Hideki Kuki has been the President of Mitsubishi Tanabe Pharma Development America, Inc. since October 2016. With more than 20 years of experiences, he has held senior positions including General Manager of Project Management, Clinical Science, and Global Development Operations at our parent company, Mitsubishi Tanabe Pharma Corporation, in Japan and our group companies in Europe. He has successfully led Integrated Development Teams for canagliflozin (INVOKANA®/CANAGLU®) and other products, from the earliest development stage through NDA regulatory approval.
Vice President and Head of Regulatory Affairs
Doug Dobak brings extensive experience to our organization in regulatory affairs for pharmaceuticals and biologics in multiple therapeutic areas. He previously served as Global VP of Regulatory Affairs at Teva Pharmaceuticals Innovative Products. He also held senior management positions in Regulatory Affairs at NPS Pharmaceuticals, AstraZeneca, Astra Merck and Janssen Pharmaceutica.
Vice President and Head of Drug Safety
For more than 18 years, Ming has worked in clinical development and drug safety for pharmaceutical companies such as Wyeth, Amgen, TAP, and AbbVie. He has strong, diverse, global safety expertise and experience, encompassing Phase I trials, complete Life Cycle Management, and leadership of multiple product safety teams. Over the past two decades, Ming has published extensively in highly respected journals.
Head of Human Resources and General Affairs
In her role as Head of Human Resources (HR), Deborah Moorer oversees the strategic direction of all aspects of HR and is instrumental in shaping the company’s culture and employee development. She brings more than 20 years of HR experience to the role. Prior to joining Mitsubishi Tanabe Pharma Development America, Inc., she was Vice President of HR at Ipsen Biopharmaceuticals, Senior Vice President and HR Advisor at Citibank, and Vice President of HR at Alpharma.
Vice President and Head of Medical Science
As Vice President of Medical Science, Dr. Susanne Wayne directs the Medical & Clinical Science, Translational Medicine, and Medical Writing functions at Mitsubishi Tanabe Pharma Development America (MTDA). She has 30+ years of experience in clinical practice and drug development, including 15 years working in the pharmaceutical industry. Prior to joining MTDA, she worked at several medium- and large-sized pharmaceutical companies, including CSL Behring, GlaxoSmithKline, BioMarin, and AbbVie. Her extensive clinical development experience covers Phase 1 to Phase 4 across a broad range of therapeutic areas, including immunology, inflammation, neuroscience, neuromuscular, and musculoskeletal disorders.
Vice President and Head of Production Technology and Supply Chain
Hiroyuki Yamada joined Mitsubishi Tanabe Pharma Development America, Inc. in April 2018 as Director of Production Technology & Supply Chain Department from its parent company, Mitsubishi Tanabe Pharma Corporation (MTPC). In October 2019, he went back to MTPC as Vice President and Head of the Analytical Research Department. In August 2021, he returned to MTDA as Vice President and Head of the Production Technology & Supply Chain Department, responsible for the strengthening of global CMC (Chemistry Manufacturing & Control) development and the supply chain function. He also directs all global CMC project teams from early development stage through launch.
Hiroyuki has more than 25 years of experience in CMC development, including 2 years at the University of Minnesota learning the advanced analytical techniques for the characterization of the pharmaceutical drugs. More recently, he led the Production team for edaravone (Radicava®) launch in US.
Vice President and Head of Clinical & Technical Operations
A native from Colombia, Mauricio brings twenty-seven years of experience in pharmaceutical and biotech Companies in clinical research project management and operations. Mauricio has worked in many therapeutic areas, including infectious disease, virology, immunology, oncology, inflammation, and CNS. He previously served as Vice President and Global Head of Clinical Operations & Program Management at ReViral. Prior to that he was Vice President of Program Management & Clinical Operations at Chimerix where he was also involved in a long- standing collaboration with BARDA. He has also held leadership positions at EMD Serono, Vertex, Eli Lilly and Glaxo SmithKline. Mauricio holds a doctorate in immunology from the University of Stockholm, Sweden and has published over 20 peer reviewed articles.