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  FIRST QUARTER 2011

KenKaitinphotoI'm delighted to present our first Tufts CSDD Quarterly Update of 2011, highlighting current research, publications, programs, news, and other activities over the past three months. It's been a busy first quarter for Tufts CSDD, with several new projects getting underway, many projects ongoing, the usual large number of staff presentations, our first Tufts CSDD Executive Forum roundtable of 2011, and a very successful running of our annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation - our 38th Annual program! 

 

Our Tufts CSDD Executive Forum roundtable, held February 24th, focused on Managing Global Investigative Sites, and included speakers from Sanofi-Aventis, Quintiles, Astellas, Genentech-Roche, as well as CSDD's own Ken Getz and Mary Jo Lamberti, who presented findings from a recently completed Center study on the topic. The discussion was extremely lively and productive. A Tufts CSDD R&D Management Report, highlighting the speaker presentations and discussion points, will be available in the next few weeks.  

 

Tufts CSDD's annual Postgraduate Course was held February 7-11 at the Taj Hotel in Boston, and was well received by the students enrolled in the program. We were delighted, once again, to have Rear Admiral Sandra Kweder, Deputy Director of FDA's Office of New Drugs, discuss current challenges within the agency and participate in an informal Q&A. This year's program also included new lectures on health literacy, the use of epidemiology in drug development, and health informatics. Plans are already underway for our 39th annual Postgraduate Course.   

 

The year 2011 represents a major milestone for Tufts CSDD - our 35th Anniversary! Founded in 1976 by Dr. Louis Lasagna at the University of Rochester, the Center remains committed to providing strategic information to help all stakeholders - including drug developers, regulators, and policy makers - improve the efficiency and productivity of pharmaceutical R&D. We greatly value your commitment and support, and, as always, I welcome your feedback.

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

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

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Tufts CSDD's 38th annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation was held February 7-11, 2011 at the Taj Hotel in Boston. It was another successful course and highly rated by attendees. This long-running program consists of lectures, breakout sessions, and student presentations. Attendees enjoyed a networking reception during the course's first evening. Mark your calendars for Tufts CSDD's 39th annual Postgraduate Course, taking place February 6-12, 2012. To sign up for email updates please contact Jonathan Hsieh at 617-636-0840 or via email.

 

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Tufts CSDD Publications and Reports

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

New or modified approvals for existing drugs have steadily increased in U.S., Vol. 13, Issue 2, March/April 2011
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Drug developers seeking new revenue streams have stepped up their efforts to seek regulatory approval for new or modified indications for existing drugs. Those efforts, summarized
in this Tufts CSDD Impact Report, underscore the enormous pressure on drug firms to expand their market and bolster sales in the United States.

 

U.S. healthcare stakeholders uncertain on benefits of risk evaluation strategy, Vol. 13, Issue 1, January/February 2011  

Drug developers are required to submit a proposed Risk Evaluation & Mitigation Strategy (REMS) to the U.S. Food and Drug Administration (FDA) as part of a new product approval application (or even for a prior approved product) when the FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. To assess the impact of the REMS program on a diverse set of stakeholders groups, Tufts CSDD interviewed and surveyed payers, pharmacists, health care providers, patient advocates, and biopharmaceutical companies to determine their concerns about program implementation and its impact on the delivery of healthcare.   

Commissioned Research & Multi-Company Studies

  • Benchmarking Preclinical through Early Clinical Drug Development
  • Global Landscape for Study Monitoring 
  • Clinical Supplies Market Analysis 
  • Patient Recruitment and Retention Practices
  • Assessing the Impact of New Outsourcing Strategies
  • Evaluating Factors Driving Clinical Trial Costs
Email us for additional information about Commissioned Research Projects. 
Upcoming Programs and Events 

Tufts CSDD Executive Forum

This unique program of highly interactive, one-day roundtables for senior R&D leaders, is hosted by Tufts CSDD, and was developed in response to industry concerns that there were few opportunities for pharma leaders to meet in a neutral venue to exchange information, discuss industry trends, and network with colleagues.  

 

For more information or to register for upcoming 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 roundtables:
Management Implications of the Global Regulatory Environment,
May 19, 2011, Boston, MA

As the research-based industry moves toward more global drug development programs, understanding and reacting to the global regulatory environment is becoming increasingly vital. This roundtable will provide insight into the present-day global regulatory environment and assess the implications for pharmaceutical and biotechnology companies.
 

Designing and Maintaining Successful Innovation Partnerships, September 15, 2011, Boston, MA  

Partnership, co-development agreements, and collaborations are rapidly becoming the new face of pharmaceutical innovation. Transformational strategies, including the creation of novel entities such as Chorus, Enlight Biosciences, and the Alzheimer's disease industry consortium, highlight industry's efforts to leverage the strengths and core competencies of key stakeholders in innovation. This roundtable will explore these models as well as factors associated with successful industry-academic partnerships.

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.
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Tufts CSDD Leadership  for Drug Development Teams
July 12-13, 2011, Boston, MA

Designed in collaboration with R&D leaders from every segment of the industry, the curriculum is based on specific challenges that hundreds of team leaders, program managers, and functional directors have described in real-life cases. Two-thirds of the course is devoted to hands-on casework, and one-third to interactive discussions with the faculty. Click on Tufts CSDD Leadership Course on our website for more information.

Tufts CSDD Recent Publications   

DiMasi JA, Faden LB. Competitiveness in Follow-on Drug R&D: A Race or Imitation? Nature Review Drug Discovery 2011;10(1):23-27.

 

Kaitin KI, DiMasi JA. Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade, 2000-2009. Clinical Pharmacology & Therapeutics 2011;89(2):183-188.


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


Ken Getz: R&D Leadership Summit, Miami, February 3-4, 2011

Andrew Wilson: Commercialization Strategies and Market Access for Personalized Medicines and Companion Diagnostics, NextLevelPharma, Miami, February 9-10, 2011

Kenneth Kaitin: 2011 Winfield and Rachel Cotton Lecture at the University of Mississippi, Oxford, MS, February 15, 2011

Joshua Cohen: Global Market Access, University of Sorbonne, Paris, February 20, 2011

Kenneth Kaitin: CHI's Molecular Medicine Tri-Conference, Keynote Presentation, San Francisco, February 23, 2011

Christopher Milne: CHI's Molecular Medicine Tri-Conference, Track Chair, San Francisco, February 23-25, 2011

Kenneth Kaitin: American Society for Clinical Pharmacology and Therapeutics Annual Meeting, State-of-the-Art Lecture, Dallas, March 3, 2011

Janice Reichert: Future Trends in the Development of Monoclonal Antibodies for the Treatment of Cancer, swissnex, Boston Consulate of Switzerland, March 17, 2011

Kenneth Kaitin: Health Network Communication conference, Keynote Presentation, Boston, March 23, 2011

Joshua Cohen: Center for Business Intelligence conference on risk-sharing arrangements, Philadelphia, March 25, 2011
I N   T H I S   I S S U E
38th Annual Postgraduate Course
Tufts CSDD Publications and Reports
Commissioned Research & Multi-Company Studies
Upcoming Programs and Events
Tufts CSDD Recent Publications
Staff Presentations
FYI. . .

On Feburary 15, 2011, CSDD Director Kenneth Kaitin gave the 2011 Winfield and Rachel Cotton Lecture at the University of Mississippi, in Oxford, MS. Also, on March 3, 2011, Dr. Kaitin delivered the State-of-the-Art Lecture at the American Society for Clinical Pharmacology and Therapeutics annual meeting in Dallas, TX.
. . . . . . . . .
Ken Getz has been nominated for an American Business Media Neal Award for his bi-monthly column 'Clinical Trial Insights'.
. . . . . . . . .
Congratulations to CSDD staffers Andrew Wilson and Rachel Zuckerman on their promotions to Senior Research Analyst.
. . . . . . . . .

We welcome new staff member Jonathan Hsieh, Marketing & Communications Coordinator.

. . . . . . . . .

Tufts CSDD is now on Twitter, LinkedIn and Facebook!
Stay informed about upcoming events and 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

The Chronicle of Higher Education
March 6, 2011
Universities Look Askance as NIH Plans New Way to Promote Their Research

 

Pharmaceutical companies have "more than adequate tools" to screen drugs when they have the economics incentives to do so, said Kenneth I. Kaitin, a professor at Tufts University who directs the Tufts Center for the Study of Drug Development. "Industry has been working on this problem for 30 years. The idea that the NIH suddenly is going to solve the problems is na´ve."

 

The New York Times
March 6, 2011

Patent Woes Threaten Drug Firms 

 

"This is panic time, truly panic time for the industry," said Kenneth I. Kaitin, director of the Center for the Study of Drug Development at Tufts University. "I don't think there's a company out there that doesn't realize that they don't have enough products in the pipeline or the portfolio to generate enough revenue to sustain their research and development."


The Lancet
February 26, 2011
NIH Proposes New Drug Development Centre
 

 

"The problem is the industry has been suffering for many years with a broken business model", says Ken Kaitin who heads the Tufts University Center for the Study of Drug Development, Boston, MA, USA. "The industry relies on very few products in its portfolio to generate the revenues to sustain its own growth."


Pharma Times
January 13, 2011
FDA Risk Evaluation Plan Benefits "Impossible to Measure"

"Most respondents said it is virtually impossible to measure the benefits of a REMS - compared to its burdens on patient access and cost of health care delivery - for a newly-approved drug, and that even for an already-approved drug it would likely require two years or more to effectively conduct such an assessment," said Christopher-Paul Milne, associate director at Tufts CSDD, who conducted the assessment.

FDA news

January 11, 2011

 Tufts: Drugmakers Look to Partnering With Development Costs Soaring

Major drug makers this year are expected to continue partnering with both rivals and smaller companies to hedge the risks of expensive and time-consuming drug development, according to the Outlook 2011 report by the Tufts Center for the Study of Drug Development. The joint ventures, which have become increasingly common over the past few years, come as the cost for developing a new drug has now risen to its highest level ever - about $1.3 billion, the report says.

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January 10, 2011
 The Ongoing Debate over R&D Output

In their paper in PLoS ONE last May, Joshua Cohen and colleagues at the Tufts Center for the Study of Drug Development (CSDD) at Tufts University, Boston, USA argue that Trouiller et al. appear to have undercounted the total number of drugs approved for NTDs and tuberculosis between 1975 and 1999.

Pharma Times

January 6, 2011
 Drugmakers "Aggressively Changing the Way They Do R&D"

"The research-based drug industry, in the United States and globally, is not sitting still, but the question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable," according to Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development (CSDD).


SENIOR RESEARCH STAFF

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