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Last Updated: 12/23/2021

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.

NCI Drug Development Workshop: How to Advance a Therapeutic Candidate from Bench to Bedside

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

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