​FDA-AACR-ASTRO Regulatory Science and Policy Workshop 

FDA-AACR-ASTRO Clinical Development of Drug-radiotherapy Combinations

Date: Feb. 22-23, 2018.

See the agenda. Read the speaker bios. Read the guest blog post by workshop cochair, Amanda Walker, MD. Read the follow-up blog post and the CCR Perspectives in Regulatory Science and Policy article.

Download the slides: Day 1, Day 2. Read the transcript.

Watch the videos: Session I. Session IIA. Session IIB. SessionIII. SessionIVA. Session IVB.

Some speakers have elected to have some or all of their slides withheld.

Day 1

SESSION I: Preclinical Considerations

SESSION II: Clinical Considerations

Day 2

SESSION III: Immunotherapy

SESSION IV: Other Targeted Therapies

Purpose: There is great interest among clinicians as well as regulatory authorities to address the lack of drug development for products intended specifically for use with radiation therapy. Emerging from the enthusiasm and momentum of a session at the AACR-sponsored Accelerating Anticancer Agent Development and Validation Workshop (May 3-5, 2017, Bethesda, Maryland), this two-day workshop will bring together regulatory agencies, industry, and academia to discuss the challenges in greater depth and come up with a path forward.

Workshop Co-chairs:

  • FDA:
    • Amanda Walker, MD, associate director (acting), Oncology Center of Excellence; medical officer, Division of Oncology Products 1, Office of Hematology and Oncology (OHOP), Center for Drug Evaluation and Research (CDER), FDA
  • AACR:
    • Stephen M. Hahn, MD, deputy president and chief operating officer; chair and professor, Department of Radiation Oncology, UT MD Anderson Cancer Center
    • Theodore S. Lawrence, MD, PhD, professor and chair, Department of Radiation Oncology, University of Michigan
  • ASTRO:
    • Marka Crittenden, MD, PhD, director, Translational Radiation Research, Earle A. Chiles Research Institute, Providence Cancer Center; radiation oncologist, The Oregon Clinic
    • Phuoc T. Tran, MD, PhD, associate professor, Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University