Laurie Smaldone Alsup, MD

Dr. Laurie Smaldone Alsup, COO/CSO, has 25 years of executive leadership experience in drug development, regulatory strategy, and regulatory approvals across all major therapeutic areas and product technologies. She has guided global teams through over 100 US FDA and European EMA proceedings, including preparations for key FDA meetings, Advisory Committee hearings and EU Scientific Advice and Oral Arguments. Throughout her career, Laurie served in clinical and regulatory roles of increasing responsibility and scope. She has led the development and commercialization of drugs for life threatening and chronic diseases including cancer, HIV/AIDS, viral and bacterial infection, cardiovascular, endocrine, neuroscience, dermatology, inflammatory and immune-based diseases. As Senior Vice President of Global Regulatory Science at Bristol-Myers Squibb, she oversaw all regulatory functions including global strategy, pharmacovigilance and outcomes research. In addition, she served as CEO of an early-stage inflammation company. Laurie received her MD at Yale University, where she completed her residency in Internal Medicine and fellowship in Medical Oncology. She graduated with a BA in Biology from Fordham University.