November 10, 2016
National Cancer Institute Shady Grove Campus, Rockville, MD
As part of its continued effort to support awardee companies' journey to commercialization, NCI SBIR Development Center hosted a specialized workshop for awardee complanies developing molecularly targeted radiotherapy. The Workshop on Facilitating the Development of Molecularly Targeted Radiotherapy (hereinafter TRT Workshop) brought together experts from the SBIR program, NCI Radiation Research program, Food and Drug Administration's Center for Drug Evaluation and Research (FDA CDER), and Department of Energy's Isotope program to introduce the regulatory and clinical processes relevant to workshop participants.
Workshop Agenda:
9:00 - 9:15 Welcome from Michael Weingarten, Director NCI SBIR
9:15 – 9:25 Introduction to the Workshop’s Objectives, Deepa Narayanan (NCI SBIR)
9:25-10:45 Awardee Introductions (2-3 minutes per awardee organization). Each awardee
organization will provide a quick introduction of their company/institution, basic
technology, and their current project.
10:45-11:00 BREAK
11:00-11:45 Pre-clinical considerations for TRT technologies
Dr. Haleh Saber, Deputy Director, Division of Hematology Oncology Toxicology/
OHOP/CDER
11:45-12:30 Clinical considerations for TRT technologies
Dr. Amanda Walker, Medical Officer, Division of Oncology Products 1, CDER/FDA
12:30 -1:30 LUNCH/ NETWORKING
1:30-2:15 Information about DoE’s Isotope Program and Access to Isotopes
Dr. Marc Garland, Deputy Director, Department of Energy Isotope Program
2:15-2:30 BREAK
2:30-4:30 Interactive discussion with the DOE & FDA, Moderated by Dr.Jacek Capala (NCI RRP)
4:30-4:45 Closing Remarks
Click here to view the workshop handout.