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  1. Oncology Center of Excellence

Oncology Regulatory Expertise and Early Guidance (OREEG)

OREEG Graphic

Project Catalyst’s Oncology Regulatory Expertise and Early Guidance (OREEG) is an educational initiative of the Oncology Center of Excellence (OCE), providing early-stage oncology companies with product-type advice to inform sound product-specific drug development decisions. This dynamic self-learning platform will be updated and monitored on a continual basis.

This platform consists of three components:

  • Bench to Bedside chats with regulatory science experts. This series of prerecorded chats highlights concepts in selected guidance documents relevant to early-stage oncology product development. Bench-to-Bedside chats also provide insight into development of drugs and biologics for imminently life-threatening oncology indications.
  • Frequently asked oncology drug development questions and answers. Organized by topic, these questions and answers provide helpful advice.
  • Opportunities to direct questions to OREEG’s regulatory science experts. Although we welcome questions regarding oncology drug development issues not covered in other OREEG materials, we are limited in scope. Questions should only reference drug development plans not ready for a pre-IND submission to FDA. We ask that you refer to our template and guidelines below before submitting questions.

Bench to Bedside Chats

Early-Stage Oncology Guidance Documents

Small Business and Industry Assistance (SBIA) and OCE “Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups” review concepts to consider for early-stage drug development, providing useful summaries of regulatory expectations for first-in-human oncology trials. 

Project Catalyst strongly recommends reviewing the following regulatory support information offered by Innovator Support Services, Small Business Education and Entrepreneurial Development, NIH Office of Extramural Research:

Additional Information

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