Sr Group Director, Clinical Pharmacology Regeneron Pharmaceuticals Tarrytown, New York
COVID-19 has changed the way we live our lives. It has also brought numerous challenges in drug development. For COVID-19 related drugs and vaccines, development timelines were shortened to months between initiation of non-clinical studies to FIH dosing to regulatory filing, which normally would take years in pre-pandemic development situations. Such timelines required more than a sense of urgency, and Clinical Pharmacology had to bring innovative strategies complemented with Model Informed Drug Development approaches to expedite regulatory submission of these dossiers. This symposium will focus on the clinical pharmacology strategies employed to accelerate drug development of COVID-19 therapies focusing of approaches taken for small molecule and monoclonal antibodies. This also required close collaboration with regulators who deployed various approaches for acceleration. Kenneth Turner, PhD, Regeneron, will cover the clinical pharmacology aspects of developing REGEN-COV, an intravenous and subcutaneous monoclonal antibody therapy for the treatment and prevention of COVID-19.
Learning Objectives:
Upon completion, participants will understand the key data and Clinical Pharmacology principles utilized to support REGEN-COV dose selection for the prevention and treatment of COVID-19
Upon completion, participants will appreciate the collaboration between Sponsors and Regulators required to develop anti-COVID-19 therapies at unprecedented speed
Upon completion, participants will understand key factors impacting effectiveness and future development of anti-COVID-19 monoclonal antibody therapies
Upon completion, participants will be able to appreciate the role of Clinical Pharmacology in the accelerated development and authorization of anti-COVID-19 monoclonal antibody therapeutics
