Tufts CSDD FACULTY
Kenneth I Kaitin, PhD
Professor of Medicine and Director
Dr. Kaitin is a Professor at Tufts University School of Medicine and Director of the Tufts Center for the Study of Drug Development. Dr. Kaitin also holds appointments as Advisory Professor at Shanghai Medical College of Fudan University in Shanghai, China; Visiting Executive at the Tuck School of Business at Dartmouth College; and faculty of the European Center for Pharmaceutical Medicine at the University of Basel. An internationally recognized expert on drug development science and policy, Dr. Kaitin writes and speaks regularly on factors that contribute to the slow pace and high cost of pharmaceutical R&D and efforts to improve the development process. He has provided public testimony before the U.S. Congress on pharmaceutical development, regulation, and policy issues, and he currently serves as an expert consultant to the U.S. Department of Defense on bioterror countermeasures initiatives. Dr. Kaitin is frequently quoted in the business and trade press on global R&D trends and new models of innovation. A former President of the Drug Information Association, Dr. Kaitin is currently Editor-in-Chief of Expert Review of Clinical Pharmacology. He is on the editorial boards of a number of peer-review journals, and he serves on the boards of directors of several public, private, and not-for-profit life sciences companies and organizations. In 2011, Dr. Kaitin received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators. Dr. Kaitin received a B.S. from Cornell University and an M.S. and Ph.D. in pharmacology from the University of Rochester.
Christopher-Paul Milne, DVM, MPH, JD
Director of Research and Research Associate Professor
Dr. Milne's research focuses on the following: identifying and evaluating problems and solutions affecting innovation efficiency and the globalization of R&D; tracking the progress of incentive programs for special patient populations (pediatric and orphan diseases) and neglected diseases of the developing world; assessing the impact of emerging regulatory and reimbursement trends, such as risk evaluation and mitigation strategies (REMS) in the US and Europe’s risk management plan (EU-RMP) program, comparative effectiveness, and risk-sharing arrangements; and, updating developments in new science and policy initiatives, such as personalized medicine, FDA’s Regulatory Science initiative, the EU’s Innovative Medicines Initiative, and Translational Medicine.
Joseph A. DiMasi, PhD
Director of Economic Analysis and Research Associate Professor
Dr. DiMasi's area of expertise is in R&D efficiency, approval success rates, development and regulatory approval time metrics, impact of regulatory policies, economics of innovation in the pharmaceutical and biotechnology industries. 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, 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. His current research initiatives include:
R&D Costs for New Drug Development – New estimates of the R&D cost per approved new drug will be developed for drugs as a whole, by phase of development, and molecule type. The costs of failures and time costs will be considered.
Cancer Drug Development Trends – Analyses of approval success rates and phase transition rates for first and follow-on indications for oncology drugs by molecule type, as well as analysis of reasons for failure.
Kenneth A. Getz, MBA
Director of Sponsored Research and Research Associate Professor
Mr. Getz' area of expertise includes: Pharmaceutical R&D management, protocol design complexity, R&D operating efficiency, R&D outsourcing and vendor management, global investigative site management, trends impacting the study conduct landscape, patient participation in clinical research. Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution. Mr. Getz' current research initiatives include:
Evaluating the ROI of Patient Engagement -- Principal Investigator
Assessing the Magnitude and Cost of Unused Protocol Data -- Principal Investigator
Evaluating the Root Cause and Economic Impact of Drug Shortages -- Principal Investigator
Benchmarking the Clinical Study Planning and Forecasting Process-- Principal Investigator
Mapping the Global Investigative Site Landscape-- Principal Investigator
Benchmarking Patient Recruitment and Retention Practices -- Principal Investigator
Assessing the Accuracy and Completeness of Adverse Event Report Data -- Principal Investigator
Richard I. Shader, MD
Medical Consultant and Professor Emeritus
Dr. Shader is Professor Emeritus of Molecular Physiology and Pharmacology and Professor Emeritus of Psychiatry at the Tufts University School of Medicine in Boston, Massachusetts. He is a former chairman of the Department of Pharmacology and Experimental Therapeutics and of the Department of Psychiatry. Dr. Shader until 2010, served as Program Director for the graduate studies in the Program in Pharmacology & Experimental Therapeutics at the Sackler School of Biomedical Sciences. He is also 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 for the National Institute of Mental Health (NIMH). He has served on an NIMH study section and is 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. At present, he is 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. Dr. Shader is past president of the American College of Neuropsychopharmacology, the American Board of Psychiatry and Neurology, and the American Association of Chairmen of Departments of Psychiatry. He is a former Director and member of the Executive Committee of the American Board of Emergency Medicine and now serves as a Senior Director. Dr. Shader was an individual winner of the American Psychiatric Association’s Seymour Vestermark Award for Psychiatric Education, and received it a second time with colleagues from the American College of Neuropsychopharmacology. 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 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 the NIMH in Bethesda, Maryland. He also graduated from the Boston Psychoanalytic Institute. He is Editor-in-Chief of the Journal of Clinical Psychopharmacology. In addition, he is the author or co-author of over 600 scientific publications and the author, editor, or co-editor of 18 scientific books and monographs. Among the latter is the very popular Manual of Psychiatric Therapeutics first published by Little Brown and Company (now Lippincott-Williams & Wilkins).
Tufts CSDD research STAFF
Mary Jo Lamberti, PhD
Associate Director of Sponsored Research
Research Assistant Professor
Dr. Mary Jo Lamberti manages multi-sponsored and grant funded research projects at Tufts CSDD. She has extensive experience conducting market research on pharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was director of market research at CenterWatch. She has also worked on federally funded research studies in science education reform. Dr. Lamberti holds a BA from Wellesley College and a PhD in psychology from Boston University.
Stella Stergiopoulos, MS-MPH
Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a BA from Brandeis University, and an MS and MPH from Tufts University.
Josephine Awatin, BS
Josephine Awatin participates in projects with the Tufts CSDD research faculty to build a detailed understanding of clinical pharmacology, drug development and regulation. Ms. Awatin received a BS from Syracuse University in Biotechnology with a minor in Economics. Her prior experience includes neuroscience research that explored the molecular mechanisms that control seizure activity at Syracuse University.
Michael Wilkinson, BA
Senior Research Analyst
Michael Wilkinson works for the Sponsored Research program within the Tufts CSDD focusing on database creation and development, grant research, and pharmaceutical company and product research. Mr. Wilkinson received a BA from the University of Massachusetts Lowell in the field of Sociology focusing on quantitative research, while obtaining minors in both legal studies and business. In the past, he has been employed by the U.S. Department of the Interior: Office of Surface Mining Reclamation and Enforcement, helping to support and coordinate their VISTA program and the sociology department at UML where he assisted by performing initial literature reviews for faculty research and presenting material to students.
Yaritza Peña, bs
Yaritza Peña is a research analyst in the sponsored research group where she focuses on drug development trends, outsourcing and patient recruitment and retention. Ms. Peña received a BS from Bentley University in Economics with a concentration in Information Design and Corporate Communications. She has experience conducting research on sustainable agricultural practices in the Caribbean and on the effects of the drivers of economic growth and development on real GDP and economic growth in South American countries.
Zachary Smith, ma
Zachary completed his BS at Florida Southern College, and received his MA from Brandeis University. He has worked as a research assistant at a variety of labs including the Etter Lab at the University of Massachusetts, and the Evolutionary Psychology Lab at Harvard University.
Tufts CSDD administrative staff
Sundé Daniels, MBA
Director of Administration and Development
Miss Sundé W. Daniels works with the Tufts CSDD Director in the design and implementation of all CSDD activities. This includes: operations and logistics, financials (budgets, fundraising, sponsorship), educational programs (continuing education, career | professional development workshops), 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 biopharmaceutical innovation. Her career has afforded her to work with companies and institutions such as Pfizer (formerly Wyeth), Boston University Boston Medical Center and Harvard University. Most recently she served as Department Administrator for two different departments at Harvard University.
Grant & Program Administrator
Ms. Evelyn Chan is responsible for planning, managing, and forecasting the budget and financial activities for the Tufts CSDD. Ms. Chan handles registrants’ payments for courses, Tufts CSDD publication purchases, and financial inquiries.
Rachel Stanton, BFA
Special Projects Coordinator, Design | Staff Assistant
Ms. Rachel Stanton, an alumna of Massachusetts College of Art and Design (BFA, Illustration), provides administrative, marketing, and design project support for Tufts CSDD. Her primary duties include providing assistance to the Administrative Manager in maintaining Tufts CSDD’s Sponsorship Program, as well as providing critical support for Center meetings, events, and office management. She is the in-house designer for Tufts CSDD.
leanora karnath, ba
Marketing and Communications Coordinator
Ms. Karnath handles the Center's social media accounts, executes marketing campaigns for CSDD courses, and handles publications and subscriptions. She is a current MS Candidate in the Health Communication program at Tufts University.