MassBio CEO & President Kendalle Burlin O’Connell originally posted this update to LinkedIn.
Before we head into the weekend, some important updates from D.C. This week brought leadership shake-ups at the FDA, fresh signs of life in the biotech IPO market, and a continued drumbeat of China hawkishness on Capitol Hill. Here’s what caught our attention:
FDA Names Acting CBER Director: Katherine Szarama has stepped in as acting director of the FDA’s Center for Biologics Evaluation and Research after Vinay Prasad’s departure. Szarama, who joined CBER as Prasad’s deputy in December 2025, is a biophysicist who previously served at CMS and ARPA-H. She joins a long list of HHS leaders serving in acting capacities, with NIH Director Jay Bhattacharya still pulling double duty as acting CDC head and Tracy Beth Høeg leading CDER in an acting capacity. Stable, predictable leadership at CBER matters enormously for Massachusetts, which is home to a deep bench of developers of cell and gene therapies, vaccines, and advanced biologics. Sponsors navigating complex biologics applications need a steady counterpart at the agency, and we’ll be watching closely for a permanent CBER nominee and a return to predictable review timelines that companies can plan around.
House Panel Wants China Data Out of FDA Applications: The House Appropriations Subcommittee on Agriculture and FDA, led by Rep. Andy Harris (R-MD), added language to its spending bill report this week directing FDA to bar clinical trial data generated in China, Russia, Iran, or North Korea from being used in IND applications. The committee cited concerns over IP theft and lower ethical standards abroad. Report language doesn’t carry the force of law, but appropriators use it to send strong signals about how taxpayer dollars should be spent. The proposal builds on the broader China-hawkish posture we’ve been tracking, including last week’s Senate Judiciary hearing on IP theft. This presents a potential challenge for the industry that we’ll be watching closely. Many MassBio members are licensing or originating molecules from China-based partners as a way to bring novel science to patients faster and at lower cost. An outright ban could complicate pipeline strategy without necessarily strengthening U.S. competitiveness. This is a conversation we’ll have with members in the months ahead.
Massachusetts Biotechs File for IPOs; Continued Capital Raising Momentum: Several Massachusetts biotechs (Seaport Therapeutics, Hemab Therapeutics, and Avalyn Pharma) priced IPOs on Thursday, raising a combined more than $800M. Seaport brought in approximately $254.9 million with Hemab and Avalyn Pharma about $300M. The three IPOs pushed 2026 biotech IPO proceeds to nearly $3.2 billion, an encouraging uptick after a tough 2025. This is exactly the kind of momentum we were hoping to see in the wake of the SEC Small Business Capital Formation Advisory Committee’s Monday meeting on reviving the IPO market. Public capital is essential for the long, capital-intensive work of bringing new medicines to patients, and Massachusetts companies are once again proving the depth of our ecosystem.
FDA Goes Live on Real-Time Clinical Trials: On Tuesday, FDA announced two significant steps to implement what it’s calling real-time clinical trials, a framework where sponsors stream safety and efficacy signals directly to the agency as they’re generated, rather than waiting months for data to be cleaned, analyzed, and submitted. AstraZeneca’s Phase 2 TRAVERSE trial in mantle cell lymphoma and Amgen’s Phase 1b STREAM-SCLC trial in small cell lung cancer are the first proof-of-concept studies. FDA also released a Request for Information seeking public input on a broader pilot launching this summer, with comments due May 29 and final pilot selections expected in August. Commissioner Makary said the approach could shave 20–40 percent off overall trial timelines. For MA biotechs, this is a development worth watching closely. It’s also a real opportunity for industry to shape how the framework evolves, and we plan on weighing in via the RFI before the May 29 deadline.