S E C O N D   Q U A R T E R   2 0 1 4

From the Director


Welcome to our second Tufts CSDD Quarterly Update of 2014. As we reach the midpoint of the calendar year, we at CSDD find that it's a good time to look back at what we've accomplished to date, and recalibrate our efforts as necessary to ensure that we meet our research and programming goals for the year. It's certainly been a productive and fulfilling first six months, and I'm excited about what's in store for the second half of 2014.


On a personal note, on May 30th I had the privilege of participating in a Healthcare Innovation Panel, hosted by Bill Gates and held at the Bill and Melinda Gates Foundation in Seattle. Thought leaders from academia, the drug and device industries, venture capital, and foundations engaged in a stimulating and far-reaching discussion of how to boost cutting-edge AND cost-cutting innovation to treat broad indications, such as cardiovascular disease, type 2 diabetes, and Alzheimer's disease, which are putting an unsustainable strain on global healthcare systems. Bringing the best minds together to address these issues is a critical step forward.


This quarter we say goodbye to research analysts Abbie Felix, Jessie Moskowitz, and Paulami Naik, who are leaving to pursue new career opportunities. We thank them for their hard work and dedication to CSDD and wish them success in all their endeavors. Despite their departure, our research efforts have not slowed a bit, as we have a stellar group of new interns and research analysts who have joined an outstanding core of research support staff at the Center.


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




Kenneth I Kaitin, PhD
Director and Professor

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
  • Evaluating the Impact of Integrated Outsourcing Relationships on Performance and Quality
  • Measuring the Adoption of eClinical Solutions and Standards  


Sponsored Research 

  • Challenges Facing Biosimilar Uptake
  • Impact of Reimbursement on Innovation
  • Mapping Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings
  • Mapping the US Generic Manufacturing Landscape
  • Personalized Medicine Landscape
  • Profiling Cycle Time and Cost of Vaccine Development
  • Profiling New R&D Innovations Driving Performance and Efficiency
  • Quantifying the Use of ePRO in Clinical Trials 


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

Recent CSDD Publications   


DiMasi JA, Milne C-P, Tabarrok A. An FDA report card: wide variance in performance found among agency's drug review divisionsProject FDA Report. No. 7, April 2014;  Manhattan Institute for Policy Research.


Getz KA. Improving protocol design feasibility to drive drug development economics and performance. International Journal of Environmental Research and Public Health. 2014;11(5):5069-5080.


Lamberti MJ, Getz KA, Naik P, Costello M. Clinical supply capabilities, practices, and perceptions among investigative sites. Applied Clinical Trials Online 2014. [Published online before print May 12, 2014]


Milne C-P, Garafalo S, Bryan C, McKiernan M. Trial watch: Personalized medicines in late-stage development. Nature Reviews Drug Discovery. 2014;13(5):324-325.


Smed M, Getz KA. Site characteristics influencing the translation of clinical research into clinical practice. Therapeutic Innovation & Regulatory Science 

2014. [Published online before print March 13, 2014] 

For more information on publications from Tufts CSDD's faculty staff, please contact our Information Services Librarian Sandra Peters.

Latest Tufts CSDD Reports
Tufts CSDD Impact Report
Collaboration & Risk-sharing Programs Experience Longer Development Times, May/Jun 2014, Vol. 16 No. 3 [View press release

Tufts CSDD R&D Management Report

Predictors of Clinical Success to Boost Success Rates, Apr 2014, Vol. 9 No. 2 [View press release]   


Upcoming Staff Presentations   
Selected presentations to be given by Tufts CSDD faculty and staff:


Mary Jo Lamberti: Barnett Clinical Trial Oversight Summit, Boston, MA, June 2-5


Christopher-Paul Milne: American Conference Institute (ACI), 5th Annual Summit on Biosimilars, New York, NY, June 4-5 


Kenneth Getz: Pharmaceutical Executive Conference, New York, NY, June 12


Joseph DiMasi, Kenneth Getz, Kenneth Kaitin, Mary Jo Lamberti, Stella Stergiopoulos: Drug Information Association Annual Meeting, San Diego, CA, June 16 -19



Joseph DiMasi: World Transplant Congress, San Francisco, CA, July 26-31

I N   T H I S   I S S U E
FYI. . .


We're pleased to announce that Tufts CSDD recently released a new white paper on Industry Usage of Social and Digital Media Communities in Clinical Research. For more information or to download the white paper, visit the Reports section of the Tufts CSDD website
. . . . . . . . . 
Only a few seats remain for the 2014 Tufts CSDD Leadership Course, July 8-9 at the DoubleTree by Hilton Hotel in Boston, MA. For more info and to register, visit our course page. 


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 Tufts CSDD in the News
In the second quarter of 2014, CSDD faculty and staff were quoted in over 30 news source, including The Wall Street Journal, Bloomberg News, the Daily Beast.com, Forbes, The Christian Science Monitor, The Hill-Congress Blog, the Washington Post, and BusinessWeek.  
Quote of the Quarter

"It's widely expected that adaptive dose finding-a very promising approach that few companies are using routinely at this time-has the potential to improve the success rates of drugs in later-stage development programs"... says Ken Getz of the Tufts Center for the Study of Drug Development.

Nature Medicine
April 7, 2014

Kenneth I Kaitin, PhD 
Director and Professor

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

Joseph A. DiMasi, PhD
Director of Economic Analysis, Assistant Professor

Joshua P. Cohen, PhD
Assistant Professor

Ken A. Getz, MBA
Director of CSDD Sponsored Research Program, 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

Sandra Peters, MLIS
Information Services Librarian

Tufts CSDD
617.636.2170 | csdd.tufts.edu