The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.
From his vantage point as an independent biotech journalist, Luke Timmerman has been watching the expansions and retractions of the industry for a couple of decades now. His unique perspective is hard to equal, and that perspective is, despite tough markets and tepid public sentiment, decidedly bullish.
Delivering Genetic Editing Therapies To Market
Manufacturers with proven expertise in areas such as viral vector production and analytics are needed now more than ever to get breakthrough, deliverable gene editing therapies to patients.
The Promise Of PCM: Getting To Maturity
PCM offers several advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industrywide adoption.
Join Bioprocess Online Live for a discussion on two approaches to adoption of computational technology — do-it-yourself and outsourcing. Whether you're considering how AI and ML can increase drug discovery, design, and development efficiencies, dabbling in it already, or leading the charge, you won't want to miss this conversation from the edge of what's possible. Registration is free thanks to the support of Cytiva. Register now
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