Tufts CSDD Team
Tufts CSDD Faculty
Kenneth A. Getz, MBA
Center Director and Research Professor
Ken Getz is the 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 ROI of patient engagement
Mapping clinical data management practices
Monitoring changes in the global investigative site landscape
Assessing the incidence and causes of deliberate protocol dose nonadherence
Joseph A. DiMasi, PhD
Director of Economic Analysis and Research Associate Professor
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
Associate Director of Sponsored Research, Research Assistant Professor
Dr. Mary Jo Lamberti is a Research Assistant Professor at Tufts University School of Medicine and Associate 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
Jennifer Kim, PhD
Research Assistant Professor
Dr. Jennifer Kim is a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. Her research background is in organizational behavior and I/O psychology and focuses on Diversity, Equity, and Inclusion (DEI). Her research is centered on not only identifying systemic barriers faced by historically marginalized groups in organizations but also implementing systemic, holistic interventions that dismantle visible and invisible barriers faced by underrepresented groups. Dr. Kim is particularly interested in examining how DEI dynamics impact individual, group, and organizational outcomes, including individual engagement, team and organizational output and productivity in drug development. Dr. Kim holds a BA from Wellesley College and a Ph.D. in Organizational Psychology from Columbia University.
Kenneth I Kaitin, PhD
Professor and Senior Fellow
Dr. Kenneth Kaitin is a Professor of Medicine and Senior Fellow at the Tufts Center for the Study of Drug Development. He previously served as the group’s Director for 23 years. He is also Advisory Professor at Shanghai Medical College at Fudan University, and he serves on the faculty of the European Center for Pharmaceutical Medicine at the University of Basel. Dr. Kaitin is an internationally recognized authority on drug development science and policy. He consults, speaks, teaches, and writes on global trends in pharmaceutical development and regulation, and he has provided public testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin recently 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, and in 2020 he was named a Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians. 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
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
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.
Paul Beninger, MD, MBA
Adjunct Research Professor
Dr. Beninger is an adjunct research professor at Tufts CSDD and an Associate Professor of Public Health & Community Medicine at Tufts University School of Medicine. He has more than three decades of career experience as a regulator, industry executive, and as a member of the academic community. Dr Beninger began his career in drug development in 1987 at the US Food and Drug Administration, first as a reviewer and manager for drugs against HIV/AIDS and opportunistic infections and then as a division director for medical devices. He joined Merck & Company in 1995 in regulatory affairs, medical affairs and drug safety in the areas of anti-infective drug and biological products, vaccines, anti-diabetic drug products and oncology drug products, before joining Genzyme as vice-president of pharmacovigilance in 2006. Dr. Beninger trained in internal medicine and infectious diseases. He received his MD from the University of California, Davis, his BA from Claremont McKenna College in Claremont, California, his MBA from St Joseph’s University in Philadelphia, Pennsylvania, and his graduate certificate in epidemiology from Tufts. He consults regularly and has published and presented his research and insights extensively. Dr. Beninger has been affiliated with Tufts Center for the Study of Drug Development since 2014 and Tufts Clinical and Translational Science Institute since 2021.
Ronald P. Evens, B.S. Pharm., Pharm.D., FCCP
Adjunct Research Professor and Biotechnology Industry Consultant
Dr. Evens is an internationally recognized expert on the biotechnology industry, a market that he has studied for more than 30 years. He has extensive experience in both academia and in industry. He was an adjunct professor of pharmacy at University of Florida and the University of Pacific; an Associate Professor & Chairman, Department of Pharmacy Practice, University of Tennessee; and Associate Professor & Director of the Drug Information Center at the University of Texas at Austin. Dr. Evens was also a Senior Director of the Professional Services Department at Amgen; and an Associate Director, Clinical Research & Medical Services at Bristol-Myers Company. He is the editor and author of four books; has authored over 100 publications; given more than 150 professional and industry presentations; and serves on a variety of non-profit and for-profit boards. Dr. Evens is also the president of M.A.P.S. 4 Biotec, Inc, a consulting firm that he founded focusing on the biotechnology industry for medical affairs. Dr. Evens received a B.S. in Pharmacy from the University of Buffalo and received his Pharm. D. From the University of Kentucky.
Tufts CSDD Research Staff
Zachary (Zak) Smith, MA
Senior Analyst and Data Scientist
Zak Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics and innovation adoption. Many of these projects involve creating, compiling, and analyzing very large datasets. Zak completed his BS at Florida State College and received his MA from Brandeis University. He is a former research analyst at Tufts CSDD and has worked as a research assistant at Harvard University and at the University of Massachusetts.
Maria I. Florez, MA
Senior Analyst and Research Consultant
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
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
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.
Sundé Daniels, MBA
Director of Administration and Development, Administrative Manager
Miss Sundé W. Daniels plans and directs all administrative, financial, and operational activities. She organizes and prioritizes critical issues and required information to facilitate efficient decision making to ensure the smooth operation of Tufts CSDD. This includes areas such as: operations and logistics, financials (budgets, fundraising, sponsorship), professional development programs, and identification of opportunities for collaboration with internal and external partners. Sundé’s strong background in the pharmaceutical industry, academia, and business fuels her passion for industrial R&D strategy, improving operational efficiency as well as operations. Her career has afforded her to work with companies and institutions such as Pfizer, Boston University Boston Medical Center and Harvard University. Sundé received her BA in Biochemistry (Eastern University) and holds a Master of Business Administration, with a concentration in Pharmaceutical Business (University of the Sciences Philadelphia). She is a Certified Life Coach and Notary Public, as well as a Certified NFL Contract Negotiator.
Evelyn Chan is responsible for planning, managing, and forecasting the budget and financial activities for Tufts CSDD. Evelyn handles registrants’ payments for courses, Tufts CSDD publication purchases, and financial inquiries.
Luna Rodriguez, BA
Marketing and Communications Coordinator
Luna Rodriguez received her BA from Boston University in Political Science. As Marketing and Communications coordinator, she manages the Center’s promotional and outreach campaigns. In her role she also coordinates essential office operations, provides logistical support for all of our courses, maintains the Center’s records, and organizes logistics for various meetings and events.
Michela Davola, MFA
Associate Director, Development and Fundraising
Michela Davola is the new Associate Director, Development and Fundraising, working to create a robust and engaging philanthropic community. Michela has a strong background in donor engagement and cultivation, and comes to Tufts with a BA in Art History and an MFA in Architectural History. As a Massachusetts native, Michela currently lives on the North Shore and spends her free time reading or hanging out with her rescue pup Walter.