Podcast recap: Max Bronstein on the intersection of biotech and policy

On the latest episode of The Genetics Podcast, Patrick speaks with Max Bronstein, founder and CEO of Aviva Strategies, a health policy firm dedicated to supporting biotech and pharma companies in rare, ultra-rare, and precision medicine. With two decades of experience, Max has had a front-row seat to how public policy shapes the future of therapeutic development. The conversation covers the rapid shifts in Washington, the challenges at the FDA, and the opportunities to reimagine how we develop and deliver treatments for rare diseases.

Policy turbulence meets scientific innovation

Max began by reflecting on the whirlwind of changes following the new US administration earlier this year. Leadership turnover at the FDA has created uncertainty for companies and patients alike. The loss of institutional memory, combined with the pace of innovation in biologics and gene therapy, raises pressing questions: Can the FDA review novel therapies with both speed and expertise? Will companies keep early-stage clinical trials in the US, or increasingly move them abroad to countries like Australia?

Despite challenges, Max sees reasons for optimism: new leadership at the FDA with industry experience, fresh voucher programs to incentivize onshoring clinical development, and signs of momentum around modernization.

Patients as partners in development

A major theme of the conversation was the growing role of patients throughout the drug development process. Historically, patients were treated as trial “subjects,” but today they are increasingly recognized as co-pilots. Max explained that this shift is both cultural and practical: trials designed without patient input often fail to recruit, place unrealistic burdens on families, or rely on outdated biomarkers that do not reflect quality of life.

Engaging patients early helps companies select endpoints that matter to both regulators and the people living with disease. It also ensures trial protocols are feasible. They should avoid unnecessary travel demands, inconvenient sampling schedules, or overly complex designs. For rare and ultra-rare diseases, this approach can make the difference between success and failure.

Incentives and the rare disease landscape

The discussion turned to incentives like the Pediatric Priority Review Voucher (PRV) program, which expired at the end of last year. For many ultra-rare diseases that affect only a few hundred children globally, the PRV has been essential for making drug development financially viable. Max emphasized that reauthorizing and strengthening such incentives is urgent, given their life-or-death impact.

Looking forward, he drew a parallel to the Orphan Drug Act of 1983, which transformed the rare disease landscape. He argued that a similar framework for ultra-rare diseases (clear definitions, incentives, and regulatory flexibility) could unlock the next wave of innovation.

ARPA-H and creative policy models

Max also shared insights from his time in the White House, where he helped establish ARPA-H, the Advanced Research Projects Agency for Health. Modeled on DARPA, ARPA-H is designed to fund bold, high-risk, high-reward health innovations that traditional grant systems shy away from. For Max, it represents one of the most exciting policy developments in decades and is an example of how creative policy models can accelerate breakthroughs.

Aligning policy and politics

One of Max’s core lessons from his career is that policy must be shaped to fit the politics of the day. Programs that fail to adapt risk dismantling, no matter their scientific merit. For rare and ultra-rare diseases, this means framing legislation and incentives not only as matters of health equity, but also as issues of national security and economic competitiveness.

Toward a future of curative therapies

Max closed with a powerful vision of a world where every rare disease patient has access to a curative therapy, ideally from birth. Advances in sequencing, AI, and gene editing are making this future technically feasible. The challenge is ensuring that public policy keeps pace and facilitates rather than inhibits access.

Listen to the full episode below.