Healthcare Industry News: kidney disease
News Release - April 2, 2008
Bradmer announces new additions to management teamAppoints Jukka Karjalainen M.D., Ph.D. to the position of Chief Operating and Medical Officer and Robert Tuttle, Ph.D.to the position of Senior Vice-President Manufacturing
TORONTO, April 2 (HSMN NewsFeed) - Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today announced that it has appointed Jukka Karjalainen, M.D., Ph.D. to the position of Chief Operating and Medical Officer and Robert Tuttle, Ph.D. to the position of Senior Vice-President Manufacturing.
"Dr. Karjalainen's experience in late stage drug development and commercialization and Dr. Tuttle's experience with commercial manufacturing will be crucial as we complete the final preparations to initiate our Phase III trial for Neuradiab," said Alan M. Ezrin, Ph.D., President and CEO of Bradmer Pharmaceuticals. "Appointing Dr. Karjalainen and Dr. Tuttle to our executive team demonstrates our ability to attract key people who are able to support our progress as we enter a multi-center clinical setting complete with cGMP grade material and support plans for the execution of our trial."
Dr. Karjalainen has extensive medical expertise, international pharmaceutical and clinical trial experience. He has played a key role in all phases of drug development and commercialization at both private and public companies. Most recently, he was Vice President, Drug Development at Cytochroma where he led drug development in Dermatology, kidney disease, and Oncology. He held the position of Director, Medical & Regulatory Affairs at Biovail, and was Medical Director at Eli Lilly & Company in Finland. Dr. Karjalainen also spent three years as Research Manager and Core Clinician with Leiras Inc. and Schering AG respectively. Dr. Karjalainen received his M.D. in 1983 and Ph.D. in 1989 from the University of Oulu, Finland where he is an Associate Professor and Senior Registrar and Lecturer in Pediatrics. He is an author of numerous original publications, regulatory and health outcome study reports, review articles and abstracts.
Robert C. Tuttle, Ph.D. has more than 27 years of experience in leading therapeutic monoclonal antibody and recombinant protein cGMP process development, validation and large scale manufacturing. His experience includes the manufacturing of two radio-labeled monoclonal antibodies approved by the FDA for the treatment of cancer, as well as other various types of monoclonal antibodies. In 2006-2007, he was responsible for the production of hundreds of kilograms of state of the art monoclonal antibodies for the Strategic National Stockpile managed by the U.S. Department of Health & Human Services' BARDA Program. In 2005-2006 he served as Vice-President Manufacturing for Genetix Pharmaceuticals, where he successfully led the cGMP manufacturing of the first clinical recombinant Lentivirus biologic for hemophilia gene therapy. He was Project Manager in the Biodefense Medical Systems Department of the Battelle Memorial Institute for four years and from 1997-2000 he served as the Director of Biologics for Novopharm Biotech. He has held numerous consulting positions throughout his career, including senior executive consultant for Boston Biotech Consultants. Dr. Tuttle received his Ph.D. from Harvard University and post-doctoral fellowships from Norwegian Technical Institute, University of Liverpool and the University of California San Diego.
About Bradmer Pharmaceuticals Inc. (www.bradmerpharma.com)
Bradmer Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of new and innovative cancer therapies. Bradmer's lead clinical candidate, Neuradiab, was developed at Duke University Medical Center as a proprietary therapy for a particularly aggressive form of brain cancer, glioblastoma multiforme. To date, over US$60 million in grants and related support has driven research and development of the licensed treatment, which has been delivered to over 200 patients with promising results and has completed Phase II clinical trials at Duke University. Bradmer is currently in the process of organizing a pivotal multi-center clinical trial of the licensed treatment. Neuradiab has been granted Orphan Drug Status by both the U.S. Food and Drug Administration and the European Medicines Agency.
Bradmer Pharmaceuticals Inc.'s common shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state regulatory agency in the United States. The resale or transfer by a U.S. investor of such common shares of Bradmer Pharmaceuticals Inc. is subject to the requirements of Rule 904 of Regulation S of the Securities Act or such other applicable exemption thereunder, and other applicable state securities laws.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties, which may include but are not limited to, the receipt of all regulatory approvals required to conduct the proposed clinical trial of Neuradiab, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
Source: Bradmer Pharmaceuticals
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