Description:

In this seminar featuring Mitchell Glass, Principal at Broom Street Associates, will explore academic researchers' challenges when preparing for an Investigational New Drug (IND) application and best practices for smooth interactions with the FDA. Mitchell will share critical steps in the IND process, from pre-submission preparations to post-submission interactions with regulatory agencies. He will highlight common pitfalls encountered during the IND process, including what academics tend to “overdo” and “underdo” in their IND-enabling data package. Mitchell will share insights on a winning strategy to secure IND authorization and share advice for working productively with the FDA.

SPEAKER BIO:
Mitchell Glass, MD is a seasoned pharmaceutical industry veteran with three decades of expertise, spanning leadership roles in top pharmaceutical companies, start-up management, and biotech investments. Notably, he established the pulmonary therapeutics group at ICI Pharmaceuticals, led cardiovascular and respiratory drug development at SmithKline Beecham, and served as CMO at AtheroGenics. Mitchell is also a principal at Broom Street Associates, offering regulatory services to diverse healthcare companies. Serves as the CMO of Tikkun Olam Pharmaceuticals, he focuses on the FDA-regulated development of marijuana strains, complementing his extensive career in pharmaceutical innovation.