Learning and Unlearning to Succeed as a CMO

Marcie is currently the Chief Medical Officer at Tectonic Therapeutic, Watertown MA. She has over 18 years of experience in drug development across all stages of clinical drug development from translational/early development through post approval and across multiple modalities including small molecules, siRNA and biologics. She was named one of the 2023 Top Women in BioPharma by Endpoints News. Prior to joining Tectonic, she was VP and Head of Clinical Development for the Immunology/Inflammation Therapeutic Area at Regeneron Pharmaceuticals. In that role she led the clinical development of Dupixent® through over nine Phase 3 trial initiations and multiple regulatory approvals globally, including approvals for adult and pediatric asthma, pediatric AD, chronic rhinosinusitis with nasal polyps. She was instrumental in the pivotal study design and its execution supporting the recent approval in eosinophilic esophagitis and design of COPD studies. Over her career, which has included time at Merck and Alnylam and EMD Serono, she has built and led clinical development and cross functional groups across a range of therapeutic areas including respiratory, inflammation, bone, anemia and metabolic and rare diseases. Prior to entry into drug development, Marcie held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Program. She holds an AB from Princeton University and a MD/ MS from Washington University, St. Louis and completed her internal medicine and pulmonary fellowship training at Harvard Medical School affiliated hospitals.

Norman L. Sussman, M.D., FAASLD, joined DURECT as Chief Medical Officer in November 2020. He has extensive clinical experience and expertise in the field of liver disease and brings over 30 years of clinical research and development experience in academia and industry. Prior to joining DURECT, he was an Associate Professor of Medicine and Surgery at Baylor College of Medicine and a faculty member of Baylor College of Medicine from 1985 to 1990 and again from 2003 to 2020 with some time also spent as the Chief of Hepatology at the University of Utah School of Medicine. During his academic career, he served as a principal investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman gained leadership experience in industry as the Founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc. from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as director of the telehealth program, Project ECHO®, at Baylor St. Luke’s Medical Center. Dr. Sussman received his Bachelor of Medicine and Surgery from the University of the Witwatersrand in Johannesburg, South Africa. He then completed his residency at St. Louis University Hospital and his postdoctoral fellowship at Washington University. He is board certified in internal medicine, gastroenterology, and transplant hepatology. Dr. Sussman is also a fellow of the American Association for the Study of Liver Diseases, which is a designation that recognizes his superior level of professional achievement in the field of hepatology.

Dr. Bach is a pediatric endocrinologist with over 30 years of global clinical research and pharmaceutical development experience, during which time he has led clinical teams that have successfully launched innovative pharmaceutical products into global markets. He is currently Chief Medical Officer at GentiBio. Prior to this, he was CMO with Structure Therapeutics, where he built a clinical team and helped lead the organization through a successful IPO. For over a decade, Dr. Bach was based in Asia, and served as Head of Asia Pacific Medical Sciences, Head of Japan R&D and Head of China R&D at Janssen Pharmaceutical Co. Before that, he held positions of increasing responsibility in Clinical Research at Merck & Co., Inc., ending his tenure there as Vice President of Clinical Research Operations Worldwide. Dr. Bach has lectured in national and international forums, has numerous publications and served on professional society advisory boards to advance the field of endocrinology and clinical research. Dr. Bach received an M.D. from Baylor College of Medicine, a Ph.D. in Pathology (Immunology) from The University of Chicago, and a B.A. in chemistry from Carleton College.

Jeremy Sokolove, MD is the Chief Medical Officer In-Residence at Roivant Sciences, supporting business development and operational efforts to rapid, efficient, and high quality development of new biotech and healthcare technology ventures. Previously, he served as Chief Medical Officer at Odyssey Therapeutics, where he led clinical and translational strategies across immunology and oncology, advancing their lead asset in IBD to Phase 2 trials. At GSK, Jeremy was Senior Vice President and Head of Clinical Pharmacology and Experimental Medicine, overseeing early and translational development for Specialty Pharma. Under his leadership, nearly 20 INDs/CTAs were filed, and multiple programs progressed to late-stage clinical development. Earlier in his career, Jeremy headed Immunology Translational Science at AbbVie, developing portfolio-wide strategies across all development phases and leading several early-phase programs and phase 3 registrational studies and supported the global filing of upadacitinib (Rinvoq). Before AbbVie, he was a Clinical Assistant Professor at Stanford University, Principal Investigator at the VA Palo Alto, and co-founder of several biotech companies including Atreca (NASDAQ: BCEL). Jeremy has over 90 peer-reviewed publications and several textbook chapters in rheumatology and immunology. For 18 years, he maintained a broad clinical practice in Rheumatology, Internal Medicine, and Emergency Medicine, earning multiple teaching awards for his contributions to education. He completed his residency and chief residency at Boston University Medical Center, followed by fellowship and post-doctoral training in Rheumatology and Immunology at Stanford.