Currently Dr. Steven Lee is Chief Executive Officer and Founder of BioGENEXUS, LLC (USA), which provides broad-spectrum global biotech consulting services including senior leadership team building, bioprocess development and biologics manufacturing, strategic business planning, and development of disruptive biologics process and integrated manufacturing technology. Dr. Lee also serves on many Boards, SABs and as executive coach for startup CEOs. Supporting the rapid growth of biopharmaceutical industry in China, Dr. Lee is engaged in launching of the very first biosimilar by 2018 yearend, while building global CDMO business in both China and US for novel biologics development and commercial manufacturing.
Prior to his current role, Dr. Lee was the Global Head, Biologics Technical Operations and CEO of Singapore Operations, Pte Ltd, for Dr. Reddy s Labs (DRL) Biologics (NYSE listed company), one of Asia s leading biosimilar developers and manufacturers. Joined DRL in 2012, he was responsible for manufacturing four commercial biologics while supporting six biosimilars development. From 2010 to 2012, Dr. Lee was the Global Head, Biologics Business of Luye Pharma Group, a China-based pharmaceutical company, which acquired A-Bio Pharma Pte Ltd, a pioneering biotech company founded by Singapore government. He served as A-Bio Pharma s CEO since 2008. Under Dr. Lee s leadership, Luye Pharma Group enabled A-Bio Pharma to be the R D center for their biologics pipeline, aiming at China s rapidly growing biopharmaceutical market and unmet medical needs.
Prior to his return to Asia, Dr. Lee was Vice-President and General Manager, Process Development and Biologics Manufacturing, Bristol-Myers Squibb Company (BMS) where he was responsible for leading the Syracuse, New York Manufacturing and Process Development teams, developing and launching a wide range of protein therapeutics and late stage development biologics including Orencia, Belatacept [Nulojix], Ipilimumab [Yervoy], Angioce from Adenxus, and antiCD137, etc. Moreover, he also played the role of Global Head of Biotechnology Development Center of Excellence, in an attempt to integrate BMS company-wide biotech resources to achieve business goals. Under constraints, Dr. Lee built a high-performance team to develop sustainable infrastructure for the BMS biologics franchise and obtained FDA approval in 2005 to launch the very first BMS internally developed biologics, Orencia for rheumatoid Arthritis and autoimmune diseases. Also launched Ixempra (breast cancer) in US in 2007, Europe in 2008 under his leadership. Having engaged mega-CMOs such as Lonza and Celltrion in Orencia supply worldwide, Dr. Lee led team efforts to build its own large-scale commercial Cell Culture Manufacturing Facility (6x20,000L bioreactors) in Devens, MA. The ground-breaking success of global launch of OrenciaTM has enhanced the foundation for BMS to become the leader in oncology/immunology medicines worldwide today.
Prior to joining BMS in 2002, Dr. Lee worked for two global pharmaceutical companies including Merck Co, Inc (USA) and Hoffmann-La Roche (USA). At Merck, Dr. Lee held several positions of increasing responsibilities at both Merck Research Laboratories in Rahway, NJ, where he developed various bioprocesses for vaccines and biologically-derived therapeutics including launching antifungal agent, Cancidas; and Merck Manufacturing Division in West Point, PA, where he built and led an integrated sterile process, engineering technical services group to support all commercial biologics (more than 100 images) and introduced novel vaccines including VARIVAX/VARIVAX II, MMR-II, ProQuad, MMR-II-V, VARIVAX PU, RotaTeq [Rotavisus], Recombivax (Hep B) and VAQTA (Hep A). Also led investigation to sustain commercial supplies of many medically significant, high-potency sterile pharmaceuticals such as EDECRIN, MUSTARGEN, TRUSOPT and COSOPT. At Hoffmann-La Roche (NJ, USA), a subsidiary of Roche Holding, Dr. Lee led the team efforts for launching recombinant Interferon alfa-2a (ROFERON-A) and developing novel biologics including Interleukins 1 and 2.
Dr. Lee received his Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology (MIT), Cambridge, MA, USA; M.S. in Chemical Engineering from The University of Michigan, Ann Arbor, MI, USA; B.S. in Agricultural Chemistry from National University of Taiwan, Taipei, Taiwan..