Training Course: From Active Molecules to Approved Therapeutics: Navigating Drug Development and Regulatory Challenges | An ISSX 2021 Short Course

This course will cover the fundamentals in the translation from preclinical data to FIH dose selection and data needed in support of successful IND application and clinical studies.

Chair: Christine Fandozzi, Merck & Co., Inc., West Point, Pennsylvania, USA

What makes a drug a medicine? Clinical Pharmacology Considerations in Preclinical and Early Clinical Development
Gianluca Nucci, Pfizer Inc., Cambridge, Massachusetts, USA

From Drug Development to Approval: Keys to Successful Regulatory Submissions
Lei Zhang, US Food and Drug Administration, Silver Spring, Maryland, USA

What makes a drug a medicine? Clinical Pharmacology Considerations During Phase 2 and Phase 3 of Drug Development
Vikram Sinha, Takeda, Berwyn, Pennsylvania, United States