F I R S T   Q U A R T E R   2 0 1 5

From the Director



Welcome to our first Tufts CSDD Quarterly Update of 2015. And what an incredible kick-off to the year it's been here in New England! Despite several punishing blizzards, over nine feet of accumulated snow, numerous university and business closures, and the near paralysis of public transportation, CSDD has remained engaged in a full slate of research projects and has moved forward on a host of new programs. 


Our 42nd annual CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, held the first week of February, went off without a hitch, despite a major snowstorm at the beginning of the week that brought much of the region to a standstill. We had nearly full attendance, and only a few faculty on the first day needed to give their presentations via Skype. Despite the challenges, the class was attentive, engaged, and eager to learn. Every year I'm amazed how the course agenda, which covers a broad range of topics and is organized to meet the needs of students with very varied backgrounds and experiences, comes together so nicely to create such a rich and novel learning experience. We are indebted to our outstanding faculty and all the many wonderful students we've had over the years for helping to make the Tufts CSDD Postgraduate Course a superb and enduring benchmark for educational programming on pharmaceutical innovation.


Also in February, we held our first quarterly R&D Management Roundtable of 2015 - part of our CSDD Executive Forum. The topic, "FDA's Breakthrough Therapy Designation-A Three-Year Assessment," generated a very animated and productive discussion. The program included a presentation of new CSDD metrics on BTD approvals, talks on company experiences with BTD development programs, and a featured presentation by Dr. Sarah Pope Miksinski, Acting Division Director for the Division of New Drug Quality Assessment 2 in the Office of New Drug Quality Assessment within the Center for Drug Evaluation and Research, on the FDA's current thinking on BTDs. Our next roundtable, to be held May 14th, will focus on "Diagnostic-Therapeutic Co-development Strategies and Best Practices." If you haven't had an opportunity to attend one of our R&D Management Roundtables, I encourage you to register. I think you'll find the events stimulating and different. For more information on the series, visit our website.


Finally, I'm pleased to note that our Director of Research and Associate Professor Chris Milne is expanding Tufts CSDD's global reach through a three-month research and teaching fellowship at Kyushu University in Japan. During his stay, Chris will be teaching undergraduate and graduate level courses and will be managing several CSDD-Kyushu collaborative research projects. We're excited to make this new connection with colleagues in Japan.


As always, thank you for your support. 


Kenneth I Kaitin, PhD
Professor and Director

Research Opportunities 

As part of its broad research agenda, CSDD holds 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 Sponsored Working Groups

  • Assessing Health Care Provider Perceptions of, and Referral Experiences with, Clinical Research
  • Benchmarking Site Selection and Management Practices
  • Evaluating the Impact of Integrated Outsourcing Relationships on Performance and Quality
  • Quantifying the Cost of Implementing Protocol Amendments and Evaluating Steps to Reduce Amendments
  • Social Media in Clinical Research Standard Practices and Policies

Sponsored Research

  • Benchmarking Real World Data Usage in Clinical Trials
  • Challenges Facing Biosimilar Uptake
  • Current Landscape for Personalized Medicines
  • Impact of Reimbursement on Innovation
  • Mapping Direct and Indirect Study Conduct Costs
  • Mapping Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings 
  • Pandemic & Bioterror Medical Countermeasures (MCMs)
  • Personalized Medicine Landscape
  • Public/Private Sector Contributions to R&D
  • Sizing and Segmenting the High Throughput Screening Market
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   


Chakravarthy R, Cotter K, DiMasi JA, Milne CP, Wendel N. White paper: Public and Private Sector Contributions to the Research & Development of the Most Transformational Drugs of the Last 25 Years. Boston: Tufts Center for the Study of Drug Development. January 2015.

Cohen JP. Roadblocks preventing personalized medicine from reaching its Potential.
Biomarkers in Medicine 2015;9(1):5-8.


Evens R, Kaitin KI. The evolution of biotechnology and its impact on health care. Health Affairs 2015;34(2):210-219.


Getz KA, Kaitin KI. The impact of bad protocols. In: Schuler P, Buckley B, eds. Re-engineering Clinical Trials: Best Practices for Streamlining Drug Development. Amsterdam: Academic Press; 2015:105-116.


Getz KA, Kaitin KI. Why is the pharmaceutical and biotechnology industry struggling? In: Schuler P, Buckley B, eds. Re-engineering Clinical Trials: Best Practices for Streamlining Drug Development. Amsterdam: Academic Press; 2015:3-15.


Grabowski, HG, DiMasi JA, Long G. The roles of patents and research and development incentives in biopharmaceutical innovation. Health Affairs 2015;34(2):302-310.


Milne C-P, Bryan C, Garafalo S, McKiernan M. Complementary versus companion diagnostics: apples and oranges? Biomarkers in Medicine 2015;9(1):25-34.


Milne C-P, Kaitin KI. Meeting unmet medical needs: the disparity dilemma. Pharmaceutical Executive 2015;35(2):26-28.


Stergiopoulos S, Surgeon L. The facilitated clinical trial protocol review: is the theory being put into good practice? Chimica Oggi [Chemistry Today] 2014;32(6):52-56.

Latest Tufts CSDD Reports

Tufts CSDD Impact Report:


Tufts CSDD R&D Management Report: 

Upcoming Staff Presentations 
Selected presentations by Tufts CSDD research staff:


Kenneth Getz: R&D Leadership Summit, Miami, FL, March 5-6


Kenneth Kaitin: U.S. Biomedical Advanced Research and Development Authority (BARDA) Distinguished Speaker Series, Washington, DC, March 11 


Mary Jo Lamberti: Forecasting and Optimization of the Clinical Supply Chain Summit, Philadelphia, PA, March 16-17

Kenneth Getz: Patients as Partners, Philadelphia, PA, March 16-17   


Kenneth Getz: Oracle Industry Connect, Washington, DC, March 24-26

Joseph DiMasi: IVAL Hepatocyte Technology Conference, Malden, MA, April 14  


Kenneth Kaitin: Clinical Research Forum Annual Meeting, Washington DC, April 17 

Kenneth Getz: Partnerships in Clinical Research, Boston, MA, April 22-23

Kenneth Getz: ACRP Annual Meeting, Salt Lake City, UT, April 25-27

Kenneth Getz: Chief Medical Officers East, Boston, MA, May 4-5   


Kenneth Kaitin: Convergence Forum, Chatham, MA, May 15 


Joseph DiMasi: National Bureau of Economic Research (NBER) Productivity Seminar, Cambridge, MA, May 26   


Kenneth Getz: OCT East, Boston, MA, May 27-28   

Joseph DiMasi: American Diabetes Association 75th Annual Meeting, Boston, MA, June 5   


Joseph DiMasi: Bates White Life Sciences Symposium, Washington, DC, June 8-9   


Christopher Milne: NextLevel Pharma, Pharma Access Leaders Forum, Brussels, June 8-10


Kenneth Kaitin: 17th Annual Shanghai BioForum, Co-chair of Global Pharmaceuticals Innovation Strategy Symposium, Shanghai, China, June 9 


Joseph DiMasi: Special Libraries Association 2015 Annual Meeting, Boston, MA, June 14 

I N   T H I S   I S S U E
FYI. . .
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Tufts CSDD's Outlook 2015 is now available on our website. Published each January, the report highlights near-term pharmaceutical and biopharmaceutical development trends. Purchase your copy today on our website.
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Tufts CSDD's most recent figure on the cost of drug development, released November 2014, continues to generate discussion. Lead author Joseph DiMasi recently responded to a letter from the Union for Affordable Cancer Treatment (UACT). The UACT letter and Dr. DiMasi's response can be viewed on our website.
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Christopher Milne recently started a three-month research and teaching fellowship at Kyushu University in Japan. We wish him well in his time overseas.
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Ken Getz was elected a member of the Class of 2015 Fellows of the DIA.
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Welcome to Ms. Josephine Awatin, who joined the Tufts Center staff as a Research Analyst in January.

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 Tufts CSDD in the News

Over the past quarter, Tufts CSDD faculty have been featured and Center research cited in over 80 news sources, including The Wall Street Journal, Associated Press, Forbes, Fortune, The Financial Times, The Huffington Post, The Economist, Reuters Health, Time Magazine Online, and The Boston Globe.

 Quote of the Quarter
"It's no longer reasonable for large pharma companies to try to maintain the capabilities to bring compounds from the laboratory bench all the way to the marketplace. It's too expensive. It's too difficult to justify the upfront cost, and it's just not a formula for success." 
-Kenneth I Kaitin,Tufts CSDD

Genetic Engineering and Biotechnology News

February 18, 2015


Kenneth I Kaitin, PhD 
Professor and Director

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

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

Joshua P. Cohen, PhD
Research Associate Professor

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

Ronald Evens, PharmD, FCCP
Adjunct Research 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

Josephine Awatin, BS
Research Analyst


Sandra Peters, MLIS
Information Services Librarian
Tufts CSDD
617.636.2170 | csdd.tufts.edu