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 read
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 read
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 read
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 read
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 read
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 read
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...
Dec 12, 20232 min read
The Rare Disease CMC Crunch
Drug development is slow. Tell this to a mother or a father of a suffering child, or the terminally-ill on their deathbed. Still…There is...
Dec 11, 20232 min read
The Documentation Paradox
I have a million photos of my daughters. Per week. You can literally run them sequentially and get a stop motion video of every single...
Dec 10, 20232 min read
The 7 Stages of Compliance
The seven stages of regulatory compliance, in a Biotech Startup: Denial- “we only need to think about it when we’ve secured funding for...
Nov 25, 20232 min read
Regulatory "Events"
Most startups consider their regulatory submissions as a singular “Event”. One that takes place when approaching the regulatory authority...
Nov 24, 20232 min read
Knowledge Culture
Everyone talks about Quality Culture, but what about Knowledge Culture? What is there to “culture” about knowledge, anyway? ICH Q10...
Nov 23, 20232 min read
Don’t call me name(s)
How do you call an impurity never seen before? Impurity X is already taken, as it was the first one observed, and X is the most popular...
Nov 20, 20231 min read
Stop Wasting your Knowledge!
Knowledge in Pharma is expensive. Hundreds of millions of dollars expensive. No surprise new drugs cost so much, and many don’t make it...
Oct 4, 20232 min read
Somewhere over the rainbow...
Somewhere over the rainbow, there’s: The funding round The clinical trial interim results The next stability time point THE manufacturing...
Oct 3, 20231 min read
Knowledge, Risk and Benefit
Drug Development is a knowledge-intensive, Risk-intensive endeavor, and we target to establish a very high-quality manufacturing...
Oct 2, 20232 min read
Tech-Knowledgy Transfer
They say that the things you like most about your partner at the beginning become the things that annoy you most later on in life.... In...
Oct 1, 20231 min read
QTPP of a Boiled Egg...
If you ever peeled a hard-boiled egg, you know it doesn’t always come out right. Sometimes it sticks, leaving behind a patchy egg white...
Sep 5, 20232 min read
Digital Swimming lessons
Tossing your child into the deep end of the pool is a sure way to teach them fast. But what does it teach them? They surely learn how not...
Jul 24, 20232 min read
ICH guidelines and the tower of Babel
Pride and arrogance are not something new. We all saw what happened in the Tower of Babel, but we don’t have to look hard and find more...
Jul 9, 20232 min read
Don't grow up, it's a trap!
Don’t grow up, it’s a trap! Seriously. Don't. If you are young, and reading this- you probably know this joke already, but I urge you to...
Jul 5, 20233 min read
Jargonauts
- You do know what #$@!% means, don’t you? - W… Well, of course, I do! - Then you must understand that #$@!% is THE most critical aspect...
Jun 1, 20231 min read
What Machines Need
Machines are stupid. (Hope this doesn’t get me in trouble when they rule the world). They compensate for what they can’t, with their...
May 30, 20231 min read
Early Intervention
I love the atmosphere in very early startups. The focus is still mainly on the Science and Proof-of-concept. The possibilities are...
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