Richard Pops has lived the biotech roller coaster over three decades as CEO of Alkermes: an IPO, M&amp;A, near-death events for his company, FDA setbacks, battles with an activist investor, and the satisfaction of knowing that millions of patients have benefited from the company’s medicines. He has led PDUFA reauthorization negotiations for industry, chaired BIO, and advocated for the interests of mid-sized biotechs. As Pops prepares to retire as CEO (he will remain chairman), he spoke with BioCentury Washington Editor Steve Usdin about the ways policy and economics shape the development of medicines. Pops discussed the impact of the Trump administration’s most favored nation (MFN) drug pricing policy and the Inflation Reduction Act (IRA), concerns about FDA’s loss of talent, and competition and collaboration with China’s life sciences sector. View full story: https://www.biocentury.com/article/659601 #DrugPricing #BiotechLeadership #FDAPolicy #LifeSciencesPolicy #DrugDevelopment 00:00 - Introduction 01:40 - Alkermes’ Evolution 05:12 - PBMs, Pricing &amp; Access 10:54 - IRA 18:14 - MFN 24:36 - PDUFA Negotiations 28:05 - FDA Staffing 31:40 - China &amp; U.S. Policy

Ep. 110 - Richard Pops on Three Decades in Biotech: Drug pricing, FDA and China

The BioCentury Show

# Full Transcript

**Podcast:** The BioCentury Show

## Participants

- **Steve Osden** (BioCentury)
- **Richard Pops** (Alkermes)
- **Richard Pops** (Alkermes)

## Transcript

This is the BioCentury Show. Brought to you by BioCentury Grand Rounds. Join BioCentury and Regional Host Chair Allen Institute this June in Seattle for an R&D forum at the interface of industry and academia. I'm Steve Osden, Washington Editor of BioCentury. My guest today is Richard Pops. Richard's stepping down as CEO of Alkermes in July and will remain as chairman. He has lived the modern era of biotechnology.

He became CEO in 1991 at the age of 28, and Alcremes had about two dozen employees. Today, it has thousands, a market cap over $6 billion, and, most importantly, a portfolio of drugs for serious psychiatric and addiction disorders that have reached millions of patients, and drugs for other serious conditions nearing the market. Alcremes has navigated the classic ups and downs of biotech.

IPOs, mergers, near-death experiences, battles with activists, investors, complete response letters, everything, you name it. Throughout all of this, Richard has had a deep engagement with public policy. He chaired Bio, he serves on the board of Pharma, and he was a central figure in PDUFA reauthorization negotiations for more than, and still is, for more than two decades. And I've learned a lot from Richard over the years.

A recurring theme in our conversations has been how economics and public policy shape what's possible in drug development, not in the abstract, but in concrete terms. What he could build, what he couldn't build, and why. And that's what I want to explore today. But I want to start actually at the beginning with something I have never asked you, and I've always wanted to, which is, how did a 28-year-old become a CEO of a drug company? Well, it's ill-advised, I would say.

But I was working in this brand new area trying to figure out how to finance biotechnology companies. When I was young, there was a new group that had started up in New York within Payne Weber, trying to figure out sources of capital for the first biotech companies who had gone public. Genentech, Amgen, Cetus, Chiron, who had gone public with great expectations about the power of re-commonent DNA technology.

But then proceeded to obviously disappoint investors because the products were a long way off. So we were innovating these different types of R&D limited partnerships and other direct investments to try to support what we knew would probably end up being a really transformational technology. And through that, I met a guy named Michael Wall, who had founded Centacore. And he asked me to come up and join Alkermes. And in the beginning, I didn't know what job he wanted me to do. But he asked me to be the CEO.

And after I smiled and laughed, he said he was serious. And of course, the rest is history. So you started, Alkermes started as a drug delivery company. And the idea was pretty simpl...

Ep. 110 - Richard Pops on Three Decades in Biotech: Drug pricing, FDA and China

Transcript

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Ep. 110 - Richard Pops on Three Decades in Biotech: Drug pricing, FDA and China

Transcript

Built for investment professionals

Every day you wait, your competitors are findingedge in conversations you're not hearing.

Every day you wait, your competitors are finding
edge in conversations you're not hearing.