Dr. Novak provides high-level strategic, product and clinical development consulting for the pharmaceutical and biotechnology industry. As the Principal Consultant and owner of CBR International she is consulting in the areas of Process, Clinical and Regulatory Program Development. Dr. Novak offers expertise in Product and Assay Development, Quality Assurance Systems Development and Quality Control Systems Assessment, cGMP Assessment, GCP Compliance and Regulatory Strategy Development from Pre-IND through Post-Marketing. Dr. Novak provides detailed scientific and regulatory consulting, program and project management services, and staff training in the areas of FDA submissions, FDA interactions, FDA regulations/guidelines, cGMP compliance, GCP compliance and Quality Assurance.

Prior to consulting, Dr. Novak was an FDA Senior Reviewer in the Center for Biologics Evaluation and Research (CBER). She most recently served as the BLA Project Manager for the Associate Director for Policy at CBER. In that role, Dr. Novak coordinated efforts for future implementation of a single Biologics License Application (BLA) for all CBER regulated products.

While at CBER and the Office of Vaccine Research and Review (OVRR). Dr. Novak served as the primary reviewer of over 70 INDs, the regulatory coordinator for over 20 PLA/BLA/supplements. Her CBER experience included the review of product manufacture, preclinical data, clinical trial design, coordination and presentations at advisory committee meetings, and pre-approval inspections (PAIs).

Prior to joining the FDA, Dr. Novak conducted scientific research at United States Army Medical Research Institute of Infectious Diseases, Fort Detrick. She worked in the areas of cell biology, immunology and protein chemistry with emphasis on bacterial toxin mechanisms of action, development of novel vaccines and development of quantitative assays. Dr. Novak also maintained research collaborations studying the cell biology and protein processing of HIV-infected cells.

Dr. Novak received a Ph.D. in Experimental Pathology and a B.S. in Biology from the University of Utah. She is on the editorial board of Clinical and Diagnostic Laboratory Immunology and is co-author of numerous scientific and regulatory publications. Dr. Novak has presented numerous regulatory seminars at professional conferences sponsored by RAPS, DIA, IBC and others. She is an active member of ASM, the Drug Information Association (DIA), the Regulatory Affairs Professional Society (RAPS), the International Association of Biological Standardization, International Society of Pharmaceutical Engineers (ISPE), American Society for Quality (ASQ), International Association for Biologicals and PDA, an International Association for Pharmaceutical Science and Technology.

As the Principal Owner and Consultant of CBR International, Dr. Novak has expanded the company expertise by developing affiliations with numerous consulting groups throughout the U.S., Canada and Europe. Through these affiliations, Dr. Novak subcontracts high quality professionals that work as a team to address specific client program issues in a highly cost effective manner.

For a comprehensive assessment of your program requirements, please contact us by calling (720) 746-1190 or by email at info@cbrintl.com.