2010 Biobootcamp Presenter
CEO and President, CBR International Corp
 Dr. Jeanne Novak is a recognized authority in the vaccine, biotechnology and pharmaceutical arenas with nearly 20 years of experience in regulatory affairs, clinical program design and strategy, quality program development and CMC process development. Dr. Novak is a lecturer and advisor to industry and government. Dr. Novak has co-authored numerous scientific and regulatory publications. She has presented over fifty seminars at international conferences on topics including process development, technology transfer, clinical trial design for various product indications, GCP, cGMP and international regulatory program strategies.
Dr. Novak received her PhD in Experimental Pathology (Cell Biology) in the Department of Pathology from the University of Utah. She served as a Staff Research Scientist at USAMRIID in Frederick, Maryland developing novel vaccines for infectious diseases. In 1993, Dr. Novak accepted a regulatory scientist position at CDRH then CBER at FDA. As a FDA Senior Reviewer in DVRPA, CBER she served as the primary reviewer on countless vaccine and therapeutic product INDs and numerous license applications. Dr. Novak was a credentialed PAI/GMP FDA Investigator while at CBER.
Dr. Novak transitioned to the commercial side of the biological and pharmaceutical industry and joined Quintiles Strategic Regulatory Division in 1998. She began independent consulting and product development efforts in 1999 and created a multidisciplinary (clinical, regulatory, CMC and quality) development group in Boulder Colorado in 2003.
Dr. Novak and the twenty-plus members of the CBR International Corp.® team provide a unique and extensive development services to clients around the globe. The team is responsible for designing and overseeing numerous successful product development programs and pivotal clinical trials resulting in several approved vaccine, biotech and pharmaceutical products in indications such as endocrine, oncology, infectious disease and others.
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