Clinical and manufacturing working groups created to develop FDA engagement policies

NEW CANAAN, CT, April 7, 2004—The regulation of cancer vaccines by the U.S. Food and Drug Administration (FDA) and European Union offers both opportunities and potential pitfalls for industry and research, according to speakers at last week’s meeting of the Cancer Vaccine Consortium (CVC), “Federal Regulation and Cancer Vaccines.” As part of the meeting, the CVC launched two new working groups to address regulatory issues and engage the FDA in policy discussions. The meeting, held in Orlando, Florida, was the CVC’s third semi-annual meeting.

The meeting featured a workshop with Dr. Steven Hirschfeld, MD, PhD, of the FDA’s Center for Biological Evaluation and Research. Dr. Hirschfeld’s presentation outlined the process FDA uses in evaluating and licensing cancer vaccines. He said that the FDA was interested in working with industry to develop processes and procedures for evaluating cancer vaccines.

Dr. John Calfee, Resident Scholar at the American Enterprise Institute, warned, though, that the cancer vaccine market could be ripe territory for price controls, especially in light of the newly-passed Medicare bill. His talk, entitled “Cancer Vaccines: The Economics is as Tough as the Science,” looked skeptically at the FDA’s regulatory process and questioned the agency’s success in pharmaceutical licensing.

Other presentations at the meeting included an overview of the cancer vaccine regulation process in the European Union by Dr. Thomas Hinz of the Paul-Ehrlich-Institut, and an analysis of the emerging cancer vaccine market by Steven Heffner of Kalorama Information.

The meeting prompted the Cancer Vaccine Consortium to launch two new working groups to address issues and challenges in federal regulation of cancer vaccines. The working groups, focused, respectively, on clinical issues and manufacturing issues, will prepare a series of position papers on specific issues and engage the FDA in a series of meetings to address these issues.

“These clinical and manufacturing working groups are an important step in the Cancer Vaccine Consortium’s development,” said Dr. Nathan Tinker, executive director of the CVC. “The CVC’s ultimate goal is to help cancer victims by getting cancer vaccines out of the laboratory and into patients. By addressing regulation directly with FDA, we can have a tangible impact on the process and, hopefully, find opportunities to bring these important therapies to market.”

About the Cancer Vaccine Consortium

The Cancer Vaccine Consortium was founded in 2003 under the auspices of the Albert B. Sabin Vaccine Institute. The mission of the CVC is to pursue common goals and overcome common hurdles in the development of cancer vaccines, and to serve as a vehicle through which to engage the public, regulators, policymakers, and patients about developments in this emerging field. More than 25 companies, universities and research institutes comprise the CVC. For more information, contact Dr. Nathan Tinker, Executive Director, at (203) 972-7907 or cvc@sabin.org; www.sabin.org/cv_consortium.

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