Breakthrough West arrives at a very interesting moment

BREAKTHROUGH WEST | SF & VIRTUAL

Makary is gone. Breakthrough West is next week.

Dear readers:

I almost feel like Al Pacino in “The Godfather Part III”: Just when I thought we were out of talking about the Food and Drug Administration, they pull us back in.

On Tuesday the FDA commissioner, Marty Makary, resigned, and I explained in a piece for STAT why I believe he was the agency’s worst commissioner of the past quarter century.

You can bet that the aftermath of Makary’s reign will be a topic of discussion next Tuesday at STAT Breakthrough Summit West.

We already have plans for three panelists to weigh in on the agency’s approach to rare disease drug development, one of the many pain points that engulfed Makary’s FDA in controversy. Ted Love, longtime biotech CEO and former chair of BIO, will be joined by Holly Fernandez Lynch, one of STAT’s favorite FDA whisperers, and Yael Weiss, another industry veteran and the CEO of a company dealing with the problems of rare disease drug development in real time.

The session will be moderated by STAT’s amazing, award-winning Jason Mast, the most important reporter covering the rare disease space. I’ll be there with the mic in the audience to make sure your perspectives — and maybe mine — get heard.

VIEW THE AGENDA

That’s not all we’ll have for a moment that is shaking biotechnology. Adam Feuerstein will sit down with Neil Kumar, the CEO of BridgeBio, and William Lewis, the CEO of Insmed. Both companies have recently secured approvals for new medicines with blockbuster potential, but growing a sustainable, biotech business, of course, can come with challenges. Can BridgeBio and Insmed become biotech’s next Amgen or Regeneron?

We’ve thought hard about this agenda, and feel confident it’s jam-packed with opportunities to discuss so much of interest these days — everything from Oura and Whoop to fetal genetic surgery.

Check out what we’re planning. And either sign up to attend virtually, or to join me in the room, ask your questions live, and enjoy a STAT featured cocktail or mocktail at the end of the day.

I hope to see you there!