T H I R D   Q U A R T E R   2 0 1 4

From the Director

Welcome to Tufts CSDD's third Quarterly Update of 2014, providing an overview of current CSDD research, recent publications, staff presentations, and other news.

I'm very excited to announce that in November we will release the results of our newest study on the cost of drug development. Like past CSDD studies, our new study is a comprehensive and scholarly assessment of drug development costs based on data provided by a mix of drug and biopharmaceutical companies. As always, lead author, Joseph DiMasi, and co-authors Henry Grabowski and Ron Hansen, made sure that the study is scientifically airtight, to buffer it from the deluge of attacks we typically receive from critics of the study. On the other hand, we know that the number we report will quickly be embraced by policy-makers, regulators, academics, and industry as the "true" cost of drug development. Stay tuned for the date and further details about this important event.

In other news, I'm proud to announce the academic promotions of several of CSDD's faculty. Director of Research Dr. Christopher Milne, Director of Economic Analysis Dr. Joseph DiMasi, and Dr. Joshua Cohen have all been promoted to the rank of Research Associate Professor at Tufts University School of Medicine. It is well-deserved recognition of their scholarly achievements as well as their worldwide reputation for academic excellence in the fields of law, economics, and health policy. Congratulations to my three esteemed colleagues!

As always, feel free to contact me directly to share your thoughts and perspectives. And thank you for your support.


Kenneth I Kaitin, PhD
Professor and Director

Research Opportunities 

As part of its broad research agenda, CSDD runs Multi-Company Working Groups and conducts Sponsored Research on a wide variety of topics identified by individual or multiple sponsors. Here is a list of projects currently in progress:

Multi-Company Working Group Studies
  • Benchmarking Global Clinical Supply Logistics Practices and Performance
  • Benchmarking Study Volunteer Screen Failure, Enrollment and Drop-out Rates by Therapeutic Area and Phase
  • Evaluating the Impact of Integrated Outsourcing Relationships on Performance and Quality
  • Measuring the Adoption of eClinical Solutions and Standards
Sponsored Research
  • Assessing Site Selection and Activation Practices and their Effectiveness
  • Challenges Facing Biosimilar Uptake
  • Impact of Reimbursement on Innovation
  • Mapping Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings
  • Measuring the Impact of Initiatives to Reduce Protocol Amendments 
  • Personalized Medicine Landscape
  • Relative Contributions of the Private and Public Sector to the R&D of New Drugs
  • Update on the R&D Environment and Market Prospects for Personalized Medicines/Companion Diagnostics


Email us if you are interested in participating in one of our Multi-Company Working Groupsor if you would like additional information about sponsoring research at CSDD.

Recent CSDD Publications    


Cohen JP. Patient access to orphan drugs faces new set of challenges. Formulary. [Published online before print September 15, 2014]


Cohen JP, Felix AE, Riggs K, Gupta A. Barriers to market uptake of biosimilars in the US. Generics and Biosimilars Initiative. 2014;3(3):107-114.


Cohen JP, Sturgeon G, Cohen A. Measuring progress in neglected disease drug development. Clinical Therapeutics. 2014;36(7):1037-1042. 

DiMasi JA, Kim J, Getz KA. The impact of collaborative and risk-sharing innovation approaches on clinical regulatory cycle times. Therapeutic Innovation and Regulatory Science. 2014;48(4):482-487. 

Getz KA. The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial. 2nd ed. Boston: CISCRP; 2014. 

Getz KA. Q&A with Jean Burns: Insights from a study volunteer. Applied Clinical Trials Online. [Published online before print May 28, 2014]

Getz KA, Birch P, Stergiopoulos S. Adaptive trial design: prepping for adoption. Pharmaceutical Executive. 2014;34(6):48.

Stergiopoulos S. Non-clinical drug development in Asia. Pharma Focus Asia. 2014;(20):5-6.

Von Eschenbach A, Sharp P, Kaitin KI. An Rx for making wonder drugs [Op-Ed]. Boston Herald. August 26, 2014:16.
Latest Tufts CSDD Reports


Tufts CSDD Impact Reports  

Tufts CSDD R&D Management Report
Upcoming Staff Presentations   
Selected presentations given or scheduled to be given by Tufts CSDD staff


Kenneth Getz & Mary Jo Lamberti: Patient Centered Clinical Trials, Boston, MA, September 4-5


Kenneth Kaitin & Christopher Milne: Mansfield Foundation Japanese Scholars Program, Boston, MA, September 15


Kenneth Kaitin & Kenneth Getz: Optimizing Drug Development Performance, Boston, MA, September 15-16


Mary Jo Lamberti: Contract Pharma Contracting & Outsourcing Conference, New Brunswick, NJ, September 18-19

Joshua Cohen: Rare Diseases Summit, Boston, MA, September 22

Kenneth Getz: FDA Workshop on Adaptive Designs, Washington, DC, September 22-23



Kenneth Getz: Outsourcing East, Boston, MA, October 7-8


Kenneith Kaitin: Gifu Pharmaceutical University Innovation Symposium: The Development of New Medicines for Alzheimer's Disease, Gifu, Japan, October 10


Kenneth Kaitin: ERT PROFICIENCY Seminar, Tokyo, Japan, October 14

Joseph DiMasi: CancerRx 2014, Cambridge, MA, October 26-28

Christopher Milne: CHI's Re-Entering Antibacterial Drug Development Summit, Boston, MA, October 29



Kenneth Kaitin: Fudan University's Center for the Study of Pharmaceutical and Healthcare Strategy Symposium, Shanghai, China, November 4


Kenneth Getz: CDISC Interchange, Bethesda, MD, November 12-13


Joseph DiMasi: Drug Development Boot Camp, Boston, MA, November 19-20
I N   T H I S   I S S U E
FYI. . .

This Fall, Tufts CSDD welcomed Ms. Pili Mary Kamenju and Ms. Carrie Brown to the staff as Research Analysts.

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Registration has opened for the 2015 Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, taking place February 2-6, 2015 at the Ritz- Carlton Hotel in Boston, MA. For more info and to register, visit the course page.

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 Tufts CSDD in the News
Over the past quarter, CSDD faculty have been featured and their research cited in over 30 news sources, including National Public Radio's Marketplace, Boston Herald, The Wall Street Journal, FDANews.com, and The Pink Sheet.
Quote of the Quarter

"Oncology is one of the most active areas in drug development today and has been for some time," said Kenneth Getz, director of sponsored programs at the Tufts CSDD and chairman of the nonprofit Center for Information and Study on Clinical Research, or CISCRP. One of every four drugs presently in development targets cancer-related illness, "which is remarkable, and has dictated some of the new directions in innovation."


Will Adaptive Design Become the New Paradigm for Cancer Trials?

Life Sciences Connect

August 20, 2014


Kenneth I Kaitin, PhD 
Professor and Director

Christopher-Paul Milne, DVM, MPH, JD
Director of Research and Associate Professor 

Joseph A. DiMasi, PhD
Director of Economic Analysis and Associate Professor

Joshua P. Cohen, PhD
Associate Professor

Kenneth A. Getz, MBA
Director of CSDD Sponsored Research Program and Associate Professor

Richard I. Shader, MD
Medical Consultant and Professor Emeritus, Molecular Physiology and Pharmacology
Mary Jo Lamberti, PhD
Senior Research Fellow
Stella Stergiopoulos, BA
Senior Project Manager
Ranjana Chakravarthy, BA
Research Analyst

Pili Mary Kamenju, MD, MPH
Research Analyst

Carrie Brown, MS
Research Analyst
Sandra Peters, MLIS
Information Services Librarian
Tufts CSDD
617.636.2170 | csdd.tufts.edu