It is with pleasure that I present our second Tufts CSDD Quarterly Update of 2011, highlighting current research activities, recent faculty publications and presentations, and other programs and events at CSDD. As always, the Tufts CSDD staff has been extraordinarily busy, conducting a large number of research projects, hosting seminars and working group meetings, and giving talks at conferences, academic centers, public forums, and industry symposia. I'm particularly pleased with the enormous success of our Multi-Company Project Series and the Tufts CSDD Executive Forum. There is truly an atmosphere of collaboration and openness within the research-based industry, and I believe that CSDD is ideally positioned to serve as a neutral venue for the sharing of ideas and experiences among companies, contract research organizations, regulatory authorities, and academic institutions. If you haven't participated in one of these programs, I encourage you to contact our offices to learn more. I guarantee that you'll find it a stimulating and valuable experience.


In closing, I would like to mention a personal honor I recently received. On April 30, I was privileged to deliver the Louis M. Sherwood Memorial Lecture at the ACRP annual meeting in Seattle. The honor is bestowed by the Academy of Pharmaceutical Physicians and Investigators to commemorate the commitment and contributions of Dr. Sherwood, a renowned endocrinologist, with a distinguished career that spanned academics and industry. It is with great humility that I accept this honor, and I offer my sincere gratitude to the Board of Trustees of the APPI and the ACRP. 


As always, we at Tufts CSDD greatly value your commitment and support. I welcome your feedback. 

Kenneth I Kaitin, Ph.D.
Director and Research Professor

Tufts CSDD Publications and Reports

Tufts CSDD R&D Management Reports  
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.

Using Translational Science to Improve Drug Development, Vol. 6, R&DmngRpts2011
Issue 1, January 2011

To remain competitive, pharma/biotech companies need to make smart decisions about what targets to pursue. Although many traditional drug development approaches still have utility, they likely won't produce drug candidates at the pace the industry needs. Translational science is providing a way forward. [View press release]  


Managing Global Investigative Sites for Peak Operational Efficiency , Vol. 6, Issue 2, April 2011 

The need for the pharmaceutical and biotech industry to increase drug development efficiency-from discovery through approval-has sponsors and contract research organizations (CROs) seeking operational improvements wherever possible. Many agree that opportunities abound for boosting clinical trial efficiency and performance. [View press release


Click here to sign up for a subscription or purchase recent Tufts CSDD R&D Management Reports. To participate in our next Tufts CSDD Executive Forum roundtable, contact us.

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Tufts CSDD Impact Report

Tufts CSDD's research, refined. The Tufts CSDD Impact Report is our premier bi-monthly publication, presenting the latest Tufts CSDD research findings in a concise and easy-to-read format. With key data, analyses, and insights on critical drug development and regulatory issues, it's an industry "must-read." Visit our website for current Tufts CSDD Impact Reports and become a subscriber today.

Biopharmaceutical product approvals in the U.S. rose dramatically in 2000s, Vol. 13, Issue 3, May/June 2011

The U.S. biopharmaceutical market has nearly doubled in new product marketing approvals by the Food and Drug Administration (FDA) in the past decade. This issue of Tufts CSDD Impact Report examines the challenges developers face in bringing biopharmaceutical products to market. [View press release


Commissioned Research & Multi-Company Studies

Tufts CSDD's research spans a broad range of critical issues facing the industry. Here is a listing of multi-company projects currently underway at Tufts CSDD:

  • Assessing Product Averse Event Reporting
  • Benchmarking Preclinical through Early Clinical Drug Development
  • Global Landscape for Study Monitoring 
  • Clinical Supplies Market Analysis 
  • Patient Recruitment and Retention Practices
  • Assessing the Impact of New Outsourcing Strategies
  • Evaluating Factors Driving Clinical Trial Costs
  • Success Rates for Drugs for Neurodegenerative Diseases
  • Peptide Therapeutics Development Trends
If you would like to commission a Tufts CSDD project or participate in one of our current or upcoming Multi-Company Studies, contact Robert Chung for more information.
Upcoming Programs and Events 

Tufts CSDD Leadership for Drug Development Teams
July 12-13, 2011, Boston, MA

Designed in collaboration with R&D leaders from every segment of the industry, the Tufts CSDD Leadership for Drug Development Teams course is a fast-paced learning experience designed to improve communication and productivity within drug development teams. Targeted towards drug development staff and leaders alike, the Tufts CSDD Leadership curriculum is based on specific challenges that hundreds of team leaders, program managers, and functional directors have encountered in real-life cases.


Two-thirds of the course is devoted to hands-on casework, and one-third to interactive discussions with the faculty. Limited to 35 attendees, the Tufts CSDD Leadership course provides personalized attention and effective strategies specific to your team's needs. Visit the course registration site for more information and to reserve seats for you and your staff today.


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Tufts CSDD Executive Forum

This unique program of highly interactive, one-day roundtables for senior R&D leaders, is hosted by Tufts CSDD, and was developed in response to industry concerns that there were few opportunities for pharma leaders to meet in a neutral venue to exchange information, discuss industry trends, and network with colleagues.  


For more information or to register for upcoming 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 roundtables: 

Designing and Maintaining Successful Innovation Partnerships, September 15, 2011, Boston, MA  

Partnerships, co-development agreements, and collaborations are rapidly becoming the new face of pharmaceutical innovation. Transformational strategies, including the creation of novel entities such as Chorus, Enlight Biosciences, and the Alzheimer's Disease Neuroimaging Initiative, highlight industry's efforts to leverage the strengths and core competencies of key stakeholders in innovation. This roundtable will explore these models as well as factors associated with successful industry-academic partnerships.

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   


Getz KA, Zuckerman R, Cropp AB, Hindle AL, Krauss R, Kaitin KI. Measuring the Incidence, Causes, and Repercussions of Protocol Amendments. Drug Information Journal 2011;45(3):265-75

Getz KA. Protocol Amendments: A Costly Solution. Applied Clinical Trials Online Publish date: May 1, 2011

Lamberti M, Zuckerman R, Howe D, Shapiro L, Getz K. Factors Influencing Investigative Site Willingness and Ability to Participate in Clinical Trials. Drug Information Journal 2011;45(3):377-90 

Reichert JM. Antibody-based Therapeutics to Watch in 2011. MAbs 2011 Jan-Feb;3(1):76-99

Stergiopoulos S, Soenen M, Getz K. Honing Reforms from Clinical Development. Pharmaceutical Executive Feb 1, 2011
Staff Presentations     
Selected presentations given or scheduled to be given by Tufts CSDD staff:

Kenneth Kaitin: Global Clinical Supply Group Annual Meeting, Keynote Presentation, Jacksonville, FL, April 4, 2011

Ken Getz: Partnerships in Clinical Trials, Phoenix, March 30-April 1, 2011

Christopher Milne: Biopharmaceutical Plenary Speaker, RAPS Horizon Conference, Vancouver, Canada, April 7, 2011


Ken Getz: AAHRPP Annual Conference, Washington, DC, April 8, 2011


Kenneth Kaitin: American Federation of Medical Research Annual Meeting, Washington, DC, April 9, 2011


Joseph DiMasi: Me-Too Drugs: R&D Innovations or Imitations, American Chemical Society Webinar, April 14, 2011


Ken Getz: Bio-IT Conference, Boston, April 14, 2011


Kenneth Kaitin: Pharma PPM Think Tank 2011, Meeting Chair and Keynote Presentation, Vienna, Austria, April 14-15, 2011


Joshua Cohen: Rutgers Business School 2011 Annual Healthcare Symposium, Newark, April 21, 2011


Joseph DiMasi: UCLA Seminar in Pharmaceutical Economics and Policy, Los Angeles, April 21, 2011


Joshua Cohen: Academy of Managed Care Pharmacy Annual Meeting, Minneapolis, April 28, 2011


Kenneth Kaitin: ACRT-AFMR-SCTS Joint Meeting, Session Chair, April 29, 2011


Kenneth Kaitin: ACRP Annual Meeting, Seattle, April 30, 2011


Kenneth Kaitin: Deutsche Bank Investors Conference, Boston, May 3, 2011


Janice Reichert: Protein Engineering Summit, Boston, May 9, 2011


Joshua Cohen: Pharmaceutical Business Intelligence and Research Group Annual Meeting: "Future Challenges to Drug Development: Comparative Effectiveness, San Antonio, May 17, 2011


Kenneth Kaitin: Aptuit Science Day: Tackling Attrition, Verona, Italy, May 17, 2011


Christopher Milne: National Organization for Rare Disorders (NORD) Corporate Council Meeting, Washington, DC, May 17, 2011


Kenneth Kaitin: Convergence Life Sciences Leaders Forum, Chatham, MA, May 20 , 2011 


Janice Reichert: Summer Neuropeptide Conference, Boston, May 23, 2011


Kenneth Kaitin: University of Minnesota College of Pharmacy and Academic Health Center, Minneapolis, June 8, 2011


Janice Reichert: Drug Discovery Leaders Summit, Zurich, Switzerland, June 8, 2011


Kenneth Kaitin: Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION), an FDA Public-Private Partnership, Silver Spring, MD, June 15, 2011

Kenneth Kaitin: Drug Information Association 47th Annual Meeting, Executive Session Chair, Chicago, June 21, 2011


Joseph DiMasi: Drug Information Association 47th Annual Meeting, Session Chair and Speaker, Chicago, June 22, 2011

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. . .

On April 30, 2011, CSDD Director Kenneth Kaitin gave the Louis M. Sherwood Memorial Lecture at the ACRP annual meeting in Seattle.
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Ken Getz received a Lifetime Achievement award from the Institute of International Research at their Conference in Phoenix, AZ on April 1, 2011

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Ken Getz will be chairing the Drug Information Association's 47th Annual Meeting, June 20-23 in Chicago.
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Sandra Peters headshotMs. Sandra Peters has joined the Tufts Center as our new Information Services Librarian and manager of Tufts CSDD's Louis Lasagna Library of Drug Development Science and Policy. Sandra is your primary contact for research queries, press requests, CSDD publication info, and general questions for Tufts CSDD faculty. Feel free to contact Sandra at 617-636-2185 or sandra.peters@tufts.edu. Welcome, Sandra!
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 Tufts CSDD in the News
Selected excerpts from recent articles

May 6, 2011
Special Report: Big Pharma's Global Guinea Pigs

"In practice, things are a bit different, according to Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development in Boston. He believes off-shoring clinical research is not quite the bargain many drugmakers had thought. Getz reckons the per patient cost of running a trial in India and China is probably about half what it would be in Western Europe or the United States -- a big margin, of course, but considerably less than Garnier had suggested. And then there is the considerable extra cost of managing multiple studies across myriad sites."

Pharmaceutical Commerce
April 21, 2011
With a Few Stumbles, REMS Begins to Hit Its Stride


"Most respondents [to a survey published in January 2011 by Tufts CSDD] said it is virtually impossible to measure the benefits of a REMS, compared to its burdens on patient access and cost of healthcare delivery for a newly approved drug, and that even for an already-approved drug, it would likely require two years or more to effectively conduct such an assessment," said Christopher-Paul Milne, associate director at Tufts CSDD, who conducted the assessment. 


April 21, 2011

Former Pfizer R&D Chief Urges Big Pharma To Go Small


 "The current business climate is challenging pharmaceutical and biotech companies to rethink their approach to outsourcing and how best to build alliances with external service providers as part of a long term drug development strategy," [Tufts CSDD] said in a report last year. "The global economic downturn and operating pressures to launch new products faster and more efficiently have increased the need to leverage the benefits of outsourcing," CSDD Senior Research Fellow Ken Getz said in the report. "But sponsors are rethinking how to best integrate [contract research] partners, given their unique corporate cultures, development and operating philosophies, and legacy processes and systems. That's why integrated partnerships are being supported through hybrid outsourcing relationship models."

FierceBiotech IT
April 4, 2011

Necessity Driving Leery Pharma "Open"  


When it comes to open-source drug R&D, "the clinical side is the conservative side," says Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development. But the downturn in the economy has stimulated thinking among big pharmas. "A cultural shift is happening as companies downsize in some cases," he says. Success in open-source development efforts, perhaps first in translational medicine, "will lead to changes that are profound," says Getz.

Managed Care magazine
March 2011
Stakeholders Say FDA Must Change REMS Program

"Seventy-five percent of the participants [to a Tufts CSDD survey on FDA's Risk Evaluation and Mitigation Strategy program] felt the REMS program needs a major overhaul," says Andrew Wilson, a senior research analyst at the Tufts University Center for the Study of Drug Development, which conducted the study.

Innovations News Daily 

March 29, 2011

Start Your 'Innovation Engine': Software Predicts Drug Winners

Pharmaceutical giants such as Sanofi-Aventis and Pfizer have cut back sharply on their own spending to find new drug candidates, said Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development and an advisor for Relay's co-founders. He added that the industry is looking to outside sources for innovation. "I think it is panic time for the industry," Kaitin said in a phone interview with Innovation News Daily. "They're gambling that they'll be able to find new assets - new drug candidates - and replace some of their research activities with collaborations involving small companies and academic institutions."

Centerwatch News Online
March 29, 2011
Neuroscience Drug Development Slows, Requires Funding


The Tufts Center for the Study of Drug Development said clinical trial costs for neuroscience programs tend to be more expensive than other fields, even as the approval rate for new drugs is lower.


Kenneth I Kaitin, PhD
Director and Research Professor

Christopher-Paul Milne, DVM, MPH, JD
Associate Director and Research Assistant Professor

Joseph A. DiMasi, PhD
Director of Economic Analysis

Joshua P. Cohen, PhD
Research Assistant Professor

Kenneth A. Getz, MBA
Senior Research Fellow

Janice M. Reichert, PhD
Research Assistant Professor

Richard I. Shader, MD
Senior Research Fellow & Medical Consultant

Tufts CSDD
617.636.2170 | csdd.tufts.edu