Potency Assurance Strategy
In this revised draft, FDA gives a substantial facelift to its original 2011 guideline on Potency assays for Cell and Gene Therapies. It...
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The Daily Leaflets
Dec 25, 20231 min
Critical Thinking
“When everything is critical, nothing is critical” So goes the saying… And indeed, it’s a tough conundrum- because in Pharma, we have to...
Dec 21, 20231 min
Big Data vs. Big Pharma
AI is big but Pharma is bigger. Let me rephrase: AI applications for Pharma and Drug Development are being developed for very specific...
Dec 19, 20232 min
Hidden Opportunities
Regulatory submissions are an inherent part of drug development. They are often considered as an “event” that a project goes through when...
Dec 15, 20232 min
Take it personally
You are a unique snowflake. You like your coffee with Soy milk, in a thick glass, with no sugar, and extra foam. And it must be boiling...
Dec 14, 20232 min
Careful Innovation
Yesterday’s "Early Adopters" has made some waves in our little pond, and brought up two fundamental questions. So let’s roll our sleeves...
Dec 13, 20232 min
Early Adopters
When I just joined in the Pharma industry, they told me we are very conservative with new technologies because we are a highly regulated...