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

Date: Feb. 22-23, 2018.

Workshop Materials

Agenda Speaker Biographies Pre-workshop Blog CCR Perspectives in Regulatory Science and Policy Article AACR Cancer Research Catalyst Blog

Slides Decks and Transcript

Transcript Slide Deck: Day 1 Slide Deck: Day 2

Workshop Video

Session I Session IIA Session IIB Session III Session IVA Session IVB

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

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 Cochairs

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