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  FIRST QUARTER 2010
KenKaitinphoto I'm pleased to present our first Tufts CSDD Quarterly Update of 2010, highlighting our current research agenda and other exciting initiatives at the Tufts Center. As the new year and decade get underway, stakeholders in bio/pharmaceutical innovation - developers, regulators, policy-makers, service providers, investors, and academics - face a remarkable panoply of challenges and opportunities.  Rest assured that we here at Tufts CSDD remain committed to providing the types of critical analyses, high-quality programming, and unique insights that you have come to expect from the Tufts Center. 
 
So far, in 2010, we've released our highly regarded Tufts CSDD Outlook 2010 report, we've held our 37th annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, we've rolled out our new and easier to navigate Tufts CSDD website, and we've just kicked off year three of our enormously successful Tufts CSDD Executive Forum roundtable series. 
 
I encourage you to check out our new website to get more details on our research programs and other activities. And as always, I'm deeply appreciative of your support. I wish you a successful and fulfilling 2010. 
 
Sincerely,
 KenKsignature
Kenneth I Kaitin, Ph.D.
Director
Professor of Medicine
Professor of Pharmacology and Exp. Therapeutics

Tufts CSDD's 37th Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation
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Tufts CSDD 37th annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation was held February 8-12, 2010 at the Taj Hotel in Boston. It was another successful course and highly praised by attendees. This long-running course consists of lectures, breakout sessions, and student presentations. Attendees enjoyed a reception during the course's first evening. Mark your calendars for the 38th annual course, February 7-11, 2011. 

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Tufts CSDD Publications and Reports

Tufts CSDD Outlook 2010 Report
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Tufts CSDD's Outlook report, published each January, highlights near-term pharmaceutical and biopharmaceutical development, regulation, and marketing trends. The data and analyses contained in Tufts CSDD Outlook 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
Click on Tufts CSDD Outlook to obtain more information and to purchase a report.
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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.

U.S. orphan product designations more than doubled from 2000-02 to 2006-08 | Jan/Feb 2010 issue
Since the Orphan Drug Act of 1983 was signed into law in the U.S., there have been more than 2,000 designations and 350 market approvals of drugs and biologics intended to treat rare diseases. This Tufts CSDD Impact Report summarizes the Tufts Center's latest analysis of orphan product development and regulatory trends.

Drug approvals for neglected diseases increase along with more R&D funding | Nov/Dec 2009 issue
Between 2000 and 2009, a significant increase in global R&D for neglected diseases has led to 26 drugs and vaccines receiving worldwide marketing approval. This Tufts CSDD Impact Report reviews the Tufts Center's recent study on development trends for neglected diseases.
Commissioned Research: Multi-Company Studies  
Evaluating the Incidence, Causes and Impact of Protocol Amendments
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.

Assessing Development Program Complexity and its Impact on ROI
Tufts CSDD is gathering data 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
Tufts CSDD and participating companies have developed a standardized process flow of preclinical through early stage clinical activity.  The working group will be collecting data to benchmark cycle time data.
 
Identifying Best Practices in Capacity Planning and Forecasting
Organized by Tufts CSDD, a working group of companies is refining definitions and measures of clinical development roles and tasks to identify opportunities to streamline capacity and shorten cycle times.

Assessing the Drivers of Oncology per Patient Costs
Tufts CSDD and participating companies are studying the economics of oncology studies and the factors that are driving rising per patient costs.
 
Measuring Factors that Influence Sponsor-Site Relationship Quality and Effectiveness
Tufts CSDD and participating companies are conducting a comprehensive survey among global investigative sites to identify factors that contribute to high performing sponsor-site interactions.

Update Study on the Fastest Drug Development Companies
Study updating Tufts CSDD's drug development speed measures and the common strategies and tactics implemented by the fastest drug developers.

Email us for additional information about Commissioned Research Projects.
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 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 stella.stergiopoulos@tufts.edu.
 
Upcoming Tufts CSDD Executive Forum roundtables:

Strategies for Managing Drug Development Risk: Maintaining Portfolio Diversity | May 13, 2010 | Boston, MA
Discussion will examine company reviews of the obstacles and opportunities offered by these and other risk mitigating strategies.
 
Outsourcing Strategies Across the Value Chain | September 16, 2010 | Boston, MA
A presentation of Tufts CSDD original research findings on strategic outsourcing trends across the industry will be followed by specific examples of outsourcing strategies in both large and small pharma and biotech companies.
 
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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Tufts CSDD Leadership for Drug Development Teams Course
July 14-15, 2010 | 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 

Cohen JP, Bridges JFP. Assessing comparative effectiveness research in the US. Applied Health Economic Policy 2009;7(4):219-24 [RS 2925]

DiMasi JA, Feldman L, Seckler A, Wilson A.  Trends in risks associated with new drug development: Success rates for investigational drugs. Clinical Pharmacology & Therapeutics 2010;87(3):272-277.
 
Kaitin KI Deconstructing the drug development process: The new face of innovation. Clinical Pharmacology and Therapeutics 2010;87(3):356-361.

Kaitin KI How I see it: Drug development shifts to small-scale, focused targets. Mass High Tech (MHT), December 16, 2009. .
 
Milne CP, Kaitin KI.  Commentary. Translational medicine: An engine of change for bringing new technology to community health. Science Translational Medicine 2009;1(5):5cm5

Milne C-P, Tait (University of Edinburgh). 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 Journal 2009; 64(4): 733-753.

Reichert JM. Probabilities of success for antibody therapeutics. mAbs 2009;(4):387-9 [RS 2920]

Wilson A, Milne C-P. The translational medicine movement in the Asia Pacific region. [RS 2923] Pharma Focus Asia 2009 (12):30-2

Bridges J, Cohen JP, Grist P, Muhlbacher A. International experience with comparative effectiveness research: Case studies from England/Wales and Germany. In vol. 22 of Advances in Health Economics and Health Services Research, "Pharmaceutical Markets and Insurance Worldwide,"
edited by Avi Dor. Cambridge University Press; 2009.
 
Niezen M, de Bont A, Busschbach J, Cohen JP, Stolk E. Finding legitimacy for the role of budget impact in drug reimbursement decisions. International Journal of Technology Assessment in Health Care 2009; 25: 49-55.
Staff Presentations 
Presentations given or scheduled to be given by Tufts CSDD staff

Kenneth I Kaitin, Ph.D. and Joseph DiMasi, Ph.D.: CBMS Training Conference | Frederick, MD | October 7, 2009
 
Kenneth I Kaitin, Ph.D.: Marcus Evans 2009 Evolution Summit (keynote and conference chair) | Montreux, Switzerland | October 21-23, 2009
 
Kenneth I Kaitin, Ph.D.: Future Breakthroughs Panel discussion (sponsored by MedImmune) | Washington DC | October 30, 2009
 
Joshua Cohen, Ph.D.: Tufts CSDD/PhRMA Conference on Marketing Progress in Neglected Disease Drug Development | Washington, DC | October 2009
 
Kenneth I Kaitin, Ph.D.: Aptuit Executive Roundtable (keynote) | Princeton | November 17, 2009
 
Joshua Cohen, Ph.D.: NextLevel Pharma | Prague | December 2009
 
Kenneth I Kaitin, Ph.D.: Tuck Business School at Dartmouth College (annual lecture) | Hanover, NH | January 12, 2010
 
Joshua Cohen, Ph.D.: Sorbonne University | Paris | January 2010
 
Kenneth I Kaitin, Ph.D.: IIR Annual Central Labs West Conference (keynote) | San Francisco | February 4, 2010
 
Kenneth I Kaitin, Ph.D. and Ken Getz, MBA: Annual Meeting of the American Society of Experimental NeuroTherapeutics (ASENT) | Bethesda, MD | March 4-5, 2010
 
Christopher Paul Milne: NextLevel Pharma Meeting | Brussels | March 15, 2010
 
Kenneth I Kaitin, Ph.D.: PMI Pharmaceutical Specific Interest Group's 5th Annual Biopharmaceutical Project Management Conference (keynote) | Philadelphia | March 17, 2010
 
Kenneth I Kaitin, Ph.D.: Aptuit Executive Roundtable (keynote) | New York City | March 17, 2010
I N   T H I S   I S S U E
Tufts CSDD Postgrad Course
Tufts CSDD Publications and Reports
Commissioned Research: Multi-Company Studies
Upcoming Programs and Events
Tufts CSDD Recent Publications
Staff Presentations
FYI. . .
Tufts CSDD Launches New, Redesigned Website
Tufts CSDD's new website  features one-click navigation that provides easy access to current information on Tufts CSDD research, publications, courses, forums, and press releases. Visit today!
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Tufts CSDD Executive Forum
May 13, 2010
Our next Tufts CSDD Executive Forum roundtable will focus on Strategies for Managing Drug Development Risk and will be held Thursday, May 13, from 10:00 a.m. - 4:00 p.m. at our offices at 75 Kneeland Street, Suite 1100, Boston, MA. For program details and to register, see the Tufts CSDD Executive Forum on our website.
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Ken Getz has accepted an invitation to chair the Drug Information Association's 2011 Annual Meeting, to be held June 2011 in Chicago.
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Tufts CSDD director Kenneth Kaitin has recently joined the Editorial Advisory Board of the journal Pharmaceutical Executive.
 Tufts CSDD in the News
Selected excerpts from recent articles

Pharmaceutical Executive
January 2010
A Fresh Look at the Industry's Future

Keynote speaker Ken Kaitin of the Tufts University Center for the Study of Drug Development said it best: Youth and experience can be a compelling combination - the booster shot for securing next stage innovations against an endlessly morphing profile of disease.

MSNBC.com
January 20, 2010
Orphan Drug Applications Doubled in 10 Years

The Tufts Center for the Study of Drug Development says the Food and Drug Administration granted orphan drug status to 425 experimental products between 2006 and 2008, up from 208 between 2000 and 2002.

BusinessWeek
January 6, 2010
Is Drug R&D in Jeopardy?

The layoffs might not slow drug introductions, says Kenneth Kaitin, director of Tufts University's Center for the Study of Drug Development.  Increasingly, pharmaceutical companies are outsourcing R&D to universities and bioscience startups, which may have more expertise and work for less money. The recent job cuts will likely hasten more linkups to keep pipelines from running dry.

TheStreet.com
December 11, 2009
Glaxo, Wyeth Cut Costs With Trial Software

Three of 10 marketed drugs produce revenue that exceeds the $1.1 billion in average development costs, according to the Tufts Center for the Study of Drug Development.

Bio-IT World
December 8, 2009
Getz: Industry Trends Suggest More Trials will go to Top Sites

"Within five years, I think we'll see a totally different relationship between sponsors, CROs, and sites," says Kenneth Getz. "Not enough attention has been paid to the fundamental problem of public trust [of clinical research] and protocol design."

Financial Times
December 7, 2009
New Lease of Life

"Over the past eight years [of the previous administration], there was only a true, confirmed commissioner for three and a half years," says Kenneth Kaitin, director of the Center for the Study of Drug Development at Tufts University in Boston. "That was very little time for someone to serve as the face of the agency and articulate its views to the public and Congress. It was open season for the critics."

Washington Times
November 28, 2009
Volunteers for Drug Trials Hard to Find

"It's not lack of patient willingness but because many of the diseases being studied today involve smaller and more targeted populations - some for a specific [product] only shown to be needed in a smaller, more targeted subset," said Kenneth Getz, a Tufts University School of Medicine research fellow and founder/chairman of the Center for Information and Study on Clinical Research Participation... He also said that getting patients to learn about the trials is "a communications challenge," especially in the cluttered Internet age.

Medical News Alert
November 23, 2009
Gene Silencing to Boost Biological Drug Yields

Janice Reichert, senior research fellow at Tufts Center for the Study of Drug Development in Boston, Massachusetts, told Bloomberg that anything that can reduce the time it takes to produce from the cell line, or that improves the efficiency of the process would be a good thing... "CHOs are the default option for biotech drugs, they're the workhorse of the industry," she said.

The Scientist
November 6, 2009
Team of Rivals: Enlight Biosciences has a business model that's compelling enough to coax pharmaceutical companies to do something they rarely do-work together.

"If you know about this industry and how insular and proprietary it is, then these [large pharma consortia represent] very substantial changes in approach and strategy," says Ken Kaitin, director of the Tufts Center for the Study of Drug Development. ... "It is an industry that desperately needs a new strategy," says Kaitin. "They've been talking about this for two decades, but now it's an imperative."

SENIOR RESEARCH STAFF

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