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.
Accelerator Innovator Discussion (AID) Meetings
Project Catalyst facilitates through collaborative efforts across FDA offices and centers a 90-minute interaction with project teams supported by academic life science accelerators and small businesses. These meetings are informal, non-binding scientific discussions that can help answer early-phase drug development questions regarding oncology therapeutics—from avoiding unnecessary challenges to understanding guidance documents and everything in between. If your team or small business (under 20 employees) is interested in coordinating a meeting, please Register Here.
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
- August 24, 2023: FNIH, NCI, and FDA Public Meeting—Creating a Public-Private Partnership to Support Development of Anti-Cancer Therapies for Ultra-Rare Tumor Indications. Visit the link to review meeting materials and summary. Watch on YouTube.
Project Leaders:
Jeff Summers, MD, Associate Director Translational Sciences, Office Oncologic Diseases
Project Manager: Joan Ferlo Todd, Senior Health Scientist, OCE
Please send your questions and information to Jeffery Summers at:
OCE-Catalyst@fda.hhs.gov
Additional Information:
FDA Oncology Center of Excellence
CDER Small Business & Industry Assistance (SBIA)