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Today's Rundown

Featured Story

Ex-Merck scientist accused of stealing trade secrets on Keytruda, raising threat of 10-year prison term

A former Merck immuno-oncology director faces up to 10 years in prison for allegedly stealing trade secrets about Keytruda and other drugs. The researcher is charged with stealing and transmitting trade secrets around the time he left Merck to take up a position at AstraZeneca in 2019.

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Thank you to Catalent for sponsoring this year's JPM 2021 coverage.

Top Stories

Sinopharm claims COVID-19 vaccine safe in kids aged 3 and up

A clinical trial has found a COVID-19 vaccine in development at a Sinopharm subsidiary to be safe in children aged three to 17 years, according to Chinese state media.

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Eli Lilly chips $30M into VC fund aimed at minority-owned healthcare companies

Eli Lilly invested $30 million in Unseen Capital Health Fund, a venture fund aimed at supporting founders of early-stage healthcare companies who are Black or of other racial minorities. In addition to identifying, funding and supporting minority-led businesses, the fund will also target companies working on solutions for marginalized communities.

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NextCure nabs NexImmune, Celgene research vet as new CMO 6 months after former CMO quit

A year after Eli Lilly abruptly pulled out of an R&D pact with NextCure and its CMO left after weak trials results, the biotech is shoring up its research team with the addition of ex-Celgene exec Han Myint, M.D..

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Landos Biopharma guns for a $100 million IPO to boost AI autoimmune R&D work

Xontogeny’s Landos Biopharma is jumping into warm biotech IPO waters as it looks to go public with a $100 million offering.

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Chutes & Ladders—Bristol Myers hematology chief Ahmed hits exit

Ahmed ends stint as hematology chief at Bristol Myers; Moderna taps Le Goff as chief commercial officer; Fierce 15 winner Amylyx picks Frates for CFO.

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Fierce Pharma Asia—BeiGene-Novartis PD-1 deal; Sinovac vaccine; Celltrion antibody COVID-19 data

Novartis licensed certain ex-China rights to BeiGene's PD-1 tislelizumab in a deal worth up to $2.2 billion. BeiGene CEO John Oyler talked to us about the drug's market opportunity in and outside China. Sinovac's COVID-19 vaccine reported confusing data, and Celltrion showed its coronavirus antibody worked in a trial. And more.

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JPM: Thermo Fisher picks up Novasep’s viral vector business for $878M outright

Thermo Fisher's CEO said 2021 will see the company quickly accelerate its long-term plans, including a full pipeline of M&A deals. He wasn’t kidding.

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How a gene linked to the circadian clock could point to new prostate cancer treatments

Studies have shown that disruptions in circadian rhythms caused by chronic sleep deprivation and other lifestyle-related issues are linked to an increased incidence of some cancers, including prostate cancer. A new study found that a "clock" gene called CRY1 is elevated in late-stage prostate cancer—a discovery that could inspire new treatments.

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Resources

Webinar: Using SPOT™ & CHO-BC® During Cell Line Development for Titers up to 9 g/L

Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards.

Whitepaper: Success in Rare Diseases: Understanding the Rare Disease Ecosystem

Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.”

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Whitepaper: Accelerate innovation and manufacturing to better serve patients

A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields.

Survey: Cell and Gene Clinical Supply Needs Market Research Survey

Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity.

Whitepaper: Gene and Cell Therapy: A New Age of Medicine

Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine.

Executive Summary: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

Infographic: 6 Ways Phenotypic Data Improves Decision-Making in Your Drug Development Program

Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline.

Whitepaper: The Future of Pharmacovigilance

Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality.

Whitepaper: Survey Reveals Demand for Clinical Trial Innovation in the Wake of COVID-19

The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement.

Research: Premier Research Resource Hub

Browse the latest learnings and insights from our clinical development professionals.

Infographic: Reducing Time to Clinic for Your Biomedical Applications

This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments.

Whitepaper: Gene and Cell Therapy: Planning for Manufacturing Success Early

Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience.

Whitepaper: Companies Need An Effective Remote Workforce Cloud Strategy To Survive

A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Whitepaper: Why Your Business Needs a Ransomware Strategy To Avoid Being Hacked!

Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now!

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.

Events