As we reach the unofficial midpoint of summer, I'm pleased to share with you our third Tufts CSDD Quarterly Update of 2011. The summer of 2011 will no doubt be remembered as one in which much of the country baked under soaring temperatures and oppressive humidity, while Washington sizzled in acrimonious debate over raising the debt ceiling. Whereas an unprecedented economic default was narrowly avoided, world markets currently appear to be in parlous freefall. It's reassuring, therefore, that despite the turmoil, the FDA has continued their negotiations with industry on reauthorization of the Prescription Drug User Fee Act (PDUFA V). Plans are on track to make the agreement available for public comment in September, send the final version to Congress in January 2012, and have the President sign the bill by June 2012, a full three months before PDUFA IV expires. Tufts CSDD is proud to be an active participant in debates and hearings on various provisions of the act. 


This summer saw several staff changes at CSDD. In July we bid a sad farewell to two exceptional research analysts, Rachael Zuckerman and Andrew Wilson, who left to enter doctoral programs at Johns Hopkins University and Brandeis University, respectively. We wish them much success in their educational programs and future pursuits. They will be missed at CSDD. We are thrilled, however, to welcome two new research analysts to the team, Ashley Malins and Adam Mathias. Ashley formerly worked at the Caring for Carcinoid Foundation and is in the MPH graduate program at Tufts, while Adam worked at Health Care Solutions and Allergan and is currently in the MPH program at Boston University. Welcome to both!


These are challenging times for the global research-based industry and regulatory authorities worldwide. I firmly believe that in the current environment, the work of the Tufts Center has never been more important. Now in our 35th year, CSDD remains committed to providing the kind of scholarly research, professional training, and productive exchange of ideas essential to promoting innovation and ensuring that new medicines reach waiting patients. As always, I thank you for your support.    

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

Tufts CSDD Publications and Reports 

Tufts CSDD Impact Report: July/August 2011

MayJuneIR11.jpgLack of clinically useful diagnostics hinder growth in personalized medicines, Vol. 13,
Issue 4

While the number of personalized medicines and companion diagnostics in use in the U.S. has gradually increased - from a handful in 2001 to several dozen in 2011 - surveys conducted by Tufts CSDD show that lack of evidence concerning the clinical usefulness of many current companion diagnostics is a major factor limiting the potential of personalized medicine. [View press release]   

Tufts CSDD Impact Reports are our premier bi-monthly publication, presenting the latest 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.


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Tufts CSDD R&D Management Report: August 2011  

Aug2011MngmntRptManagement Implications of the Global Regulatory Environment, Volume 6, Issue 3 

As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate. [View press release]  

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.

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

Current CSDD Multi-Company Studies

  • Biologics for Cancer 
  • Global Landscape for Study Monitoring
  • Patient Recruitment and Retention Practices
  • Assessing the Impact of New Outsourcing Strategies
  • Evaluating Factors Driving Clinical Trial Costs
  • Comparing the Economics of Local versus Central Lab Services
  • Evaluating Completeness and Accuracy of Adverse Event Reportingn 

Tufts CSDD's research spans a broad range of critical issues facing the industry.
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 Executive Forum Roundtables:  

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

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.


Resource Management and Other Strategies to Optimize Performance and Manage Pipeline Risk, Boston, November 3, 2011 

Across the biopharma sector, companies are increasing their focus on  resource management and other strategies to manage pipeline risk in drug development. This roundtable will include a discussion on successful outsourcing strategies, as well as the use of adaptive and enhanced trial designs to minimize risk. The roundtable will also include a presentation of the results of a recently conducted Tufts CSDD analysis.  


The Tufts CSDD Executive Forum is a unique program of highly interactive, one-day roundtables for senior R&D leaders. Hosted by Tufts CSDD, the Executive Forum 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. After each roundtable, members receive the Tufts CSDD R&D Management Report, which provides highlights of the roundtable presentations and discussion.

For more information or to register for upcoming roundtables, visit our website or contact Stella Stergiopoulos by email or by phone at 617-636-0322. 


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Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation
February 6 -10, 2012, TAJ Boston Hotel
For the past 39 years, Tufts CSDD has assembled top speakers from industry, government, and academia to bring you our highly acclaimed, five-day Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation. This CME-accredited course provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety, and new drug regulation. Thousands of drug development professionals are alumni of this prestigious program. Visit our website to find out more and register now to take advantage of early-bird pricing.  
Tufts CSDD Recent Publications   


Getz K, Campo R, Kaitin K.  Variability in Protocol Design Complexity by Phase and Therapeutic Area. Drug Information Journal 2011;45(4):413-420. 


Kaitin K, Milne CP.  Commentary. A Dearth of New Meds: Drugs to Treat Neuropsychiatric Disorders Have Become Too Risky for Big Pharma. Scientific American August 2011, http://www.scientificamerican.com/article.cfm?id=a-dearth-of-new-meds


Simmons D, Chappell J, Getz K, Hallinan Z. Are Pharmacists a Viable Channel for Education about Clinical Trial Participation? Drug Information Journal 2011;45(4):443-453. 

Faculty Presentations
Selected presentations given or scheduled to be given by Tufts CSDD staff:

Janice Reichert: Antibody Engineering and Design Conference, Boston, MA, July 19, 2011  


Kenneth Kaitin: European Center for Pharmaceutical Medicine, University of Basel, Basel, Switzerland, September 5, 2011  


Janice Reichert: IMPULSE EFIS-EJI Symposium, Visegrad, Hungary, September 5, 2011  


Joshua Cohen:  Cambridge Healthcare Institute's Third Annual ADAPT Congress: Making Personalized Therapy a Reality (keynote); Philadelphia, September 7-9, 2011  


Kenneth Kaitin: American Course in Drug Development and Regulatory Science, UCSF, Washington, DC, September 12, 2011  


Kenneth Getz: 15th Annual eClinical Integration Summit, Boston, MA, September 19-21, 2011  


Kenneth Kaitin: IIR Central Labs Annual Meeting (keynote), Boston, MA, September 19, 2011  


Kenneth Getz: Clinical Trials: Recruiting, Retaining, and Analyzing Data for Women and Underserved Populations. Society for Women's Health Research and FDA Conference, Washington, DC, September 22-23, 2011

Kenneth Kaitin: CBI Preclinical Development Forum (keynote), Boston, MA, September 26, 2011  


Kenneth Kaitin: CTSA Public-Private Partnership Webinar Series, National Institutes of Health, September 28, 2011

I N   T H I S   I S S U E
Tufts CSDD Publications and Reports
Current CSDD Multi-Company Studies
Upcoming Programs and Events
Tufts CSDD Recent Publications
Faculty Presentations
FYI. . .

AshleyMalinsWelcome to Ms. Ashley Malins who joined the Tufts Center staff on July 18, 2011 as one of our new Research Analysts. She can be contacted at Ashley.Malins@tufts.edu. Welcome Ashley!
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Also welcome to Mr. Adam Mathias who joined CSDD as a Research Analyst on June 13, 2011. He can be contacted at Adam.Mathias@tufts.edu. Welcome Adam!
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Ken Getz has been invited to join the Empirical Advisory Committee serving President Obama's Bioethics Commission.

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 Tufts CSDD in the News
Selected excerpts from recent articles

Nature News
August 22, 2011
Toxic antibodies blitz tumours

Janice Reichert, an analyst at the Tufts Center for the Study of Drug Development in Boston, Massachusetts, expects more approvals to follow. Between 2000 and 2005, only six antibody-drug conjugates entered the clinic for the first time, she says.

Chemical & Engineering News

August 15, 2011
Pfizer augments academic network, collaboration: San Diego hosts the drugmaker's latest partnership

Kenneth I Kaitin, director of the Tufts Center for the Study of Drug Development, says Pfizer's partnering strategy is "particularly good" because it calls for industry and academic scientists to work side by side. ... In the process, he says, Pfizer gains access to cutting-edge science, and academics can tap into the company's development and commercialization expertise.

Fierce Biotech
July 25, 2011
Analysis: Grim stats on CNS drugs demand fresh approach to development

It's no secret that neuropsychiatric diseases like schizophrenia, depression and Alzheimer's present one of the toughest challenges to drug developers. Ken Kaitin and Christopher Milne at the Tufts Center for the Study of Drug Development crunched the numbers in their database to see just how tough it is, and came up with a daunting set of figures.

Express-News (San Antonio)
June 26, 2011
Clinical trials are in need of patients

There are currently about 3,300 drugs being tested around the world, which means as many as 80,000 trials are actively recruiting volunteers, according to Ken Getz, senior fellow at the Tufts Center for Drug Development in Boston. Finding patients to fill those slots can be difficult."

"Outreach is one of the toughest challenges research facilities face today," said Getz, who is also the founder of the nonprofit Center for Information and Study on Clinical Research Participation.

Chemistry World -RSC
(Royal Society of Chemistry)

June 22, 2011
US approves cancer drugs twice as fast as Europe


Joshua Cohen, research assistant professor at Tufts Center for Drug Development in Boston, US, was less surprised. "The results are consistent with several studies we've done recently," he says. "Cancer is an area in which the US still has a comparative advantage. Many products are biotechnologically derived and, generally speaking, biotechnology still does better in the US than Europe. Cancer advocacy is very powerful in the US, and there is still a lot of market upside in cancer therapeutics here, while many other therapeutic categories are saturated." 

Nature News

June 22, 2011

Drug buddies


"My big fear is that we're going to create a polarization within academic centres," says Kenneth Kaitin, director of the Tufts [CSDD] in Boston.


Tightening federal budgets are also putting financial strains on academic labs, making industry collaborations more attractive. "Every academic centre is looking at all this money flying around and asking: 'how do we get a piece of this action?'" says Kaitin.

June 16, 2011

Off a Cliff: $100 Billion in Revenues Will Disappear From Drug Business by 2013  


Pfizer (PFE) will lose more revenues than any other company - $29.2 billion in through 2013 - when its cholesterol blockbuster Lipitor and other drugs lose the patent protections that give them exclusive marketing rights, according to research by Prof. Ken Kaitin of Tufts University's Center for the Study of Drug Development.     


Boston Globe
June 14, 2011
Biotechs are spending less on drug discovery

Kenneth I. Kaitin, director of the Tufts [CSDD] in Boston, said some venture capitalists have soured on biotechnology investments because their need to cash out in a relatively short time conflicts with the increasingly long time it takes to get a new drug on the market. At the same time, pharmaceutical companies - which are sitting on cash but are having limited success with their in-house research - are more eager than ever to strike partnerships with biotechs.


"Biotechs can't do it the way they did it in the past, so they're turning to Big Pharma for funding,'' Kaitin said. "The biotechnology industry is being viewed [by Big Pharma] as a potential provider of assets for drug companies as they cut back on their own research and development spending.''


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
Professor Emeritus, Senior Research Fellow & Medical Consultant
Tufts CSDD
617.636.2170 | csdd.tufts.edu