T H I R D   Q U A R T E R   2 0 1 3

From the Director



There is a lot to share with you in this, our third Tufts CSDD Quarterly Update of 2013. In addition to our review of current research activities, recent publications, upcoming programs, and other news from the Tufts Center, you'll find an informative overview of CSDD's Louis Lasagna Library of Drug Development Science and Policy, written by our Director of Library Services, Sandra Peters.


The Lasagna Library was dedicated in 2004 to honor CSDD's founder Dr. Louis Lasagna, a preeminent scholar, visionary, and mentor. Dr. Lasagna's vision for CSDD - to serve as an academic source of scholarly analysis and interpretation that would raise the intellectual level of debate on questions of public policy and bioinnovation - remains our guiding principle today. The Lasagna Library is a unique repository for relevant literature, one-of-kind documents, and economic, scientific, legal, and political reports. It serves as a vital resource not just for CSDD research staff, but also for the broader Tufts community and external interests worldwide.


This fall, CSDD established and launched the Louis Lasagna Library Fund, to ensure that the Lasagna Library may sustain its efforts to collect, maintain, and disseminate information crucial to all stakeholders involved in the development, regulation, and utilization of new medicines. I encourage you to learn more about the Lasagna Library, and to consider contributing to the Library Fund. For more information, see our website, or feel free to contact me or Sandra Peters directly.


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


Kenneth I Kaitin, Ph.D.
Professor and Director
Louis Lasagna Library embraces the new global digital age

Over the nearly four decades since its founding, Tufts CSDD has amassed a formidable collection of one-of-a-kind documents and letters, as well as articles and reports covering the full spectrum of the bioinnovation landscape, from translational research and clinical trials to intellectual property, regulation, and marketing. This material is housed in Tufts CSDD's Louis Lasagna Library of Drug Development Science and Policy, a unique resource for information on pharmaceutical and biopharmaceutical R&D.


As the Louis Lasagna Library's Director of Library Services, I am responsible for fielding the over 1,000 information requests we receive each year from individuals in industry, academia, regulatory agencies, the media, service providers, law firms, consultancies, and venture capital. In addition, I serve the research needs of the CSDD faculty and staff, as well as those of the broader Tufts community. It's a challenging but enormously rewarding endeavor.


The Louis Lasagna Library is located in Tufts CSDD, at 75 Kneeland Street in Boston, MA.  If you are in the area please let us know - we'd be delighted to introduce you to our collection.  


I'm also excited to announce that we are undertaking a major initiative to improve the overall functioning of the Louis Lasagna Library.  For example, we plan to inventory and catalog reference material, making it available in virtual format to the extent that copyright law allows. Our goal is to increase patron access and awareness of the collection itself, thereby expanding the global footprint of the library. To assist with the cost of this new initiative, we have established the Louis Lasagna Library Fund to allow individuals, corporations, and foundations to financially support this important endeavor.


For more information about the Louis Lasagna Library and Library Fund, click here. Going forward, be on the lookout for changes to our library web pages. Our initial goal is to transform the current CSDD Bibliography - a 79 page downloadable PDF file - into an indexed, searchable, web-based document. . . Stay tuned! 


Sandra Peters


Recent Tufts CSDD Reports   


Tufts CSDD Impact Reports  

Tufts CSDD R&D Management Report

Research Participation 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 Fully-Loaded Sponsor and CRO Costs
  • Post-Approval Evidence Collection and Utilization Challenges
  • Social Media in Clinical Research Standard Practices and Policies
Sponsored Research
  • FDA Review Division Performance Evaluation Project
  • Profiling Progressive Initiatives Improving Drug Development Performance and Efficiency
  • Quantifying the Impact of Generic Manufacturers on State Economies
  • Review and Analysis of Recently Approved Personalized Medicines and Those in Late-Stage Development

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, Milne C-P. Is the increasing cost of treating rare diseases sustainable? Expert Opinion on Orphan Drugs 2013;1(8):581-583.


DiMasi JA. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications. Clinical Therapeutics 2013;35(6):808-818.


DiMasi JA, Reichert JM, Feldman L, Malins A. Clinical approval success rates for investigational cancer drugs. Clinical Pharmacology & Therapeutics 2013;94(3):329-335.


Getz KA. Lifting up a fragmented study conduct landscape. Applied Clinical Trials 2013;22(7/8):22,24.


Getz KA, Kim J, Stergiopoulos S, Kaitin KI. New governance mechanisms to optimize protocol design. Therapeutic Innovation & Regulatory Science 2013.[Published online before print on July 10, 2013]


Malins A, Milne CP. Population dynamics, demographics, and disease burden of infants and children across the world. In: Mulberg AE, Murphy D, Dunne D & Mathis LL, eds. Pediatric Drug Development. 2nd ed. Singapore: John Wiley & Sons, Inc.;2013:16-36.  


Milne CP. On the partnering path from the US to Asia: how far, how fast for university-industry collaborations? Pharma Focus Asia 2013;(18):40-45.

Milne CP, Malins A. Pharmaceutical economics and market access for pediatric medicines. In: Mulberg AE, Murphy D, Dunne D & Mathis LL, eds. Pediatric Drug Development. 2nd ed. Singapore: John Wiley & Sons, Inc.;2013:37-56.


Stergiopoulos S, Kim J, Getz KA. Characterizing the cost of non-clinical development activity: understanding a critical R&D segment. Contract Pharma 2013;15(5):70-73.

Staff Presentations   
Selected presentations given or scheduled to be given by Tufts CSDD staff


Ken Getz: Achieving Protocol Optimization and Simplification, The Conference Forum, Boston, MA, Sep. 18


Ken Getz: Strategic Outsourcing to address a Changing Landscape, ACP-LS Annual Meeting, Philadelphia, PA, Sep. 19


Ken Kaitin: IIR Clinical Collaboration Congress (keynote and meeting chair), Boston, MA, Sep. 25-27



Ken Getz: National Perspectives and Opportunities in Recruitment and Retention, CCTSI Research Ethics Conference, Denver, CO, Oct. 3-4


Ken Kaitin: Xconomy Healthcare Summit, Lincoln, MA, Oct. 15


Ken Getz: Optimizing Drug Development Performance, CenterWatch Conference, Las Vegas, NV, Oct. 16-18


Joshua Cohen: Business of Biosimilars, IIR Conference, Boston, MA, Oct. 17


Mary Jo Lamberti: Benchmarking Patient Recruitment and Retention Practices, Clinical Trial Optimization Conference, Bethesda, MD, Oct. 21-23


Ken Getz: Characterizing a Changing Global Clinical Research Enterprise, Gothenburg, Sweden, Oct. 22-25



Ken Getz: Defining the New Landscape for Clinical Supplies, ISPE Annual Meeting, Washington, DC, Nov. 4-6


Joseph DiMasi: Drug Development Boot Camp, Harvard University Office of Technology Development and Spied & Associates, Boston, MA, Nov. 21


Ken Getz: Drug Development Landscape Changes Driving New Collaborative Alliances, ASAP Annual Meeting, Boston, MA, Nov. 21-22

I N   T H I S   I S S U E
FYI. . .

Paulami Naik 

Welcome to Ms. Paulami Naik, who joined the Tufts Center staff as a Research Analyst this past July. Paulami can be reached at paulami.naik@tufts.edu.

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 Tufts CSDD in the News
Over the past quarter, CSDD research and faculty quotes have been cited in over 35 news sources, including Forbes, the Chicago Tribune, Bloomberg News, The Pink Sheet, the Boston Business Journal, FierceBiotech Research, and Pharmaceutical Executive.
Quote of the Quarter

"The skills and logistical coordination needed to drive today's drug development programs are often too complex for individual research organizations to tackle in isolation," Tufts CSDD Director Kenneth Kaitin said in a statement. "While best practices are still evolving, the encouraging news is that new, collaborative approaches to drug development will likely lead to innovative new medicines reaching the market faster and in greater numbers than we've seen in the past."


Industry-Academic Partnerships Could Help Propel Metabolic Disease Research

FierceBiotech Research 

August 20, 2013



Kenneth I Kaitin, PhD 
Professor and Director

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

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

Richard I. Shader, MD
Professor Emeritus, Department of Integrative Physiology and Pathobiology, Professor Emeritus, Department of Psychiatry
Mary Jo Lamberti, PhD
Senior Project Manager
Stella Stergiopoulos, BA
Project Manager
Abigail Felix, BA
Research Analyst
Paulami Naik, MSPH
Research Analyst
Sandra Peters, MLIS
Information Services Librarian
Christina Coffin, MLIS
Library Assistant
Tufts CSDD
617.636.2170 | csdd.tufts.edu