 molecules held by Scripps Research to identify small molecules that could be active against the virus class.

All of the drugs in the library have previously been used in humans, which means their side effects are better known, hastening development.

“If we can find any drugs that have gone into human beings if one of those has activity against COVID-19 proteins those would make it more rapidly through clinical trials.”

CARE is a five-year project funded by the cash contributions from the EU, 11 European Federation of Pharmaceutical Industries and Associations (EFPIA) companies, and three IMI partners.

Companies include Johnson & Johnson’s Janssen unit, Takeda and Boehringer Ingelheim.

Hallett noted that the project is an example of how European countries and organisations can work together, something that he hopes will continue as the UK heads for Brexit.

“It’s a reflection of what the IMI was set up to do. It’s shame we are leaving as it’s a good example of what Europe can do when it comes together.”

“We can move forward quickly with this, fingers crossed.”

Feature image courtesy of Rocky Mountain Laboratories/NIH

 

 

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Interest in rapid Covid-19 antigen tests continues despite accuracy concerns

Earlier this month, Ohio Gov. Mike DeWine received a false-positive result from a rapid antigen test for Covid-19, raising concerns about the tests’ accuracy. The assay’s maker, Quidel, said it is investigating the case.

Trials of Gilead’s remdesivir in Covid-19 not diverse enough, experts write

In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.

Report: Russia says its Covid-19 vaccine ready for market despite no Phase III data

Russian President Vladimir Putin said a vaccine developed at a Moscow research institute that appears to still be in Phase I development among fewer than 100 participants had undergone all necessary tests.

Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead

Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

Shots:

  • The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs
  • The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments but for high throughput testing, an automated version of the assay is used for the optimization  of a workflow consisting of the Sentosa SX101 instrument, in conjunction with ABI 7500 Fast Dx PCR instrument or the Sentosa SA201 instrument
  • ViroKey SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval from the Singapore Health Sciences Authority

Click here ­to­ read full press release/ article | Ref: Vela Diagnostic | Image: Biospectrum Asia




J&J in $1B supply pact with federal government for one-shot Covid-19 vaccine

Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.

Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan

Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.

Sanofi, GSK nab $2.1B deal from federal government to provide Covid-19 vaccine

The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.

Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

Moderna gets further $472m as expanded phase 3 COVID-19 trial begins

A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab.

The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483 million, awarded to kick-start development of Moderna’s mRNA-based vaccine codenamed mRNA-1273 in April.

Moderna has decided to expand the number of participants in a phase 3 trial after discussions with the FDA and with the Trump administration’s Operation Warp Speed.

The total number of patients involved in the phase 3 trial will be 30,000, and total funding awarded is around $955 million.

The phase 3 COVE study is expected to begin today and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

After a review by the FDA, the trial will involve a 100 microgram dose and the endpoint will be prevention of symptomatic COVID-19 disease.

Key secondary endpoints include prevention of severe COVID-19 disease – defined as the need for hospitalisation – and prevention of infection by SARS-CoV-2.

Moderna says it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021 thanks to its manufacturing collaboration with Lonza.

The company also has a large-scale fill and finish contract with Catalent’s biologics facility in Indiana, following $1.3 billion in funding from investors in a public equity offering in May.

Moderna’s vaccine is based on cutting-edge but unproven technology, which uses a strand of mRNA to instruct the patient’s body to make copies of the “Spike” protein found on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

It’s hoped that this will prime the immune system to swing into action and neutralise the virus should patients become infected.

According to a regularly updated document from the World Health Organization, there are now 25 potential COVID-19 vaccines in clinical development.

A candidate developed by China’s Sinovac is at the top of the list, although Moderna’s drug may move up in the WHO’s reckoning following the latest development.

Feature image courtesy of Rocky Mountain Laboratories/NIH

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Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine

The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are only preliminary data so far.

Here’s how Covid-19 has affected funding, development in infectious diseases

“Everybody’s an infectious disease company now,” ARCH Venture Partners Managing Director Bob Nelsen said. By contrast, a report last year showed a huge decline in venture capital investment in the infectious disease space.

Synairgen says inhaled biologic lowered risk of Covid-19 worsening in hospitalized patients

The company said that patients receiving the drug, SNG001, had a 79% lower risk of requiring ventilation or dying compared with those on placebo, sending the company’s stock soaring more than 400%, but it did not clarify what that meant in terms of patient numbers.

AstraZeneca Covid-19 vaccine shows antibody levels comparable to recovered patients

The company announced the publication of interim data from the Phase I/II study of a vaccine it is developing with the University of Oxford. The news comes the week after Moderna announced the publication of data for its vaccine.

FDA guidance eases some Covid-19 vaccine concerns, but others remain

Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.

Sinopharm launches Phase III trial of inactivated-virus vaccine in Abu Dhabi

The Beijing company said it selected the United Arab Emirates because of its ethnic diversity, which will enable it to determine the feasibility of taking its program global. It claims that its study is the first Phase III inactivated vaccine trial, but another Chinese firm has also launched one in Brazil.

Russian hackers suspected in Covid-19 vaccine intellectual property theft, report says

A joint report by cybersecurity agencies in the U.K. and Canada, endorsed by their U.S. counterparts, states that the hacker group Cozy Bear had been targeting organizations involved with Covid-19 vaccine development efforts.

Moderna publishes Phase 1 Covid-19 vaccine data showing robust immune responses

Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.

Gilead Covid-19 drug remdesivir benefited from $6.5B in NIH-funded basic research, study finds

Research on the drug’s molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.

NIAID launches clinical trial network for preventive drugs, vaccines against Covid-19

The NIAID create the Covid-19 Prevention Trials Network by combining four existing ones, primarily focused on HIV and AIDS, which will continue that work in addition to their new focus on Covid-19.

BARDA, DoD give Regeneron $450M contract for Covid-19 antiviral drug

The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.

Regeneron starts late-stage trials of antiviral antibody cocktail in Covid-19

The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.

The FAIR Toolkit Helps Researchers with Data Challenges

Since the spread of COVID-19 was first reported, researchers
of all types have mobilized to meet the challenges its causative agent,
SARS-CoV-2, presents to the world. Data scientists in particular have been
quick to apply their expertise to the problems of identifying, tracking and
predicting outbreaks; diagnosing COVID-19; identifying infected individuals and
detecting non-compliance with virus countermeasures; discovering new
therapeutic interventions or repurposing existing ones; and searching for a
safe, effective vaccine.

We’re learning more about SARS-CoV-2 and COVID-19 every day,
and researchers are becoming more sophisticated in their exploration of
everything from the virus’s basic biology to improving patient outcomes. Almost
every question they ask requires information from multiple sources to be found
and integrated, and almost every time a question is answered, it prompts
another question that requires information from yet another source.

The process of assembling data and information to answer
significant research questions usually begins with researchers assessing:

  • What data are available? Do the required data exist at all?
  • How can the data be accessed once we find them? What rights do we
    have to use the data?
  • Are the data and metadata understandable? Can we put them all
    together in a meaningful way?
  • Are all the data valid, or are there outliers or duplicates to
    eliminate?

This iterative process of finding information in all of the places it resides, bringing it together, cleaning it up and organizing it can take up much of a data scientist’s time, perhaps as much as 80% of their time according to a 2016 survey. The remaining 20% is spent more productively by actually using the data for analysis or for training predictive models. The diagram below depicts a typical data science workflow on a timeline.

Press, Gil. Forbes, March 2016. Cleaning Big Data: Most Time-Consuming, Least Enjoyable Data Science Task, Survey Says,
https://www.forbes.com/sites/gilpress/2016/03/23/data-preparation-most-time-consuming-least-enjoyable-data-science-task-survey-says/

This process of putting data together to enable the analysis and modeling that lead to insight is usually slow and tedious because the majority of the data available to researchers today is not FAIR, meaning that the data and metadata typically do not adhere to the FAIR Guiding Principles of Findability, Accessibility, Interoperability, and Reusability. Adherence to the FAIR Principles makes data more easily reusable, so that they efficiently can be applied to any purpose, even unanticipated ones, compressing time-to-insight and increasing the inherent value of the data. Putting the effort into FAIRifying data to make them efficiently reusable allows for quicker results over a broader range of applications.

At Elsevier, we’re committed to helping scientists and clinicians find new answers, reshaping human knowledge and tackling the most urgent human crises—and we believe that data and information are the keys to success. We are proud to support efforts to help researchers make use of the FAIR Principles to be the best data stewards they can be. We are particularly proud to have participated in the development of the Pistoia Alliance’s FAIR Toolkit, freely available to all data stewards, laboratory scientists, business analysts and science managers.

The FAIR Toolkit contains use cases to help life sciences researchers better understand FAIR Data and how to FAIRify their own data. It also provides access to FAIR tools and training, as well as containing information to help organizations manage the change that adherence to the FAIR Principles requires. Like many of the organizations we serve, we at Elsevier, and within the Entellect team, have made a commitment to FAIR Data and encourage researchers to check out the Pistoia Alliance’s FAIR Toolkit to learn more.

Drug Repurposing for SARS-CoV-2 Using Network Polypharmacological Approach

Drug development is a multidisciplinary field that requires a drug to successfully pass through different stages — from chemical design to biological experimentation on cells and animals, and finally three phases of human clinical trials — before being approved by the FDA for clinical administration. However, following such a path would not be feasible under circumstances where rapid discoveries are required, such as in the case of the current SARS-CoV-2 outbreak. Hence, repurpose of already approved FDA drugs could help in such circumstances, which can save effort, time and money.

In this regard, network medicine (NM) has proved to be a potential cornerstone in drug discovery and repurposing1. Indeed, NM has provided a platform to identify the molecular complexity of particular diseases and has helped decipher the molecular relationships among distinct diseases and drug targets. For example, we can identify treatments to a specific disease based on its underlying molecular mechanisms that could be targets for potential therapeutics.

Three main drug target strategies exist for SARS-CoV-22,3: (1) block entry of the virus
into the host, (2) block replication inside the host and (3) reduce the
undirected inflammatory response in the host. Angiotensin-converting enzyme 2
(ACE2), the receptor protein in host cells responsible for mediating SARS-CoV-2
infection, is a critical enzyme that also mediates local anti-inflammatory
pathways within human tissues. Although several ACE2 inhibitors are available
in the market, it is not clear yet if such treatments would worsen the undirected
inflammatory response of the host.

On the other hand, while the molecular signature of SARS-CoV-2 is still under investigation, we thought it would be useful to determine the interactions of drugs with key proteins related to other coronaviruses, such as SARS-CoV-1 and MERS-CoV. The molecular pathways and genetic signatures associated with inflammatory responses in human host cells are also well characterized, and exploring those can provide valuable insights. We therefore aimed to identify a treatment, using network medicine and polypharmacology, that could inhibit viral entry and replication, as well as the endogenous immune response of the host.

Pathway Studio, a biomedical database
derived from relationships extracted from more
than 30 million academic
manuscripts, was first used to create a biological knowledge graph that was employed to develop a model that could predict links between drugs, proteins (genes) and
diseases caused by other coronavirus (i.e. SARS-CoV-1 and MERS-CoV).

First, we used this model to predict down-regulators of processes that SARS-CoV-1
and MERS-CoV rely on, as well as ACE2, and then the top regulators of
autophagy, a biological process in the host cell known to play a significant role
in controlling viral infection. Next, we used FDA-approved drug combinations to identify
potential complementary combinations
for disease regulation, which were further explored for their possible regulatory actions on biological processes and molecular functions
deregulated in the disease state
of SARS-CoV-1 and MERS-CoV. After that, we
identified hub proteins/genes in these deregulated pathways, which we proposed as
key regulators linking drug mechanisms to disease state. Finally, we provided a simplified sub-graph of our biomedical knowledge graph showing possible drug regulatory interactions with SARS-CoV-1 and MERS-CoV
through key regulatory genes.

We hope that our simplified graph will help researchers in understanding the mechanistic pathways of SARS-CoV-2 and aid in the fruitful development of efficient treatments using synergistic and complementary drug combinations of drugs that are able to target both viral infection and immunomodulatory pathways. The full study, A Network Polypharmacology Approach to Drug Repurposing for SARS-CoV-2, is currently under journal review, so we will let you know in this blog when it has been published.

REFERENCES:

1. Barabási,
A.-L., Gulbahce, N. & Loscalzo, J. Network medicine: a network-based
approach to human disease. Nat. Rev. Genet. 12, 56–68 (2011).

2. Jakovac, H. COVID-19 – is the ACE2 just a foe? Am. J.
Physiol. Lung Cell Mol. Physiol.
(2020) doi:10.1152/ajplung.00119.2020.

3. Quartuccio, L., Semerano, L., Benucci, M., Boissier, M.-C.
& De Vita, S. Urgent avenues in the treatment of COVID-19: Targeting
downstream inflammation to prevent catastrophic syndrome. Joint Bone Spine
87, 191–193 (2020).

Coronavirus: 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic

Today I am going to share some important ways that doctors, hospitals and healthcare marketers can use social media to inform the public during the COVID-19 crisis.

  1. Priority One: Use social media to convince people to comply with social distancing, and consequently help us all, “flatten the curve!”

The US Surgeon General, Dr. Jerome Adams, understands the power of social media to help get information out about the COVID-19 crisis. He was recently asked during a Good Morning America interview how to get younger Americans to take the coronavirus crisis seriously. Dr. Adams responded: “Well, I have a fifteen and a fourteen-year-old, and the more I tell them not to do something, the more they really want to do it.”

“We need to get Kylie Jenner, we need to get our social media influencers out there, in helping folks understand that look, this is serious, this is absolutely serious…People are dying.”

Hours later, Jenner responded by exposing myths and sharing the importance of social distancing with her 166 million Instagram followers. “The coronavirus is a real thing…Please stay inside you guys: practice social distancing, self-quarantine. If you live with your parents, you don’t want to home and get your parents sick. You might have it, and not even know and be infecting other people… It’s serious, and, the only way we’re going to slow this down is if we do this since there’s not a cure right now. Nobody is immune to this. Millennials are not immune to this. New evidence actually shows that a large percentage of people in the hospital right now are young adults.”

Doctor sitting at desk with cell phone in hand

Healthcare social media and healthcare digital marketing during the COVID-19 crisis.

Jenner’s video was, of course, a step in the right direction, which leads me to ask you…

If the US Surgeon General trusted Kylie Jenner to help get the word out about how we can fight the Coronavirus, don’t you think healthcare clinicians and medical professionals should use their social media accounts to help too?

Let’s face it. There’s a lot of misinformation out there, and millions of Americans nationwide still wildly underestimate the seriousness of coronavirus. You have the opportunity – I would argue responsibility – to use your social media accounts to influence others positively.

If you are a doctor or nurse, I recognize that you probably do not have a vast social media following. That doesn’t matter. Clinicians often forget how much influence they have upon the people they do know. When my kids were little, whenever they got hurt or sick, the first person we usually turned to was our neighbor Denise, who was also a critical care nurse. “Miss Pumpkin” (as our daughters called her), wasn’t just a friend; she was a healthcare thought leader for our family and our neighborhood.

Medical clinicians and other concerned healthcare professionals can share information with friends and family on Facebook, Twitter, Instagram, and other social media channels. Also, don’t forget you can simply email friends and family as well. I know a biologist who copies me (and all his friends) on relevant COVID-19 updates via his personal email.

If you are a professional healthcare marketer, you have enormous potential to educate your community through scale. Your first step will be to convince your hospital or practice leadership that your organization not only can, but should, take a leadership role during this crisis, and “join the fight.”

As I mentioned in last week’s blog about how you should adjust your marketing efforts during COVID-19, now is a fantastic time to build your organization’s thought leadership and brand by doing the right thing.

Certainly, you can start by updating all your organization’s website and various organic social media properties [e.g., Facebook, Instagram, Twitter, YouTube (see a Healthcare Success Healthcare Marketing and COVID webinar on YouTube), LinkedIn, Pinterest, etc.] with important updates and tips.

You can also work with your leadership (e.g., Healthcare CEO, Pharmaceutical CMO, Medical Director) to encourage your doctors and medical practice staff likewise to share info on their personal social media accounts.

Beyond that, if you want to reach your community, you can significantly expand your reach via paid social media advertising. Remember, Facebook and Instagram favor personal accounts over business Pages, and as little as 4% of your hospital’s followers will have the opportunity to see your “organic” (“free”) posts there.

By contrast, you can reach tens of thousands (or millions) of people cost-effectively through paid social media advertising. You have nearly limitless options to influence people through paid social media, whether you use boosted posts, video ads, or other formats. You can create and buy social media campaigns yourself or enlist the help of an agency like ours.

We’ll expand on the benefits of social media advertising in future posts – stay tuned for that.

  1. Use social media to help guide people in your community who fear they may have the virus.

Due to a lot of missteps and mixed messages, people are confused about what they should do if they think they have COVID-19. What’s more, beyond the general advice that is available everywhere (e.g., wash your hands, do not go out if you are sick, avoid people who look ill), the appropriate course of action can vary by community. Here are some of the questions people want answers to:

  • “What are COVID-19 symptoms, and should I get tested?”
  • “Where in our community can I get tested?”
  • “Should I see my primary care doctor, an Urgent Care, or the local hospital?”
  • “Is telemedicine an appropriate first step?”
  • “Should I stay home if my symptoms are minor?”
  • “How will I know when it is time to seek help at a hospital?”
  • “How do I avoid infecting others?”
  • “Which hospitals in my area are able and ready to take new COVID-19 patients?”
  • “What are the risks of the transmission of coronavirus infectious disease at home?”
  • “Is there anything else should I know about coronavirus disease diagnosis and transmission?”

If you represent a hospital or other larger healthcare organization, you may already have answers to some of these questions on your website. If so, great—utilize social media to drive people in your community to your appropriate website pages or posts.

If you do not have coronavirus content on your website, you can add whatever information makes sense. Anything you post must be medically accurate, and you’ll need to ensure appropriate legal and ethical safeguards in place.

Alternatively, you can of course simply share information from trusted sources (such as HHS/CDC Coronavirus/COVID-19 website, the CDC.gov, or NIH.gov) on your social media. (See some additional links and resources below.)

  1. Use email and social media to inform your patient base with additional, important updates and advice.

Beyond educating the wider community, you should guide and inform your patients (or their caregivers) throughout the COVID-19 crisis. Beyond the fact that it is the right thing to do, your valuable information will grow your authority and your relationship with your patients at a time when they need it most.

In addition to some of the topics we’ve already covered above, you can use social media and HIPAA compliant email to help guide patients with additional tips, such as how to:

  • Boost your immune system
  • Care for and speak to small children at home
  • Deal with fear and stay positive
  • Cope with stress or sleeplessness
  • Pass the time
  • Protect their family
  • General information and updates as they become available

Make sure all your communications are informative, relevant, accurate, empathetic, and “in touch” with the current environment. Right now, your tone should generally be serious, but over time as people begin to go stir crazy, you may see an opportunity to mix it up with some lighter content.

My wife’s doctor does a great job of providing this kind of information to patients through email and via Instagram.

Also, for inspiration, here is a helpful email I received from Aetna that describes some COVID-19 benefits they have put into place for members.

Email to Aetna insurance members about COVID-19

Sample Email From Aetna to Patients

  1. Reassure your patients that your hospital or practice has proper safety precautions in place.

A close friend whose husband has colon cancer emailed me last Friday:

So be sure to communicate your safety measures everywhere you can, on your website, social media properties, via email, on the phone, and in-person at the office. You can even post a video on your website, like this example from one of our clients.

  1. To attract new patients now or immediately following the COVID-19 crisis, think digital healthcare marketing first.

Just like virtually every type of business, many hospitals, medical practices, skilled nursing facilities, and other healthcare organizations are suffering economically from the COVID-19 crisis.

Some providers can (or must) wait for the crisis to end before they begin marketing efforts to attract new patients, while others need to generate revenue and new patients now. While we believe strongly in the power of traditional advertising, our favorite “go-to” in times like these is digital.

Take, for example, the leaders of a multi-city, specialty practice who contacted me this past Friday. Due to COVID-19, their physician liaisons cannot get in to see referring doctors. Even worse, recent Medicare reimbursement cuts have severely reduced their revenues.

Their specialty is medically essential, so they must remain open for business even though prospective patients and their families are distracted by COVID-19.

Our recommendations will likely include:

  1. Email and social media campaigns that will reach referring doctors directly, without relying on physician liaisons.
  2. Paid search campaigns on both Google and Bing networks. We did an analysis, and despite COVID-19, there are still thousands of searches each month for the services.
  3. As you might guess, based upon the rest of this post, paid social media to reach patients and their families.
  4. If budget permits, we might test connected TV (CTV) and digital radio.

Remember, due to coronavirus, millions of Americans are staying at home right now, and people are spending more time online than ever. We’ll expand more on that in a forthcoming blog post.

Conclusion: COVID Digital Healthcare Marketing & Social Media

While these are incredibly challenging times for everyone, smart social media and digital marketing strategies can still influence patients in a positive, profound way.

Here are 2 sample emails and some jpegs for your convenience. I am also sharing some credible, “shareable” links below. For more updates on COVID-19 and other important topics, follow me on Twitter, @StewartGandolf.

COVID-19 Prevention Chart

COVID-19 Prevention Chart

COVID-19 Symptoms Chart

COVID-19 Symptoms Chart

Social distancing guidelines from CDC

Maintain 6’/six-foot distance

The following are Healthcare Success COVID-19 campaign images to support social distancing. Out of home and social media are displayed below.
If you would like more information on these, or to use them in a campaign, please give us a call at 800-656-0907.
Out of home alternate COVID accouncement

Healthcare Success Out of Home – Six feet

Instagram spread the word COVID announcement

HS Instagram COVID, “Spread the Word.”

Entire COVID prevention campaign

Healthcare Success COVID prevention campaign

#LetsFlattenTheCurve: Creative to encourage social distancing during COVID-19

The Coronavirus Can Be Stopped, But Only With Harsh Steps

The Doctor Who Helped Defeat Smallpox Explains What’s Coming

Coronavirus: The Hammer and the Dance: What the Next 18 Months Can Look Like, if Leaders Buy Us Time

Coronavirus: Why You Must Act Now. Politicians, Community Leaders and Business Leaders: What You Should Do When

This is How We Can Beat the Coronavirus

Younger Adults Make Up Big Portion of Coronavirus Hospitalizations in U.S.

How to Clean and Disinfect Yourself, Your Home and Your Stuff

Why It’s Crucial to Avoid the ER if You Can

How to Fight the Coronavirus SARS-COV-2 and Its Disease, COVID-19

Coronavirus Could Overwhelm U.S. Without Urgent Action, Estimates Say

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