F O U R T H   Q U A R T E R   2 0 1 3
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From the Director


Welcome to our fourth Tufts CSDD Quarterly Update of 2013. In it you will find an overview of current Center research, recent publications, staff presentations, and other news. As 2013 comes to a close, I look back with pride over all that the Center has accomplished this past year: 33 publications (including 19 peer-reviewed articles, two book chapters, and one white paper); four dynamic and productive CSDD Executive Forum Roundtables; an extraordinary number of staff presentations at conferences, companies, academic institutions, and government-sponsored events; numerous staff honors; and an astonishing number of references to CSDD research in the general media and trade press, as well as published interviews with and quotes by Center staff.


2013 also saw the rollout of the Louis Lasagna Library Fund, created to help sustain the Center's Louis Lasagna Library of Drug Development Science and Policy. A unique repository for relevant literature, one-of-a-kind documents, and authoritative reports, the Louis Lasagna Library collects, maintains, and disseminates information crucial to all stakeholders involved in the development, regulation, and utilization of new medicines. The Louis Lasagna Library Fund was created to ensure that the Louis Lasagna Library continues to serve as a crucial resource not just for the Tufts community, but for external interests worldwide.


This past year, we also celebrated an important CSDD milestone; in February we held our 40th annual Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation. This perennially popular, CME-accredited, 5-day program, which I have the privilege to co-direct with my colleague Dr. Richard Shader, is designed to provide a fundamental overview of the pharmaceutical development landscape. I believe that the continued relevance and popularity of the program is a testament to the vision and commitment to education of the course's founder, Dr. Louis Lasagna. Plans are well underway for our 41st program, scheduled for February 3-7, 2014 in Boston, and I'm pleased to report that enrollment has been robust.


It's been a wonderfully productive and fulfilling year for us here at CSDD, and I'm looking forward to an equally successful 2014. On behalf of all of us at the Tufts Center, I wish you and yours a very happy, healthy, and peaceful holiday season. And as always, I thank you for your support.




Kenneth I Kaitin, Ph.D.
Professor and Director
Recent Tufts CSDD Reports


Tufts CSDD Impact Report: 

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

  • Evaluating the Impact of Integrated Outsourcing Relationships on Performance and Quality
  • Measuring the Adoption of eClinical Solutions and Standards
  • Social Media in Clinical Research Standard Practices and Policies 

Sponsored Research

  • Challenges Facing Biosimilar Uptake
  • Impact of Reimbursement on Innovation
  • Mapping Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings  
  • Personalized Medicine Landscape 
Email us for additional information about sponsoring research at Tufts CSDD or participating in one of our Multi-Company Working Groups.
Latest CSDD Publications   


Getz KA. Leveraging pharmacists as a channel to raise clinical research literacy among patient communities. Applied Clinical Trials 2013;22(10):30-33. 


Getz KA, Campo R. Drug development study designs have reached the danger zone. Expert Review of Clinical Pharmacology 2013;6(6):589-591.


Kaitin KI, Honig PK. Guest editors. (Includes: Kaitin KI and Honig PK, editorial. Reinventing bioinnovation, pp 279-283) Clinical Pharmacology and Therapeutics 2013;94(3).


Lamberti MJ, Naik P, Stergiopoulos S, Kim J, Getz KA. Characterizing the global market for Contract R&D Services. Chimica Oggi [Chemistry Today]: Monograph Supplement Series CROs/CMOs 2013;31(4):9-13.


Milne CP. Prospects for rapid advances in the development of new medicines for special medical needs. Clinical Pharmacology & Therapeutics 2013. [Published online before print on October 30, 2013]

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



Joshua Cohen: NSURE Paradigm - Facilitating Prescription to Over-the-Counter Switches, Brookings Institution, Washington, DC, Nov. 4, 2013


Christopher-Paul Milne: Analytical Life Science & Diagnostics Association (ALDA) Service Executives Annual Meeting, Boston, MA, Nov. 12, 2013


Kenneth Kaitin: Northeastern University's Open Classroom Public Forum, Boston, MA, Nov. 20, 2013



Christopher-Paul Milne: Pharma Value and Growth through Academic-Industry Partnering, Copenhagen Business School, Denmark, Dec. 3, 2013


Joseph DiMasi: Janney Montgomery Scott Annual Investor Meeting, New York, NY, Dec. 4, 2013



Kenneth Kaitin: American Course in Drug Development and Regulatory Science (ACDRS-UCSF), Washington, DC, Jan. 7, 2014


Mary Jo Lamberti: CROWN Clinical Operations Summit, Philadelphia, PA, Jan. 22-23, 2014


Ken Getz: SCOPE Conference, Miami, FL, Feb. 4-6, 2014

Kenneth Kaitin: PhRMA's Annual Patient Advocacy Retreat, Annapolis, MD, Feb. 10, 2014


Ken Getz: R&D Leadership Summit, Boca Raton, FL, Feb. 10-11, 2014

Ken Getz: Clinical Trials Canada, Ontario, Canada, Feb. 27, 2014


Mary Jo Lamberti: Patient Adherence & Advocacy Summit, Philadelphia, PA, Feb. 27-28, 2014 

I N   T H I S   I S S U E
FYI. . .
CSDD is pleased to announce the recent promotions of Dr. Mary Jo Lamberti, from Senior Project Manager to Senior Research Fellow, and Ms. Stella Stergiopoulos, from Project Manager to Senior Project Manager. Congratulations!
. . . . . . . . .

Ranjana Chakravarthy
Research Analyst
Jesse Moskowitz
Research Analyst

This fall, Tufts CSDD welcomed Ms. Ranjana Chakravarthy and Mr. Jesse Moskowitz to the staff as Research Analysts.
. . . . . . . . .

We are excited to announce the appointment of Ronald Evens, PharmD, FCCP as Adjunct Faculty and Biotechnology Consultant to the Center.
. . . . . . . . .

Registration for Tufts CSDD's 41st Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation (February 3-7, 2014) is underway. Enrollment is limited, so register today.
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 Tufts CSDD in the News
Over the past quarter, CSDD staff have been quoted and their research cited in over 30 news sources, including the Los Angeles Times, Forbes, The Pink Sheet, Boston.com, FierceBiotech, and the Washington Drug Letter.
 Quote of the Quarter
"Ten years of research at the Tufts Center has informed the identification of key opportunities [in curtailing protocol complexity in clinical trials]. But our research is centered around a very simple concept: Everything we do to simplify study design will ultimately improve performance, quality, cost, and efficiency. It's an unusual win-win." (From an interview by associate web editor Mia Burns with Ken Getz, Director of the Sponsored Research Program at Tufts CSDD.)

Drugs.com and Pharmalive
October 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

Ronald Evens, PharmD, FCCP
Adjunct Faculty and Biotechnology Consultant with Tufts CSDD


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
Abigail Felix, BA
Research Analyst
Jesse Moskowitz, BS
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