OCE Insights is written by members of the Oncology Center of Excellence (OCE) and the Office of Oncology Diseases (OOD) at the U.S. Food and Drug Administration. In this installment, Jeff Summers, MD, OOD Acting Associate Director for Translational Sciences, and Marc R. Theoret, MD, OCE Deputy Director, explore initiatives aimed at enhancing the translation of insights originating from the academic basic-science lab bench into effective anticancer therapies.
Jeff Summers, MD
Marc R. Theoret, MD
Update on Project Catalyst
What is Project Catalyst?
The OCE began Project Catalyst in early 2020 with the goal of providing guidance and educational resources to help support informed anticancer therapy development in small pharmaceutical companies and academic life science accelerators to expedite the availability of directed and novel cancer treatments to the public. The access to information, important drug development concepts, explanation of guidance documents, and informal scientific discussions may provide early-stage oncology companies with product-type advice that can inform sound product-specific drug development decisions. A recent and worthwhile example of the OCE and Project Catalyst’s efforts in these endeavors is the Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups.1
Why was Project Catalyst necessary?
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, we decided to develop a project that will help oncology innovators and fledgling companies with limited resources navigate the sometimes-complex drug development process. In this way, their science and epiphanies may expediently be translated into potential breakthrough therapies.
The ability to develop patient-specific cellular therapies, to intervene in neoplastic processes through previously undruggable targets, and the rapidly advancing ability to identify pharmacophore structures via in silico methods that can be used for further structure activity relationships in drug design highlight just a few of the technologies democratizing oncology drug development to the academic lab-bench. Of note, cancer omics is continually subtyping what were once large cancer types into many smaller subtypes that may have actionable altered pathways. These small cancer subtypes generate less economic incentive for large commercial pharma but are interesting and motivating diseases for the academic scientist. Project Catalyst hopes to guide these scientists and their ideas into tangible oncology therapies.
Who can be a part of Project Catalyst?
Small companies and academic innovators who have development programs that are too early for a productive formal investigational new drug submission are the primary focus of Project Catalyst. One of Project Catalyst’s efforts is the Oncology Regulatory Expertise and Early Guidance (OREEG) program, which consists of the following:
- Guidance documents relevant to early-stage oncology drug development;
- Bench-to-bedside chats with regulatory science experts, highlighting concepts in selected guidance documents relevant to early-stage oncology product development as well as providing insight into development of drugs and biologics for imminently life-threatening oncology indications;
- Frequently asked oncology drug development questions and answers organized by topic and opportunities to direct questions to OREEG’s regulatory science experts for questions that are not adequately addressed in the educational materials provided.
Looking Ahead
What does Project Catalyst have planned for the upcoming year?
The OREEG program will continually be expanded to include additional education materials and will attempt to address stakeholders’ input on important issues to explore. Project Catalyst plans to develop live Ask the Expert seminars, which will focus on specific topics quarterly.
Although the worldwide COVID experience has certainly had a dampening effect on travel and conference interactions, the OCE hopes to sponsor some “speed-dating” interactions with various academic accelerator programs and the companies therein to foster scientific discussion on their technologies and platforms under development.
OCE and Project Catalyst are excited to be working with the National Cancer Institute Small Business Innovation Research Development Center on various programs. One goal is to help companies develop drugs for rare oncology indications when preclinical data suggest paradigm-changing potential. For more information, visit www.fda.gov/about-fda/oncology-center-excellence/project-catalyst.
DISCLOSURE: Dr. Summers and Dr. Theoret reported no conflicts of interest.
REFERENCE
1. U.S. Food and Drug Administration: Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups. Available at https://www.fda.gov/drugs/news-events-human-drugs/oncology-therapy-development-workshop-pivotal-steps-and-avoiding-pitfalls-start-ups-03302021. Accessed on December 21, 2021.
