Building Up a CMO Team as Your Company Evolves

Harold S. Bernstein MD, PhD brings more than three decades of experience and is an internationally recognized leader in basic scientific research, translational medicine and clinical development both in industry and academia. He currently serves as President, Head of Research and Development, and Chief Medical Officer at Maze Therapeutics, where he is shaping and contributing to the creative strategy and thorough scientific process aimed at delivering new, genetic-based medicines. Before joining Maze, Dr. Bernstein was Senior Vice President, Chief Medical Officer and Head of Global Clinical Development at BioMarin Pharmaceutical. Prior to that, he served as Head of Translational Medicine and Vice President of Global Medicines Development and Medical Affairs at Vertex Pharmaceuticals, and held roles of increasing responsibility at Merck and Co, including head of early development for Cardiometabolic Diseases. He was Professor of Pediatrics and a senior investigator at the Cardiovascular Research Institute and the Broad Center of Regeneration Medicine and Stem Cell Research at the University of California, San Francisco (UCSF). He also served as attending physician at UCSF Benioff Children’s Hospital in Pediatric Cardiology, and at the Mount Sinai Kravis Children’s Hospital in Cardiovascular Genetics. Currently, Dr. Bernstein holds an appointment as Adjunct Professor of Pediatrics and the Mindich Child Health and Development Institute at the Icahn School of Medicine at Mount Sinai. He studied biomedical science, human genetics, and medicine at the Mount Sinai School of Medicine, earning MPhil, PhD, and MD degrees. He completed a pediatric residency, cardiology fellowship, and postdoctoral fellowship at UCSF and earned an undergraduate degree in biological sciences from Harvard College.

TBA

Raul Lima is a proven leader in Clinical Operations with over twenty (20) years of experience utilizing strategic, tactical, and hands-on experience in the management of global multi-center clinical trials. He has extensive experience with timeline management, clinical trial budget management, and people management and has successfully led cross-functional teams, including the management of CROs. He has repeatedly demonstrated an ability to execute strategies ensuring that clinical operations activities supporting clinical trial management are conducted effectively and efficiently, are quality driven, and comply with all applicable regulations. He possesses an uncanny vision, expertise in communicating that vision to help influence strategies to progress cross-functional projects, and an unwavering passion for championing development.

Daniel Bloomfield is the CMO at Anthos Therapeutics.  Prior to joining Anthos, Dan helped create Cardurion Pharmaceutical in May 2017 as its first CEO.  Dan had a 14-year career at Merck and Co. culminating as SVP, Global Clinical Development, Therapeutic Area Head for Cardiovascular, Diabetes, Endocrine, and Women’s Health, and was responsible for Merck’s R&D organization in China across all therapeutic areas.   Dan had a diverse career at Merck that included leadership roles in cardiovascular discovery, as well as early and late clinical development, he chaired the governance committee responsible for all compound entering clinical development and spent a year as Chief of Staff for Ken Frazier, Merck’s CEO. Dr. Bloomfield was a founding member and co-chair of the Cardiac Safety Research Consortium (a public private partnership with the FDA, academia, and industry). Dr. Bloomfield also served as Rapporteur for the ICH E14 implementation working group for 9 years.  After finishing a BA in Chemistry at Haverford College, Dan took a master’s degree in social Anthropology at the University of Oxford as a Rhodes Scholar, attended Harvard Medical School, did his Internal Medicine and Cardiology training at Columbia before joining the faculty.  As an Associate Professor of Medicine, his academic research was supported by grants from the NIH (K08, R01, K24), multiple foundations, and industry. He became recognized internationally as an expert in syncope (fainting spells), as well as novel methods used to identify patients at risk for sudden cardiac death. 

Jing L. Marantz, M.D., Ph.D. has over 25 years of experience in the biopharmaceutical industry spanning R&D, business development, and medical affairs in multiple specialties and rare diseases. She is currently Chief Medical Officer of Scholar Rock. Dr Marantz was previously Chief Business Officer of Krystal Biotech, after serving on its board for a year. Prior to Krystal, she was Senior Vice President of Medical Affairs of Acceleron Pharma Inc. until its acquisition by Merck & Co., Inc. Dr Marantz has held leadership positions at Alnylam, Alexion, Biogen, ARIAD, and Millennium Pharmaceuticals across development, medical affairs, and business development. Earlier in her career, she was a management consultant with Strategic Decisions Group and briefly affiliated with Massachusetts General Hospital following a post-doctoral fellowship at the Dana-Farber Cancer Institute. Marantz is a member of the Board of Directors for Arcturus Therapeutics, Inc. She received her medical training from Tongji Medical College, a Ph.D. in Biochemistry and Molecular Biology from Medical University of South Carolina, and an MBA from the University of California at Berkeley.