
Click the picture to learn more about Dr. Caligiuri
By: Michael Caligiuri, MD
Chief Executive Officer, The James Cancer Hospital & Solove Research Institute
Vice President for Health Sciences, Cancer Programs
Director, The OSU Comprehensive Cancer Center
Want to frustrate a cutting-edge clinical cancer researcher? Suggest that he or she organize a clinical trial that combines two experimental targeted agents that together could paralyze cancer cells in multiple ways. No matter how convincing or brilliant the evidence that the combination could benefit patients, such trials are off-limits. Frustration is an understatement.
Currently, two compounds can be tested together in clinical trials only after both agents are approved by the U.S. Food and Drug Administration (FDA). Additionally, if the two agents are owned by different pharmaceutical companies, it raises business, legal, liability and intellectual property issues that are so thorny no one has wanted to touch them.
Recognizing the seriousness of the problem, the FDA last December released a draft guidance document that provides recommendations for addressing certain scientific and regulatory issues that arise during co-development of two or more experimental drugs. The business world, however, has yet to figure out how to move quickly and successfully to co-develop drugs that are owned by different companies. Solving that problem is the goal of this roundtable.
The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute and Friends of Cancer Research have organized this Cancer Drug Development Roundtable to address the industry hurdles and make co-development of two or more experimental drugs a reality. The recommendations will be announced later this year.
There are tremendous rewards in store if we can overcome these obstacles. I applaud the FDA for issuing its Guidance Document and setting up the scientific framework to co-develop two investigational drugs. If we can now solve the legal and business side of the problem, we can achieve our ultimate goal—to speed life-saving treatments to our patients and create a cancer-free world.
Tomorrow’s Roundtable brings together leaders in cancer research, the pharmaceutical industry, the FDA and cancer advocacy. We will begin with an open session that will enable researchers, advocates, patients and media to learn more about the issue and ask questions of a panel. That will be followed by a closed working session lasting the remainder of the day. The open-session panel participants include:
- Michael Caligiuri, M.D. – Director of The Ohio State Comprehensive Cancer Center and CEO of the James Cancer Hospital and Solove Research Institute
- Jim Doroshow, M.D. – Director of the Division of Cancer Treatment and Diagnosis at the National Cancer Institute
- Eric Rubin, M.D. – Vice President, Oncology Clinical Research, Merck
- Ellen Sigal, Ph.D. – Chair and Founder, Friends of Cancer Research
- Janet Woodcock, M.D. – Director, Center for Drug Evaluation and Research, FDA
For more about co-development of experimental agents, we recommend the following:
“Development of Rational Drug Combinations with Investigational Targeted Agents” Friends of Cancer Research document
“When it takes two to tango, FDA suggests a new regulatory dance” article from Nature, March 2011, summarizes the early work on this topic
“Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements” article from Nature Reviews, Nov. 2010