Biotech companies face mounting pressure to bring products and therapies to market faster. However, setbacks as a result of regulatory barriers remain a challenge. The industry has strict guardrails, especially as a single misstep in clinical trial design or a late-stage misunderstanding with the FDA can cost years, even lives. And with technologies like AI opening new possibilities for how data is analyzed and decisions are made, collaborative engagement with regulators and smarter development strategies are essential now more than ever.
Angela Nelson, Chief Strategy Officer at Boston Biodevelopment, is helping biotech firms rethink how they approach the entire regulatory lifecycle. With over 20 years of combined experience in regulatory affairs and computational chemistry, she’s led submissions across more than 50 markets and helped secure approvals for complex therapies, including a recent FDA Fast Track designation for an opioid withdrawal treatment.
She also believes that AI has the potential to reduce risk when applied thoughtfully. “Can we teach AI to identify safety risks, complex mechanisms of action, potential therapeutic application, using early-stage data and thus identify more effective regulatory pathways or study designs earlier in development? I believe so and that’s something that excites me,” she asserts.
She now leads a team exploring how AI can support adaptive trial designs, predict regulatory outcomes, and streamline authoring for submissions without replacing the core value of strategic judgment. Nelson’s approach is rooted in science and is shaped by real-world execution. She’s managed a $23 million global portfolio spanning more than 100 drug products across oncology, virology, and primary care.
Her goal is to adhere to regulations as well as be ready for commercialization and cross-border expansion. For Nelson, AI is one piece of a larger puzzle: aligning science, strategy, and global health priorities in a way that works for regulators and patients alike.
