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Today's Rundown

Featured Story

Bluebird bio CMO quits amid a roller coaster year and upcoming split

Bluebird bio’s chief medical officer David Davidson, M.D., is hitting the exit, though remaining as a consultant, as the biotech looks to navigate through its gene therapy issues.

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Top Stories

Merck taps Amathus in neurodegeneration deal, snagging buyout option

Merck is adding another partner in neurodegenerative disease to the roster: Amathus Therapeutics, a biotech taking aim at molecular chaperones, a group of proteins that guide the folding of other proteins. Under the deal, Amathus will identify small molecules that activate chaperones and advance them through preclinical discovery.

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MaaT links microbiome drug to GvHD responses, plans phase 3

MaaT Pharma has posted midphase data on its microbiome treatment for acute graft-versus-host disease, positioning the French biotech to step up its preparations for a phase 3 program.

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In Partnership: Meeting the challenge to deliver COVID-19 relief around the world

Each challenge COVID-19 has presented in the past year has seemed insurmountable yet at every step those obstacles have been overcome, particularly in the pharmaceutical industry tasked with developing vaccines and therapies to combat this crisis.

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Cloonan quits Sage to pursue a biopharma CEO position

Mike Cloonan is set to step down as chief operating officer of Sage Therapeutics. Cloonan is leaving to pursue a CEO position in the biopharma industry shortly after being overlooked for the top job at Sage.

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Sponsored: Avoiding Gene Therapy CMC and Clinical Supply Issues

Gene therapy manufacturing and clinical supply strategies should be in place early to avoid potential late-stage development delays.

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Bluebird bio alums bolster leadership team at B-cell-focused Be Biopharma

A pair of former bluebird bio executives are reuniting at Be Biopharma, a biotech developing B-cell therapies that launched last October. Joanne Smith-Farrell, Ph.D., is Be Bio’s new CEO, while Rick Morgan, Ph.D., takes the post of chief scientific officer.

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In wake of biopharma mega buyouts, FTC kicks off review of industry's dealmaking

With hundreds of pharma M&A deals in the books from recent years, the Biden administration’s Federal Trade Commission is kicking off an in-depth review of its approach to biopharma M&A. The process could bring tougher enforcement for biopharma's deal-makers going forward. 

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Inflammatix nets $102M to advance its immune system tests for infectious diseases

Inflammatix secured $102 million in new financing to help commercialize its point-of-care diagnostics portfolio aimed at profiling a person’s immune response to quickly ascertain bacterial and viral infections and help curb potential antimicrobial resistance.

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Could low-cost leprosy drug clofazimine be repurposed for COVID-19?

New COVID-19 drugs such as Gilead Sciences’ remdesivir have their limitations, so scientists continue to look for ways to repurpose existing medicines as quick solutions to the pandemic. Now, an international team has promising data in hamsters showing that an old leprosy drug, clofazimine, may help fight the coronavirus.

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Resources

Content Hub: Emerging Biotech Resource Center

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

Annual Report: Clinical Trial Landscape In Russia and Eastern Europe, 2020.

Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical.

Guide: Labs of the Future: How to choose a Lab Information Management System in 2021

Interested in moving from hand-written lab notebooks or spreadsheets to a modern research platform? Read this guide on Lab Information Management Systems (LIMS) to learn how modern companies are using software to innovate faster.

Report: State of the Industry Report: Embracing Trial Change and Elevating IRT Systems

This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty.

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

Guide: How to maximize your drug commercialization investments

Unlock product potential by making the most of your commercialization investments. 

Whitepaper: New Data: A Better Way to Run CHO Cell Culture Experiments

Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly.

eBook: Optimize Trial Performance with AI-enabled Technology & Advanced Analytics

Unlock competitive advantage with AI and advanced analytics.

Whitepaper: The Crush: How COVID-19 Is Impacting Mature Brand Revenue & Long-Term Value

Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How.

Whitepaper: Overcoming the hurdles of Real-World Data Access through a federated global network

Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights.

Free Infographic: The Future of Vaccine Development

Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain.

Whitepaper: 2021 Outlook for Cell-Based Therapies in Oncology: CAR-T Expansion & Beyond

A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones.

Whitepaper: Seasonal Vaccine Manufacturing

While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Content Hub: How to improve the virtual work you do every day

We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met.

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.

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.

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.

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