A modern(a) leap

In my past life as a management consultant, I spent a year working for Pfizer in the UK early in the past decade. It remains my only stint working with big pharma and it was fascinating to be exposed to a world I hadn’t previously known – patents, clinical trials, and such.

Pfizer, at the time, was facing patent cliffs of some very lucrative products in the coming years and there was a lot of debate about what would be the next superstar drug. Speculation was rife that the way forward for Pfizer and other big pharma companies was to acquire themselves out of trouble. That meant finding promising biotech companies doing interesting work, partnering early in the drug development process, and acquiring them if things looked promising.

The promise of biotech was that we’d see a democratization of drug development as technology would make it make it possible to produce drugs/vaccines with newer and more innovative methods. But, just as there was promise, there were big questions that remained to be answered. How would a small company survive the process of bringing a new drug/vaccine to life? What about the challenges of taking that to market? The heavy investment involved favored large incumbents.

So, I was curious about what we’d learn from the process of creating the COVID-19 vaccine. I expected the usual suspects – the likes of J&J, Roche, Pfizer, AstraZeneca, et al – to be among the leading contenders in creating and eventually mass producing the eventual vaccine.

But, following Pfizer’s announcement, it was heartening to see a much smaller Biotech company come out with a solution with impressive efficacy. It was particularly heartening because their story had all the elements of the biotech dream – find a problem, plug data into a computer, give software a day to figure out the solution, and then test it.

Of course, if it were a software company, you might A/B test it immediately. That’s not how medicine works – for good reason. We need randomized controlled trials with large enough populations for statistical significance. But, these comparisons aside, Moderna’s story was just as magical. Two days after the COVID-19 genetic sequence was released on January 11th, the Moderna vaccine was ready.

By the time the first American death from COVID-19 was announced, the vaccine was already manufactured and shipped for its Phase I trial.

That vaccine was approved by the FDA today. It is a giant leap forward for the Moderna team and for the many scientists and technologists who’ve been championing the potential of biotechnology for over a decade. The future is here.