I'm pleased to present our
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.
Kenneth I Kaitin, Ph.D.
Professor of Medicine
Professor of Pharmacology and Exp. Therapeutics
|Tufts CSDD Publications and Reports
Tufts CSDD Outlook 2010 Report
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:
Click on Tufts CSDD Outlook to obtain more information and to purchase a report.
- R&D Efficiency
Prescription Drug Policy
Drug Development Management Trends
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Tufts CSDD Impact
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
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
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.
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.
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.
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.
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.
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 email@example.com.
Upcoming Tufts CSDD Executive Forum roundtables:
for Managing Drug Development Risk: Maintaining Portfolio Diversity | May 13,
2010 | Boston, MA
will examine company reviews of the obstacles and opportunities offered by
these and other risk mitigating strategies.
Strategies Across the Value Chain | September 16, 2010 | Boston, MA
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.
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 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
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
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.
JM. Probabilities of success for antibody therapeutics. mAbs 2009;(4):387-9
A, Milne C-P. The translational medicine movement in the Asia Pacific region.
[RS 2923] Pharma Focus Asia 2009 (12):30-2
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,"
by Avi Dor. Cambridge University Press; 2009.
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.
Presentations given or scheduled to be
given by Tufts CSDD staff
Kaitin, Ph.D. and Joseph DiMasi, Ph.D.: CBMS Training
Conference | Frederick,
MD | October 7, 2009
Kaitin, Ph.D.: Marcus Evans 2009 Evolution Summit (keynote and
chair) | Montreux, Switzerland | October 21-23, 2009
Kaitin, Ph.D.: Future Breakthroughs Panel discussion (sponsored
| Washington DC | October 30, 2009
Cohen, Ph.D.: Tufts CSDD/PhRMA Conference on Marketing Progress
Disease Drug Development | Washington, DC | October 2009
Kaitin, Ph.D.: Aptuit Executive Roundtable (keynote) |
Princeton | November
Cohen, Ph.D.: NextLevel Pharma | Prague | December 2009
Kaitin, Ph.D.: Tuck Business School at Dartmouth College
(annual lecture) | Hanover,
NH | January 12, 2010
Cohen, Ph.D.: Sorbonne University | Paris | January 2010
Kaitin, Ph.D.: IIR Annual Central Labs West Conference
(keynote) | San
Francisco | February 4, 2010
Kaitin, Ph.D. and Ken Getz, MBA: Annual Meeting of the American
Society of Experimental
NeuroTherapeutics (ASENT) | Bethesda, MD | March 4-5, 2010
Paul Milne: NextLevel Pharma Meeting | Brussels | March 15,
Kaitin, Ph.D.: PMI Pharmaceutical Specific Interest Group's 5th
Biopharmaceutical Project Management Conference (keynote) | Philadelphia
Kaitin, Ph.D.: Aptuit Executive Roundtable (keynote) | New York
City | March
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!
Tufts CSDD Executive Forum. . . . . . . . .
May 13, 2010
Our next Tufts CSDD Executive
roundtable will focus on
Strategies for Managing Drug
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.
Ken Getz has accepted an invitation to chair the Drug Information Association's 2011 Annual Meeting, to be held June 2011 in Chicago.
. . . . . . . . .
Tufts CSDD director Kenneth Kaitin has recently
joined the Editorial Advisory Board of the journal Pharmaceutical Executive
|Selected excerpts from recent articles
A Fresh Look at the
speaker Ken Kaitin of the Tufts University Center for the Study of Drug
said it best: Youth and experience
can be a compelling combination - the booster shot for securing next
innovations against an endlessly morphing profile of disease. MSNBC.com
2010Orphan Drug Applications Doubled in 10 Years
The Tufts Center for the Study of
Drug Development says the Food and Drug Administration granted orphan
status to 425 experimental products between 2006 and 2008, up from 208
2000 and 2002.BusinessWeek
January 6, 2010
Is Drug R&D in Jeopardy?
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
more expertise and work for less money. The recent job cuts will likely
more linkups to keep pipelines from running dry.
December 11, 2009
Glaxo, Wyeth Cut Costs With Trial SoftwareThree of 10 marketed drugs
revenue that exceeds the $1.1 billion in average development costs,
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,"
Kenneth Getz. "Not enough attention has been paid to the fundamental problem of
trust [of clinical research] and protocol design."Financial Times
2009 New Lease of Life"Over
the past eight years [of the previous administration], there was only a
confirmed commissioner for three and a half years," says Kenneth Kaitin,
director of the Center for the Study of Drug Development at Tufts
Boston. "That was very little time for someone to serve as the face of
agency and articulate its views to the public and Congress. It was open
for the critics."
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]
shown to be needed in a smaller, more targeted subset," said Kenneth
a Tufts University School of Medicine research fellow and
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
Gene Silencing to Boost Biological Drug Yields
Reichert, senior research fellow at Tufts Center for the Study of Drug
Development in Boston, Massachusetts, told Bloomberg that anything that
reduce the time it takes to produce from the cell line, or that improves
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
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
very substantial changes in approach and strategy," says Ken Kaitin,
of the Tufts Center for the Study of Drug Development. ... "It is an
that desperately needs a new strategy," says Kaitin. "They've been
about this for two decades, but now it's an imperative."
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