Project Catalyst
Providing a regulatory platform to connect scientific knowledge, creative insight, and medical professionals to foster early-stage product innovation
Advances in science and technology, and an evolving academic environment, have accelerated the growth of start-up companies developing anticancer therapies. With the increasing numbers of small innovative companies emerging from academia, the Oncology Center of Excellence Project Catalyst was developed.
Working primarily with small pharmaceutical companies and academic life science incubators and accelerators, Project Catalyst provides guidance and educational resources that help support informed anticancer therapy development to expedite the availability of directed and novel cancer treatments to the public.
Oncology Regulatory Expertise and Early Guidance (OREEG)
Project Catalyst’s educational initiative entitled Oncology Regulatory Expertise and Early Guidance (OREEG) is a self-directed platform providing early-stage oncology companies with product-type advice to inform sound product-specific drug development decisions.
Project Leaders:
Marc R. Theoret, MD, Deputy Director, Oncology Center of Excellence
Jeff Summers, MD, Associate Director Translational Sciences, Office Oncologic Drugs
Please send your questions and information to Jeffery Summers at:
[email protected]
Additional Information:
FDA Oncology Center of Excellence
CDER Small Business & Industry Assistance (SBIA)