FDA workshop to highlight event
NEW CANAAN, CT— The Cancer Vaccine Consortium (www.sabin.org/cv_consortium.htm) will hold its third semi-annual meeting April 1-2, 2004 in Orlando, Florida, to explore federal regulation of cancer vaccines. The meeting immediately follows the annual conference of the American Association for Cancer Research in Orlando.

“Beyond the scientific complexity of developing cancer vaccines, the federal regulatory hurdles are among the most daunting challenges that developers must overcome before these breakthrough therapies become available to physicians and the cancer patients they serve,” said Dr. Nathan Tinker, Executive Director of the Cancer Vaccine Consortium. “Cancer vaccines hold promise for the next wave of breakthroughs in treatment across a spectrum of specific cancers. With our Orlando meeting, researchers and developers will have the unique opportunity to engage directly with the FDA in the regulatory process.”

With some 19 therapeutic vaccines in Phase III clinical trials, and several on the verge of FDA approval, cancer vaccines are the hope of the very near future. But, like other pharmaceuticals, these therapies are facing stiff review from the U.S. Food and Drug Administration. To address this, the centerpiece of the conference will be a half-day workshop with FDA regulators on the review process of cancer vaccines lead by Dr. Steven Hirschfeld, a key member of the FDA’s regulatory team.

The meeting’s speakers include:

Steven Hirschfeld, MD, PhD, (Leader, FDA Workshop) Division of Oncology Drug Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. He is a member of the Public Health Service Disaster Medical Assistance Team and has been deployed to locations around the United States, most recently for the Orange Alert time period.

John Calfee, PhD, (Issues and Challenges in the Regulatory Process) Resident Scholar, American Enterprise Institute. His research focuses on pharmaceuticals, the Food and Drug Administration, health care policy, the tort liability system, and tobacco. He is the author of Prices, Markets, and the Pharmaceutical Revolution.

Thomas Hinz, PhD, (Cancer Vaccine Regulation in the European Union) Paul-Ehrlich-Institut. He is laboratory head project leader at the Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines at Langen, Germany. He is the expert for immunologicals/biologicals and biotechnology products at the European Agency for the Evaluation of Medicinal Products.

Steve Heffner, (The Emerging Cancer Vaccine Market) Kalorama Information. Kalorama’s recently released report on the global market for cancer vaccines suggests that the industry could reach more than $1 billion in sales by 2008.

The meeting will take place at the Rosen Centre Hotel in Orlando, Florida. For more information about the Third Semi-Annual Meeting of the Cancer Vaccine Consortium, including registration and special rates at the Rosen Centre Hotel, contact Nathan Tinker, CVC Executive Director, at 203-972-7907.

The Cancer Vaccine Consortium (CVC) is the leading organization for the cancer vaccine industry. Comprising more than 22 companies and research institutions from around the globe, the CVC’s mission is to pursue common goals and overcome common hurdles in the development of cancer vaccines, and to serve as a vehicle for disseminating information to the public, regulators, policymakers, and patients about developments in this emerging field. The CVC is part of the Albert B. Sabin Vaccine Institute. Founded in 1993, the Institute pursues Dr. Albert Sabin’s vision of a world protected from disease by vaccines.

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