Healthcare Industry News: influenza
News Release - February 11, 2009
Genocea Biosciences Names Jane Halpern Vice President of Regulatory AffairsFormer Director of Regulatory Affairs at GSK Biologicals and NIAID Brings Extensive FDA and Big Pharma Vaccine Experience to Genocea
CAMBRIDGE, Mass.--(HSMN NewsFeed)--Genocea Biosciences, a leading vaccine discovery and development company, today announced that Jane L. Halpern, Ph.D. has joined the company as Vice President of Regulatory Affairs.
"Jane’s pharma industry and governmental regulatory experience, combined with her knowledge of the FDA vaccine review process, is invaluable to our company," said Genocea Co-Founder and Chief Executive Officer Robert Paull. "She understands both U.S. and European regulatory pathways and her strong track record at bringing vaccines into the clinic and through the approval process will help Genocea accelerate its path to market.”
“Genocea is working on some of the most important pathogens for which we don’t have a vaccine,” said Dr. Halpern. “I am excited to bring my years of vaccine regulatory experience to accelerate Genocea’s path to and through the clinic.”
Dr. Halpern was most recently Director of Regulatory Affairs and Head of Technical Regulatory Affairs, North America for GlaxoSmithKline (GSK) Biologicals. At GSK, she was responsible for management of the Chemistry, Manufacturing, and Controls and technical regulatory activities at three North American GSK manufacturing sites. Dr. Halpern also had overall responsibility for submission activities and maintenance of influenza vaccine licenses in Canada. Prior to GSK, Dr. Halpern was Vice President of Global Regulatory Affairs for ID Biomedical Corporation. In 2005, ID Biomedical was acquired by GlaxoSmithKline for $1.4 billion.
Dr. Halpern was formerly Associate Director of Regulatory Affairs at the U.S. office of ERA Consulting. Prior to joining ERA, she had been at the vaccine division of the U.S. FDA's Center for Biologics Evaluation and Research (CBER) for ten years where she was responsible for the scientific and regulatory review of both licensed and investigational products. Dr. Halpern received her Bachelor’s degree in Physiology from University of California at Davis and her doctorate in Pharmacology from the University of Rochester.
About Genocea Biosciences:
Genocea Biosciences was founded in 2006 to commercialize key breakthroughs in vaccine discovery and development. Genocea can rapidly identify antigens that result in the in vivo stimulation of protective antigens, targets that can be immediately incorporated into existing vaccine delivery systems to produce multivalent vaccine formulations that have the highest probability of generating protective cell-mediated immunity. Genocea is currently developing vaccines for chlamydia trachomatis, streptococcus pneumoniae and other undisclosed targets. In 2008, Genocea was selected as “Best Vaccine Startup” at the World Vaccine Congress and was selected one of the 15 most exciting biotech startup companies by FierceBiotech. Investors include Lux Capital Management, Polaris Venture Partners and Morningside Ventures. Visit www.genocea.com for more information.
Source: Genocea Biosciences
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