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Journalist and author Sebastian Junger called it a Perfect Storm, when three major weather-related phenomena converged off the coast of Massachusetts in 1991 to create a cataclysmic and perilous tempest. As we get ready to usher in the new year, some within the research-based industry might conclude the expression aptly describes 2010.Strong economic, regulatory, and political forces have converged, pressuring companies to critically re-examine old R&D practices and explore new paradigms for developing novel and more effective medicines. 

I'm proud to say that Tufts CSDD, through its research, publications, teaching, workshops, forums, and courses, remains a committed partner to all stakeholders in innovation, helping to meet the formidable challenges of the current environment and improve the process of bringing new medicines to market. Together we can work to make 2011 a productive and successful year.


On behalf of all of us at Tufts CSDD, we wish you a very joyous holiday season and a fulfilling, happy, and peaceful 2011.

Kenneth I Kaitin, Ph.D.
Director and Research Professor

Tufts CSDD Publications and Reports

Tufts CSDD Outlook 2011
Coming in January! Tufts CSDD's Outlook 2011: Tufts CSDD's annual compendium highlighting near-term pharmaceutical and biopharmaceutical development, regulation, and marketing trends. The data and Outlook2011shdwanalyses contained in Tufts CSDD Outlook 2011 are based on proprietary research conducted by the Tufts CSDD research staff and insights into current industry, regulatory, and policy trends. Specific areas covered include:
  • R&D Efficiency
  • Regulatory Environment
  • Biotechnology Trends
  • Prescription Drug Policy
  • Drug Development Management Trends

Tufts CSDD's Outlook 2011 will be available in early January 2011. Click here for more information. E-mail us to request to be added to our mailing list.

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Tufts CSDD Impact Reports
This bimonthly publication presents data, analyses, and insights on critical drug development and regulatory issues. Go to novdec10IRshdwTufts CSDD Impact Reports on our website for more information and to subscribe.

Personalized medicine is playing a growing role in development pipelines, November/December 2010
Since the unraveling of the human genome, pharmacogenomic research has influenced the growth of personalized medicine. This Tufts CSDD Impact Report summarizes the Tufts Center's study of nearly two dozen companies that are on the front lines of this new field.

Commissioned Research & Multi-Company Studies
  • Benchmarking Preclinical through Early Clinical Drug Development
  • Global Landscape for Study Monitoring
  • Sponsor-Site Relationship Quality and Effectiveness
  • Clinical Supplies Market Analysis
  • Electronic Medical Records & Health IT Solutions: Planning, Management, and Execution
  • Patient Recruitment and Retention Practices
Tufts CSDD's new Multi-Company Studies series is based on a unique working group format that convenes top pharmaceutical and biotech companies and service providers to harvest and review robust and reliable data on critical drug development issues. For more information on Tufts CSDD's Multi-Company Studies series, contact Robert Chung at Tufts CSDD via email or telephone (617.636.2187).
Upcoming Programs and Events

38th Annual Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation

February 7-11, 2011, Boston, MA
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Now in its 38th year, the Tufts CSDD Postgraduate Course remains the only course that cross-links the topics of clinical pharmacology, trial design and the regulation of new drugs and biologics. Taught by leading experts from industry, FDA, and academia, this CME-accredited course is a comprehensive program in clinical pharmacology, drug development, and product regulation.

Visit our website for more information and to register.

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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 CSDD, and developed 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 for roundtables, go to Tufts CSDD Executive Forum on our website or contact Stella Stergiopoulos at 617-636-0322 or via email.

Upcoming Tufts CSDD Executive Forum roundtable:
Managing Global Investigative Sites for Peak Operational Efficiency, February 24, 2011, Boston, MA
Discussion will focus on strategies and practices currently being implemented to improve global investigative site performance and operating efficiency.
After each roundtable, Tufts CSDD Executive Forum members receive the Tufts CSDD R&D Management Report, which provides highlights of the roundtable presentations and discussion.
Tufts CSDD Recent Publications 

Kaitin KI, Milne CP. Impact of the New US Healthcare Reform Legislation on the Pharmaceutical Industry: Who are the Real Winners? Clinical Pharmacology & Therapeutics 2010;88:589-592; doi:10.1038/clpt.2010.167

Nelson AL, Dhimolea E, Reichert JM. Development Trends for Human Antibody Therapeutics. Nature Reviews Drug Discovery 2010;9(10):767-774

Reichert JM. Metrics for Antibody Therapeutics Development. MAbs 2010 Nov 30;2(6):695-700

Cohen JA, Looney W. What is the Value of Oncology Medicines? Nature Biotechnology 2010; 28:1160-1164

Zuckerman R, Getz K, Kaitin KI. A New Mechanism for Tracking Publicly Available Study Volunteer Demographics. Drug Information Journal 2011;45(1):53-62
Staff Presentations 
Presentations given or scheduled to be given by Tufts CSDD staff

Joshua Cohen: EMAUD conference on global market access, Sorbonne, Paris, December 3, 2010

Ken Getz: NHLBI program on Clinical Research Landscape, Bethesda, December 7-8, 2010

Christopher Milne: Best Practices in Phase IV Research, NextLevelPharma, Barcelona, December 8-9, 2010

Joshua Cohen: Diabetes & Obesity Medication Regulatory Challenges and Reimbursement, NextLevelPharma, Amsterdam, January 26-27, 2011

Kenneth Kaitin: 2011 Cotton Lecture, University of Mississippi, February 15, 2011

Kenneth Kaitin: Molecular Medicine Tri-Conference, San Francisco, February 23, 2011
I N   T H I S   I S S U E
Tufts CSDD Publications and Reports
Commissioned Research & Multi-Company Studies
Upcoming Programs and Events
Tufts CSDD Recent Publications
Staff Presentations
FYI. . .
Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation, February 7-11, 2011
Reserve your spot for this highly regarded five-day course. Click here for more infomation and to receive special, limited-time only early bird rates.
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Peg Hewitt, Tufts CSDD's research librarian for over 17 years, retired from her post in October. We bid Peg farewell with warm congratulations, and thank her for her years of extraordinary service.
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Tufts CSDD is proud to announce that Center director Ken Kaitin has been selected to deliver the 2011 "Cotton Lecture", an endowed lectureship at the University of Mississippi, on February 15.
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Tufts CSDD associate director Chris Milne presented the findings of a recently released Tufts CSDD Impact Report at the sixth annual personalized medicine conference in Boston hosted by Harvard's Medical and Business schools.
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Tufts Center director Ken Kaitin has been appointed Editor-in-Chief of the peer-reviewed journal Expert Review of Clinical Pharmacology.
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Tufts CSDD is now on Twitter and Facebook!
Stay informed about upcoming forums & courses, promotional specials on our various publications, the latest press releases and more! Follow us today:

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 Tufts CSDD in the News
Selected excerpts from recent articles

GenomeWeb Daily News

November 18, 2010
FDA's Companion Dx Guidance Slated for Early 2011

Most pharma companies believe that "biomarkers make it easier to make go/no-go decisions and that personalized medicine is a natural trajectory for the direction that advances in science and medicine were taking drug R&D," said Christopher-Paul Milne, associate director at the Tufts Center for the Study of Drug Development.

New York Times
November 16, 2010
Drug Companies Pursue Personalized Medicine Approach

Pharmaceutical companies are now actively pursuing personalized medicine, according to a new report from the Tufts
Center for the Study of Drug Development at Tufts University. "They are really going at this whole hog,'' said Christopher-Paul Milne, associate director at the Tufts Center..."They are basically transitioning the way they do development into a personalized medicine approach.''

FDA news
October 29, 2010
Patent Expirations Mean Changes in Drug Development Landscape

While an estimated $125 billion of patent-protected drug revenue is at risk in the next few years, replacements in the drug development pipeline pale in comparison to existing blockbusters. As a result, the current drug development landscape will require major changes in how clinical research is conducted, Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development, says.

Los Angeles Times
October 9, 2010
Under Obama, a reinvigorated FDA

The FDA has long been seen by consumer groups as too slow, too entangled in its own bureaucracy, and too cozy with the industries it was supposed to regulate. Now, "I think the general approach has clearly been more warning letters, more regulatory activity, and a much more rigorous approach to regulating products on the market," said Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development.


Kenneth I Kaitin, PhD
Director and Research Professor

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

Joseph A. DiMasi, PhD
Director of Economic Analysis

Joshua P. Cohen, PhD
Research Assistant Professor

Kenneth A. Getz, MBA
Senior Research Fellow

Janice M. Reichert, PhD
Research Assistant Professor

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

Tufts CSDD
617.636.2170 | csdd.tufts.edu