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  1. Oncology Center of Excellence

Project Catalyst

Providing a regulatory platform to connect scientific knowledge, creative insight, and medical professionals to foster early-stage product innovation

Project Catalyst

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. 

Accelerator Innovator Discussion (AID) Meetings

Project Catalyst can facilitate “Speed Dating” like interactions with Project Teams at your Academic Accelerators and Life Science Hubs through virtual meetings, allowing investigators to ask questions regarding their drug development plans at an early stage prior to a Pre-IND Meeting. Contact Project Catalyst at OCE-Catalyst@fda.hhs.gov for more information and to coordinate a session.

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. 

Meetings and Workshops

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:

Additional Information: 

FDA Oncology Center of Excellence
CDER Small Business & Industry Assistance (SBIA)

Twitter: #OCECatalyst
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