NCI Drug Development Workshop:

How to Advance a Therapeutic Candidate from Bench to Bedside

The Developmental Therapeutics Program convened a 10-part webinar series from July through December 2021 (agenda).
The recordings of the individual webinars are posted below.

Research Challenge

Navigating through Investigational New Drug (IND)-enabling activities and acquiring the full set of resources for the preclinical stage of drug development

Workshop Goals and Target Audience

Provide researchers who are interested in  preclinical product development of anti-cancer agents with a guide to key IND-enabling activities and resources to facilitate successful translation from the lab to the clinic

Workshop Design

• Reflect the interrelated, milestone-driven nature of IND-enabling activities
• Introduce first-in-human trial design to emphasize a ‘clinical trial-directed’ mindset
• Discuss available NCI translational resources
• Share entrepreneurship experience
• Deliver lectures by subject matter experts from the NCI, the Food and Drug Administration (FDA), academia, and private sectors

Webinar Recordings

Session Information	Link to Recording
Session I: Grand Overview	Recording
Session II: Preclinical Proof of Concept: Establishing Activity, Bioavailability, and Associated Effect in Cancer Relevant Models	Recording
Session III: Non-clinical Toxicology	Recording
Session IV: Chemistry Manufacturing and Controls of Small Molecules	Recording
Session V: Development of Biological Products	Recording
Session VI: Regulatory Considerations	Recording
Session VII: Clinical Translation	Recording
Session VIII: Entrepreneurship: Partnering and Advancing	Recording
Session IX: NCI Translational Resources and Programs	Recording

Contact: Weiwei Chen chen.weiwei@nih.gov, Sharad Varma sharad.verma@nih.gov, or Rachelle Salomon rachelle.salomon@nih.gov