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Oncology Times:
doi: 10.1097/01.COT.0000394947.99856.22
Opinion

FDA Gives Guidance to Scientists Studying Multiple Unmarketed Drugs; Now It's Time for Business to Get on Board

Caligiuri, Michael MD

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Cancer cells are smart, and figure out multiple pathways to survive. Combination therapies are key to fatally crippling the cells. Waiting for each agent to be approved individually before testing it with another takes precious time in discovering new treatments for our patients.

MICHAEL CALIGIURI, M...
MICHAEL CALIGIURI, M...
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Recognizing this, the US Food and Drug Administration recently issued a Guidance Document (http://www.fda.gov/downloads/Drugs/auidance ComplianceRegulatoryInformation/Guidances/UCM236669.pdf) for industry co-development of two or more investigational drugs for use in combination.

But the lab and the clinic are not the hurdles here; it's the C-suite. The Guidance Document does not speak to the business and legal issues that arise when two different companies own the compounds that need to be tested together. Questions about intellectual property and who is responsible if anything goes wrong can bring a co-development agreement to a screeching halt.

The business world has not yet figured out a way to move quickly and successfully to co-develop drugs that are owned by different companies. As a cancer researcher, I may have brilliant reasons why two compounds can effectively work together. But I must first get the two companies to agree to provide the material. I have personally tried to get two pharmaceutical companies to come together so we could study their compounds together, and it went nowhere after years of negotiation. It's simply a deal-breaker.

So much of the work with novel cancer therapies is conducted at academic cancer centers and NCI-designated centers such as our own Ohio State University Comprehensive Cancer Center. Many of our colleagues around the country have experienced the same frustration in trying to test multiple compounds in this way, and it vexes all of us who are so passionate about getting new and better treatments to patients with cancer.

The Guidance Document is a great start. Now it's up to major stakeholders to hammer out the next critical part of the equation. This calls for action on the part of a broad coalition—the FDA, patient advocates, scientists, the National Institutes of Health, along with the pharmaceutical companies and others—to devise a template for co-development of agents owned by two different companies. Such a model would provide a starting point from which we could draw up such agreements, and move drug development along much more expeditiously.

There are tremendous rewards in store if we can overcome the obstacles. I applaud the FDA for issuing this Guidance Document and setting up the scientific framework to co-develop two investigational drugs. If we can now continue with the legal and business side of matters, we can achieve the ultimate goal—to speed life-saving treatments to our patients and create a cancer-free world.

© 2011 Lippincott Williams & Wilkins, Inc.

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