Changing Oncology Regulations


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Product Description

Developing oncology therapies can be complex. These products often have a tough time making it to the market. In fact, a study released in February by the Biotechnology Industry Organization and BioMedTracker shows that oncology products had the lowest Phase III success rate among seven therapeutic areas, with only 34% of candidates succeeding at this stage over a seven-year period.
At the same time, officials at the Food and Drug Administration are considering tightening the accelerated approval standards. In February, the agency’s Oncologic Drugs Advisory Committee recommended that sponsors should generally conduct…

Garo Armen, Ph.D. Chairman and CEO, Agenus Inc., a biotech company  developing treatments for cancers and infectious diseases. For more information, visit, or email
Scott Bazemore. Director, ­Clinical Development, US Oncology Research, a research ­network in America specializing in Phase I to Phase IV oncology trials. For more information, visit
Jens Oliver Funk, M.D. Senior VP and Global Head of TA Oncology, EMD Serono Inc., an affiliate of Merck KGaA and a U.S. biopharmaceutical company. For more information, visit ­
Kirsten Hanton. Senior VP, Managing Partner, Harrison and Star, an advertising agency. For more information, visit
Jeffrey Weisberg. Senior ­Medical Director, i3 Research, a ­full-service, global clinical research ­organization. For more information, visit