KenKaitinphoto I'm pleased to send you our third Tufts CSDD Quarterly Update of 2009, highlighting research and other activities going on at Tufts CSDD. I hope you find this quick-read, electronic version of the update informative and useful. We have had a very busy summer, with ongoing and new research projects, staff presentations, and preparations for fall courses and programs. I'm also thrilled with the enormous popularity and success of our Tufts CSDD Executive Forum series. Don't miss out on your chance to be part of this unique program. Join today!
I deeply appreciate your support of Tufts CSDD.  As always, we welcome your feedback and encourage you to send us your ideas.  

Kenneth I Kaitin, Ph.D.
Professor of Medicine
Professor of Pharmacology and Exp. Therapeutics

Tufts CSDD Impact Reports
main findings from the September/October 2009 issue:

Marketing exclusivity for first-in-class drugs has shortened to 2.5 years
  • Marketing exclusivity periods for first-in-class drugs have fallen dramatically in recent decades.

  • The average time between the first and second follow-on drugs in a class fell even more rapidly.

  • The vast majority of follow on drugs had initial pharmacologic testing and were in clinical studies prior to approval of the first-in-class drug.

  • The findings contained in this Tufts CSDD Impact Report underscore the highly competitive nature of pharmaceutical development, and highlight the fact that drug companies are more often engaged in development races than in after-the-fact imitation.
Want to read more? Subscribe today.
Sponsored Research: Multi-Company Studies  

Mapping the Market for Centralized Cardiac Assessment Services
Examine market trends, attitudes, perceptions and use of centralized ECG services

Sponsor and CRO Clinical Research Task Economics
Developing and applying accounting methods to accurately compare the 'true' economics of performing clinical research tasks using internal or contract resources

The Global Investigative Site Landscape
Mapping the size and operating structure of the global investigative site community

Evaluating Program Complexity and Its Impact on Development Program Return on Investment
Measuring clinical program complexity and its affect on drug development program cost and performance (e.g. budgets, cycle time, and success rates)

Assessing the Incidence and Impact of Protocol Amendments
Quantifying the incidence of protocol amendments, their root causes and cost to resolve, and identifying measures to prevent them in the future

Email us for additional information about Commissioned Research Projects.
Upcoming Programs and Events

T u f t s   C S D D  p r e s e n t s
Neglected Diseases in the Developing World:
Progress, Current Challenges, and Promising Approaches

October 16, 2009
Dirksen Senate Office Building, Room SD-562
Washington, DC

Confirmed speakers include:
Dr. Mary Moran, The George Institute for International Health
Dr. Joshua Cohen, Tufts Center for the Study of Drug Development
Dr. Michael Reich, Harvard University - School of Public Health
Dr. David Ridley, Duke University
Dr. Lorenzo Savioli, World Health Organization

For more information, please contact Charlene Neu at 617.636.2187 or charlene.neu@tufts.edu
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Tufts CSDD Executive Forum
An ongoing program of highly interactive, one-day roundtables for senior R&D leaders, hosted by the Tufts Center for the Study of Drug Development, and created in response to industry concerns that there were few opportunities for senior pharma and biopharma leaders to meet in a neutral venue to exchange information, discuss industry trends, and network with colleagues. For more information or to register, click here or contact Charlene Neu at 617 636 2187 or charlene.neu@tufts.edu
Upcoming roundtables:
  • November 12, 2009 - Comparative Approaches To Capacity Forecasting
  • February 25, 2010 - Improving ROI and Late Stage Clinical Success Rates

  • May 13, 2010 - Strategies for Managing Drug Development Risk: Maintaining, Portfolio Diversity 

  • September 16, 2010 - Outsourcing Strategies Across the Value Chain

  • November 4, 2010 - Strategies for Optimizing the Drug Development Process: Translational Science, New Technologies, and Clinical Design Improvements
Tufts CSDD R&D Management Reports highlight roundtable discussions and are sent to all Tufts CSDD Executive Forum members following the event.
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Leadership For Drug Development Teams: Developing Effective Leadership and Cross-Functional Teamwork Skills For Pharma and Biopharm Professionals
October 19 - 21, 2009
Boston, MA

Now in its eighth year, this three-day, hands-on learning program is designed in collaboration with R&D leaders from every segment of the industry. The course features group discussions and team building exercises, as well as presentations by industry and academic leaders. Click here for more information and to register.
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Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation
February 8-12, 2010 
Boston, MA

This five-day, CME-accredited program, taught by an esteemed faculty of academic, regulatory, and industry leaders, focuses on clinical trial design, the regulatory process, drug safety and pharmacovigilance, clinical trial ethics, compliance, drug-device combinations, outcomes research, epidemiology, and information technology in clinical development. Further details and registration information will be available on our website as we get closer to the course dates.
Tufts CSDD Recent Publications 

Getz KA  Zuckerman R  DiMasi JA  Kaitin KI. Drug development portfolio and spending practices after mergers and acquisitions. Drug Information Journal 2009;43(4):493-500 http://www.nxtbook.com/nxtbooks/dia/druginformationjournal0709/#/118 [RS 2916]

Cohen J. Market access in the wake of NICE: biopharma's friend or foe?  European Pharmaceutical Review 2009;#48:8-12 http://csdd.tufts.edu./_documents/www/Doc_233_7909_826.pdf [RS 2915]

Cohen J  Wilson A  Faden L. Off-label use reimbursement. Food and Drug Law Journal 2009;64(2):391-403 [RS 2914]

Reichert JM. Global antibody development trends. mAbs 2009;1(1):86-7  http://csdd.tufts.edu./_documents/www/Doc_233_7905_826.pdf [RS 2911]
I N   T H I S   I S S U E
Tufts CSDD Impact Reports
Sponsored Research: Multi-Company Studies
Upcoming Programs and Events
Tufts CSDD Recent Publications
FYI. . .
Our next Tufts CSDD Executive Forum roundtable will be held on Thursday, November 12, from 10:00 a.m. to 4:00 p.m. at our offices at 75 Kneeland Street, Suite 1100, Boston, MA. The topic: Comparative Approaches to Capacity Forecasting. Space is limited; register today!
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Neglected Diseases in the Developing World Forum, Washington DC, October 16.  Dr. Christopher-Paul Milne and Dr. Joshua Cohen will be presenting at a Tufts CSDD sponsored Capitol Hill Forum on progress being made to develop effective treatments for neglected diseases.
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Our most recent Tufts CSDD Executive Forum roundtable, held on September 10, focused on Best R&D Practices, and featured presentations by Merck, Covance, Biogen Idec, Pfizer, and Tufts CSDD.

 Tufts CSDD in the News
Selections from second quarter 2009

Boston Globe
September 9, 2009
Tufts: Marketing exclusivity for new drugs is shorter

"Marketing exclusivity periods for first-in-class drugs have fallen from a median of 10.2 years in the 1970s to 2.5 years in the early part of this decade, the Tufts Center for the Study of Drug Development said in a new study."

FDA News
September 9, 2009
Tufts sees drug companies building R&D pipeline

"Major drug companies are taking steps to deal with revenue drops coming as products go off patent by building up their pipelines of developing drugs, according to an analysis by the Tufts Center for the Study of Drug Development reported in the center's latest Impact Report."

Investor's Business Daily
August 26, 2009
Another Attack On Big Drugmakers

"The cost, according to research from Tufts University, is $1.3 billion per drug. And only three of every 10 drugs that make it to the market recoup [average] R&D costs."

Financial Tiimes
August 14, 2009
Remedy for a malady

"Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, which produced the $1bn per drug cost estimates, says: 'The industry has been talking about [R&D process improvements] for years, but there were never the drivers that there are now.'

Med City News
July 28, 2009
Kendle International realigns executives to drive innovation, productivity, efficiency

"A majority of all clinical trials are done overseas, according to a study published in February in the New England Journal of Medicine. Kendle cited Tufts Center for the Study of Drug Development research stating up to 65 percent of FDA-regulated clinical trials will, in the next three years, be conducted outside the United States with many moving to Asia."

Howe Street
July 20, 2009
How to Take the Risk Out of Biotech Investing

"It's ... incredibly expensive to bring a new drug to the Food and Drug Administration for approval. In fact, pharmaceutical spending in 2007 was an incredible $45 billion, according to Tuft's Center for the Study of Drug Development."


Kenneth I Kaitin, PhD
Director, Professor of Medicine, Professor of Pharmacology and Exp. Therapeutics

Christopher-Paul Milne, DVM, MPH, JD
Associate Director

Joseph A. DiMasi, PhD
Director of Economic Analysis

Joshua P. Cohen, PhD
Senior Research Fellow

Kenneth A. Getz, MBA
Senior Research Fellow

Janice M. Reichert, PhD
Senior Research Fellow

Richard I. Shader, MD
Senior Research Fellow & Medical Consultant

Peg Hewitt, MS, L&IS
Research Librarian

Tufts CSDD