NCI Drug Development Workshop (Materials)

Materials

The recording of each session will be posted within a week of its completion.

The Developmental Therapeutics Program (DTP) offers drug discovery and development resources and services to the research community. Visit https://dtp.cancer.gov/ for more information.

The Division of Cancer Treatment and Diagnosis (DCTD) is seeking project proposals for viral vector and cell therapy production at NCI.

The recordings are archived for future access at NCI Drug Development Workshop: | News & Events | DCTD (cancer.gov).

 

Session I - July 23, 2021
Recording link:

https://nci.rev.vbrick.com/#/videos/117154fc-1fac-46eb-bf35-3f4ea692111b

Presentation:

NCI Workshop Session I Grand Overview
Key milestones in drug development and components of an IND-package

Session II - July 30, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/52da8ce9-9635-4f2b-907f-e230cea5eeb4

Presentation:

Pre-clinical Proof of Concept: Establishing Activity, Bioavailability, and Associated Effect, in Cancer Relevant Models
Preclinical pharmacology in IND-enabling studies and clinical pharmacology in clinical protocol development

Session III - August 6, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/040958fd-d596-460f-af17-14719fa2eee2

Presentation:

Preliminary and IND-directed toxicology studies
Assays and endpoints for toxicology studies to assess immune-related adverse events

Session IV - August 20, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/1980c808-bd8a-44c9-96b2-863021095e98

Presentation:

Assays and Analytical Methods Needed for API Release
Challenges in Early Phase API Scale Up
The Role of Occam's Razor in Formulation Design

Session V - September 10, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/33cf956b-b1fb-4e8c-8ae8-0f89f6a71224

Presentation:

Overview of Biologic Types and Various Applications in Cancer
PROCESS DEVELOPMENT: Navigating the UP/DOWNstreams
Characterization and Quality Control of Biological Products
Cell Therapy: CMC considerations to prepare a bridge from preclinical to clinical

Session VI - September 24, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/0cdb3459-8004-4740-9fb3-ab39b33410ba

Session VII - October 29, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/7f8c8fea-30dd-42e7-a69c-c9619f8b351a

Presentation:

Clinical development of immunotherapies
Building Effective Biomarker Plans: The Questions to Ask BEFORE You Write Your Letter of Intent
Phase I trial design considerations and CTEP clinical trial resources

Session VIII - November 19, 2021
Recording link:

https://nci.rev.vbrick.com/#/videos/336b47f7-e2f2-44e2-b1ec-48364562c5fd

Presentation:

Creating a data package for biopharm/biotech
Engaging with development partners

Session IX - December 3, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/adbdf9b2-4205-4ece-98a4-214ec90aff46

Presentation:

NCI SBIR Funding for Drug Development
NCI DTP Resources andthe Stepping StonesProgram
NCI Experimental Therapeutics Program (NExT):A Government, Academic, Industry Partnership for Cancer Drug Discovery
NExTCollaborations: How to Partner with NCI
NCI DIVISION OF CANCER TREATMENT AND DIAGNOSIS (DCTD) FUNDING OPPORTUNITIES FOR EARLY PHASE THERAPEUTIC CLINICAL TRIALS
The National Cancer Institute’s Patient-Derived Models Repository (PDMR)

Session X - December 10, 2021
Recording link:

https://nci.rev.vbrick.com/sharevideo/196f018b-fc67-40d5-ade0-91dbffc9654d?startAt=00m00s