Dr. Grudzinskas is a
founding member of the Company’s Scientific Advisory Board. He has over 35 years
of pharmaceutical research and development executive experience, including 5
years at NIH establishing a drug discovery and development organization. Dr.
Grudzinskas’ experience spans discovery, development, clinical, regulatory and
project/portfolio planning and management, and business development. In 2003, he
became a Founding Member and Principal of NDA Partners LLC, a strategic and
regulatory service company. Before forming his own consulting firm, Dr.
Grudzinskas served from 1996 to 1998 as Vice President, Medications Development
and Project Management for G.D. Searle & Company. From 1991 to 1996, he was the
Director, Medications Development Division of the National Institute on Drug
Abuse (NIDA), NIH and in 1993-94 was the Acting Deputy Director of NIDA. Dr.
Grudzinskas held several positions with the Medical Research Division of
American Cyanamid over a 20 year period, with his last position being Director
of New Product Management. Over his career, Dr. Grudzinskas has been directly
associated with over 10 NDA approvals and has managed over 75 additional
development projects in hypertension, sepsis, thrombosis, oncology, growth
factors, infections, inflammation, insomnia, pain, and drug abuse treatment. His
expertise in developing drug discovery and development programs has resulted in
consistent delivery of approvable NDA packages with short FDA review times. Dr. Grudzinskas received a Bachelor of Science degree from the University of California at Los Angeles (UCLA) and a Ph.D. from the University of Minnesota. He is a member of the American Society of Clinical Pharmacology and Therapeutics, and the College for Problems of Drug Dependence. He was a founding member and Chairperson for the PhRMA Project Management and Finance Subsection. Dr. Grudzinskas is an Adjunct Professor and a member of the Center for Drug Development Science at Georgetown University. He is a member of the FDA/CDER Academics to CDER Annual Program Committee. Dr. Grudzinskas is a faculty member for the PERI drug development courses as well as the NIH Principles of Clinical Pharmacology and Principles of Clinical Research courses. He is a registered U.S. Patent Agent.
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