The U.S. Food and Drug Administration plays a critical role in shaping public health, drug development, and medical innovation. And like a lot of other federal agencies these days, it’s currently going through significant changes, including the April 1 swearing in of a longtime FDA critic, surgeon Martin Makary, as the Trump administration’s FDA commissioner.

That’s likely to be one of the topics next Wednesday, April 16, when the Pegasus Park Speaker Series presents a panel discussion called “Insights From The Frontlines Of Health Policy” from 4:00 p.m. to 5:30 p.m. within the Pegasus Park Conference Center at 3000 Pegasus Park Drive, Room 101, Dallas.

Power-packed lineup of former FDA leaders

The power-packed panel will be a lineup of former FDA leaders, including Dr. Amy Abernethy, co-founder of Dallas-based Highlander Health and former principal deputy commissioner and acting CIO of the FDA. Abernethy will be accompanied on the panel by former FDA Commissioners Dr. Mark McClellan and Dr. Robert Califf. They will share their insights on “how the FDA has evolved across four presidential administrations,” organizers said.

Highlander Health Co-Founder Dr. Brad Hirsch will moderate the discussion, which will be free and open to the public. 

‘From regulatory shifts to scientific advancements and policy challenges, these leaders will explore the agency’s enduring mission, the impact of changing leadership, and what the future holds for healthcare innovation and regulation,” organizers said.

Highlander Health launched last fall with public interest and investment arms

With both the moderator and a key speaker on Wednesday’s panel representing Highlander Health, here are some insights into the new Dallas company.

Co-founders Abernethy and Hirsch launched Highlander Health last September to advance evidence generation and personalized health care for the new era of medical innovation.

“We’re not shying away from big problems,” Abernethy said in statement last fall. “After more than five decades in health care, and seeing the industry’s challenges from all angles, Brad and I are more optimistic than ever. Our experience — across academia, at companies small and large, and at FDA — illuminates the bold solutions needed. And what’s more, how best to assure the commercial viability and utmost impact of any one solution.”

Highlander Health encompasses Highlander Health Institute, a public interest platform, and Highlander Health Partners, an investment arm. The co-founders said at their launch that they will “closely direct and support the activities of both entities using full-system know-how to progress the learnings and technology crucial to advancing evidence generation and care.”

“There’s an enormous opportunity to improve clinical research and care, particularly at their intersection,” Hirsch said in September. “We’ve shown success in this regard at Duke, Flatiron, SignalPath, and Verily, but we’ve only scratched the surface. Our investments, and our shoulder-to-shoulder collaboration with portfolio company management will catalyze new businesses, capabilities, and opportunities among new and traditional players alike.”

Hirsch was a featured speaker at the 2024 Venture Dallas summit on the topic of healthcare innovation.

Wednesday event details

Wednesday’s agenda at Pegasus Park will include the following:

4:00 p.m. – 4:15 p.m. – Doors Open
4:15 p.m. – 5:00 p.m. – Program
5:00 p.m. – 5:30 p.m. – Networking Reception

To register for the free public event, you can visit Eventbrite.

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