Members of the Asymmetry Group team recently attended the BIO International Convention in Boston, a conference that brought together global leaders across science, policy, and investment to explore the future of biotech. While the industry faces a rapidly evolving and uncertain regulatory landscape and continued funding challenges, the tone at the conference reflected the determination and dedication to the mission that characterizes the biopharma community. Here are a few thoughts we took away from our time at the conference:
- Keep following the science and focusing on the patient. Across sessions, there was recognition that we are in a time of swirl and rapid change with respect to policy, the impact of AI, and capital markets. However, the consistent guidance for navigating the complex environment centered on doubling down on the industry’s core strength: driving innovation through world-class science motivated by a shared commitment to improving the lives of patients.
- Commercial planning needs a seat at the table earlier. Several conversations stressed the need to integrate commercial strategy and planning early, especially where innovative treatments may require the development of new care pathways across the healthcare delivery ecosystem. Many early clinical-stage companies focus too narrowly on the path to regulatory approval, while delaying consideration of access and reimbursement, barriers to clinical behavior change, and care pathway infrastructure requirements until later in the development lifecycle. The message from BIO was clear: scientific, regulatory, and commercial thinking must advance together and earlier.
- Greater FDA focus on flexibility and efficiency may accelerate time to market for innovation: In his keynote address at BIO, FDA Commissioner Marty Makary highlighted changes aimed at removing inefficiencies and speeding up drug approval times without cutting corners. The FDA is reviewing legacy processes for opportunities to streamline, such as enabling review of selected data elements (e.g., CMC data) prior to NDA / BLA submission to save time. Commissioner Makary also talked about the recently announced National Priority Vouchers program, in which companies “aligned with US national priorities” will be awarded vouchers that shorten the drug review timeline from 10-12 months to 1-2 months. The FDA is also considering a new Conditional Approval pathway for Rare Disease drugs, which would enable approval based on a “scientifically plausible mechanism of action” without the requirement for 2 randomized clinical trials, relying instead on robust post-marketing surveillance to further validate clinical efficacy. How these proposed changes will play out is still unclear, but the message conveyed was one of openness to new ideas that accelerate access to life-changing innovations.
The discussions at BIO reflected both the challenges biotech companies are facing and the steady resolve to move forward with clarity. The path ahead will require coordination, adaptability, and a more integrated approach across science, regulation, and commercialization. If there was one key point from this year’s conference, it’s that the industry isn’t just waiting for the future; it’s helping to create it.