Nov 30, 2022
Reimagining R&D Webinar Series presenting “Role of a Clinical Pharmacologist in Setting Regulatory Strategy.”
Vivpro Corporation has partnered with experts and industry leaders to discuss critical pharma and biotech topics. Our goal is to share valuable information and allow the audience to engage with questions while they receive real-time feedback
For our November session, we are joined by Dr. Jennifer DiGiacinto, PharmD, Senior Vice President of Clinical Pharmacology & Pharmacometrics at RRD International, LLC.
Session Overview
List the key clinical pharmacology strategy deliverables.
Understand the process of obtaining the knowledge to substantiate the strategy.
How is it done currently? Which step takes the most time? How can we improve it?
About Dr. Jennifer DiGiacinto, PharmD
Dr. DiGiacinto has more than 22 years of experience in drug development, focused on clinical pharmacology, biopharmaceutics, PK/PD, and regulatory affairs with small molecules and biologics via traditional 505(b)(1), 505(b)(2), BLA, and biosimilar pathways across a broad range of therapeutic areas. Dr. DiGiacinto began her career at the FDA, Division of Antiviral Products, where she served as a Clinical Pharmacology Reviewer for seven years. Following her tenure at FDA, she joined Salamandra, LLC, where she spent six years as a Senior Clinical Pharmacology Consultant. As head of RRD’s Clinical Pharmacology & Pharmacometrics Group, Dr. DiGiacinto is responsible for developing strategy and providing management oversight of clinical pharmacology programs execution on behalf of RRD’s Partners, including oversight of all pharmacometrics projects (modeling & simulation/population PK/PD), and working closely with RRD’s internal cross-functional product development teams to ensure program expectations are met.
Dr. DiGiacinto received her PharmD from the University of Nebraska Medical Center (UNMC) - College of Pharmacy. Following graduation, she completed a Pharmacy Practice Residency at UNMC. Then she completed a 2-year Clinical Pharmacology Fellowship at the University of Illinois College of Medicine, funded by the FDA.
