Gary Musso, PhDPresident at Musso and Associates LLCSpeaker
Profile
A goal-driven accomplished pharmaceutical executive with over fourty years of broad-based experience. Significant achievements in drug discovery, product development, product approval, drug delivery and regulatory affairs. Provides strategic vision for programs from inception/discovery phases through commercialization. Inventor of several patents and author of many successful regulatory filings and peer-reviewed publications. Expertise to transform science and technologies into clinically and commercially viable products in oncology, inflammation, neurology, and endocrinology. Currently, heading CMC technical and regulatory activities for multiple biotech organizations and strategic adviser to several others. Major contribution to the following approved drugs: Kyprolis®, Vyleesi®, Angiomax®, Tymlos®, Trulance®, Plenaxis®
Agenda Sessions
Workshop Leader’s Welcome and Opening Remarks
, 1:30pmView SessionCMC Regulatory Area for Peptides including EMA Draft Guidance on Synthetic Peptides
, 3:30pmView Session