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TEAM Michele L. Yelmene – Vice President of Regulatory Affairs  Michele Yelmene joined the Company as Vice President of Regulatory Affairs in March 2007. Ms. Yelmene has over 25 years of operational and project management, clinical and scientific research and regulatory affairs experience in the biotechnology and pharmaceutical industries. From 2002-2006, she was Executive Director, Clinical and Regulatory Affairs and Corporate Secretary for Perlan Therapeutics, a privately-held company focused on development of recombinant protein-based drugs. From 1998-2002, Ms. Yelmene was Director of Biomedical Operations for Genzyme Corporation and from 1996-1998 she was Manager of Medical and Regulatory Affairs for Mallinckrodt. During her career, Ms. Yelmene was responsible for clinical development, preparation, and presentation of 14 FDA-approved products and over 25 investigational new drug applications (INDs) for both pharmaceutical and biologics-based therapies in the areas of viral infections, respiratory, CNS, metabolic and endocrine diseases, and lysosomal storage disorders. She has participated in meetings with the FDA at all phases (pre-IND through Advisory Committee) of clinical development. Ms. Yelmene is a member of the Regulatory Affairs Professional Society, Drug Information Association and Co-Chair of the FDA Committee at BIOCOM in San Diego. She received a BS degree in Biology and BA degree in English Writing, both from Rider University. BACK TO TEAM |
