Description:

In this seminar, Mitchell Glass, Principal at Broom Street Associates, will describe the anatomy of an Investigational New Drug (IND) application and provide a practical “how-to” guide for academic investigators contemplating applying for an IND. Mitchell will walk through critical sections of the application and share insights on what a preclinical data package should look like, recommendations for when and how often to engage with the FDA, and tips for best preparation for those meetings. Mitchell will also discuss the nuances of combination products and the importance of pre-RFD and RFD meetings. Overall, this session will help demystify the IND application process and provide an actionable roadmap for academic researchers preparing an IND submission.

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.