Jenn Visich

Biography

Dr. Jennifer Visich joined Certara in September 2016. She joined CSC as a clinical pharmacology expert with 20 years of experience in mid-size and large biotech companies. She has worked extensively with biologics and has been very proactive in incorporating various quantitative methods into science-based, clinical pharmacology strategies to expedite development programs, gain regulatory acceptance and provide important guidance for physicians and patients on proper dosing. To date, Dr. Visich has authored approximately 23 peer-reviewed papers and over 20 conference abstracts. Dr. Visich received her PhD in from Virginia Commonwealth University where her studies were focused on respiratory drug delivery and PKPD characterization of inhaled proteins and peptides pharmacokinetics. Before joining Certara, Jenn worked in industry for 20 years at ZymoGenetics in Seattle, WA and Genentech and Amgen in San Francisco, CA. In each of her positions, Jenn led groups comprised of individuals with experience in preclinical PKPD, clinical pharmacology and pharmacometrics. She has been a key contributor in over 12 successful NDA/BLAs and 15 INDs. She has experience in several therapeutic areas such as; pulmonary, inflammation/auto-immunity, ophthalmology, hemostasis, anti-infectives, cardiovascular and oncology (solid tumors, immunotherapy, blood cancers and myelomas) as well as with the development of drug delivery devices. In addition to filing activities, Jenn has had extensive experience as the clinical pharmacology representative for global regulatory authority interactions including Pre-IND, EOP1, EOP2, Type C meetings and a participant on FDA Advisory board and CHMP oral explanation meetings.

Research Interest

Healthcare