MassBio CEO & President Kendalle Burlin O’Connell originally posted this update to LinkedIn.
Two strong days in Washington for Massachusetts biotech, during one of the busiest weeks of the fall in DC.
Our timing with FDA couldn’t have been better. The agency launched its Expedited IND Pilot on Tuesday, an Operation TrialBlazer initiative aimed at getting first-in-human trials started faster in the U.S.. And on Wednesday Zag Bio CEO and MassBio Vice Chair Jason Cole and City Therapeutics CEO Andy Orth joined me for a meeting with new CBER director Karim Mikhail, BPharm. MSc. and CDER senior advisor Kathleen Davies. It was hugely beneficial for MassBio, our members, and two executives who are building companies right now, to receive more clarity on the intent of TrialBlazer to make the U.S. a viable option for FIH trials and to continue to compete globally on innovation. We will share more soon.
On the Hill, our Head of External Affairs Benjamin Bradford and our new Director of Federal Policy & Strategic Initiatives Nathan Dinh met with offices on both sides of the aisle, including Sens. Richard Blumenthal (D-CT) and Eric Schmitt (R-MO) and Reps. Scott DesJarlais (R-TN), Don Bacon (R-NE), Chrissy Houlahan (D-PA), Brad Finstad (R-MN) and Don Davis (D-NC). Our asks were clear: reshore clinical trials, protect NIH integrity, and make FDA more efficient. Each of those asks supports early-stage biotech innovation, which is how the U.S. keeps its lead.
MassBio’s Federal Policy Working Group also met in DC, and it was a great opportunity to engage with some of our larger member companies about what is top of mind for them in D.C. and how our advocacy for early-stage biotech is complementary to their own work. The meeting ran right into our annual DC Fall Reception at Sonoma, which was a energetic full house. Thank you to the members of the Massachusetts congressional delegation for making time for us with so much competing for your attention this week.
During remarks, stories were shared that made both the economic and the patient cases. Some were personal about how breakthroughs from this industry touched them and those they love. Others were a look behind the curtain at how FDA modernization and policies to improve clinical trials could happen.
Grateful to our members, partners, and the delegation for showing up for this industry.
DC Trip – September 2026
