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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 and Early-Stage Oncology Guidance Documents

Small Business and Industry Assistance (SBIA) and Oncology Center of Excellence (OCE): “Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups” provide excellent overviews and concepts to consider in your early-stage drug development efforts and are useful summaries of general regulatory expectations for first-in-human (FIH) oncology trials. Individual presentations will be referenced with links in the following discipline-respective sections.

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