Ep. 261, Chapter 6: Regulatory Engagement For Biotechs With Amber Salzman, Ph.D.

23:21 – 28:23

Salzman suggests that biotechs hoping to effectively engage with regulators, especially for novel drug modalities, "follow the science and the data" and trust their scientific instincts. She recounts an example where a consultant recommended a questionable animal model for a safety study, but her team chose to present their scientifically sound proposal directly to the FDA. She emphasizes that regulators care about patients and are willing to listen to well-defended, logical arguments.

On the current state of the FDA, expresses optimism about recent changes and praises new leadership for suggesting common-sense, out-of-the-box ideas, such as submitting certain sections of an approval application early to streamline the review process. She believes that these changes, combined with a willingness to embrace new technologies like AI, will ultimately lead to a more efficient and effective regulatory environment.