Welcome to my new weekly column, CDMO World Weekly.
If we haven’t met yet, I’m Ray Sison — longtime pharma guy, CMC veteran, CDMO whisperer, and the person people usually call after their tech transfer derails, their timelines slip, or their CDMO partner suddenly isn’t returning emails. I’ve spent the better part of two decades bouncing between big pharma, scrappy biotechs, and global CDMOs, helping teams fix the operational fires no one wants to talk about on LinkedIn… but everyone secretly deals with.

Over the years, I’ve had the privilege of working in development labs, commercial manufacturing suites, sterile fill lines, and yes — the dreaded conference rooms where your “risk register” looks more like a bingo card. I’ve also been on podcasts talking about the real-world messiness of outsourcing, tech transfers, regulatory expectations, people dynamics, and how all those pieces shape whether a molecule makes it to patients.

In this weekly column, I’ll be breaking down what’s happening across the CDMO universe — the trends, the shifts, the surprises, the deals, the failures, and the quiet operational lessons you only learn by being in the room where decisions get made. Expect straight talk, context, and the occasional tough-love reminder that “hope” is not a CMC strategy.

Each week I’ll cover:

• What CDMOs are really struggling with right now
• What sponsors should be doing earlier (but usually don’t)
• How regulatory pressure is reshaping partner expectations
• The good, the bad, and the fixable in tech transfer
• Why supply chain always bites back — and how to avoid it
• And yes, the occasional war story (names changed to protect the guilty)

My goal is simple: give you a short, punchy, insider brief that helps you make better decisions, ask smarter questions, and avoid the expensive mistakes I see every week across the industry.

So grab your coffee — or your MSAT survival kit — and welcome to the first edition of CDMO World Weekly. Let’s get into it. – Ray