How Regeneron Got an FDA-Approved Therapy for COVID in Record Time

Bari Kowal joined Regeneron in 2015 and became Head of Global Clinical Operations in 2017. Ms Kowal currently serves as Senior Vice President, Development Operations and Portfolio Management and is responsible for clinical trial strategy and execution, along with overseeing our development shared services functions. Prior to Regeneron, Ms Kowal was previously at Pfizer where she held the positions of Vice President, Business Operations and Analytics, and, prior to that, Vice President, Strategic Alliance and Development Operations Lead. Ms. Kowal also served as Vice President, Clinical Operations, on the clinical research organization side of the industry at a number of biotech organizations in a variety of clinical research roles early in her career. She holds a BS in Biology from the State University of New York at Binghamton and an MS in Neuroscience from New York University.

Craig Lipset leads at the forefront of innovation in clinical research and medicine development. Mr Lipset is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. He was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Mr Lipset designed and launched multiple industry firsts — from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants. He currently serves on the Board of Directors for the Decentralized Trials & Research Alliance (Co-Chair), Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. He is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.Mr Lipset has received the red jacket ‘hall of fame’ recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List and the AlleyWatch Who’s Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.