KenKaitinphotoI'm delighted to present our third Tufts CSDD Quarterly Update of 2010, highlighting current Center research, news, publications, events, and other activities over the past three months. The fall months perennially represent one of the busiest times of the year for Tufts CSDD, with new projects getting underway, a large number of staff presentations, a new academic season, Executive Forum R&D roundtables, and preparations for our annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation - our 38th Annual program! (scheduled for February 7-11, 2011 in Boston). 
I'm thrilled to announce that on September 16th, we held our third quarterly Tufts CSDD Executive Forum roundtable of 2010, which focused on Outsourcing Strategies Across the Value Chain. After hearing insightful and revealing presentations by Pfizer, Millennium, Otsuka, and Endo Pharmaceuticals, the group engaged in a very lively and productive discussion about different ways to structure and manage outsourcing relationships. A Tufts CSDD R&D Management Report, highlighting the speaker presentations and discussion points, will be available in the next few weeks. 
I'm pleased to say that our agenda for the 2011 Tufts CSDD Executive Forum roundtable series is now available. Topics include Managing Global Investigative Sites, and Dealing with The Global Regulatory Environment.  If you're not already a member of the Tufts CSDD Executive Forum, I encourage you to join today. And don't forget our November 3, 2010 roundtable on Translational Medicine and Other Strategies for Optimizing the Drug Development Process. Please join us for what is sure to be a very timely, stimulating, and useful discussion.
Few would argue that the environment for pharmaceutical innovation is currently undergoing seismic shifts. It is at times like these, I believe, that the work of the Tufts Center is more critical than ever. Tufts CSDD remains committed to providing strategic information to help all stakeholders - 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. 

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

Tufts CSDD Publications and Reports

Tufts CSDD Impact Reports
This bi-monthly publication - the only one of its kind - 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.

Comparative effectiveness research impacts patient access to cancer drugs, July/August 2010
Comparative effectiveness research assesses the relative strengths and weaknesses of various medical interventions which could help close the gap between what is known and what is done in pharmaceutical care in the U.S.  This Tufts CSDD Impact Report summarizes the Tufts Center's study on market access to oncology drugs in the U.S. and Australia.

Clinical approval success highest for smallest firms among the top 50, September/October 2010
The top 10 pharmaceutical companies out of the world's top 50 have lower estimated overall clinical approval success rates than do smaller firms in that group, but nonetheless appeared to have some R&D productivity advantages. This Tufts CSDD Impact Report summarizes a Tuft's Center's study finding that success rates were nearly 30% higher for the 30 smallest firms vs. the 10 largest.

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Tufts CSDD R&D Management Report
Tufts CSDD R&D Management Reports summarize speaker presentations and main discussion points from our quarterly Tufts CSDD Executive Forum roundtable series. At each roundtable, senior executives from large pharma, small and mid-tier companies, and contract service providers join the CSDD research staff in a lively discussion on current drug development challenges and strategic initiatives within the research-based industry.

Maintaining Portfolio Diversity to Manage Drug Development Risk, August 2010
Drug developers need to change the way they allocate resources for new product development, lifecycle management, and business development and licensing - collectively known as portfolio management.

Click here to purchase the August 2010 Tufts CSDD R&D Management Report or to subscribe. To participate in our next Tufts CSDD Executive Forum roundtable, click here.

Commissioned Research & Multi-Company Studies
Evaluating the Incidence, Causes, and Impact of Protocol Amendments*
Multi-Company Study: Tufts CSDD and participating companies have designed a methodology to gather data on the incidence and causes of protocol amendments and their associated impact on drug development cycle time, cost, and performance.
Mapping the Global Landscape of Study Monitoring*
Multi-Company Study: Tufts CSDD and participating companies have developed a study that will quantitatively characterize the global CRA landscape and measure trends and the impact of changing monitoring strategies and practices.

Assessing Development Program Complexity and its Impact on ROI*
Multi-Company Study: Tufts CSDD is gathering data from participating companies and other sources on 100+ research programs to evaluate study complexity and its impact on program development and regulatory cycle times, data quality, cost, and other performance measures.
Benchmarking Preclinical through Early Stage Clinical Development Cycle Time*
Multi-Company Study: Tufts CSDD and participating companies have developed a standardized process flow of preclinical through early stage clinical activity, from which Tufts CSDD will be collecting data to benchmark cycle times.

Assessing the Drivers of Rising Oncology Product per-Patient Costs*
Multi-Company Study: Tufts CSDD and participating companies are studying the economics of oncology product development clinical programs and the factors that are driving increasing per-patient costs.

Benchmarking/EMR and Health IT Solutions Use in Drug Development Planning, Management and Execution*
Multi-Company Study:Tufts CSDD is conducting a study gathering data from participating companies on planned and actual uses of electronic medical record and health IT solutions to support a variety of areas including protocol design, adverse event reporting and patient recruitment and retention.

* Part of Tufts CSDD's new Multi-Company Studies series, 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
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 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 info rmation, 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:

Strategies for Optimizing the Drug Development Process: Translational Science, New Technologies, and Clinical Design Improvements, November 4, 2010, Boston, MA
Discussion will focus on those tools and technologies that provide the greatest benefits and how companies have integrated them into their R&D activities.
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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38th Annual Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation
February 7-11, 2011, Boston, MA
Tufts CSDD's highly acclaimed, five-day program provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety, and new drug regulation. Visit our course page for more information and to register.
Tufts CSDD Recent Publications 

Cohen J  Looney W.  Re: how much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question.  JNCI 2010 Jun 22 http://jnci.oxfordjournals.org/cgi/reprint/djq246
Milne C-P  Tait J.  Evolution along the government-governance continuum: FDA's orphan products and fast track programs as exemplars of "what works" for innovation and regulation.  Food and Drug Law Journal 2009;64(4):733-53 (pdf provided upon request)
Cohen J  Dibner MS  Wilson A.  Development of and access to products for neglected diseases.  PLoS ONE 2010 May;5(5) http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0010610

Getz K  Zuckerman R.  Today's Global Site Landscape.  Applied Clinical Trials 2010;19(6):34-38
Vernon JA Golec JH DiMasi JA. Drug development costs when financial risk is measured using the Fama-French three-factor model. Health Economics 2010;19(8):1002-5
Upcoming Staff Presentations 
Presentations given or scheduled to be given by Tufts CSDD staff

Kenneth I Kaitin: CHI Accelerating PoC Conference (keynote), Philadelphia, October 4, 2010

Christopher-Paul Milne: Orphan and Specialty Drugs for Emerging Markets, Miami Beach, October 12, 2010

Kenneth Getz: DIA Partnerships to Advance Patient Recruitment and Retention in Clinical Research. Rockville, MD. October 14-15

Kenneth Getz: Site Solutions Summit, Clearwater, FL. October 17

Kenneth Getz: ACPU Annual Meeting. Cincinnati OH. October 18-20

Janice M. Reichert: Peptide Therapeutics Symposium, San Diego, October 21-22, 2010

Joshua Cohen:IIR Value-Driven Pharma, Princeton, October 21-22, 2010

Christopher-Paul Milne: DIA India Conference: Trends in Global Pharmaceutical R&D and India's Role in Furthering Innovation, Bangalore, India, October 23-26

Stella Stergiopoulos: CHI Resource & Portfolio Management Conference, Philadelphia, November 3, 2010

Kenneth I Kaitin: DIA's Latin American Congress on Clinical Research, Sao Paulo, Brazil, November 10-12, 2010

Joshua Cohen: Rutgers University Seminar on biopharmaceutical innovation, Newark, November 15, 2010

Christopher-Paul Milne: Personalized Medicine Coalition, Cambridge, MA, November 18, 2010

Janice M. Reichert: European Antibody Congress, Geneva, November 29- December 1, 2010
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 Executive Forum Roundtables
Our September Tufts CSDD Executive Forum roundtable on Outsourcing Strategies Across the Value Chain was a rousing success! Our next roundtable will focus on Strategies for Optimizing the Drug Development Process and will be held Thursday, November 4 from 10:00 am - 4:00 pm at our offices at 75 Kneeland Street, Suite 1100, Boston, MA. Click here for program details and to register.
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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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Tufts CSDD is now on Twitter!
Stay informed about upcoming forums & courses, promotional specials on our various publications, the latest press releases and more! Follow us today at twitter.com/TuftsCSDD

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 Tufts CSDD in the News
Selected excerpts from recent articles

The Atlantic
July/August 2010
No Refills

If companies have really stopped caring about R&D, why is it that according to Joseph DiMasi, an economist at Tufts who specializes in the pharmaceutical industry, spending on R&D is 11 times what it was 30 years ago?

August 20, 2010
Lilly's Alzheimer Flop Prods Collaboration

[According to] Kenneth Kaitin, head of the Tufts University Center for the Study of Drug Development, "We don't know if amyloids are the heart of the problem," he told IBD.

Los Altos Town Crier
August 17, 2010
Clinical trials benefit from gift of participation

There are many important questions to answer before joining a clinical trial. "The Gift of Participation: A Guide to Making Informed Decisions about Volunteering for a Clinical Trial" (Jerian Publishing, 2007) is a good place to start. Author Ken Getz is a senior research fellow at the Tufts Center for the Study of Drug Development and founder of the non-profit Center for Information and Study on Clinical Research Participation.

Boston.com (Boston Globe)
August 16, 2010
Sanofi seeks efficiencies with new model
"The fully independent [industry] unit, operating under the parent company umbrella, is a break from the traditional big pharma business model and represents companies' interest in duplicating the flexibility and cost-efficiencies of small biotech and biotech-like companies,'' said Ken Kaitin, director of the Center for the Study of Drug Development at Tufts University. "The dual goals are, first, to have science rather than business drive development decisions, and second, to lower costs by keeping overhead and resource demands to a minimum.''
Medical News Today
August 9, 2010
Complexity Of Clinical Trials Mitigated By Therapeutic Expertise

Research recently completed by the Tufts Center for the Study of Drug Development linked clinical study complexity to increased research costs. Tufts researchers found, for example, the median number of procedures per clinical trial increased by 49% between 2000-03 and 2004-07. The total effort required to complete those procedures grew by 54%. 

August 5, 2010
Pfizer May Gain as U.S. Devises Speedy Alternative to Animal Safety Tests

About 30 percent of potential drugs that pass animal testing make it through the first two of three phases of human trials usually needed for U.S. regulatory approval. Almost a third of those medicines typically fail in the final phase, according to Joseph DiMasi, a researcher at Tufts University in Boston, Massachusetts, and Henry Grabowski, of Duke University in Durham, North Carolina, in a 2003 study published in the Journal of Health Economics.

Nature Medicine
August 2010
After Avandia, some seek split in drug approval and monitoring
Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development in Boston, sees significant improvements in the safety evaluation process at the FDA, particularly in the area of safety monitoring. ... "The FDA is now going to be looking into what your plan is once the drug has entered the market, which isn't a bad idea," Kaitin says.

July 30, 2010
Is Pharma Running Out of Brainy Ideas?

[A] report, commissioned by IOM for the June meeting and prepared by the Tufts Center for the Study of Drug Development, identified 1747 drugs in development for a much longer list of disorders, including degenerative diseases like multiple sclerosis and neurological conditions like epilepsy.  Indeed, the Tufts report suggests that the pipeline has expanded rapidly for many conditions in recent years. ... Moreover, when CNS drugs fail, they tend to do so in late-stage clinical trials, after a significant investment has been made, says Kenneth Kaitin, director of the Tufts center.

July 14, 2010
Drug Approval Process Slowing As FDA Seeks To Stress Safety

Drug developers themselves can help speed the process, says Kenneth Kaitin, director of the Tufts Center. One suggestion is to share scientific information so they don't repeat each other's mistakes, he says.   "It used to be they'd rather fail alone than share in success," Kaitin said. That's starting to change. A dozen companies are sharing Alzheimer's research data, he says. They're networking more because they realize failure is more likely if they don't.


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
617.636.2170 | csdd.tufts.edu