Kenneth A. Getz, MBA

Executive Director and Research Professor
Email: Kenneth.Getz@tufts.edu

Ken Getz is the Executive Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine. He is an internationally recognized expert on pharmaceutical R&D management and execution, protocol design, contract service provider and investigative site management, eClinical technology and data usage, and patient engagement. A well-known speaker at conferences, symposia, universities, investor meetings, and corporations, Ken has published extensively in peer-review journals, books, and in the trade press. He holds a number of board appointments in the private and public sectors. He received his MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and his bachelor’s degree from Brandeis University. Ken is also the chairman of CISCRP — a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise — and the founder of CenterWatch, a leading publisher in the clinical trials industry and one of several businesses that he has sold. 

KEN’S CURRENT AND RECENT RESEARCH INITIATIVES INCLUDE:

• Quantifying clinical trial participant diversity and disparities 

• Benchmarking protocol design practices and their impact on performance

• Examining remote and virtual drug development activity and its effectiveness

• Evaluating the adoption and value proposition/ROI of innovative practices and solutions

• Measuring the impact of regulatory reforms on the cost and efficiency of drug development

  Examining clinical data and real-world data management practices 

• Monitoring structural and operating changes in the global investigative site landscape

  Assessing the evolving role of outsourcing and contract services in drug development 

Joseph A. DiMasi, PhD

Director of Economic Analysis and Research Associate Professor
Email: Joseph.Dimasi@tufts.edu

Dr. Joseph DiMasi is an internationally recognized expert on the economics of the pharmaceutical industry. He serves on the editorial board of Therapeutic Innovation and Regulatory Science and has previously served on the editorial boards of the Drug Information Journal, the Journal of Research in Pharmaceutical Economics, and the Journal of Pharmaceutical Finance, Economics & Policy. He has published in a wide variety of economic, medical, and scientific journals and has presented his research at numerous professional and industry conferences. Dr. DiMasi testified before the U.S. Congress in hearings leading up to the FDA Modernization Act of 1997 and reauthorization of the Prescription Drug User Fee Act. He received the Donald E. Francke Award from the Drug Information Association for the best article in the Drug Information Journal published in 2000. Dr. DiMasi received his doctorate in economics from Boston College in 1984.

Dr. DiMasi’s research interests include the R&D cost of new drug development, clinical success and phase attrition rates, development and regulatory approval times, R&D efficiency, the role that pharmacoeconomic evaluations have played in the R&D process, pricing and profitability in the pharmaceutical industry, innovation incentives for pharmaceutical R&D, and changes in the structure and performance of the pharmaceutical and biotechnology industries.

Mary Jo Lamberti, PhD

Director of Sponsored Research, Research Associate Professor
Email: Mary_Jo.Lamberti@tufts.edu

Dr. Mary Jo Lamberti is a Research Associate Professor at Tufts University School of Medicine and the Director of Sponsored Research at Tufts CSDD. She is an internationally recognized expert on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical supplies, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has published extensively and is a frequent speaker at global conferences. Dr. Lamberti holds a BA from Wellesley College and a PhD in psychology from Boston University.

Dr. Lamberti’s Current Initiatives Include:

• Study volunteer diversity in clinical trials

• Machine learning and artificial intelligence (AI) in clinical research

• Benchmarking patient recruitment and retention practices

• Industry use of automation, IT technologies and applications

Kenneth I Kaitin, PhD

Professor and Senior Fellow
Email: Kenneth.Kaitin@tufts.edu

Kenneth Kaitin is Professor of Medicine at Tufts University School of Medicine and Senior Fellow at Tufts Center for the Study of Drug Development, where he previously served as Director for 23 years. He is also an Advisory Professor at Shanghai Medical College at Fudan University in China, and serves on the faculties of the European Center for Pharmaceutical Medicine at the University of Basel, the American Course on Drug Development and Regulatory Science at the University of California, San Francisco, and the IFAPP Academy-Kings College London Medical Affairs in Medicines Development Certification Program. Dr. Kaitin is internationally recognized for his contributions to the field of drug development policy and science. He consults, speaks, and writes on global trends in pharmaceutical development, and has provided public testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin served as Editor-in-Chief of Expert Review of Clinical Pharmacology, and as a consultant to the U.S. Department of Defense on bioterror countermeasures. In 2011 he received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators; in 2020, he was named Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians in 2020; and in 2021, he received the Distinguished Achievement Award from the Sino-American Pharmaceutical Professionals Association (SAPA). Dr. Kaitin is a director on the boards of Curis, Inc. (NASDAQ: CRIS), Bio-Tree Systems, Inc., and QCDx LLC. He earned his BS from Cornell University and MS and PhD in pharmacology from the University of Rochester.

Richard I. Shader, MD

Medical Consultant and Professor Emeritus
Email: Richard.Shader@tufts.edu

Dr. Richard Shader is Professor Emeritus of Immunology and Professor Emeritus of Psychiatry at the Tufts University School of Medicine in Boston, Massachusetts. Prior to joining the Tufts faculty, he was on the faculty at Harvard Medical School where he achieved the rank of Associate Professor. He is a former chairman of both the Department of Pharmacology and Experimental Therapeutics and the Department of Psychiatry at Tufts. Dr. Shader also served as Program Director for graduate studies in the program in Pharmacology & Experimental Therapeutics at the Sackler School of Biomedical Sciences. Currently, he is a Senior Research Fellow and Medical Consultant at the Tufts Center for the Study of Drug Development. In addition to being a former MERIT Investigator of the National Institutes of Health (NIH), Dr. Shader was also a member of the National Advisory Mental Health Council appointed by President Ronald Reagan. He has served on a NIMH study section and was a frequent ad hoc reviewer. He was a member of the Scientific Advisory Board for the NIMH Hypericum Trial and of the Advisory Board for the NIMH Research Units in Pediatric Psychopharmacology. He served on the overall Data Safety Monitoring Board (DSMB) for the NIH Center for Complementary and Alternative Medicine as well as on the DSMB for its Silymarin trials. He currently chairs the DSMB for COMPASS Pathway’s Psilocybin for Depression trial. Dr. Shader was the President of the American College of Neuropsychopharmacology (ACNP), the American Board of Psychiatry and Neurology (ABPN), and the American Association of Chairmen of Departments of Psychiatry (AACDP). He is a former director and member of the Executive Committee of the American Board of Emergency Medicine (ABEM) and still serves as a senior director. Dr. Shader was an individual winner of the American Psychiatric Association’s Seymour Vestermark Award for Psychiatric Education. He received this award a second time with colleagues from the ACNP. He has been a member of the Scientific Advisory Board of the Alzheimer’s Foundation and the Association for Aging Research. During the academic year 1990–1991, he was the Kaiser Family Fellow at the Center for Advanced Studies in the Behavioral Sciences in Stanford, California. A 1956 graduate of Harvard College, Dr. Shader received his medical degree from the New York University School of Medicine in 1960. He received his psychiatric training at the Massachusetts Mental Health Center at Harvard Medical School and at the NIMH in Bethesda, Maryland. He graduated from the Boston Psychoanalytic Institute where he was a Joseph Michels merit scholar. He was the founding Editor-in-Chief (E-i-C) of the internationally known journal, the Journal of Clinical Psychopharmacology (1980–2020) and was also the E-i-C of the international journal Clinical Therapeutics (2012–2019). He is now E-i-C Emeritus for both journals. In addition, he is the author or co-author of over 1,000 scientific publications and the author, editor, or co-editor of 21 scientific books and monographs. According to ResearchGate, as of January 2021 his publications have received over 26,250 citations in peer-reviewed journals; and his h-index is 86. According to Google Scholar, his h-index is 101. This includes book chapters.

Robert Franco, PhD

Senior Fellow Tufts CSDD and President, Coe Point Associates LLC
E-mail:  robertjfranco176@gmail.com

With over 24 years of consulting experience, Dr. Franco led PricewaterhouseCoopers’ Pharmaceutical R&D practice where he specialized in improving pharmaceutical drug development, technology transfer, clinical trial operations and manufacturing. The breadth of his career includes having worked with the senior management of several large pharmaceutical and biotechnology companies, Non-government Organizations (NGOs) and multinational organizations to implement complex change management initiatives to improve growth, reduce costs and remediate quality and regulatory issues. In addition to Dr. Franco’s writing which includes eight management consulting articles and thirteen technical publications, he has three patents to his name and has served on several international technical review and regulatory standards committees. Dr. Franco holds a Doctor of Philosophy and Master of Science in Biochemistry from the University of Rochester.

Project Manager and Data Scientist 
Email: Zachary.Smith605922@tufts.edu

Maria I. Florez, MA

Senior Consultant
Email: Maria.Florez@tufts.edu

Maria Florez is involved with projects conducted by the Tufts CSDD Sponsored Research Group, including studies looking at the impact of digital transformation in clinical research and at organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for more than a decade. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities. Maria holds a bachelor’s degree with honors in economics from Stony Brook University and a master’s degree from The Fletcher School of Law and Diplomacy at Tufts University.

Beth Harper, MBA

Project Manager and Senior Research Consultant
Email: bharper@clinicalperformancepartners.com

Beth Harper works closely with Tufts CSDD Director Ken Getz and the Sponsored Research Group on a variety of projects, including studies on: drug development execution; sponsor-site relationship management; study feasibility and start-up; investigative site selection; patient recruitment and retention; workforce effectiveness and competency; and the adoption and impact of operating and data management innovations. Beth is the president of Clinical Performance Partners, Inc., and is also an Adjunct Assistant Professor at George Washington University. She has published and presented extensively. Beth received her BS in Occupational Therapy from the University of Wisconsin and her MBA from the University of Texas.

Emily Botto, BA

Senior Research Analyst
Email:  Emily.Botto@tufts.edu

Emily Botto is involved with projects in the Sponsored Research Group where she works on a variety of studies focusing on clinical research execution strategies and practices as well as clinical trial diversity and inclusion. Emily brings experience as a managing and contributing editor for a newspaper and book publishing company. She also worked as a market research analyst with the VDC Research Group. Emily graduated from Brandeis University with BAs in Business and Communication.

Ava Feuer, BS