The current vaccine rollout fiasco reminds me of a conversation I had once with a brilliant clinical pharmacologist. He asked what my company did. I told him we were a global clinical development organization, known as a ”CDO” in the trade. A brief thread. 1/x

I was a little astonished — here was this veteran physician-scientist, who had been personally responsible for patient safety for novel/compassionate use drug compounds but he didn't grok what we did. I explained we managed complex global phase III clinical trial logistics. 2/

He listened politely and carefully, nodding along but with semi-furrowed brows. When I finished, he paused, looked down, deep in thought, then went quiet. Then, “So, your group records what's in the patient charts? And then sends that back to the drug company? Is that right? 3/

I suddenly felt like I was living out that manager scene in Office Space: “So you -physically- take the specs from the engineers to the customers?” No. I mean, yes, we -do- serve as the document of record to the FDA, but that's just a small part of it. “I see.” (He didn't) 4/

So I turned it around: Wait, you've been a key part of clinical trials before, right? “Yes of course.” So, how does that work? Like do your research assistants & nurses do patient scheduling, coordinate with the clinic staff, arrange financial reimbursements, handle blinding? 5/

“Sure.” Well, that's what we do. Plus a lot more. But let me ask — who deals with customs, or local currencies, or trial volunteer follow-ups & PI DSMBs? “Yes—Hold on. What do you mean 'customs'? And 'currencies'?”
That was my aha moment. 6/

It finally hit me: this deeply respected, incredibly talented researcher *had*, in fact, been working in clinical trials. For a decade+ at least. But he was a dept chair at a university hospital and his experience was all in pre-clinical (animal/tissue) and phase I trials. 7/

His world was 2 years of planning to run a week or two safety trials on site in the unit. Basically, give a new/experimental compound to humans (mostly local town residents & students), often for the first time ever. Incredibly challenging and plenty of risk/complexity. 8/

But my mention of "customs" & local currencies completely glitched him. His world was 15 or 20 patient volunteers *there*. A couple dozen people basically down the hall from his office and classrooms. The trials I was involved in ran in *thousands* of centers around the world. 9/

We were responsible for logistics of shipping cardiac monitors around the world (good luck to newbies navigating customs in Brazil or Tel Aviv), reimbursing clinic staff in 30+ currencies, liaising with hundreds of data safety monitoring boards. Dozens of national regulators. 10/

24x7 comms to every type of telco infrastructure you could imagine. And constant data transfers (remind me to tell the story of monkeys borking night time batch satellite uplinks in Ghana; good times). The point is: His was a different universe. And so we are with vaccines. 11/

This isn't "just" a logistics problem. It's a staggeringly complex ballet of movements and the "just get the drugs shipped at -70°C" is the *easiest* part. The fact that we now have localities like Cleveland county Oklahoma just throwing up a SignUp Genius is the first crack. 12/

This will only get solved with hardcore leadership and the grown ups in the room stepping up. Governors, big pharmacy chains, mobile clinics, local & regional public health authorities and, yes, the White House. I have slightly more faith in governors than most politicians. 13/

But only slightly. I hope I'm wrong, but even with 3 more compounds in the queue I fear we're still nine+ months away from anywhere near majority coverage. This will take serious funding, hard sweat, massive public education campaigns, and will get done largely by companies… 14/

…few people have ever heard of. Like McKesson, AmerisourceBergen, Cardinal Health to name a few We'll get there, probably with Army Corp of Engineers-level planning. But it's going to be an ugly ride along the way, and god help you if you live in a poor state or rural area. /fin