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Cancer Researcher Dan Von Hoff, M.D. Advocates for "Context of Vulnerability," A Powerful New Paradigm for Targeted Drug Development
Date:2/17/2009

lute number of deaths, has been down for two years in a row. It should have been going up like a rocket because we're all aging."

Dr. Von Hoff's team believes a new approach for targeted drug development, "context of vulnerability," is the key to developing powerful targeted therapeutics. The term, coined by TGen's Spryo Mousses, Ph.D., refers to the genetic configuration in a patient's tumor that makes it susceptible to a specific drug. "Context of vulnerability provides the genetic rationale for a targeted therapy," Dr. Von Hoff explains.

"If you let context of vulnerability guide drug development, you would put only those patients who have the appropriate susceptibility to the drug on trial," he says. "This optimizes your chance of seeing efficacy with a much smaller n. It's essentially how Herceptin® got approved with an n of 480. If they hadn't pre-selected patients for the context of vulnerability, estimates say that it would have taken about 23,000 patients to get the drug approved."

In the abstract, Dr. Von Hoff provides a detailed look at the promise and potential of this approach::

1. How to establish a patient's context of vulnerability;
2. How using context of vulnerability to guide drug development can improve your chance of seeing efficacy with a much smaller n;
3. Incorporating context of vulnerability as the oncologist's "sixth vital sign;"
4. A case study of context of vulnerability in use and how it improves patient care and new agent development;
5. The gap between known contexts of vulnerability and available therapeutics;
6. How CMOs can flip their drug development planning to leverage this approach;
7. Feedback from the FDA, nation
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Cancer Researcher Dan Von Hoff, M.D. Advocates for "Context of Vulnerability," A Powerful New Paradigm for Targeted Drug Development 
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