Development of a cancer drug

Published on May 31, 2022   46 min

A selection of talks on Clinical Practice

0:00
Hello. My name is Martin Edelman. I am the Chair of the Department of Hematology / Oncology and Deputy Director for Clinical Research at the Fox Chase Cancer Center in Philadelphia, Pennsylvania. I'm going to be discussing the development of a cancer drug with a focus on how the process goes through from the molecule with the target through to FDA approval, with an emphasis on the regulatory aspects and trial design aspects.
0:32
These are my disclosures and disclaimers, and I'd like to emphasize that the material that I'm presenting is an overview of the drug development process as perceived by myself an oncology drug investigator. I do not work for companies and I have not been part of the corporate world and this is intended for educational purposes. It is not intended to be encyclopedic, nor is guidance, nor is legal advice and has not been reviewed by the US Food and Drug Administration or any other regulatory organization.
1:01
This is my perspective. It's distilled from my review of various FDA presentation statements, papers regarding drug approval, as well as some recent drug approvals and rejections, and my own personal experience in the design and execution of various trials. I am not associated with the FDA in any way, and I have never personally submitted a drug for FDA approval. I have submitted for INDs and exemptions.
1:26
This is the overview. The overview is that I am going to discuss the regulatory aspects, the evolution of US law laws regards drug approvals, a bit about the structure of the FDA focusing on oncology and definitions of terms. I'm going to talk a little bit about preclinical studies and target identification, what the issues are with cell lines, animal studies, etc., and moving up to optimization of the molecule target assessment and validation. But the major focus will be on the clinical aspects of how one goes from early phase, phase II and III and ultimately to approval.