S E C O N D   Q U A R T E R   2 0 1 3

From the Director



Welcome to our second Tufts CSDD Quarterly Update of 2013, providing an overview of current research, recent publications, upcoming programs, and other news from the Tufts Center. As you'll see, there is a lot going on at CSDD on all fronts.


On May 17th I chaired our quarterly Tufts CSDD Executive Forum roundtable, and I was thrilled with the candid discussion and high level of participation that has become a hallmark of these interactive, small-group events. The topic of the roundtable was Partnerships, Alliances, Consortia, and Other Risk-Sharing Collaborations. The presentations, which described a variety of novel partnership models, were outstanding. We kicked off the roundtable with a group of informative presentations by the CEO of the Michael J. Fox Foundation, and two partnering companies, Pfizer and Sanofi. We also heard from the managing director of the Boston-based venture capital firm Atlas Ventures about new models of VC-industry partnerships. Next we heard a fascinating account of how a major pharma company terminated a successful alliance. And we wrapped up with a review by the managing director of Quintiles' consulting group of innovative partnerships between CROs and companies. Several thoughts emerged from the roundtable. First, while risk-sharing partnership models are still evolving, they represent a critical component of the new innovation landscape. Second, there is an important need for stakeholders to engage in these types of interactions, where they can share experiences, gain insight, and establish new relationships. That's where I believe the Tufts CSDD Executive Forum roundtables, by providing a neutral and open forum for these discussions, play a vital and unique role. Our next roundtable, entitled Outsourcing to Maximize Operating Efficiency, will be held September 12th at our offices in Boston.


I hope that you will take a look at the rest of this update to learn more about some of our current activities. In particular, I'd like to draw your attention to our two Feature pieces. The first is by Merle Kummer, of Kummer Consulting, describing her work on our Tufts CSDD Leadership for Drug Development Teams course, which she has been running since 2002. Our next program is scheduled for July 9-10, 2013, in Boston. The second is by Ken Getz, director of CSDD sponsored research and associate professor, on the Tufts Center's Multi-Company Working Group series. This enormously popular program fills an important need within the research-based industry to address critical strategic and operational issues, share insights with peer companies, and develop best practices.


As always, we're interested in your thoughts and perspectives, Thank you for your support.





Kenneth I Kaitin, PhD
Professor and Director
Feature: Tufts CSDD's Leadership for Drug Development Teams
By: Merle Kummer

Through my 18 years of consulting experience with life science and technology organizations of all sizes and stages, I've seen first-hand that productive communication and highly effective teams are critical for achieving technical and commercial success. That's what led me to work with the Tufts Center to create the Tufts CSDD Leadership for Drug Development Teams Course. First offered in 2002, the course has a clear set of learning objectives: (1) to allow industry leaders to redefine their roles, from managing action to building knowledge for decisions, (2) to enable cross-functional teams to capitalize on differing perspectives rather than argue about them, and (3) to translate theories of effective leadership into everyday actions that work in pharma R&D teams.


Learning to see things from other people's perspectives is central to the curriculum. Course alumni tell me, time and again, how much this skill has enabled their teams to see challenges more clearly and generate better options for action. Here's a typical reflection: "It's been six years since I took the course, but I use what I learned nearly every day in my job." Comments like these tell me that we're on the right track.

Feature: Tufts CSDD's Multi-Company Working Group Series
By: Ken Getz

As Director of CSDD's Sponsored Research Program, I'm proud to introduce our Multi-Company Working Group Series, which I organize and direct. These working groups have become increasingly popular among research sponsors, contract research organizations and service providers because - in many cases - they are the best way for these organizations to obtain robust and scholarly benchmark assessments of critical processes and practices. 


Working group participation offers significant benefits, including the opportunity to participate in a dynamic, data-driven research program that addresses key strategic and operational issues that directly impact industry efficiency and productivity. Participants in working groups shape critical and timely research questions, and collectively interpret study results. Moreover, participants are able to interact with colleagues from peer companies and share ideas, experiences, and insights - all in a neutral and facilitative academic setting. 


At the end of each working group study, participating companies receive a confidential report comparing their data with industry benchmarks, which they can share with senior management and staff. In some cases, participants may be interested in co-authoring an article with CSDD for submission to a peer-reviewed or trade journal, or co-presenting findings at conferences.


CSDD's Multi-Company Working Group Series is a unique opportunity for companies to assess and recalibrate their R&D strategies and operating models. I encourage you to check our website regularly to see what projects are currently enrolling and to participate in our working group programs.

Tufts CSDD Reports
Tufts CSDD Impact Report
Clinical Success Rates for New Cancer Drugs Double While More Enter Testing, May/June 2013, Vol. 15 No. 3 [View press release

Tufts CSDD R&D Management Report

New Protocol Design Approaches Will Improve Clinical Trial Performance and Efficiency, April 2013; Vol. 8 No. 2 [View press release]   



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
  • Assessing Investigative Site Experiences with Clinical Supplies
  • Benchmarking Risk-Based and Other Optimized Monitoring Practices
  • Comparative Economic Study of Fully-Loaded Sponsor Versus Contract Clinical Service Provider Costs
  • Standard Practices and Policies for Optimizing Social and Digital Media Communities in Clinical Research

Sponsored Research 

  • Assessing the Adoption and Impact of Adaptive Clinical Trial Designs
  • Benchmarking the Incidence and Cost of Core Protocol Procedures Conducted Excessively
  • Evaluating the Root Causes of Global Drug Shortages 
  • Identifying Predictors of Successful Transition in Late Stage Clinical Trials in Oncology and CNS
  • Measuring Progress in Neglected Disease Drug Development
  • Multi-Company Panel on Post-Approval Research
  • Review and Analysis of Recently Approved Personalized Medicines and Those in Late-Stage Development
  • Reasons for Failure and Probability of Success for Therapeutic Subgroups  

Email us for additional information about sponsoring research at Tufts CSDD or participating in one of our Multi-Company Working Groups

Tufts CSDD Recent Publications   


Cohen JP, Malins A, Shahpurwala Z. Compared to US practice, evidence-based reviews in Europe appear to lead to lower prices for some drugs. Health Affairs 2013;32:762-770.


Cohen JP, Millier A, Karray S, Toumi M. Assessing the economic impact of Rx-to-OTC switches: systematic review and guidelines for future development. Journal of Medical Economics 2013;16(6):1-10.


DiMasi JA. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications. Clinical Therapeutics 2013. [Published online May 28, 2013]


Getz KA. Impact of in-pharmacy education on patients' knowledge and attitudes about clinical trials. Therapeutic Innovation & Regulatory Science 2013. [Published online March 14, 2013]    


Getz KA, Stergiopoulos S, Marlborough M, Whitehill J, Curran M, Kaitin KI. Quantifying the magnitude and cost of collecting extraneous protocol data. American Journal of Therapeutics 2013. [Published online April 9, 2013] 


Getz KA, Lamberti MJ. Assessing global CRA workload and utilization. ACRP Monitor 2013;27(1):11-18.


Lamberti MJ, Walsh T, Getz KA. Tracking trial cost drivers: the impact of comparator drugs and co-therapies. Pharmaceutical Executive 2013;33(5): 34-37.


Smed M, Getz KA. Unfulfilled translation opportunities in industry sponsored clinical trials. Contemporary Clinical Trials 2013;35:80-86.
Staff Presentations   
Selected presentations given or scheduled to be given by Tufts CSDD staff


Joshua Cohen, Health Affairs briefing: The Triple Aim Goes Global (Sponsored by the Commonwealth Fund), Washington, DC, April 11, 2013.


Mary Jo Lamberti, ACRP Annual Meeting: Assessing Global CRA Workload and Utilization, Orlando, FL, April 13-16, 2013.

Ken Getz, BIO, Chicago, IL, April 22-24, 2013.

Christopher-Paul Milne, Post-Approval Research Summit at Harvard University, Cambridge, MA, May 8, 2013.

Ken Getz, CMO Summit, Boston, MA, May 13, 2013.

Christopher-Paul Milne, ISPOR, New Orleans, LA, May 18-22, 2013.

Joseph DiMasi, Optimizing Clinical Research Performance (CenterWatch/iiBIG), Boston, MA, May 19-21, 2013.


Ken Getz, Optimizing Drug Development Performance Conference, Boston, MA, May 20-22, 2013.


Ken Kaitin, NCDEU Annual Meeting, Hollywood, FL, May 28, 2013.


Christopher-Paul Milne, ACI Legal Summit, New York, NY, June 5-6, 2013.

Ken Getz, NIH/NINDS Current State of the Clinical Research Enterprise Workshop, Bethesda, MD, June 20-21, 2013.


Ken Kaitin, Ken Getz, Mary Jo Lamberti & Stella Stergiopoulos, DIA Annual Meeting, Boston, MA, June 24-27, 2013.



Ken Kaitin, Brookings Institution Biomedical Innovation Conference, Washington, DC, July 16, 2013.

I N   T H I S   I S S U E
FYI. . .


Welcome to Ms. Abigail Felix, who joined the Tufts Center staff as a Research Analyst in April. Abbie can be reached at abigail.felix@tufts.edu.

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We're pleased to announce that Tufts CSDD recently released an R&D Senior Leadership Management Brief on
The Adoption and Impact of Adaptive Trials Designs. For more information or to download the brief, visit our website


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 Tufts CSDD in the News

This quarter, Tufts CSDD research staff were quoted in articles published in a broad range of journals, newspapers, and trade press, including The New York Times, The Philadelphia Inquirer, Scientific American, Worchester Telegram & Gazette, GEN, and Health Affairs.
Quote of the Quarter

"The willingness to share information now is unlike anything I have seen in my 30 years of working in this field," says Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development in Boston. "I still am amazed when you hear a company say, 'Here's what we tried, here's the buy-in we got, here's how much it cost and here's why it failed.' That's something companies never used to talk about."

Scientific American
April 2013


Kenneth I Kaitin, PhD 
Professor and Director

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

Joseph A. DiMasi, PhD
Director of Economic Analysis

Joshua P. Cohen, PhD
Assistant Professor

Ken 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 Project Manager

Stella Stergiopoulos, BA
Project Manager

Jennifer Kim, BA
Research Analyst

Abigail Felix, BA
Research Analyst

Sandra Peters, MLIS
Information Services Librarian

Christina Coffin, MLIS
Library Assistant
Tufts CSDD
617.636.2170 | csdd.tufts.edu