Natalia Pripuzova
Chief Executive Officer, Founder,
Global Regulatory Affairs, CMC
Global Regulatory Affairs, CMC
Dr. Natalia Pripuzova founded NPDK Bioconsulting in 2021 and is serving as company's Regulatory CMC Principal Consultant. She holds a Ph.D. in Virology (Institute of Poliomyelitis, Moscow) and MS in Biology (Moscow State University, Biological Department). She continued her scientific career in the United States at the National Cancer Institute (NCI, NIH, Bethesda) and then at US FDA, Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER, US FDA as investigator and authored 15 scientific publications, including a book chapter on quality monitoring of induced pluripotent stem cells (iPSC) by using proteomics.
Since 2013 Natalia had focused precisely on Regulatory Science and CMC development. Dr. Pripuzova served as Product Quality (CMC) Reviewer at the Office of Pharmaceutical Quality, US FDA, CDER, where she completed review of multiple original BLA, IND phase II-III, pre-BLA packages, and post-approval supplements and participated in several Pre-License Inspections (PLI) of Drug Product and Drug Substance manufacturing facilities across USA.
In 2017 Natalia transitioned to industry and joined JSC R-Pharm, Moscow as Head of International Regulatory CMC Group to promote the company’s product portfolio towards international expansion. During the recent years Natalia held positions of Director (ADC Therapeutics, San Mateo, CA) and Head of Regulatory CMC Departments (Shoreline Biosciences, San Diego, CA) promoting the development of ADCs (pre-clinical through BLA and post-marketing stages) and iPSC-derived allogeneic NK cells (early pre-clinical to Ph. 1). She continues the regulatory support of US-based and international small and mid-size biotechnology companies.
Since 2013 Natalia had focused precisely on Regulatory Science and CMC development. Dr. Pripuzova served as Product Quality (CMC) Reviewer at the Office of Pharmaceutical Quality, US FDA, CDER, where she completed review of multiple original BLA, IND phase II-III, pre-BLA packages, and post-approval supplements and participated in several Pre-License Inspections (PLI) of Drug Product and Drug Substance manufacturing facilities across USA.
In 2017 Natalia transitioned to industry and joined JSC R-Pharm, Moscow as Head of International Regulatory CMC Group to promote the company’s product portfolio towards international expansion. During the recent years Natalia held positions of Director (ADC Therapeutics, San Mateo, CA) and Head of Regulatory CMC Departments (Shoreline Biosciences, San Diego, CA) promoting the development of ADCs (pre-clinical through BLA and post-marketing stages) and iPSC-derived allogeneic NK cells (early pre-clinical to Ph. 1). She continues the regulatory support of US-based and international small and mid-size biotechnology companies.
