Newsletter | November 3, 2022

11.03.22 -- Tips For Your Virtual Meetings With The FDA
 
Featured Editorial
Tips For Your Virtual Meetings With The FDA
 
By Kate Cook, Catherine M. Cook Group, LLC

It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.
Life Sciences RIM: Modernization And Moving Ahead
 
By Steve Gens, Gens & Associates

Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.
Industry Insights
Starting Your Sterile Injectables Program Off On The Right Foot
Article | By Jennifer Quint and Daniel Lenz, Pfizer CentreOne

How can drug sponsors and developers leverage these increasingly strategic commercial fill/finish partnerships? Explore tips on how to put programs on a firmer footing.
Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers
Article | By Akriti Seth, West Pharmaceutical Services, Inc.

Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.
Technology Transfers: A Beginner's Guide
Article | By Lei Zheng, Pfizer CentreOne

You may have questions or knowledge gaps on technology transfers. To help your understanding, we’ve compiled a beginner’s guide to technology transfer fundamentals.
From Discovery To Commercial Promise With Philogen’s Dr. Dario Neri
Article | Cytiva

In a recent episode of Business of Biotech, Philogen CEO Dr. Dario Neri sat down to explore his journey from academia to startups, as well as Philogen's own trajectory.
How Buffer pH And NaCl Affect Size Exclusion Chromatography
White Paper | Cytiva

Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.
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Solutions For Enabling Delivery Of Complex Biologics: BD Evolve On-Body Injector
BD Medical - Pharmaceutical Systems
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