The [Daily] Leaflets

You are AI-Ready. The only thing left is a mind-shift, and it can happen quick. How quick? Here is a text I wrote three days ago: AI-Readiness doesn’t start with a decision which model to use or to learn how to vibe code. It starts with an ontology - a shared meaning and structure of our Knowledge. A common source of Truth. Just between us, the Humans - a minute before we let the Robot into the party. Once we feed our knowledge into the machine, this Ontology will provide i

FAIR is a control strategy, not just a data format. Quality by Design defines how we build quality into products. Digital by Design defines how we build quality into knowledge. Design your process such that data capture is commensurate to the value/risk associated with it. Minimizing Data loss minimizes opportunity  loss, and ensures Knowledge of Quality is consistently obtained. In the world of Big Data and AI, Knowledge Quality is all there is. ================== Bypass the

What will you do in the world of the 5%?

In this revised draft, FDA gives a substantial facelift to its original 2011 guideline on Potency assays for Cell and Gene Therapies. It introduces a holistic "Potency assurance strategy" that encompasses a thorough understanding of the product MOA, QTPP and "Potency-related" CQAs (because in these therapies- potency is achieved by a combination of factors usually). It emphasizes the big picture of process understanding and a risk-based control strategy and makes several refe

“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...