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Last Updated: 10/09/2023

NCI Drug Development Workshop II: Specialized Topics in Preclinical Development of Small Molecule Cancer Drugs

The Developmental Therapeutics Program convened a six-part webinar series from June 22 — July 28, 2023. The recordings of the individual webinars are posted below.

NCI Drug Development Workshop II: Specialized Topics in Preclinical Development of Small Molecule Cancer Drugs

Workshop Theme

Address six special topics to complement the first NCI Drug Development Workshop: How to Advance a Therapeutic Candidate from Bench to Bedside to summarize the critical considerations for the entire preclinical process, from early to late drug development of small molecule cancer drugs.

Workshop Goals and Target Audience

  • Provide information on specialized topics that are important for the preclinical development of small molecule cancer drugs
  • Help investigators mitigate the risk of selected candidates during their later stages of product development and increase their chances of entering clinical evaluation

Workshop Highlights

Topic Highlight
Session I.
Critical Considerations for Lead Optimization
Speakers: Steven Olson (Sanford Burnham Prebys), Li Di (Pfizer)		 Overview of the iterative process and fundamental principles of lead optimization to improve the lead profile and drug-like properties
Session II.
Considerations for Advancing to Late Preclinical Development
Speakers: Li Di (Pfizer), Elizabeth Glaze (NCI), Apurva Srivastava (FNLCR)		 What constitutes a clinical candidate and commonly used assays and studies to support the decision-making of candidate selection; the principles of pharmacodynamic biomarker development 
Session III.
Toxicity Studies for Small Molecules
Speaker: Elizabeth Glaze (NCI)		 Description of key considerations in designing IND-enabling toxicology studies with examples
Session IV.
Formulation of Small Molecules
Speakers: Huan Xie (Texas Southern University), Jing Ling (Merck)		 Overview of the roles of formulation studies in preclinical development of small molecule cancer drugs, and introduction of principles and approaches in improving formulation in different developmental stages
Session V.
Nanoparticle Delivery of Cancer Drugs
Speakers: Stephan Stern (FNLCR), Wimolnut Manheng (FDA)		 Nanomedicine characterization, product development, and regulatory considerations
Session VI.
Good-to-Know IP Knowledge
Speaker: Jason Cristofaro (NCI)		 Overview of various types of intellectual properties with a focus on patent laws

Webinar Recordings

Session Information Link to Recording
Session I
Critical Considerations for Lead Optimization		 Recording External Link
Session II
Considerations for Advancing to Late Preclinical Development		 Recording External Link
Session III.
Toxicity Studies for Small Molecules		 Recording External Link
Session IV. Formulation of Small Molecules Recording External Link
Session V. Nanoparticle Delivery of Cancer Drugs Recording External Link
Session VI. Good-to-Know IP Knowledge Recording External Link

Contact: Weiwei Chen chen.weiwei@nih.gov