Dr. Jeanne M. Novak is founder and current CEO of CBR International Corporation. Originally known as Colorado BioReg, she founded the company in 1999. She is an internationally-recognized authority in the biotechnology and pharmaceutical industries and is currently consulting in numerous product development areas including recombinant biotechnology, naturally-derived products, cell and gene therapy, devices and vaccines. She is an author, lecturer and strategic development advisor to industry executives worldwide.
Additionally, Dr. Novak has over 20 years of experience in product and assay development and validation, clinical trial design and oversight, quality assurance systems development, cGMP manufacturing and compliance and global regulatory development to advise cost and time-optimized development for new and established biotech and pharma companies.
Prior to founding CBR International, Dr. Novak served as Senior Scientist in the Center for Biologics Evaluation and Research (CBER) responsible for several programs and policy development. Before joining the FDA, Dr. Novak conducted scientific research in the area of recombinant vaccine development at United States Army Medical Research Institute of Infectious Diseases.
Dr. Novak received a Ph.D. in Experimental Pathology (Cell Biology) and Immunology and a B.S. in Biology from the University of Utah.