KenKaitinphotoI'm delighted to present our second Tufts CSDD Quarterly Update of 2010, highlighting our current and planned research agenda, news, and Center activities over the past three months. It has been a busy spring/summer, as the Tufts CSDD staff has been working diligently on a wide variety of initiatives intended to shed light on the myriad challenges of bio/pharmaceutical innovation. Helping us in these efforts is the newest member of our team, Mr. Robert Chung, Associate Director of Development and Administration. Robert comes to us from the Harvard Center for Comparative Medicine, where he led the successful creation and implementation of occupational health and training programs. He is excited to be a point-of-contact for all of our Center-related partnerships, and I'm thrilled to welcome him to the group
Our new website went live in January, and has quickly become a popular resource for all sponsors of and visitors to the Center. We've recently incorporated an online registration system that provides simplified access to all of our subscription-based reports and course offerings, including our perennially popular Leadership for Drug Development Teams course in July
Your commitment to Tufts CSDD enables us to continue to fulfill our mission as the only academic, multidisciplinary research organization providing strategic information to help all stakeholders - drug developers, regulators, and policy makers - improve the efficiency and productivity of pharmaceutical R&D. I'm deeply appreciative of your interest and support, and, as always, 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.

Rising protocol complexity, execution burden varies widely by phase and TA, 
May/June 2010

Protocol complexity in drug development has led to significant increases in the median number of procedures per clinical trial, rising by 49% between 2000-03 and 2004-07, which has resulted in extended study cycle times and declines in clinical trial participation. This Tufts CSDD Impact Report summarizes the Tufts Center's follow-up study on the impact of protocol design on clinical trial performance.

Rising demand is expanding scope and workload of regulatory affairs function, March/April 2010
The growing volume of global drug development and commercialization activity during the past decade has dramatically increased the workload for regulatory affairs professionals at pharmaceutical and biotech companies. This Tufts CSDD Impact Report summarizes the Tufts Center's systematic assessment of global regulatory affairs performance, the first study of its kind.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.

Improving ROI and Late Stage Clinical Success Rates, April 2010
The relationship between R&D investment and bringing a new product to market remains a primary concern for the pharmaceutical and biotech industry. While roundtable participants agreed that R&D isn't predictable, the industry is actively experimenting with a growing range of new approaches and tools to reach late stage clinical success in a shorter amount of time, with varied results.

Click here to purchase the April 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
Clinical Phase Attrition Rates, Clinical Approval Success Rates, and New Indication Approvals for Oncology Drugs
Tufts CSDD has developed and mined a proprietary database of investigational oncology drugs and new indication approvals for oncology products to determine attrition rates and the extent to which firms attain multiple indication approvals.

Risk Evaluation and Mitigation Strategies (REMS) Impact Assessment
Tufts CSDD is conducting a two-part assessment of multiple stakeholder cohorts regarding experiences with REMS implementation consisting of interviews with key opinion leaders, and a survey of representatives from stakeholder groups.

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.

Identifying Best Practices in Capacity Planning and Forecasting*
Multi-Company Study: Organized and led by Tufts CSDD, a working group of companies is refining definitions and measures of clinical development tasks and resource demands to identify opportunities to streamline development processes and shorten 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.

Measuring Sponsor-Site Relationship Quality and Effectiveness*
Multi-Company Study: Tufts CSDD is conducting a comprehensive survey among global investigative sites, and along with participating companies, is identifying those factors that contribute to high performing sponsor-site interactions.

* 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 Leadership for Drug Development Teams
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 for Drug Development Teams on our website for more information.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 Robert Chung at 617-636-2187 or robert.chung@tufts.edu.

Upcoming Tufts CSDD Executive Forum roundtables:

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.
Tufts CSDD Recent Publications 

Kaitin KI. The landscape for pharmaceutical innovation: drivers of cost-effective clinical research. Pharmaceutical Outsourcing 2010 May/Jun; 11(3):28,30,32

Getz KA. Sizing up the clinical research market. Applied Clinical Trials 2010 Mar;19(3):32-4
Zycher B DiMasi JA Milne C-P. Private sector contributions to pharmaceutical science: thirty five summary case histories. American Journal of Therapeutics 2010 Jan-Feb;17(1):101-20
Staff Presentations 
Presentations given or scheduled to be given by Tufts CSDD staff

Kenneth Getz: Institute of Medicine, The Changing Investigative Site Landscape, Washington, DC, April 1, 2010

Kenneth I Kaitin.: Chinese-American Biotechnology Association Annual Meeting, Cambridge, MA, April 10, 2010

Kenneth Getz: IIR Partnerships Conference, Tracking the Evolution of Integrated Alliances, Orlando, FL, April 12-14, 2010

Christopher-Paul Milne: FDA Public Meeting on PDUFA, Washington, DC,  April 12, 2010

Janice M. Reichert: Natural Peptides to Drugs 4th Annual International Congress, Zermatt, Switzerland, April 12-14, 2010

Christopher-Paul Milne:  NextLevel Meeting, Risk-Sharing & Value-Based Pricing| Vienna, Austria, April 14-16, 2010

Janice M. Reichert: TIDES, Boston, MA, April 26, 2010

Kenneth I Kaitin: Next Generation Pharma Annual Executive Summit, Scottsdale, AZ, April 27, 2010

Christopher-Paul Milne: 2010 Evolution Summit, Clinical Trials, Miami, FL,  May 10-12, 2010

Kenneth I Kaitin: Society for Clinical Trials, Baltimore, MD, May 17, 2010

Kenneth Getz: CTTI conference, Clinical Research Operating Processes and Why They're Failing, Washington DC, May 17, 2010

Kenneth I Kaitin: American Psychiatric Association Annual Meeting, Challenges to Anti-Psychotic Drug Development, New Orleans, LA, May 22, 2010

Christopher-Paul Milne: American Chemical Society, Northeastern Chapter, Boston, MA, May 22, 2010

Kenneth Getz: Mass Biotech Society Meeting, The Necessity for Transformative Drug Development, Waltham, MA, June 11, 2010

Janice M. Reichert: Antibody Discovery and Development Forum, Amsterdam, Netherlands, June 17-18, 2010

Kenneth Getz: DIA Annual Meeting, The Prevalence and Causes of Protocol Amendments, Washington, DC, June 14-17, 2010

Kenneth I Kaitin: DIA Annual Meeting,(1) Speaker in session on PDUFA Reauthorization; (2) Speaker in Project Management Plenary Session; (3) Panelist in Executive Forum on Industry-Academic Relationships; (4) Moderator of Executive Luncheon on Healthcare Reform and Innovation, Washington, DC, June 14-17, 2010

Joshua Cohen: DIA Annual Meeting, Comparative Effectiveness Research (session speaker), Washington, DC, June 14-17, 2010

Kenneth Getz: NIH Clinical Research Management Workshop, Strategies for Improving Recruitment and Retention Effectiveness, Bethesda, MD, June 21, 2010

Kenneth I Kaitin: Institute of Medicine, Forum on Neuroscience, Washington, DC, June 22-23, 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 Leadership for Development Teams
July 14-15, 2010

There are only a few seats remaining for our highly regarded annual Tufts CSDD Leadership for Development Teams workshop, which will be held on July 14-15 at the Courtyard by Marriott in Cambridge, MA. For program details and how to register, click to the course description page here.
. . . . . . . . .
Robert Chung has joined the Tufts Center as the new Associate Director for Development & Administration. He will serve as our main contact for our corporate sponsors, course administration, and publications. He can be reached at 617-636-2187 or
robert.chung@tufts.edu. Welcome, Rob!
. . . . . . . . .
Four Tufts CSDD Research Fellows represented CSDD at the recent Drug Information Association's 46th Annual Meeting in Washington, D.C. Our staff presented in 7 different sessions and forums at the event. Tufts CSDD continues to be recognized for its authority in the areas of drug development and policy.
 Tufts CSDD in the News
Selected excerpts from recent articles

Wall Street Journal
June 17, 2010
New Effort Launched for Clinical Drug Trials

Methods for patient recruitment have improved over time with more companies making use of recruitment specialists or patient databases, but "there is a lot of hype," said Ken Getz, a senior research fellow at the Tufts Center who isn't involved in the New York collaboration. Sometimes an approach works for one study and not another, he said.

Fox Business: John Stossel's Blog
June 10, 2010
Protecting Us to Death

There is data to suggest that clinical trials are becoming more difficult to conduct, require more complex screening criteria, more data to be gathered, all at greater expense. The Tufts Center for the Study of Drug Development documents many of these trends, the most recent being the complexity of screening and data collection.

Fierce Biotech IT.com
May 31, 2010
GSK's Avandia trial faces recruitment battle

Researchers from the Tufts Center for the Study of Drug Development find that a rise in the eligibility criteria for acceptable subjects makes it hard to recruit volunteers, while an increase in the complexity of trials - thanks to the growing number of procedures per protocol - makes it hard to keep them. The more complex protocols lengthen trial timelines, discouraging subjects from participating to the end.

May 5, 2010
Tough Challenges for Clinical Trials
Kenneth Kaitin, director of [Tufts CSDD] says the increasing complexity [of clinical trials] comes from a number of factors, chief among them that the types of products being developed today tend to be geared towards more chronic and challenging indications. "Therefore the trials tend to be more complex," he says.
April 30, 2010
Dendreon Approval Sparks New Era for Cancer Vaccines

Food and Drug Administration approval of Provenge "will definitely inform the clinical development programs of other companies" working on vaccine treatments for cancer, said Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development in Boston.

Kansas City Business Journal
April 16, 2010
Federal report: Competition will reduce cost of biologics

It could take as long as 10 years and $200 million to develop a biosimilar, according to the commission. The average cost to develop a biologic is about $1.2 billion, and it can be done in about eight years, according to the Tufts Center for the Study of Drug Development.

NPR: Martketplace Morning Report
April 13, 2010
Patent Reform Could Strengthen Biotech

Tufts CSDD Director, Kenneth Kaitin, in an interview with reporter Kerry Grens of Marketplace, states, "Investors are looking for assurance that there will be adequate protection of intellectual property; if not then the risk of development becomes much greater. There are a lot of small companies that, even though they have a product in development that shows signs of success, are just running out of money."

April 12, 2010
FDA Hears Testimony on Prescription Drug User Fee Act

Two decades ago, the drug companies had to wait an average of three years for the FDA to review their applications; in 2008, the wait was just 1.5 years, said Christopher Milne, MPH, JD, associate director of the Tufts Center for the Study of Drug Development in Boston.

April 12, 2010
ClearTrial Unveils New Product Release at Partnerships in Clinical Trials Conference 2010

"Our ongoing research indicates that clinical research protocols are being conducted in more global locations at the same time that they are increasingly more complex and demanding," said Kenneth Getz, Senior Research Fellow at the Tufts Center for the Study of Drug Development. "These factors present significant challenges to the industry as it strives to achieve higher levels of efficiency and productivity."

Investor's Business Daily
April 9, 2010
If It's The Only Cure, It's Going To Cost You

Christopher-Paul Milne, associate director of the Tufts University Center for the Study of Drug Development, boils the characteristics of specialty drugs down to five elements.

April 6, 2010
Tufts' Getz sees opportunity in regulatory affairs' rising workload

"The increased volume of global work combined with limited capacity is creating much higher demand for, and pressure on, regulatory affairs professionals," says Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development.

April 6, 2010
Tufts: New approaches to drug development needed
Drug development alliances and partnerships may be the best approach to bring new drugs to market, according to a panel of pharmaceutical and biotech industry leaders recently convened by the Tufts Center for the Study of Drug Development.

April 5, 2010
In the Search for Cancer Drugs, Mice Get New Role

There are about 850 cancer drugs in clinical development, according to the Tufts Center for the Study of Drug Development, a 70 percent increase in three years.


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