On October 4, 2021 BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) reported that the Company hired two industry veterans Harold S. Bernstein, M.D., Ph.D. as Senior Vice President, Chief Medical Officer and Head of Clinical Development and Ganesh Vedantham, Ph.D. as Senior Vice President, Technical Development filling two key strategic roles (Press release, BioMarin, OCT 4, 2021, View Source [SID1234591819]).
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"We are proud of the amazing executive talent that are attracted to BioMarin and welcome both Harold and Ganesh to BioMarin. Their arrival represents a thoughtful succession plan to identify not only people with the right skills, but with values consistent with BioMarin. They both come with a level of expertise, enthusiasm and empathy to build upon the strong foundations that their predecessors astutely created to support the future growth of our pipeline," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer at BioMarin. "I look forward to working with Harold and Ganesh as we continue to advance a pipeline of potentially transformative medicines for people affected by genetic diseases."
Harold Bernstein, M.D., Ph.D., Senior Vice President, Chief Medical Officer and Head of Clinical Development
Dr. Bernstein brings more than three decades of experience in translational medicine and clinical development both in industry and academia. In this role, he will be responsible for fortifying clinical development from early to late stages, working seamlessly with research discovery and overseeing the late stage and life cycle products. Most recently, Dr. Bernstein was Head of Translational Medicine, and Vice President of Global Medicines Development at Vertex. He previously had roles of increasing responsibility at Merck including Head of Cardiometabolic Diseases. He was Professor of Pediatric Cardiology and a senior investigator at the Cardiovascular Research Institute and the Broad Center of Regeneration Medicine at the University of California, San Francisco (UCSF). He also served as attending physician at UCSF Benioff Children’s Hospital in Pediatric Cardiology, and in Cardiovascular Genetics. Dr. Bernstein currently holds appointments as attending cardiologist at Mount Sinai Kravis Children’s Hospital in New York, as well as Adjunct Professor of Pediatrics 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 an MPhil, PhD, and MD. He completed a pediatric residency, cardiology fellowship, and postdoctoral fellowship at UCSF and earned an undergraduate degree in biological sciences from Harvard University.
"Harold brings a wealth of drug development experience, experience in precision and translational medicine, along with a commitment to patient care, which is an ideal background for our bold product development efforts," said Dr. Fuchs. "Harold’s deep experience in translational medicine and genetics will further bolster our pipeline. He shares our focus on the underlying cause of disease to develop therapies that are transformational. His is committed to scientific and medical innovation to improve the lives of patients as exemplified by the more than 60 peer-reviewed publications in basic, clinical and translational science that he authored and the five patents to his name."
"I was drawn to BioMarin’s pioneering approach to drug discovery and development, as well as its collegial and caring culture. As a physician scientist, I am compelled by BioMarin’s laser focus on genetics combined with the freedom to use therapeutic modalities that are best suited to treat the root cause of disease," said Dr. Bernstein. "BioMarin is well positioned to unlock advances in human genetics, genomics and DNA sequencing to deliver the next generation of breakthrough therapies. I am thrilled to have joined the Company at an exciting time as the late stage assets move towards commercialization opening a range of possibilities in genetic diseases."
Consistent with BioMarin’s regular planning, Dr. Bernstein will succeed Geoff Nichol M.B. Ch.B., MBA, FRACP, who has served for almost five years making significant contributions to the Company’s clinical development program including three product approvals. Dr. Nichol will remain at the Company to assist with the transition and to serve in an advisory capacity on late stage clinical programs.
Ganesh Vedantham, Ph.D., Senior Vice President, Technical Development
Dr. Vedantham is a seasoned leader in the biopharmaceutical industry, with global experience in various chemistry, manufacturing, and controls (CMC) functions across R&D and Technical Operations. He brings a strong scientific background; breadth and depth in many different aspects of technical development; experience in leading technical operation groups in the strategic development, production, and distribution of diverse and complex biological products on a worldwide basis; and a strong quality and regulatory foundation that build on BioMarin’s outstanding compliance record. Previously, Dr. Vedantham spent more than two decades at Amgen/Immunex in increasingly senior roles across the organization. He is known for demonstrating strategic vision, the ability to build and lead diverse and high-performing teams, and encouraging open, collaborative, supportive, and driven cultures. Dr. Vedantham earned a Ph.D. in chemical engineering from Carnegie Mellon University, a M.S. in chemical engineering from Rensselaer Polytechnic Institute, and a B.Tech in chemical engineering from the Indian Institute of Technology, Kharagpur.
"I am delighted that Ganesh has joined BioMarin. His unique background and experience are well suited to carry on the great BioMarin tradition of melding science, compliance and strategic product development into a coherent and effective regulatory strategy. This has been and will continue to be the hallmark of BioMarin’s CMC approach to drug development," said C. Greg Guyer, Ph.D., Chief Technical Officer and Executive Vice President. "His technical skills, regulatory perspective, quality insights, business acumen combined with his affinity for our culture are a potent combination that will continue to fuel our growth."
"I am thrilled to join BioMarin, an industry leader at the cutting-edge of drug development and manufacturing complex therapies. I have a high regard for the way BioMarin focuses on addressing the root cause of genetic disease, which results in a diverse portfolio of investigational and commercial therapies that range from gene therapy to oligonucleotides to biologics to small molecules," said Dr. Vedantham. "I am impressed with the depth and breadth of manufacturing capabilities at BioMarin to meet the demands of developing both pipeline and commercial therapies through highly reliable, innovative and cost-effective processes. I share the company’s tireless commitment to ensure that current and future patients have access to our therapies."
Consistent with BioMarin’s regular planning, Dr. Vedantham will succeed Victoria Sluzky, Ph.D. who previously announced her intent to retire after almost 19 years at the Company. She took on critical leadership roles within Technical Operations, initially building out the Quality organization and then expanding her scope to lead Technical Development. Dr. Sluzky has committed to working until the end of the year to facilitate a smooth transition.