| As we enjoy the start of the summer season, I am pleased to introduce our new Tufts CSDD Quarterly Update. In the spirit of "going green", we've developed this quick-read, electronic version of our Quarterly Update, describing research and other activities going on at Tufts CSDD. Looking to the second half of 2009, we have a large number of research studies that we're working on, focusing on an array of regulatory, economic, and operational issues. We're also very excited about the enormous success of our Tufts CSDD Executive Forum series, now in its second year. Feedback on our second roundtable of 2009, held May 14, was overwhelmingly positive. A Tufts CSDD R&D Management Report, summarizing the main discussion points of the meeting, will be sent to participants within the next few weeks. Our last two roundtables of 2009 will be held September 10 and November 12. Finally, I want to call your attention to a host of very exciting multi-company commissioned projects that we're currently working on at the Tufts Center. Some of these projects are listed below. Thanks to all the companies who are participating in these studies.
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.
Director and Professor of Medicine
|Tufts CSDD Impact Reports
main findings from the May/June 2009 issue:
Therapeutic peptides in clinical study
in 2000-07 nearly doubled 1990s rate
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- The average annual number of therapeutic peptides entering clinical study in the 2000-07 period nearly doubled, to 16.9 from 9.7 during the 1990s.
- During 2000-07, new peptides entering clinical development were most frequently studied as treatments for metabolic (26%) indications, one of 15 therapeutic areas in which peptides were being developed.
- Average total clinical study and FDA approval time for new therapeutic peptides was 10.8 years.
- Efficacy issues and commercial considerations were most often cited as reasons for discontinuing clinical studies of new therapeutic peptides.
Sponsored Research: Multi-Company Studies
Underway or Recently Completed:
Impact of Protocol Complexity on Clinical Trial Success
Examine protocol design trends and assess the impact of changes on clinical trial performance
Benchmarking the Regulatory Affairs Function
Define and benchmark different operating structures, work load, staff responsibilities, and performance of the regulatory affairs function
Measuring the Incidence and Impact of Sponsor-CRO Relationship
Quantify the incidence of large and small pharmaceutical and biotechnology company use of transactional, full service provider, and alliance-based outsourcing relationships, and assess their impact on project cycle time and collaboration effectiveness
Mapping the Market for Centralized Cardiac Assessment Services
Examine market trends, attitudes, perceptions and use of centralized ECG services
Comparing Sponsor and CRO Clinical Research Task Economics
Develop and apply accounting methods to accurately compare the economics of performing clinical research tasks using internal or contracted resources
Mapping the Global Investigative Site Landscape
Map the size and structure of the global community of investigative sites and characterizing operating structures, infrastructure and clinical trial experience
Evaluating Program Complexity and Its Impact on Development Program Return on Investment
Measure clinical program complexity and its affect on drug development program cost and performance (e.g. budgets, cycle time, and success rates)
Email us for additional information about Commissioned Research Projects.
|Upcoming Programs and Courses
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 email@example.com
2009 Topics and Schedule:
2010 Topics and Schedule:
- September 10
Best R&D Practices of Top Pharma/Biotech Performers
- November 12
Comparative Approaches To Capacity Forecasting
Tufts CSDD R&D Management Reports highlight roundtable discussions and are sent to all Tufts CSDD Executive Forum members following the event.
- February 25
Improving ROI and Late Stage Clinical Success Rates
- May 13
Strategies for Managing Drug Development Risk: Maintaining Portfolio Diversity
Outsourcing Strategies Across the Value Chain
Strategies for Optimizing the Drug Development Process: Translational Science, New Technologies, and Clinical Design Improvements
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Leadership For Drug Development Teams: Developing Effective Leadership and Cross-Functional Teamwork Skills For Pharma and Biopharm Professionals
October 19 - 21, 2009
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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation
February 7-12, 2010
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
DiMasi JA Faden L Factors associated with multiple FDA review cycles and approval phase times. Drug Information Journal 2009;43:201-25
http://www.nxtbook.com/nxtbooks/dia/druginformationjournal0309/#/104 [RS 2906]
Reichert JM. Monoclonal antibodies as innovative therapeutics. Current Pharmaceutical Biotechnology 2008 Dec;9(6):423-30 http://www.benthamdirect.org/pages/b_viewarticle.php [RS 2902]
Cohen J Faden L Getz K. Mapping biopharmaceutical innovation and diffusion: how the second translational block (T2) shapes drug diffusion. The Open Pharmacology Journal 2008;2:89-106 http://www.bentham.org/open/topharmj/openaccess2.htm [RS 2903]
Milne C-P. Fixing the paradigm for biopharmaceutical R&D: where to start? International Journal of Biotechnology 2008;10(5):404-15 http://www.inderscience.com/browse/index.php?journalID=4&year=2008&vol=10&issue=5 [RS 2832]
|The third Executive Forum roundtable of 2009 will be held Thursday, September 10. The topic: Best R&D Practices of Top Pharma/Biotech Performers.
Director Ken Kaitin has been named Chair of the External
Advisory Board for the Tufts University Clinical and Translational
Science Institute (CTSI).
Janice Reichert has been named Editor-In-Chief of mAbs, the
first international peer-reviewed journal of its kind to focus
exclusively on monoclonal antibodies. The premiere issue of mAbs was
published in January.
. . . . . . . . .Tufts CSDD hosted a briefing by Colonel David Williams and other members of the Department of Defense's Chemical Biological Medical System Command.
. . . . . . . . .Tufts
CSDD continues its efforts to "Go Green" by changing to this electronic format for our Tufts CSDD Quarterly Update, and by encouraging you to sign up to receive your Tufts CSDD Impact Reports electronically as well.
Featured in the News
|Selections from first quarter 2009
Rebooting the FDA
Fortune Magazine (Tech Daily online feature)
April 3, 2009
Failed Trials Can Spell Startup Disasters
Mass High Tech
March 20, 2009
CSDD: The Future of the American Medicine Cabinet
March 19, 2009
March 10, 2009
Outsourcing of Drug Trials Is Faulted
The New York Times
February 19, 2009
Number of Targeted Therapeutics Awaiting FDA Approval on the Rise
American Medical News
February 9, 2009 (on-line) February 16, 2009 (print)
Level of FDA drug approvals in '08 called disappointing
January 6, 2009
Kenneth I Kaitin, PhD
Director and Professor of Medicine
Christopher-Paul Milne, DVM, MPH, JD
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