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. |
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
publication - the only one of its kind - presents data, analyses, and
critical drug development and regulatory issues. Go to Tufts CSDD Impact Reports
on our website for more
information and to subscribe.
protocol complexity, execution burden varies widely by phase and TA,
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
demand is expanding scope and workload of regulatory affairs function, March/April 2010
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.
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CSDD R&D Management Report
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
ROI and Late Stage Clinical Success Rates, April 2010
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
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
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.
the Incidence, Causes, and Impact of Protocol Amendments*
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.
Global Landscape of Study Monitoring*
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.
Development Program Complexity and its Impact on ROI*
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
Preclinical through Early Stage Clinical Development Cycle Time*
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.
Best Practices in Capacity Planning and Forecasting*
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.
the Drivers of Rising Oncology Product per-Patient Costs*
CSDD and participating companies are studying the economics of oncology product
development clinical programs and the factors that are driving increasing per-patient
Sponsor-Site Relationship Quality and Effectiveness*
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
|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
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An ongoing program of highly
interactive, one-day roundtables for senior R&D leaders, hosted by
Tufts Center for the Study of Drug Development, and developed in
industry concerns that there were few opportunities for senior pharma
biopharma leaders to meet in a neutral venue to exchange information,
industry trends, and network with colleagues. Upcoming Tufts
CSDD Executive Forum roundtables:
Strategies Across the Value Chain, September 16, 2010, Boston, MA
presentation of Tufts CSDD original research findings on strategic
trends across the industry will be followed by specific examples of
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
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
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
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
CSDD Leadership for Development Teams. . . . . . . . .
July 14-15, 2010
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.
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 firstname.lastname@example.org
. Welcome, Rob!
. . . . . . . . .
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.
Selected excerpts from recent articles
Wall Street Journal
June 17, 2010New Effort Launched for Clinical Drug TrialsMethods
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
2010Protecting Us to DeathThere 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, 2010GSK's Avandia trial faces recruitment battleResearchers 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.Xconomy
2010Tough 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 VaccinesFood 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
Kansas City Business Journal
2010Federal report: Competition will reduce cost of biologicsIt 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 BiotechTufts 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
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.Boston.com
2010Tufts: 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 RoleThere 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.
SENIOR RESEARCH STAFF
I Kaitin, PhDDirector, Professor of Medicine,
Professor of Pharmacology and Exp. Therapeutics
Milne, DVM, MPH, JDAssociate Director
A. DiMasi, PhDDirector of Economic Analysis
P. Cohen, PhDSenior Research Fellow
A. Getz, MBASenior Research Fellow
M. Reichert, PhDSenior Research Fellow
I. Shader, MDSenior Research Fellow & Medical
Peg Hewitt, MS, L&ISResearch