Gene Therapy Comparability

The inaugural Gene Therapy Comparability Summit is the only industry dedicated meeting to ensuring your manufacturing processes are effective and comparable at every stage of development, supporting a seamless transition to the larger scales required for commercialization.

This meeting will unite large pharma and innovative biotechs including Pfizer, Biogen, BioMarin and Takeda as they share best practices, lessons learned and analytical data across the comparability lifecycle.

Focused specifically on enhancing your gene therapy comparability approach, join us to ensure you maintain safety, quality, consistency and efficacy throughout scale-up from clinical to commercial-scale manufacturing, and satisfy regulatory demands to avoid costly delays to clinical programs.

Incorporating insights from leading CMC, Regulatory, Analytical and Process Development experts, this is your opportunity to gain extensive technical information on challenges like ensuring manufacturing processes are comparable when changing facilities and cell lines, developing effective bioassays for use in comparability studies and handling the limited gene therapy lots available.

View the full event guide here to see the full agenda, speaker faculty and more!

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Gene Therapy for Muscular Disorders

With clinical holds lifting there has been more investment and clinical progress in the gene therapy for muscular disorders space than ever before, yet the consequences of toxicity are not a distant memory. Despite the successes, there are still withstanding challenges for gene therapy developers targeting the muscle when it comes to optimizing delivery and navigating toxicity to develop truly safe and transformative therapeutics for muscular disorders patients.

The first industry-dedicated Gene Therapy for Muscular Disorders Summit will focus on overcoming the translational and clinical challenges of developing genetic therapies targeting muscular disorders, including Duchenne Muscular Dystrophy (DMD), Limb-Girdle Muscular Dystrophy (LGMD), Pompe Disease and X-Linked Myotubular Myopathy.

Join your fellow industry leaders from the likes of PTC Therapeutics, Solid Biosciences, Pfizer, AskBio Novartis at this digital event in March.

View the event guide here for the full meeting details!

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Bio Integrates 2021 (Digital)

Making new connections is vital to helping the biotech industry continue their journey. Bio Integrates creates these opportunities and provides attendees with significant opportunities to learn from and interact with our growing community, to enhance both current and future needs.

Our debate-led format provides our attendees with the opportunity to hear from and ask questions of those that have succeeded in their respective fields, whilst our face-to-face networking platform enables a replication of the chance encounters you experience at live events. Add to this opening address and fireside chats with key industry figureheads, and new for this year our ‘C-Suite Series’ from thought leaders, you can see why Bio Integrates is an event unlike others.

WHO ATTENDS BIO INTEGRATES?

From a standing start in 2019, Bio Integrates is now in its third year and attracts over 400 senior executive attendees from:

  • Biotech Organisations
  • Pharma Organisations
  • CDMOs & CROs
  • Investors
  • Regulators
  • Supply chain solution providers
  • Patient Groups

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Insights+ Exclusive: Key Takeaways from the Webinar on HEOR/ HTA: The Evolving Role in the Indian Healthcare Ecosystem

  • Intellimed Healthcare Solutions organized an online webinar on “Health Economics and Outcomes Research/ Health Technology Assessment: The evolving role in the Indian Healthcare Ecosystem” on 15th January 2021.
  • The objective was to gain insights into the current scenario and the need for HEOR/HTA in India.
  • Health economics and outcomes research (HEOR) is a growing field that provides important information for making healthcare coverage and access decisions.

The pharmaceutical & Medtech industry invests heavily in HEOR studies alongside clinical trials and continues to collect clinical, humanistic, and economic real-world data throughout the life cycle of a therapeutic product. Even after such efforts, why are some medicines not affordable and accessible? Why is there still a gap between healthcare and socioeconomic status? How can we equalize access to healthcare? The honorable speakers, panelists, and moderator addressed these important questions

Dr. K. Srinath Reddy, MD, President of Public Health Foundation of India (PHFI), delivered the key-note address. He said “the economic dimensions of health are seen to go wrong when we have a pandemic or health emergency, but afterward the health system is neglected and very scant attention is paid to the need for financing health and optimizing the investments in health interventions. This is where health economics comes in as a very important discipline. He highlighted the need for universal health coverage, reduced out of the pocket expenditure. Dr. Reddy said “horizontal equity is often seen as treating everyone equally.  Many people have been deprived of essential services and a huge gap exists in health status. Vertical equity would bridge health equity gaps, by providing additional resources/ service. Thus, we need to balance horizontal and vertical equity as we construct the universal health coverage package. Health economics and health technology play a big role in optimizing resources, ensuring cost-effectiveness and equity benefits. He spoke about a few health initiatives such as “The National Digital Health mission Rashtriya Swasthya Bima Yojana and Ayushman Bharat”. Unfortunately, even when access to healthcare increased, financial hardships did not decrease in India. He concluded by saying “we need more health for our money i.e. for every rupee invested we must get a better return, more public financing for health, allocative and utilization efficiencies. That is why we need a better understanding of HEOR and HTA and integrate it into our health systems”.

Dr. V.M. Katoch, MD MD, FNASc, FASc, FAMS, FNA NASI-ICMR Chair on Public Health Research at Rajasthan University of Health Sciences (RUHS), Jaipur; President, JIPMER, Puducherry; President, AIIMS, Madurai; Former Secretary, Department of Health Research, Govt of India and Director-General, Indian Council of Medical Research in his special address suggested that we look at healthcare-related problems in a scientific way. According to him, the best intervention for the majority of the population must be the chosen one. This pandemic has brought back health to the center stage. He said “HTA based on sound health economics creates a vibrant instrument by which there is fair play and people get good healthcare interventions.

Dr. Rajesh Balkrishnan, Ph.D., Professor of Public Health Science at the University of Virginia, School of Medicine was the guest speaker for the webinar. He highlighted his research on “Real-world effectiveness of medications in terms of affordability and adoption”. Dr. Balkrishnan spoke about the 3 E`s – Effectiveness, Efficiency, and Equity, that help in evaluating the healthcare system. He gave an overview of the conceptual model of health determinants in terms of population perspectives.

The first panelist Mr. A Vaidheesh, Chief Executive Officer at Northstar Asis LLP, said “Integration in demand with those who bring the innovation is vital for growth and innovation of the healthcare industry?

  • Mr. Manoj Saxena, Managing Director, Bayer Zydus Pharma, and CDH South Asia Bayer Pharma, our second panelist said, “In India, 70% of the expenses are out of pocket, and if the clinicians have visibility on the health economics of the treatment along with clinical evidence, it makes the composite value of treatment more clear. He said, “Around 50% of Indians suffer from anemia or iron deficiency anemia (IDA), and the cost to GDP because of anemia is 22 Billion dollars. Even though the treatment for anemia is not that expensive, why is the incidence so high? HEOR/HTA could be applied to find out the reason for lesser awareness and use of such interventions, to reduce anemia associated maternal death. Interestingly, anemic patients when become adults earn 2.5% less than their healthy peers. HEOR/HTA has applications in both, reimbursed markets and out of pocket markets to evaluate newer innovative therapies.
  • Mr. Omar Sherief Mohammad, Managing Director, Roche Diabetes Care India Pvt. Ltd. our third panelist said,This pandemic has increased connectivity between HCPs, doctors and their patients and also data sharing. Improvement in adherence to medication and self-monitoring has evident. HEOR is a part of Pharmacoeconomics whereas HTA is a different concept”.Mr. Omar also said that it is vital to bean honest industry partner and bring innovation along with an understanding and importance of HEOR.
  • The fourth panelist, Dr. Anish Desai, MD, Director of Intellimed Healthcare Solutions highlighted the importance and need for real-world evidence, both in the pharma and Medtech world. From his experience, he said, how data generation and dissemination improved insulin penetration amongst diabetics. Converting bariatric surgery, from a cosmetic procedure to a therapeutic intervention but challenging but successful, said Dr. Anish. Finally, he concluded by laying down the importance of patient centricity in assessing healthcare interventions.

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2nd Manufacturing Assets & Facility Management in Pharma (MAFM) Summit

Twenty-twenty has demonstrated the need for a 24/7reliable manufacturing environment. Emulating on the first edition in 2020, the 2nd Manufacturing Assets & Facility Management in Pharma (MAFM) Summit will return in May, dedicated to aiding Engineering, Maintenance & Manufacturing Facilities leaders to collaborate. This exclusive, industry-led community will enable you to reduce COGs and maximize efficiency over just 3 days!

Join this cutting-edge discussion with 80+ senior colleagues, including J&J, AstraZeneca, Merck KGaA to advance your predictive asset maintenance strategies, progress facilities to the next generation of manufacturing, and ensure sustainability.

Why is this Community for You? 

  • Understand how to plan and manage the next generation of biomanufacturing facilities. Accounting for sustainabilityflexibility and reliability
  • Revamp your asset management strategies to minimize downtime and extend asset lifespans
  • Implement smart asset solutions to reduce COGs such as lean manufacturing and total productive maintenance
  • Leverage industry 4.0 to utilize predictive maintenance programs
  • Hear best-in-class management for excellent capital engineering and maintaining operational readiness

Visit our website here to view the full agenda: https://ter.li/z9tcq7

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Interstitial Lung Disease (ILD) Drug Development Summit

Network with over 50 other industry pioneers including Ionis Pharmaceuticals, Genentech, Vicore, and AnaMar to hear first-hand how the latest scientific research is innovating and upgrading ILD therapeutics at this trailblazing new meeting.

The 1st Interstitial Lung Disease Drug Development Summit is a ground-breaking new conference dedicated to helping you drive forward the development of effective therapies for chronic fibrosing ILDs and achieve success in anti-fibrotic drug development beyond IPF.

Join the world’s top ILD specialists as they guide you through the seminal research and insights you need to confidently define, understand, and develop clinically effective antifibrotic therapies against connective tissue disease, rheumatoid arthritis, hypersensitivity pneumonitis, Goodpasture’s syndrome, and much more.

To view the full agenda, visit our website here: https://ter.li/8ug2my

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Exclusive Webinar: Health Economics & Outcomes Research /Health Technology Assessment: The evolving role in the Indian Healthcare Ecosystem

Intellimed in collaboration with alpha MD & IMPA along with PharmaShots as the media partner is gladly organizing a webinar on “Health Economics & Outcomes Research /Health Technology Assessment: The evolving role in the Indian Healthcare Ecosystem”

The objective of the webinar is to discuss the need for affordable healthcare in India and the role of economic evidence for affordable healthcare in India.

Key-note address:

  • Dr. K. Srinath Reddy, MD

President, Public Health Foundation of India (PHFI)

Topic: The need for affordable healthcare in India

Special address:

  • Dr. V. M. Katoch, MD

FNASc, FASc, FAMS, FNA. NASI-ICMR Chair on Public Health Research at (RUHS), Jaipur

Topic: The Role of economic evidence in India for affordable healthcare

  Guest Speaker:

  •   Dr. Rajesh Balkrishnan, PhD

 Professor of Public Health Sciences, University of Virginia School of Medicine

 Clinical Professor, University of Virginia School of Nursing

TopicReal World Evaluations of the Effectiveness of Medical Care: Relevance in the Current Scenario

Panel Discussion:

  Topic: HEOR & HTA studies for healthcare delivery in India – An Industry Perspective

  • Mr. A Vaidheesh

Chief Executive Officer Northstar Asis LLP, Former manager director/VP south Asia glaxosmithkline & former VP India Johnson & Johnson

  • Mr. Manoj Saxena

  Managing Director, Bayer Zydus Pharma & CDH south Asia Bayer Pharma

  • Mr. Omar Sherief Mohammad

General Manager, Roche Diabetes Care India Pvt. Ltd.

  • Dr. Anish Desai

  Director. IntelliMed Healthcare Solutions & Honorary Professor, Pharmaceutical Medicine MUHS.

 Moderator:

  • Mr Vivek Padgaonkar

Independent Healthcare Consultant Former-Director, Former Director OPPI (Project & Policy), Former GSK (Sales & Marketing)

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Medtronic CEO expects to submit renal denervation data to FDA this year, overcoming previous failures

Medtronic suffered a shocking setback back in 2014 when its Symplicity 3 pivotal trial failed to meet its primary endpoint of reducing blood pressure meaningfully. Now it is gearing up to present new data to the FDA.

Medical Writing Landscape Advancement Summit | Virtual

The Lincoln Health Network is excited to announce our 2nd Medical Writing Landscape Advancement Summit, March 3-4, 2021. Join us virtually, on the LHN virtual event platform to improve your medical writing strategies by understanding evolving regulatory protocols and submission guidelines, and learn how to improve quality and content optimizations. Visit our website for our frequently updated conference agenda, list of speakers, and pricing details. The earlier you register, the more money you save!

We look forward to seeing you online!

Interested in Speaking? Please contact Scott Grossman at [email protected]

Interested in Sponsoring? Please contact Kelly Hara at [email protected]

For any registration related inquiries or for more info on group discounts, please contact Jessica Vargas at [email protected]

TOPICS TO BE ADDRESSED:

  • Project Management Best Practices for Compliant and Timely project completion
  • Scientific Publications best practices
  • Implementation of AI into automation writing
  • Quality improvement by developing SOPs
  • Ensuring high-quality medical publications through study design
  • Hurdles and Benefits of cross-functional applications
  • Impact of lay summaries
  • Develop a road map for navigating protected data
  • Impact of redefining medical writing processes
  • Utilize plain language processes to stakeholder communications

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MedCity INVEST Precision Medicine spotlight: Building a BioInnovation Hub (video)

The panel, What It Takes To Build A Successful, Regional BioInnovation Hub (sponsored by Independence Blue Cross) focuses on Philadelphia — one of many cities seeking to support the continued growth of cell and gene therapy and connected health industries.

MedCity INVEST Precision Medicine spotlight: Pitch Perfect Life Science track (video)

A video from the conference spotlights startup pitches and Q&A with judges in the Life Science track of the Pitch Perfect contest.

9th Annual Neurodegenerative Drug Development Summit

The 9th Neurodegenerative Drug Development Summit is the industry’s definitive and unrivalled forum focused on revealing hot and promising pockets of innovation in drug discovery for neurodegenerative diseases and combating translational challenges by shining a light on pioneering companies leading the way to meet this dire medical need.

Building on the success of last year’s meeting, this year’s program showcases new biotechs trailblazing this space and will put the spotlight on the latest scientific in diverse targetsnovel modalities and innovative trial design. Hear from our expert speakers from the likes of Sanofi, Alzheon, European Medicines Agency, Lundbeck and Alector.

Across 3 action-packed, case-study driven days and 2 parallel tracks of content, we present the opportunity to join us online in 2021 to overcome technical and operational challenges preventing you and your team from translating promising preclinical research into evidenced clinical benefit.

Whether you are working in a team dedicated to Parkinson’sAlzheimer’sALSFrontotemporal Dementia or a rare neurodegenerative disorder, join this intimate, industry-led forum to not only to learn from those spearheading this space, but to network and build meaningful partnerships with over 180 neurodegenerative drug development experts. After all, collaboration in this industry is pivotal.

Download the program here to learn more about the digital summit.

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Operationalize: Expanded Access Programs Summit

Say Goodbye to the Worry & Uncertainty of Setting Up & Managing an Expanded Access Program

This inaugural Operationalize: Expanded Access Programs digital event is here to bring you solutions.

Dealing with a diverse and confusing global regulatory landscape, on top of an increasing number of access requests from patients, is no easy feat for people working in expanded access programs. As operational obstacles can arise at any time, from set up to close out, all stakeholders must equip themselves with the knowledge and tools to overcome these challenges.

By bringing together the world’s leading Expanded Access Programs thinkers, this exclusive platform will clarify the complex issues through end-to-end Managed Access/Compassionate Use program operationalization. Through open discussion, sharing best-practice case studies, and removing hypotheticals, this event provides an unrivalled opportunity to solve your challenges across the entire timeline.

Whether it’s Expanded Access ProgramsEarly Access,Managed AccessCompassionate UseNamed Patient Programsor even Post-Trial Access, ensure you aren’t repeating past mistakes by hearing global leaders recall their experience with a shared goal of providing you with pragmatic solutions to solve these complex hurdles.
Download the Full Event Guide to see what experts from Novartis, Stealth Bio, Santhera, Roche and Janssen will be discussing.

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5th Microbiome Movement – Drug Development Summit Europe 2021

As the first microbiome-based therapeutic steps closer to market approval, the scientific community continue to demonstrate the functional role of the human microbiome as a novel source of therapeutic, biomarker and diagnostic development. Despite this progress, the vast potential to develop effective treatments that target the human microbiome is still limited by the complex challenges in developing them.

Part of the foremost conference series for microbiome researchers in industry, the 5th Microbiome Movement – Drug Development Europe 2021 will return to unite leading scientists from the biopharmaceutical and academic community to pursue the causal role of the microbiome in disease, and help create a new generation of microbiome-targeted therapeutics with predictable modes of action and consistent clinical outcomes.

Over three jam-packed days of case-studies, discussion and debates, this year’s event will shine a light on how industry and academic leaders are understanding microbiome functionality across key therapeutic modalities, leveraging big data platforms to deduce causality, and overcoming regulatory, clinical and manufacturing hurdles to further accelerate their pipeline across new disease targets.

So whether you’re part of a microbiome-focused biotech, a pharmaceutical organization assessing this exciting field, or an academic researcher with breakthrough findings, join the Microbiome Movement as we explore the global advances in translational microbiome research, and meet like-minded peers who are continuing to understand the causal and therapeutic potential of the ‘second genome’.

Access the official 2020 agenda to see the topics that will be addressed

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What’s coming up at MedCity INVEST Precision Medicine Day 3?

dna, genomics

The final day of the conference, Friday, December 11, includes a panel on precision medicine investment trends, a look at clinical trial design innovation and the life sciences track of our Pitch Perfect startup contest. Register now!

Which startups will present at MedCity INVEST Precision Medicine Pitch Perfect?

Finish line ahead

Among the areas of interest for companies presenting at Pitch Perfect at INVEST Precision Medicine are clinical stroke detection, making medical research more inclusive, using technology to accelerate the pace of clinical trials, developing more patient friendly drug delivery systems for reconstitutable drugs, and more.

4th Antigen Specific Immune Tolerance Summit

The 4th Antigen Specific Immune Tolerance Digital Summit (ASIT) brings together industry representatives from the fields of autoimmunity, allergy, immuno-oncology and transplantation to tackle the complexities behind autoimmune disorders head on. With momentum building for antigen specific immunotherapies, ASIT 2021 will be the only antigen-specific summit offering thought-leading content to drive the field towards a more precise and ethical antigen-specific approach to drug development.

This is the industry’s definitive antigen specific drug development forum.

Across 3 packed days, thought leaders from NovartisImCyseHarvard Medical SchoolToleranziaToralgen will reveal insight, data, and lessons learned from the last 12 months to enable you to hurdle the roadblocks preventing the development of clinically safe and effective antigen-specific immunotherapies for autoimmune and immune mediated disorders.

Access the official agenda for more information.

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Cytokine-Based Cancer Immunotherapies Summit

The renewed interest in the anti-tumor properties of cytokines has led to an increase in the number of clinical trials that explore the safety and efficacy of cytokine-based drugs, not only as single agents, but also in combination with other immunomodulatory drugs.

Therapeutically targeting of soluble immune modulators in the tumor microenvironment (TME) has been shown to create a ‘hot’ tumor, increasing T cell infiltration and improving response rates to immune checkpoint blockade treatment. The immuno-oncology research community is pivoting towards engineering soluble factors and cytokines to transform the TME into an immunostimulatory state, acting as a complementary strategy to a suite of cancer immunotherapies approaches.

The virtual Cytokine-Based Cancer Immunotherapies Summit has been established to give drug developers insight into the latest clinical advancements and stimulate discussions around how to take immuno-oncology combinations forward to meet the vast unmet need of cancer patients.

Join us and leading experts from Roche, CytomX, Philogen, Bristol-Myers Squibb, Novartis and many more to discuss how to reduce toxicity and achieve an efficacious dose, determining the mechanisms of action and hear the latest data coming out of the clinic.

If you are a research team striving to advance your cytokine therapies, this is the best suited online networking forum which has been curated for you.

Access the official agenda for more information.

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PARP & DDR Inhibitors Summit 2021

Developing Inhibitors of Specific DDR Targets, in Monotherapy or in Combination, to Treat Predictable & Identifiable DDR-Defective Cancer Indications

PARP & DDR therapeutics are exploding thanks to numerous novel next generation synthetic lethal targets reaching an inflection point.

The PARP & DDR Inhibitors Summit is your only industry focused meeting dedicated to bringing DDR therapeutics to the clinic. The digital meeting will capitalize on the therapeutic application of PARP inhibitors by finding optimal treatment combinations and expanding its use in cancer indications, as well as exploring emerging targets such as Pol Theta.

Join us and the VPs, Heads and Directors of Translational Oncology, Target Discovery, and Early Drug Development to discuss how to develop novel inhibitors of specific DNA repair enzymes that can be used as either monotherapy or in combination with other agents within predictable, identifiable, DDR-defective tumor populations.

Gain insight into the latest techniques to decipher the entangled network of DNA damage response mechanisms, including multiple DNA repair pathways, damage tolerance processes, and cell-cycle checkpoints to safeguard genomic integrity.

Plan how to optimize PARP inhibitors in the clinic with treatment combinations to expand indications and deliver more selective and better tolerated medicines to improve survival rates in difficult-to-treat cancers.

Furthermore, there will be a unique pre-conference focus day looking at the rationales and approaches for enhancing replication stress in cancerous cells and inhibiting DNA repair mechanisms which prevent apoptosis.

If you are a research team striving to create best-in-class DDR therapeutics, this is the best suited online networking forum which has been curated for you.

Access the official agenda for more information.

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Insights+ Key Biosimilars Events of November 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of November, Formycon and Bioeq reported the first patient dosing in the P-III study of FYB202 while Prestige collaborated with Teva to commercialize Tuznue. Our team at PharmaShots has summarized 21 key events of the biosimilar space of Nov 2020.

Celltrion Presented Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 03, 2020

Product: CT-P17 (biosimilar, adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)

Formycon Reported BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 06, 2020

Product: FYB201 (biosimilar, ranibizumab)

  • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
  • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
  • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)

Published: Nov 09, 2020

Product: FYB202 (biosimilar, ustekinumab)

  • The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy, safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
  • FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
  • The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis, CD & for UC

Alvotech and Cipla Collaborated to Ensure Access to Biosimilars in South Africa

Published: Nov 09, 2020

Product: Biosimilar

  • Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
  • Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
  • The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar

Published: Nov 13, 2020

Product: Proposed Bevacizumab Biosimilar

  • Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents
  • Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements
  • Centus has a BLA under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent

Prestige Signed an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11, 2020

Product: Tuznue (biosimilar, trastuzumab)

  • Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
  • Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
  • Tuznue is biosimilar referencing Roche’s Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

Samsung Bioepis Initiated P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11, 2020

Product: SB16 proposed biosimilar to Prolia

  • The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
  • The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
  • With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

Henlius Reported First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11, 2020

Product: HLX14 (denosumab, biosimilar)

  • The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
  • Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. The study also evaluates PD, safety, tolerability, and immunogenicity between HLX14 and the reference drug
  • Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

Xbrane Reported Patient Enrollment Completion in P-lll XPLORE Study of Xlucane (biosimilar, ranibizumab)

Published: Nov 11, 2020

Product: Xlucane (biosimilar, ranibizumab)

  • Xbrane reported that the last patient has been enrolled into the P-III XPLORE study assessing Xlucane vs Lucentis in 580 patients with wet AMD
  • The company will conduct an interim read-out from the XPLORE study when the last patient has reached 6mos. of their treatment schedule. Top-line data is expected to be communicated mid-2021 and filing of the MAA/BLA to EMA and the US FDA anticipated to take place imminently
  • Filing of MAA/BLA is expected to take place mid-2021. With an expected 12mos. regulatory process upon filing, MAA is expected in the EU and the US mid-2022 allowing for the launch of Xlucane

Henlius Reported the NMPA’s Acceptance of HLX15 (biosimilar, daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020

Product: HLX15 (biosimilar, daratumumab)

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Samsung Bioepis Presented Results of SB11 Proposed Biosimilar to Lucentis in P-III Study at the AAO 2020 Virtual

Published: Nov 16, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
  • One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
  • The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct’2020

Samsung Bioepis and Biogen Reported the FDA’s Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

Published: Nov 18, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
  • The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi
  • In Nov’2019, Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates, SB11 (ranibizumab) & SB15 (aflibercept) in the US, Canada, Europe, Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders

The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

Published: Nov 19, 2020

Product: Biosimilar

Shots:

  • The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
  • The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of statutory requirements added by the BPCI Act
  • The draft guidance is to be published in the Federal Register on Nov 20, 2020

Alvotech Reported the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Product: Nov 20, 2020

Product: AVT02, a proposed biosimilar to Humira

  • The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21
  • The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
  • AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020

Published: Nov 20, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC
  • Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in 2EPs including OS, PFS, ORR, TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
  • The NMPA has accepted the NDA for HLX04. Additionally, Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability, designed for ophthalmic use

Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance

Published: Nov 20, 2020

Product: SAIT101 (biosimilar, rituximab)

  • Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of SAIT101 (biosimilar, rituximab)
  • Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan in 315 FL patients with ORR (66.3% vs 70.6%)
  • The companies decided to stop commercializing SAIT101 and take step for liquidation of Archigen as the product lacks commercial viability

The US FDA Approved Pfizer’s Oncology Supportive Care Biosimilar Nyvepria (biosimilar, pegfilgrastim)

Product: Nov 20, 2020

Product: Nyvepria (biosimilar, pegfilgrastim)

  • The EC has approved Nyvepria, a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
  • The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
  • Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1’21. The EC’s approval follows the US FDA’s approval granted in Jun’2020

Innovent Reported Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Product: Nov 23, 2020

Product: Byvasda (biosimilar, bevacizumab)

  • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
  • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
  • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Polyarticular Juvenile Idiopathic Arthritis

Published: Nov 23, 2020

Product: Sulinno (biosimilar, adalimumab)

  • The NMPA has approved Sulinno for the treatment of pJIA which is the fourth approved indication of the therapy in China. Earlier, Sulinno was approved for RA, PS, and psoriasis
  • The launch of Sulinno has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients
  • Sulinno is a human anti-TNF-α mAb referencing Humira. The clinical results were published at the Inaugural Issue of The Lancet Rheumatology in 2019

Alvotech and Alvotech & CCHT Signed an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Product: Nov 25, 2020

Product: Biosimilar

  • The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology
  • Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars
  • The manufacturing of biosimilars will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT. The first phase of the facility is expected to be completed in 2021

Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Product: Nov 26, 2020

Product: BAT1706 (a proposed biosimilar to Avastin)

  • The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
  • The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
  • The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

Related Post: Insights+ Key Biosimilars Events of October 2020

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Online Live Team Pharma Forecasting Training Now Available

Working remotely can have its challenges, why not get together for a fun and rewarding learning experience and refresh your forecasting skills?

Following the success of J+D Forecasting’s face to face training, the content has been redesigned to make it suitable for live, online audiences.  There are two types of courses, type one is tailored to your objectives and delivered by experienced forecasting professionals via a sharing platform. Your team is interviewed prior to the training and the focus of the training is agreed in advance with you and your colleagues.

The second type of training allows you to choose from a selection of pre-set courses that are completed when you choose. The most popular independent courses are the Fundamentals of Forecasting and Oncology Forecasting courses.

The training is suitable for anyone involved in pharmaceutical forecasting who wishes to refresh or learn new skills. It is particularly useful for Forecasters, Marketeers, Analysts and Market Researchers.

In addition, trainees gain access to FC+ software, case studies and quizzes, plus reminder cards.
For further information get in touch: [email protected] or visit jdforecasting.com

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AI Driven Repositioning and Repurposing Summit 2021

Despite advances in science and technology, denovo drug development has been a costly and time-consuming process over the past decades.

Given these circumstances, drug repositioning and repurposing has appeared as an alternative tool to accelerate drug development processes by seeking new indications for approved/shelved drugs rather than discovering de novo drug compounds.

The newest computational approach to drug repositioning showing the greatest promise is AI and machine learning. With a drug-repurposing strategy, AI can quickly detect drugs that can fight against emerging diseases (such as Covid-19) as well as existing diseases.

The AI Driven Drug Repositioning & Repurposing Summit will bring together 80+ leaders in repurposing
and pioneers in AI and machine learning to strategize how repurposing can reach its full potential to:

• Improve time and cost savings of drug development
• Leverage the safety advantage in reducing development risk
• Unlock market potential advantage
• Improve return on investment for repurposed drugs
• Explore out-licensing options

This meeting aims to help pharma, biotech and academics stay ahead of the curve in their repurposing endeavors during a period exploding with new technologies. Join cutting-edge discussions with the like of AstraZeneca, BenevolentAI, and Healx, to solve ongoing technical challenges surrounding AI tools in repurposing, understand the delicate risk-reward balance in potential repurposing opportunities and explore lessons learned from AI applications in repurposing during Covid-19.

Featuring 2 days of jam-packed content, this digital summit will provide you with all the information you need to begin implementing AI tools into repurposing projects within your organization. What’s more, our digital platform allows you to take part in live Q&A with the presenters, take a tour of the virtual exhibition, and even join online rooms where you can join targeted interactive discussion groups!

Visit our website to find out more.

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Mark your calendars for our virtual INVEST Precision Medicine conference, December 9-11

Here’s a preview of some of the panel discussions at INVEST Precision Medicine, including diagnostics, investment trends, and building a bioinnovation hub.

2nd Gene Therapy for Blood Disorders

2020 has been an exciting year for gene therapies targeting blood disorders. Despite FDA’s recent rejection of BioMarin’s hemophilia gene therapy program, the clinical landscape is progressing quickly with Pfizer and Sangamo kicking off their phase 3 and bluebird bio receiving European approval for their beta-thalassemia candidate.

With pipelines advancing and emerging companies joining the blood disorders field, it is essential for gene therapy developers to communicate and share lessons learned to accelerate their programs to market. The 2nd Gene Therapy for Blood Disorders meeting is taking place in March 2021, focusing on the clinical and commercial challenges of developing gene therapies targeting hemophilia, sickle cell disease and beta thalassemia.

Evaluate the best strategies for a commercial launch in blood disease and optimize your trial design to ultimately transform your clinical candidates into a commercial reality.

Download the full event guide to learn more from companies including bluebird bio, Spark Therapeutics and Editas Medicine.

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Gene Therapy Medical Affairs

The inaugural Gene Therapy Medical Affairs Summit is dedicated to exploring the pivotal internal and external role that Medical Affairs plays in delivering gene therapies to patients.

Industry pioneers from leading pharma and biotech companies at various stages of development and commercialization including Novartis Gene TherapyOrchard Therapeutics & Bluebird Bio will share how to engage effectively with internal clinical and commercial teams as well as external HCPs, regulators and patient advocates to create a cohesive and streamlined launch strategy for complex, high priced gene therapy products and ultimately work to remove both barriers that exist for access to gene therapies.

Join this definitive, niche conference to delve into the unique Medical Affairs challenges encountered when working with gene therapies, from adapting to the clinical realities of the rare disease space to handling long-term follow up and post-launch scrutiny, equipping you with the insights required to launch gene therapy products more efficiently and effectively than ever before.

This virtual event is set to be a highly interactive and engaging meeting. We fully understand (and quite frankly agree) that a presentation-heavy conference just isn’t up to scratch! As such we have created a new format for this meeting which maximises opportunities for engagement, discussion, and Q&A’s in order for you to get the best value from this meeting.

Access the official agenda for more information.

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TGFB for Immuno-Oncology Drug Development Summit

Are you interested in finding the next breakthrough in immuno-oncology preclinical or clinical development?

Recent scientific, clinical breakthroughs and high-profile industry deals have reignited the race to find the next blockbuster TGF-ß inhibitor for immuno-oncology applications.

As such, the TGFß for Immuno-Oncology Drug Development Summit (January 26-28) is the ONLY industry-focused meeting dedicated to pharma, biotech, and academia who will share their latest data, best practices, and top tips to expedite TGF-beta candidates into the clinic in a safe and efficacious manner.

With over 21 expert speakers presenting across 3 days packed full of content, this is your definitive guide to tame the TGF-beta double-edged sword and navigate a narrow therapeutic window, enhance tumor suppression, and maximize therapeutic potential in immuno-oncology – you won’t want to miss it!

Take a look at the full program here

Here’s a sneak peek into the world-class speaker faculty:

  • Shannon Turley, Senior Director, Cancer Immunology, Genentech
  • Rik Derynck, Professor – Departments of Cell, Tissue Biology & Anatomy, University of California San Francisco
  • Thomas Schurpf, Associate Director, Scholar Rock
  • Olaf Christensen, Vice President, Head of Bintrafusp alfa, Global Development, R&D, EMD Serono
  • Paul Rennert, President & Chief Scientific Officer, Aleta Biotherapeutics
  • Sam Shrivastava, Chairman & Chief Executive Officer, Venn Therapeutics
  • Vuong Trieu, Chairman & Chief Executive Officer, Oncotelic Inc
  • Christopher Heery, Chief Medical Officer, Precision BioSciences

Download your digital event guide here to access the full speaker faculty and conference agenda.

How can this get any better I hear you ask? Well, through our specialized digital platform, you can enjoy the full conference experience all from the comfort of your own home (without the bad conference coffee and awkward encounters at the buffet table). Using our algorithm get matched with fellow attendees and speakers for meaningful networking opportunities.

For more information visit www.tgf-beta-summit.com or email us at [email protected].

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Reimaging population health at INVEST Pop Health Virtual: Register today

MedCity News is partnering with the New Orleans Business Alliance to host the executive summit November 16-18. It focuses on population health and highlights where innovation and investment are occurring in the field.

Clinical Document World | Virtual 2021

Join us at our 2nd Clinical Document World Virtual event on January 19-21, 2021, alongside your TMF, clinical quality, document management, and clinical professionals to explore a strategic clinical process and ensure a complete Document Management Process.  This interactive event will include thought-provoking sessions from a variety of different life science professionals, each followed by a Q&A session. Over the course of this 3-day virtual event, we will cover topics including TMF, inspection readiness, quality, good clinical practices, and more. Visit our website to register or to find out more information on our speaker-lineup, featured sessions, and pricing.

WHY CLINICAL DOCUMENT WORLD SHOULD BE YOUR LEARNING & NETWORKING CHOICE OF THE YEAR:

  • Interactive educational sessions covering all aspects of clinical document management
  • Faculty Consisting of professionals from CROs, Sites, and sponsors with a diverse background in TMF, quality, technology, and inspections readiness
  • Focus on ensuring high quality documentation
  • Develop and maintain a culture of inspection readiness
  • Impact of a successful sponsor — CRO collaboration to improve quality throughout the trial
  • Impact of technology to impact a clinical trial

For more information, click here!

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Which healthcare startups will present at Pitch Perfect for INVEST Pop Health Virtual?

contest, spotlight

The healthcare startups targeting chronic conditions and population health presenting at INVEST Pop Health November 16-18 span prescription drug delivery to addressing social isolation.

Welcome to the CAR-TCR Summit Europe 2021

Accelerate the Bench to Bedside Development of Novel CAR Immunotherapies for Safe, Effective & Affordable Advanced Therapies

With CAR-TCR therapies on the cusp of achieving global approval, there are still many bottlenecks that are preventing this from becoming the ‘sell-out’ therapy that the field had hoped for.

The CAR-TCR Summit Europe (16th-18th February 2021) will unravel the technical challenges across R&D, translation, scale and delivery to provide your team with the platform to learn, collaborate and gain actionable insights to advance your therapy for clinical and commercial success.

This year’s focused agenda will delve into the technical bottlenecks encountered in every stage of the CAR-TCR drug development cycle, providing more comprehensive analysis from 55+ expert speakers across 3 streams of content including:

Research & Development Track:

  • Explore the emerging CAR-X landscape with Glycostem & Carisma Therapeutics
  • Breach the solid tumour microenvironment with Refuge Biotech Atara Biotherapeutics
  • Optimise target identification with Celyad Anocca AB
  • Investigate next-generation gene engineering techniques with Precision Biosciences

Translation Track:

  • Develop ‘off-the-shelf’ platforms with Leucid Bio
  • Provide a mechanistic rationale for combination therapies with Agenus & Ziopharm Oncology
  • Discuss ‘gold standards’ and innovations in assay development  GlaxoSmithKline & bluebird bio
  • Understand and minimise toxicity with Kite: A Gilead Company & The NHS

Manufacturing & Commercialisation Track:

  • Advance automation for cheaper, faster manufacturing with Gracell Biotechnologies & Glycostem
  • Gain regulatory guidance to initiate clinical trials in Europe from MHRA & Norwegian Medicines Authority
  • Maximise real-world evidence for value demonstration, and innovative reimbursement models with Janssen
  • Expedite batch release and maintain high-quality products with Novartis & Immatics

For agenda details and full speaker line up, find out more here

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Join the Frontiers Health 2020 Global Hybrid Conference

Frontiers Health has emerged over the last years as one of the premier global events on digital health and innovation in healthcare. In the last five years, the conference has turned into a unique platform for deal making, networking and learning in the industry and has been repeatedly defined as a home to the digital health ecosystem, gathering thousands of innovators, leaders and key players from the health industry each year in Berlin and in other locations across the world.

The 2020 edition, taking place from 12-13 November, will follow a hybrid format combining online global streaming together with offline events and activities held at Local Hubs in multiple locations such as Italy, Germany, Finland, Malta, Spain, Switzerland and USA all streamed globally too.

The conference will be dedicated to the digital health innovation in the context of the ‘new normal’, focusing on telemedicine, digital therapies, breakthrough technologies, patient-centricity, healthcare transformation, investments and ecosystem development.

The programme will start at 2:00 pm CET on both days with plenary sessions (talks and panels) and parallel break-out sessions (masterclasses, workshops, deep-dive formats) in pure Frontiers style.

The iconic Start-up Discovery sessions have also moved online, opening more opportunities to connect with both early-stage and established digital health start-ups.

Click here to learn more and take advantage of our discounted rates!

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How is population health innovation unfolding in Louisiana? [Sponsored]

With the annual INVEST Population Health virtual conference coming up November 16-18, here’s a look at our collaboration partner New Orleans Business Alliance. It plays a vital role in helping to stimulate the local economy by supporting the development and advancement of the healthcare and biotech infrastructure.

Pharma Middle East Virtual Congress (Dec 07 – 08, 2020)

Pharma Middle East Virtual Congress (PPMC2020) layout many new ideas to resolve the most important problems related to the health and wellbeing of humanity. With all the scientific experts and professionals around the world focused on novel trends and advanced strategies emerging in the areas of pharma & chemistry, it provides unique learning and career-building opportunities in your profession to encourage the nascent research that you just can’t find anywhere else.

Conference Central Topics to be discussed:
1. Pharmacy and Pharmaceutical Sciences
2. Pharmaceutics and Novel Drug Delivery Systems
3. Biosimilars and Biopharmaceuticals
4. Pharmaceutical Microbiology and Biotechnology
5. Bioavailability and Bioequivalence
6. Medicinal Chemistry and Drug Discovery
7. Pharmaceutical Chemistry and Drug Design
8. Industrial Pharmacy and Drug Development
9. Pharmacology and Toxicology
10. Clinical Pharmacy and Pharmacy Practice
11. Pharmaceutical Nanotechnology
12. Drug Delivery Technologies and Medical Devices
13. Pharmacovigilance and Regulatory Affairs

Key Speakers of the Event:

Yavuz Selim Silay, Chairman ICG, Turkey

Ahmed Hegazy, Pvigilant Health, UAE

Zareen Delawar Hussain, CEO, Integro Pharma, Bangladesh

Nitin Kaik, Frost & Sullivan, US

To register online visit our website: PPMC Virtual 2020

For 3 or more members group, contact us to avail discounts
Abstract Submission Deadline: November 27, 2020 Participation Confirmation Deadline: December 03, 2020

The post Pharma Middle East Virtual Congress (Dec 07 – 08, 2020) first appeared on PharmaShots.

Don’t miss our virtual population health conference November 16-18

For the second year, MedCity News is partnering with the New Orleans Business Alliance to host an executive summit that focuses on population health and highlights where innovation and investment are occurring in the field.

A “bald-faced lie” on LinkedIn followed by revisionist history of CMMI at HLTH panel

HLTH aimed to reflect on the success of the decade-old Center for Medicare and Medicaid Innovation (CMMI) by a panel discussion with its directors. Except the first director was never included while his successor tried claiming the mantle of the “inaugural director” riling former colleagues eager to set the record straight.

Don’t miss our patient engagement conference ENGAGE at HLTH Oct. 15

Patient engagement and experience were coming into focus as part of the overall transformation of healthcare, but the advent of Covid-19 has thrust it to the forefront. Hear from patients, providers, retailers, tech disruptors and others about why patient engagement is paramount.

Startups with tech to improve payer and provider efficiency: Video from MedCity INVEST Digital Health

Next Generation of Workers

This Pitch Perfect contest track reflected technology to remove financial barriers for their patients, automating workflows, reducing inefficiency and waste associated with the Prior Authorization process, and more.

Startups focused on chronic conditions and value-based care: Video from MedCity INVEST Digital Health

Finalists in the Pitch Perfect contest track, chronic disease management and value-based care, span virtual care for patients with neurological disorders and family caregivers, digital therapeutics for adolescent mental health, and personalized nutrition coaching to address chronic disease risk.

Product Complaints & Recalls Virtual Summit

By having an effective complaint management system, life science organizations have a better chance to ward off inspections by using the appropriate guidelines and regulations. Monitoring complaint trends over time and having a complaint program improves the customer’s experience with your products.
Part of the process is being ready for anything, while a recall is a scenario we want to avoid, we need to be ready, we need to have a plan to go to, we need to learn how to mitigate and follow regulations. Register today for the Product Complaints and Recalls Virtual Summit and gain the critical knowledge needed to be prepared to excel when facing complaints and recalls, learn how to be proactive and not reactive.
Click here to learn more and take advantage of our discounted rates!

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The COVID-19 Effect: How Pharma Can Adapt to the Evolving Patient Experience

Patient experiences are evolving. How can pharma keep up?
By listening to the people who are navigating this new landscape everyday.

Integrating personal experiences and patient-reported data, this one-day virtual event features real-time conversations between people living with chronic conditions and Health Union industry experts.
Tune in to any or all of the sessions based on your interests and hear from patient advocates living with migraineMSpsoriasis, and lung cancer; plus a lunchtime roundtable focused on telehealth featuring advocates living with Parkinson’s disease and IBD.

Tune in to any or all of the sessions based on your interests:

  • [10:00 – 10:30 a.m.] MS & Social Distancing: Devin’s Resilience
  • [11:00 – 11:30 a.m.] Psoriasis Used to Isolate Reena, Now It Connects Her
  • [12:00 – 12:45 p.m.] Telehealth Perspectives: The Good, The Bad & The Ugly
  • [01:00 – 01:30 p.m.] Healthcare + Self-Care: Kerrie’s Migraine Journey
  • [02:00 – 02:30 p.m.] Listen & Learn from People with Lung Cancer, Like Lisa

Register now

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2nd RNA Editing Summit 2020

Visit our website: www.rna-editing-summit.com

The only industry-led meeting showcasing the recent development of RNA editing mechanisms and dedicated to realizing the research and therapeutics opportunity of RNA editing as quickly as possible.

The Primary Industry Platform Solely Dedicated to the Tech Transfer, Translation & Commercialization of Exploding RNA Editing Approaches & Applications

As CRISPR genome editing struggles to overcome key specificity and delivery challenges in its pursuit to realize therapeutic applications, the 2nd RNA Editing Summit builds on its first year to deliver a speaker faculty of industry and academic leaders looking to accelerate the translation and commercialization of RNA editing for an array of research and therapeutic applications.

This virtual conference focuses specifically on the latest approaches in RNA editing systems and the targeting molecules used to direct these agents to sites of interest. Be part of interactive discussions around the core challenges for this field, including mitigating against off-targeting editing, determining pharmacodynamics/pharmacokinetics to inform dosing, identifying the right chemical modifications of editing oligonucleotides to increase specificity and stability, and preventing immunogenicity of different delivery mechanisms.

Join RNA, functional genomic and cell biology experts from large pharma, biotech and academia at the online 2nd RNA Editing Summit to solve these challenges and bring the therapeutic potential of RNA editing to rare diseases, oncology, ophthalmic disorders, cardiovascular disease and many more to a commercial reality.

Visit our website: www.rna-editing-summit.com

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AI-ML Drug Discovery & Development Summit 2021

Visit our website: www.ai-drugdiscovery.com

R&D & Clinical Processes for the Future: Accurate, Efficient & Cost-Effective

The AI-ML: Drug Discovery and Development Summit is the industry’s definitive guide to translating the wealth of tech available to successfully implement a working and practically effective drug discovery and development platform.

Designed with leading AI experts from R&D and clinical departments across big pharma, biotech, and academia, this year’s forum features 3 days of real-world case studies and interactive discussions. As such, the 2020 AI-ML Summit will provide you with a roadmap to augmented R&D and clinical decision making with reduced failure rates, increased speed, and improved margins.

This is a critical time for drug developers to make more data-driven decisions, and at the 4th AI-ML: Drug Discovery and Development Summit you will learn how to strategically leverage AI technology to transform your pipelines, and patient’s lives.

Join 80+ like-minded peers who are overhauling outdated R&D and clinical processes to reflect on both successes and failures, and importantly the lessons learned along the way from the last year of implementation and utilization.

Visit our website: www.ai-drugdiscovery.com

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Addressing behavioral health challenges for patients and employees: Video from MedCity INVEST Digital Health

mental health, face, human

In the latest video installment from INVEST Digital Health Virtual, a panel looks at behavioral health from the loneliness epidemic, workplace stress, and other challenges and the innovative tools developed to address these needs.

A debate on reimagining health insurance: Video from MedCity Invest Digital Health

In the latest video installment from INVEST Digital Health, venture capitalist Michael Yang, Managing Partner, OMERS Ventures, and healthcare entrepreneur Shawn Wagoner, Chief Revenue Officer, Bind Benefits, go head to head to debate the future of health insurance.

How Hospital Innovation is Changing Amidst a Pandemic: Video from MedCity Invest Digital Health

We’re making video segments from our INVEST Digital Health conference available for viewing. The first of these installments is a panel discussion on innovation in hospital settings during the public health crisis.

And the winners of INVEST Digital Health Virtual Pitch Perfect contest are…..

The INVEST Digital Health Virtual conference Pitch Perfect competition, from September 21-25, had some intense competition between the healthcare startup participants. Thanks to all the entrepreneurs, judges and sponsors who took part.

TIGIT Therapies Digital Summit

The TIGIT checkpoint has gained much attention in recent years due to the number of roles it plays in several malignancies. TIGIT’s diverse function in multiple cell types has made it a lucrative immunotherapy candidate, with an increasing number of candidates being investigated in pre-clinical and clinical settings.

As evidence of TIGIT’s clinical potential builds, the TIGIT Therapies Digital Summit brings you a comprehensive insight, from the fundamental biology to early clinical development, and the next wave of ICI.

Hear from leaders in TIGIT development from Merck, Compugen, iTeos Therapeutics, Agenus and more!

Core challenges must still be addressed by the community, such as:

Investigating the TIGIT pathway, ligands, and modes of action
Optimizing biomarker strategy to identify optimal patient populations and indications
Rationalizing combination strategy to leverage the TIGIT mechanism for maximum therapeutic benefit.

The TIGIT Therapies Digital Summit will gather the greatest minds in TIGIT research. Gain access to 1:1 time with leaders in TIGIT development, and take away tangible learnings with dedicated panel discussions and poster sessions throughout the event.

In such a fast-paced industry, this is a unique opportunity to provide an overview of the ‘knowns and unknowns’ in the field, and to accelerate the safe development of TIGIT therapies with maximum clinical impact.

For more details about the program, speaker faculty or pricing and discounts, download the brochure.

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How do we improve behavioral health in meaningful ways? Join the conversation at INVEST Digital Health.

mental health, mental illness, paper, writing, torn paper, mental

A panel discussion at the conference will examine what is being done to address behavioral health needs from social isolation, accentuated by the public health crisis, to the stress experienced by healthcare professionals.

A debate on the future of health insurance will be a highlight of INVEST Digital Health virtual

The upcoming INVEST Digital Health virtual conference September 21-25 will offer a spotlight for this debate to continue. It will also include conversations spanning behavioral health and how hospitals are addressing the pandemic as well as healthcare startup pitches.

What does hospital innovation look like in a pandemic? Find out at INVEST Digital Health

 The conference, in partnership with healthcare industry association Medical Alley, will include conversations spanning behavioral health, the future of health insurance and how hospitals are addressing the pandemic. It will also spotlight healthcare startups in a pitch contest.

Patient-to-Patient Supply for Cell Immunotherapies Summit

Achieving Standardization & Operational Excellence in Vein-to-Vein Supply

As an increasing number of candidates enter the clinic and promise to be a mainstay in the future of cancer treatment, cell therapies pose unique supply chain challenges.

From temperature and time sensitivity, to patient-facing delivery and chain of identity, these supply chain challenges must be overcome to ensure the delivery of safe and efficacious cell therapies at scale.

The Patient-to-Patient Supply for Cell Immunotherapies Summit (October 29-30, 2020) is a unique two-day digital platform discussing best practises in implementing robust vein-to-vein supply chains.

Our community of supply chain experts are looking forward to connecting with you in the digital world, including:

  • Christopher Baldwin, Supply Chain Director, Cell & Gene Therapy¸ GSK
  • Reggie Foster, Senior Director Labelling, Logistics & Packaging, Kite: a Gilead Company
  • Sheng Lin-Gibson, Chief, NIST Biosystems & Biomaterials Division
  • Jean Stanton, Director Commercial Apheresis, Johnson & Johnson
  • Richard McFarland, President, Standards Coordinating Body
  • Neeraj Shah, Director Supply Chain Excellence, Bristol-Myers Squibb
  • Kawa Chiu, VP CMC Supply Chain, Lyell Immunopharma
  • Alexandra Gomez, Associate Director, Patient Services Operations, bluebird bio

Get your copy of the brand-new agenda for the full list of speakers and sessions.

Join the key speakers sharing industry-leading expertise and reconnect with your community to ensure your team is equipped to navigate this pandemic with robust, commercially ready supply chains.

Join this timely discussion by registering online today.

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2nd Macrophage-directed Therapies Summit

Harnessing the Potential of Macrophage Therapies Using Small Molecule, Antibody & Cell Therapy based Approaches for Oncology and Beyond

The $4.9 billion acquisition of Forty Seven by Gilead is an example of the explosive excitement and investment into macrophage-directed therapies, utilizing CD47 checkpoint blockades, repolarization approaches and engineered macrophages, that we have witnessed in recent months.

The digital 2nd Macrophage-directed Therapies Summit (October 27-29) is a comprehensive industry focused meeting dedicated to advancing current CD47 and CAR-macrophage therapies alongside the new and exciting macrophage targets being identified and studied.

View the full event guide to see all the leading speakers and their agenda sessions.

Some highlights on the 2020 agenda:

  • Nicholas Poirier, Chief Scientific Officer, OSE Immunotherapeutics will explore a novel ‘don’t eat me’ target regulating macrophages phagocytosis and dendritic cell antigen presentation
  • Michael Klichinsky, Co-Founder & VP, Discovery, Carisma Therapeutics will discuss genetically engineering CAR macrophages & CAR monocytes
  • Yang Liu, Founder, President and Chief Scientific Officer, Oncoimmune will explore the CD24–Siglec-10 pathway as a novel innate immune checkpoint to modulate anti-tumor immunity
  • Gloria Lin, Associate Director of Translational Research, Trillium Therapeutics Inc will reveal emerging clinical data on SIRPaFc decoy receptors that neutralize the suppressive effects of CD47

To see the full speaker line up, download the full agenda

We are excited to bring the community back together at the virtual Macrophage-directed Therapies Summit to advance the fundamental understanding of macrophage biology, avoiding on-target toxicities and the emerging field of macrophage cellular immunotherapy. 

Join this timely discussion by registering online today.

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Why MedCity News should be your go-to advertising partner

MedCity News has the most engaged healthcare business audience in the industry. We can collaborate with you to develop customized content or provide a platform for your business to present sponsored thought leadership content highlighting from executives in healthcare and life sciences.

Important factors to consider when working with CRFs

What’s the background on CRFs?

A traditional paper case report form is known as a CRF (or paper CRF). An electronic case report form (eCRF) is the same as a CRF, except that it’s electronic. Both abbreviations tend to be used interchangeably, and are also referred to as forms.

CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products.

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention to detail. They must comply with the study protocol, and record its detail. They must also comply with regulatory requirements, such as those defined by the FDA.

 

CRF design & eCRF design

Good CRF Design is essential for a successful clinical trial submission and getting clinical products to the market.

Design objectives

Well-designed forms must:

  • Gather data that’s complete, accurate, and of high quality.
  • Avoid duplication.
  • Be well structured and easy for the user to complete.
  • Be unambiguous and allow for accurate data entry. For example, using coded lists to limit answers to questions. And avoid open ended questions.
  • Avoid gathering more data than what is needed.
  • Be consistent, well laid out, uncluttered, simple, and user friendly.

 

What to keep in mind at design time

To capture data correctly, here’s some things to think about:

  • Clear guidance using prompts and instructions should be included.
  • Formats, fonts and font size should be the same across all forms.
  • The layout should be simple and uncluttered.
  • Questions should be clear, precise, and easy to understand.
  • Include consistent headers.
  • Specify units of measurement.
  • Visual cues should be used to show how questions are to be answered. For example, date format, and the number of decimal places.
  • Minimize the use of free text responses or “check all that apply”.
  • Keep related questions together in sections.
  • For paper CRFs, include page numbering. Avoid circling answers, and make it clear which questions are mandatory.

 

Example of a well-designed form

Clear guidance is given for each response in the form above, so there will be no unnecessary queries. The yes / no response is coded, and should be coded in the same way across all forms in studies for consistency.

 

 Example of a poorly designed form

poor-crf-design

There’s no guidance given for responses in the form above. That means results will vary in responses from site to site, and from investigator to investigator.

 

CRF design & eCRF design challenges

3 common design challenges that typically come up:

  1. Creating forms that are consistent.
  2. Collecting precise data.
  3. Creating user friendly forms.

 

To overcome these challenges there’s a number of things that can be done.

  • Do proper planning, and start it early on in the study. This should be done by a team of people that include data management, biostatisticians, and clinicians.
  • Define clear objectives and stick to them.
  • Maintain standardized forms.
  • Get user feedback. It’s best to build this into the design and maintenance process.
  • Apply best practices.
  • Provide form completion guidelines to reduce data capture and data entry issues. This helps investigators fill in forms correctly by providing step by step guidance, and uses clear, specific instructions.

 

That’s CRF and eCRF design has been covered, the next thing to look at is annotating CRFs.

 

Why are annotated CRFs so important?

Annotated CRFs are a key submission deliverable, a mandatory requirement of the FDA. Each form in a study contains markings, or annotations. These annotations map data points on forms to the name of datasets, and variables within those datasets. In other words, “each CRF should provide the variable names and coding for each CRF item included in the data tabulation datasets” as stated by the FDA guidelines.

The FDA stipulate that a set of blank annotated CRFs be submitted in a PDF document called “blankcrf.pdf”. This document helps the FDA reviewer find the origin of variables in the SDTM datasets.

You can read more about why it’s a good idea to switch to automated CRF annotations.

Here’s an example of an annotated CRF in Formedix.

 

Why should CRFs be standardized?

It’s important to standardize forms so that stakeholders such as the investigator, data manager, biostatisticians, data entry personnel etc. have their needs met. CRFs must be user friendly and capture consistent data, that’s clear and valid.

Standardizing CRFs means you can reuse them. That’s a huge efficiency gain. They’ve already been reviewed and approved, so they’ll be consistent, and of high quality. And, annotations don’t need to be manually done on each form. You can also reuse edit checks that normally take lots of time and resources to do. So, not only is it a huge time and resource saving, it’s a lot less hassle!

 

How Formedix can help

Our clinical trial automation software lets you create forms from scratch, or upload your existing forms and store them in our clinical metadata repository. Once your forms are standardized you can quickly and easily reuse them across other standards and studies. Including annotations and edit checks. It’s easy to find, share, and update your forms. And you can preview them in different formats as you design them, as well as being able to see how they look, and work, in 7 leading EDCs including Rave and InForm. And CRF, EDC, and CDISC validation is built in, so you don’t have to worry about being compliant. You can find more about creating your CRF designs and EDC designs in Formedix.

 

If you’ve found this interesting you can click on Everything you want to know about CRFs to read the full article. And you can visit the Formedix website at https://www.formedix.com/

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Who won the MedCity INVEST Pitch Perfect competition?

Question mark heap on table concept for confusion,

Healthcare startups across health services, health IT, medical devices, biopharma and diagnostics tracks took part in the week-long competition at the conference July 20-24. Here are the winners for the five tracks.

How four healthcare executives are planning for the future of digital health

digital health smartphone

Executives with Kaiser Permanente, Houston Methodist, Providence St. Joseph Health and Highmark Health shared their thoughts on the future of digital health and how they used technology to care for their patients at the start of the Covid-19 pandemic.

How can life science companies benefit from hiring a Professional Employer Organization? [Sponsored]

In an interview, TriNet’s Vice President of Life Sciences, Maria Abouseif, talked about the role Professional Employer Organizations play in helping life science companies navigate the COVID-19 public health crisis.

Here’s what’s on the agenda for Day 2 of MedCity INVEST virtual

A panel discussion on digital health in the age of Covid-19 and the health IT track of the Pitch Perfect startup pitching contest are on the agenda for day 2 of the MedCity INVEST conference taking place online July 20-24. Register today!

Here’s what’s on the agenda for Day 1 of MedCity INVEST virtual

Our annual INVEST conference, where investors and startups meet, kicks off today as a virtual event. Chris Coburn, chief innovation officer of Mass General Brigham, is a featured speaker and startups in the area of health services will present in the first track of our INVEST Pitch Perfect contest.

Five VCs share how the pandemic has changed investing

Months into the Covid-19 pandemic, the pace of new investments for startups has picked back up. Five VCs shared what’s changed and how they’re working in the midst of the crisis.

Which health IT entrepreneurs will present at INVEST Pitch Perfect? Register now and save.

contest, spotlight

Five health IT startups with technology spanning patient engagement, optimizing care for cancer patients from China, and connected devices will take part in the startup pitching contest INVEST Pitch Perfect July 20-24. Register now while tickets are still available!

Register for MedCity INVEST and learn how Covid-19 has shaken up investment trends

Gain insights from the perspectives of healthcare investors from Maverick Ventures, Cultivation Capital, Advocate Aurora Health and Flare Capital on investment trends in 2020 at the online conference July 20-24. Register now and save.