How to Speedrun a New Drug Application (Interview with Alvea's former CEO)

By Aaron Gertler 🔸 @ 2024-03-03T00:53 (+37)

This is a linkpost to https://www.statecraft.pub/p/how-to-speedrun-a-new-drug-application

I've been enjoying the newsletter of Santi Ruiz (Institute for Progress), who covers stories about achieving policy goals and other forms of progress. I found this to cover some ground that wasn't present in the Alvea postmortem.

Excerpts

The caricature is that the FDA is the enemy of progress, medical regulators are the enemy of progress, and they're slowing everything down. On reflection, I don’t agree with that take, and our experience doesn’t really support it [...]

In drug development especially, making a thing that is plausibly good is much, much easier than making something that is actually, reliably, very good. Deploying drugs to scale requires that reliability.

It’s a very hard socio-technical problem. All the different kinds of regulatory requirements, quality management, quality control, etc., that could be naively identified as red tape or boring paperwork that slow down the innovators are actually there to achieve that reliability.

Of course, when you get into the details, there are tons of ways this could be done more efficiently. But the fact that validation, testing, and ensuring that things are as they seem is 90% of the process is just the way the world works, not any fault of the regulators.

When you work with any vendor for a pharmaceutical company, almost everybody requires an NDA to be signed. This by itself can eat up to two weeks of time on both ends of this transaction. We had automated this NDA signing process so that it would usually happen in hours. Many of our vendors would follow up and tell us how insanely fast this was and how it was the smoothest and fastest contracting experience that they had ever had.

Another big pattern is that, for some reason, for a lot of these key processes that really move the needle on speed, the standard operating procedure for the industry is to talk to maybe three to five different vendors, compare them across a bunch of categories, and then pick one and go forward with them. That never seemed to work for us. We would approach it by finding every single vendor in the world who does the thing that we need done, finding the best people, and then going in and very closely redesigning and managing their process for maximum speed. Practically, this involves parallelization and then bottleneck hunting in the vendor’s process to identify ways to make it faster.

A good example of that was the manufacturing of the drug itself, of the DNA plasmid that was our vaccine’s main active component. Our initial quotes from the first few vendors were like two years. “It takes two years. There is no way around that. This is just how long it takes.” Then we found some folks who said, “It’s going to be hard, but we can do it in a year.” Then, once we have come in and looked at it deeply and redesigned it in collaboration with these folks, we ended up doing it in just over two months if memory serves.