First-In-Human Studies: Science-Driven Strategies

Todd Johnson, MD, Senior Vice President, Early Stage Development, MDS Pharma Services

Dr. Todd Johnson, MD, became MDS Pharma Services Senior Vice President for Early Stage Development in February 2008. In this role, he has responsibility for integrating the operations of the Early Clinical Research and Bioanalytical Services lines of business for global growth.

He joined MDS Pharma Services in March 2007 as Senior Vice President for Strategy and Corporate Development. Prior to that, he was with McKinsey & Company, where he spent five years leading strategic consulting engagements with CEO- and SVP-level clients at major pharmaceutical and biotech firms. Before joining McKinsey, he was CEO of Tangerine Technologies, a 40-person biotech software firm that he founded in 1997. He began his career as a Cancer Biologist at Harvard’s Dana-Farber Cancer Institute in Boston, at the University of Pennsylvania in Philadelphia, and at the National Institutes of Health in Bethesda, Maryland.

Educated at the University of Pennsylvania in Philadelphia, he holds an MBA from its Wharton School, an MD from its Medical School, and a BA in Neurobiology from its College of Arts and Sciences’ honors program.

Robert F. Butz, PhD, Vice President, Medical & Scientific Affairs, Biovail

Robert F. Butz, Ph.D., is Vice President, Medical & Scientific Affairs, Biovail Technologies Ltd.  Prior to that he was Vice President & General Manager of the Development & Regulatory Services organization of MDS Pharma Services.  Earlier in his career he served as President and COO of Polymerix Corporation, President and CEO of Copernicus Therapeutics, President and COO of Sensus Drug Development Corporation, Vice President of VP Development at Amylin Pharmaceuticals, Vice President of Clinical Operations at Quintiles, and Vice President of Strategic Business Research with Quintiles Transnational Corporation.  Before joining Quintiles, he spent 11 years in basic and clinical R&D positions at Burroughs Wellcome Co.

Dr. Butz is an elected member of the American Society of Clinical Pharmacology and Therapeutics and the American Society of Pharmacology and Experimental Therapeutics, and serves on the Ethics and Clinical Practice Committee of the Association of Clinical Research Organizations.  He also belongs to the Regulatory Affairs Professionals Society, the American Association of Pharmaceutical Scientists, and the Drug Information Association, where he previously served on the Steering Committees for the Americas and for Biotechnology.  He received an A.B. in Biology from Kenyon College, a Ph.D. in Pharmacology from Duke University, and holds nine U.S. patents in drug analytical and delivery technology.

Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services

As Vice President, Global Clinical Pharmacology, Dr. Michelle Combs is responsible for PK/PD, Biostatistics, Data Management, and Protocol/Medical Writing services at MDS Pharma Services.  Dr. Combs has over 15 years experience in clinical research, specializing in Early Clinical Research over the past 10 years.  Dr. Combs has done extensive research in a variety of areas with publications and presentations on topics focusing on safety, tolerability, pharmacokinetics and efficacy of new compounds and formulations.

Dr. Combs joined MDS Pharma Services in 1997.  Prior to joining MDS, she was a member of the research team at the University of Iowa Clinical Trials Data Management Center, where she participated in the planning, analysis and interpretation of several Phase III clinical trials.  Dr. Combs holds Master’s and PhD degrees in Biostatistics from the University of Iowa, where her dissertation was entitled “A method for including dropouts in the analysis of clinical trial data using a two-sided truncation model”.  She is a member of the American Statistical Association and has recently served as President of the Nebraska Chapter of the ASA.

Gaetano Morelli, MD, Senior Director, Global Medical Affairs, MDS Pharma Services

Dr. Gaetano Morelli joined MDS Pharma Services in 2000 as Medical Director/ Principal Investigator for the Montreal clinical research unit. As of 2006 Dr. Morelli has assumed the role of Senior Director Global Medical Affairs for MDS.

Dr. Morelli provides expertise for clinical studies, including study design and protocol development for the Phase I centers. He is a strong advocate for quality and safety in clinical trials. Dr. Morelli has been Principal Investigator in over 1,500 Phase I studies which include First in Human and over 50 Phase III studies.

In 2006, Dr. Morelli founded and currently chairs the MDS Scientific and Safety Committee which reviews and evaluates all First-in-Human studies for MDS. In 2007, he co-authored a White Paper which was presented and accepted by the Association of Clinical Research Organizations (ACRO) entitled: “Best Practice Guidelines: Risk Minimization for First in Human studies in Healthy Volunteers.”

Dr. Morelli holds a Bachelor and Master of Science Degree from McGill University and an MD degree from the Université de Montreal. He has Canadian and American certification in Internal medicine and Gastroenterology.  He is currently an Associate Professor of Medicine at McGill University, maintains a GI clinical practice and is involved in teaching and research at the University Health Center.