Niv Caviar, M.B.A
Chief Executive Officer
Mr. Caviar is a successful life science CEO, general manager with senior functional management experience in marketing, business development, strategic planning, engineering/manufacturing and finance (Nasdaq CFO). He successfully led, raised, and negotiated 35+ partner and financial transactions for $2.5 billion in total deal capital. Mr. Caviar was responsible for commercialization/marketing and product launch for five branded products (Rx small molecule, medical device, and biologic/injectables). He is an accomplished senior leader in pharmaceutical, biotech, and medical device industry segments, with management/leadership experience in both public and private (venture and private equity) companies. Niv Caviar is the former CEO of Suneva Medical, CFO/CBO of La Jolla Pharma (LJPC: Nasdaq), VP of Bus Development and VP, Head of Dermatolgoy Marketing at Allergan. Mr. Caviar holds an M.B.A from Harvard Business School.
Neville Alleyne, M.D.
Chief Medical Officer, Founder
Dr. Alleyne is a board certified orthopaedic surgeon and is the Director of the Orthopaedic Spine Center at Tri-City Medical Center in Oceanside, CA. Dr. Alleyne’s practice is focused on treating a broad spectrum of spinal disorders, and he has established a multi-disciplinary approach, using the latest minimally invasive techniques, to relieve pain and restore spinal stability and mobility. He founded and served as chief medical director for several start-up companies developing spinal barriers and instrumentation using pedicle screws, cervical plates and artificial discs, including ProSpine, NAS Medical, and Smartdisc Inc. Dr. Alleyne is the inventor on numerous published patent applications related to spinal methods and devices. He is a member of the American Academy of Orthopaedic Surgeons, the North American Spine Society, the California Orthopaedic Association and the J. Robert Gladden Orthopaedic Society. Dr. Alleyne performed his fellowship training in total joint arthroplasty and spine surgery at Harvard University-Massachusetts General Hospital and New England Baptist Hospital in Boston, MA. Dr. Alleyne completed his residency training at Yale New Haven Hospital in orthopaedics and general surgery in 1988. Dr. Alleyne received his medical degree from Mount Sinai School of Medicine in 1983 and was an undergraduate at Columbia University in New York, NY.
Nick J. Manesis, Ph.D.
Chief Technology Officer
Dr. Manesis has over 27 years of experience focused on R & D in the Life Sciences space. He has successfully driven both new product and existing product activities for high profile companies as Allergan, CooperVision, and Hewlett-Packard Company. He has provided leadership and management to large cross-functional teams across multiple projects both domestically and internationally. He is a strong advocate of customer-supplier principles, both internally and externally. Dr. Manesis holds a Ph.D. In Chemistry and has expertise in biomaterials within the medical device industry.
Ajit Mishra, Ph.D.
Vice President, Research & Development
Dr. Mishra has 28 years of experience in the medical device industry. He was Vice President of R&D at Accriva which was successfully sold in January 2017 for $380 Million. Prior to that, he was Vice President of R&D at Stryker Orthopedics, and Vice President of Operations at Telcare. He has also held roles of increasing responsibility at Smith & Nephew Orthopedics, Johnson & Johnson, and Terumo. He and his teams have launched several dozen medical devices. The products and technologies developed by Dr Mishra and his teams have generated several billion dollars in revenues. He has expertise in development of orthopedic and spinal devices, and is the inventor/co-inventor of 18 patents. Dr. Mishra received his Ph.D. in Materials Science from the University of Delaware.
Dr. James Blackwell
Vice President, Manufacturing / Engineering
Dr. James Blackwell has extensive experience in product and process development for medical devices and therapeutics. He has played a key role in the successful commercialization of many products. His experience encompasses early process development to commercial operations, and he has worked with start-ups to multi-nationals, and to major industry investors. He has held senior positions with Repligen, Genzyme (Sanofi), and Abbott (Abbvie). He served on the formative management team and led Manufacturing and Technical Operations for Shore Therapeutics in the successful re-commercialization of Fenoglide. He has been a frequent invited speaker at industry conferences and has contributed to various industry publications. As a member of ISPE, he has held leadership positions at the Chapter and National levels. He is a member of PDA, ISPE, AAPS, RAPS, and ISA. Dr. Blackwell has graduate training in chemical engineering, microbiology, and business/technology management from Northeastern University, The Ohio State University, and the University of Maryland, respectively.
Gloria C. Lin, Ph.D.
Executive Director of Operations
Dr. Lin has extensive experience in pharmaceutical and medical product development that encompasses clinical trial design and management, pre-clinical studies, and discovery. Dr. Lin held positions of increasing responsibilities at companies including Pfizer, Johnson & Johnson, and Allergan, as well as VC-backed portfolio companies. Dr. Lin received postdoctoral training at Harvard Medical School and Massachusetts General Hospital, and holds a Ph.D. in physical chemistry from UCLA.
Deborah Miller, M.S.
Ms. Miller has been a Quality and compliance champion for medical device, pharmaceutical, biotechnology, clinical medicine and forensic toxicology organizations for over 30 years. She has consulted extensively for medical technology companies in quality and compliance, most recently with the Windshire Group. Previously, she held multiple quality and operational leadership positions at the American Red Cross, including Director of the Confirmation Laboratory and Director of Compliance. Earlier in her career, Ms. Miller served in the United States Army as a Medical Service Corps officer, holding multiple leadership positions in quality assurance, laboratory, and toxicology department management. She is a Contributing Author of Romancing the Big Q: Dancing with the Quality Gorilla and received her Masters of Science in Laboratory Medicine from the University of Washington.