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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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BioSpace Movers & Shakers, Dec. 18

The Pharma Data

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

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Dynacure Announces Appointment of Jean M. Franchi to its Board of Directors

The Pharma Data

21, 2021 /PRNewswire/ — Dynacure , a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today the appointment of Jean M. STRASBOURG, France and PHILADELPHIA , Jan. ” Ms.

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BioSpace Movers & Shakers, Nov. 6

The Pharma Data

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. acousia Therapeutics – Jonas Dyhrfjeld-Johnsen joined Germany-based Acousia in the new role of chief development officer. Denner has been with Sarissa since 2011.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

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Athersys Announces Three Appointments to Board of Directors

The Pharma Data

This prestigious group of professionals will help lead the Company as it prepares for potential commercialization of its investigational cell therapy, MultiStem ®. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Before that, Ms.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Since the 2007 NDAC meeting, several clinical trials have been conducted by industry to assess new phenylephrine doses and formulations—consistently failing to outperform placebo. This new body of data includes environmental exposure studies and clinical trials from Merck and Johnson and Johnson collected between 2011 and 2018.

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