The Daily Leaflets

In this revised draft, FDA gives a substantial facelift to its original 2011 guideline on Potency assays for Cell and Gene Therapies. It...

“When everything is critical, nothing is critical” So goes the saying… And indeed, it’s a tough conundrum- because in Pharma, we have to...

AI is big but Pharma is bigger. Let me rephrase: AI applications for Pharma and Drug Development are being developed for very specific...

Regulatory submissions are an inherent part of drug development. They are often considered as an “event” that a project goes through when...

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...

Yesterday’s "Early Adopters" has made some waves in our little pond, and brought up two fundamental questions. So let’s roll our sleeves...

When I just joined in the Pharma industry, they told me we are very conservative with new technologies because we are a highly regulated...

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...

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...

The seven stages of regulatory compliance, in a Biotech Startup: Denial- “we only need to think about it when we’ve secured funding for...

Most startups consider their regulatory submissions as a singular “Event”. One that takes place when approaching the regulatory authority...

Everyone talks about Quality Culture, but what about Knowledge Culture? What is there to “culture” about knowledge, anyway? ICH Q10...

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...

Knowledge in Pharma is expensive. Hundreds of millions of dollars expensive. No surprise new drugs cost so much, and many don’t make it...

Somewhere over the rainbow, there’s: The funding round The clinical trial interim results The next stability time point THE manufacturing...

Drug Development is a knowledge-intensive, Risk-intensive endeavor, and we target to establish a very high-quality manufacturing...

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...

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...

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...

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...

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...

- You do know what #$@!% means, don’t you? - W… Well, of course, I do! - Then you must understand that #$@!% is THE most critical aspect...

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...

​I love the atmosphere in very early startups. The focus is still mainly on the Science and Proof-of-concept. The possibilities are...