NCI Drug Development Workshop (Agenda)
July 23, 2021, 12 pm – 2:30 pm ET
Session I. Grand Overview
Introduction, Rose Aurigemma, Ph.D., National Cancer Institute
Topic 1: Clinical mindset to lead pre-IND activities: plan backward and develop forward
Rose Aurigemma, Ph.D., National Cancer Institute
Topic 2: Key milestones in drug development and components of an IND-package
Phil Jones, Ph.D., The University of Texas MD Anderson Cancer Center
Session II. Pre-clinical Proof of Concept: Establishing Activity, Bioavailability, and Associated Effect, in Cancer Relevant Models
Topic 1: Establish therapeutic activity of an agent or a combination of agents
Melinda Hollingshead, D.V.M., Ph.D., National Cancer Institute
Topic 2: Preclinical pharmacology in IND-enabling studies and clinical pharmacology in clinical protocol development
Alex Sparreboom, Ph.D., The Ohio State University College of Pharmacy & Comprehensive Cancer Center
August 6, 2021, 12 pm – 2:30 pm ET
Session III. Non-clinical Toxicology
Topic 1: Preliminary and IND-directed toxicology studies
Elizabeth Glaze, Ph.D., National Cancer Institute
Topic 2: Assays and endpoints for toxicology studies to assess immune-related adverse events
Marc Ernstoff, M.D., National Cancer Institute
August 20, 2021, 12 pm – 2:30 pm ET
Session IV. Chemistry Manufacturing and Controls for Small Molecules
Topic 1: What is a certificate of analysis, and the assays and analytical methods needed for product release?
Donald Drinkwater, Ph.D., Albany Molecular Research Inc.
Andy Leyhane, Ph.D., Albany Molecular Research Inc.
Topic 2: Clinical formulations development and factors that influence small molecule product development
Esmail Tabibi, Ph.D., National Cancer Institute
September 10, 2021, 12 pm – 2:30 pm ET
Session V. Development of Biological Products
Topic 1: Overview of product types and various applications in cancer
Jason Yovandich, Ph.D., National Cancer Institute
Topic 2: Process development: cell line development, upstream and downstream
Rachelle Salomon, Ph.D., National Cancer Institute
Topic 3: Characterization and quality control of biological product
Ray Harris, Ph.D., National Cancer Institute
Topic 4: Cellular therapy: special path from preclinical study to clinical testing
Anthony Welch, Ph.D., National Cancer Institute
Session VI. Regulatory Considerations
Topic 1: FDA overview and perspective on regulatory requirements for an IND filing for oncology products
Rachel McMullen, M.P.H., M.H.A., Food and Drug Administration
May Tun Saung, M.D., Food and Drug Administration
Topic 2: FDA's regulatory requirements for an IND filing: preclinical data assessment
Amy Skinner, Ph.D., Food and Drug Administration
Topic 3: Overview of the process, workflows, timings for filings, and interactions with FDA
Bhanu Ramineni, M.B.A., M.S., National Cancer Institute
Tracy Lively, Ph.D., National Cancer Institute
October 29, 2021, 12 pm – 2:30 pm ET
Session VII. Clinical Translation
Topic 1: Biomarkers and companion diagnostics in IND filing and clinical trial design
Topic 2: Phase I trial design and considerations and CTEP clinical trial resource
Jeff Moscow, M.D., National Cancer Institute
Topic 3: Clinical development of immunotherapies
November 19, 2021, 12 pm – 2:30 pm ET
Session VIII. Entrepreneurship: Partnering and Advancing
Topic 1: Engaging with development partners
Jeremy Caldwell, Ph.D., Inception Sciences, Incorporated
Topic 2: Creating a data package for pharma/biotech
Carolyn Buser-Doepner, Ph.D., GlaxoSmithKline
December 3, 2021, 12 pm – 2:30 pm ET
Session IX. NCI Translational Resources and Programs
NCI Experimental Therapeutics (NExT) Program, Barbara Mroczkowski, Ph.D., National Cancer Institute
Small Business Innovation Research (SBIR), Kory Hallett, Ph.D., National Cancer Institute
NCI DTP Resources and the Stepping Stones Program, Rose Aurigemma, Ph.D., National Cancer Institute
CTEP formulary and Intellectual Property-related issues, Jason Cristofaro, Ph.D., J.D., National Cancer Institute
Clinical translation grant mechanisms, Lori Henderson, Ph.D., National Cancer Institute
NCI Patient-Derived Models Repository (PDMR), Yvonne Evrard, Ph.D., Frederick National Laboratory for Cancer Research
December 10, 2021, 12 pm – 2:30 pm ET
Session X. Case Studies
Case study 1: Development of small molecule product
Jolanta Grembecka, Ph.D., University of Michigan
Mollie Leoni, M.D., Kura Oncology, Inc.
Case study 2: Development of biological products
Alice L. Yu, M.D., Ph.D., University of California in San Diego
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