F I R S T   Q U A R T E R   2 0 1 2


I'm pleased to present our first Tufts CSDD Quarterly Update of 2012, providing a snapshot of the Center's current research, publications, programs, and news from the quarter. The first few months of 2012 have seen a flurry of activity at CSDD, including a very successful Forum on the Impact of Comparative Effectiveness Research on Biopharmaceutical Innovation, hosted by Joshua Cohen, as well as a lively and productive first Tufts CSDD Executive Forum roundtable of 2012, which focused on managing the transition from nonclinical to clinical development, and included speakers from Millennium, Charles River Labs, Aptuit, and Novartis. 


The quarter was punctuated by our 39th annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, held February 6-10 at the Taj Hotel in Boston. Once again, this unique professional development experience drew rave reviews from the participants, who represented one of our most diverse groups to date. We were delighted to have Dr. Sandra Kweder, Deputy Director of FDA's Office of New Drugs, once again join us for an open discussion of current regulatory challenges and a candid Q&A session. This year's program also included several new speakers and applied-learning activities, with deeper examinations in the areas of human research subject protection, the role of chance in clinical trials, and managing CRO relationships. Plans are already underway for our 2013 program, which will mark the course's 40th Anniversary. If you haven't taken CSDD's Postgraduate Course yet, I encourage you to register for what I promise will be an exceptional learning experience.


The landscape for pharmaceutical innovation is changing. I'm extremely proud that Tufts CSDD remains at the forefront of efforts to study, describe, and improve the environment for new drug and biological development. Please feel free to contact me with any comments or questions. And as always, I thank you for your support.




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

Tufts CSDD's 39th Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation    

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Tufts CSDD's 39th annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation was held February 6-10 at the Taj Hotel in Boston. As in previous years it was a highly successful program in which we received overwhelmingly positive feedback from the attendees. The course consisted of lectures, breakout sessions, and student presentations.  


Mark your calendars for Tufts CSDD's 40th annual Postgraduate Course, taking place February 4-8, 2013. To sign up for email updates, please contact Jonathan Hsieh at 617-636-0840 or via email.



Tufts CSDD Publications and Reports

Tufts CSDD Outlook, published each January, highlights near-term pharmaceutical and biopharmaceutical development, regulatory, and marketing trends. The data and analyses contained in Tufts CSDD Outlook are based on proprietary research conducted by CSDD and insights into current industry, regulatory, and policy trends. Specific areas covered include:
  • R&D Efficiency
  • Regulatory Environment
  • Biotechnology Trends
  • Prescription Drug Policy
  • Drug Development Management Trends
Visit our website for more information or to purchase the recently available Outlook 2012 report.

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Tufts CSDD Impact Reports  
Tufts CSDD Impact Reports is 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 a "must-read." Visit our website for current Tufts CSDD Impact Reports and become a subscriber today. 

ImpRptJan_Apr12Study monitor workload high & varied with wide disparity by global region
Vol. 14, Issue 1, Jan/Feb 2012

The Tufts Center for the Study of Drug Development today announced that it has established the first global benchmark for clinical research associate (CRA) workload and utilization, giving managers insights into improving CRA effectiveness and efficiency. [View press release]  


Pace of CNS drug development and FDA approvals lags other drug classes

Vol. 14, Issue 2, Mar/Apr 2012 

Drugs developed to treat central nervous system (CNS) diseases take 35% longer to complete clinical trials and receive regulatory approval compared to other new prescription medicines, according to an analysis recently completed by the Tufts Center for the Study of Drug Development. [View press release]     


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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, where senior executives across industry convene with CSDD research staff to discuss current drug development challenges and strategic initiatives within the research-based industry.



Resource Management Strategies to Optimize R&D Performance, Vol. 7, Issue 1, Jan 2012

Pharmaceutical and biopharmaceutical companies, under pressure to increase R&D productivity, are expanding their use of strategic partnerships to bring new drugs to market more quickly and at lower cost, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development. [View press release


Visit our website for a list of recent Tufts CSDD R&D Management Reports.


Research Opportunities 

As part of its broad research agenda, CSDD runs Multi-Company Working Groups and conducts Sponsored Research on a wide variety of topics identified by individual or multiple sponsors. Here is a list of projects currently in progress: 


Multi-Company Working Group Studies

  • Assessing the Impact of New Outsourcing Strategies
  • Benchmarking the Study of Initiation Process
  • Biologics for Cancer
  • Evaluating Completeness and Accuracy of Adverse Event Reporting
  • Evaluating the Root Cause and Impact of Drug Shortages  
  • Measuring the Cost of Co-therapy and Comparator Use in Drug Development
  • PDUFA Regulatory Metrics Working Group  
  • Quantifying the Cost of Unused Protocol Data

Sponsored Research

  • Academic-Industry Partnerships in Biopharmaceutical R&D: Advancing Medical Science in the U.S.
  • Approval Success Rates for Cancer Drugs
  • Biosimilar Product Approval and Reimbursement in the US
  • Comparing Patient Access to Cancer Drugs in US and Europe   
Email us for additional information about sponsoring research at Tufts CSDD  or participating in one of our Multi-Company Working Groups. 
Upcoming Programs and Events 

Tufts CSDD Executive Forum

The Tufts CSDD Executive Forum series is a unique program of highly interactive, one-day roundtables for senior R&D leaders. Hosted by CSDD, the series 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.   



Academic-Industry Partnerships: Opportunities and Pitfalls
May 17, 2012, Boston, MA   

Partnerships between academic research centers and research-based pharmaceutical companies are a growing trend. These partnerships help industry control R&D spending and overhead, and allow academia to generate new revenue streams. Whereas both sectors have a common goal of improving healthcare by providing newer and better treatments for patients, there are significant challenges in optimizing the value of these relationships. This roundtable will assess the structure and function of existing academic-industry partnerships, and will examine strategies for increasing partnership value. 


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


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.

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Leadershpbroch12Tufts CSDD Leadership for Drug Development Teams
July 10-11, 2012, 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.  


For more information or to register, visit our website or call Jonathan Hsieh at 617-636-0840. 

Tufts CSDD Recent Publications   


Cohen JP. Overcoming Regulatory and Economic Challenges Facing Pharmacogenomics. New Biotechnology 19 Feb 2012.


Cohen JP, Christensen K, Feldman L. Disease Management and Medication Compliance. Population Health Management 2012 Feb;15(1):20-28.   


Cohen JP, Wilson A, Manzolillo K. Clinical and Economic Challenges Facing Pharmacogenomics. Pharmacogenomics Journal 10 Jan 2012.


Feldman L, Milne C-P. Current Landscape of Orphan Product Developers. Global Forum 2012 Feb;4(1):40-43.

Getz KA. Transforming Legacy R&D Through Open Innovation. ACRP Monitor 2011 Dec;25(7):17-21.


Kaitin KI. Creating Innovation Nodes to Meet Unmet Medical Needs. Pharmaceutical Technology 2011 Dec;35(12):27.


Milne C-P. Defining Conflict of Interest. Pharmaceutical Technology 2012 Mar;36(3):38. 


Milne C-P, Kaitin KI. FDA Review Divisions: Performance Levels and the Impact on Drug Sponsors. Clinical Pharmacology & Therapeutics 2012; 91(3):393-404. 


Wilson A, Milne C-P. FDA's Risk Evaluation and Mitigation Strategies (REMS): Effective and Efficient Safety Tool or Process Poltergeist? Food & Drug Law Journal 2011;66(4):569-86.

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

Kenneth I Kaitin: Diário Económico Conference on the Pharmaceutical Industry, Lisbon, Portugal, January 26, 2012


Christopher Milne: SCOPE Summit, Miami, FL, February 7-8, 2012


Kenneth Getz: Network of Networks Annual Meeting, Predictors of Successful Site Performance, Toronto, Canada, February 9-10, 2012


Kenneth Getz: Outsourcing West, Keynote, San Francisco, CA, February 13-15, 2012


Kenneth I Kaitin: International Conference on Drug Development, University of Texas, Austin, TX, February 27-20, 2012


Joshua Cohen: Town Hall Meeting on the Multidisciplinary Management of Non-small Cell Lung Cancer: A Community Perspective, Nashville, TN, March 7, 2012   


Christopher Milne: NextLevel Pharma Unmet Medical Needs Forum, London, UK, March 19-20, 2012


Janice Reichert: Scientific Forum of the Cancéropôle, Lyon, France, March 20, 2012


Kenneth I Kaitin: Marcus Evans Drug Discovery Summit, Keynote and Meeting Chair, Cannes, France, March 22-23, 2012

I N   T H I S   I S S U E
Tufts CSDD Publications and Reports
Sponsored Research
Upcoming Programs and Events
Tufts CSDD Recent Publications
Staff Presentations
FYI. . .

We're proud to announce that CSDD research assistant professor Janice Reichert was elected 2012 President of The Antibody Society.
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We're pleased to note that CSDD's newest update study on the cost of new drug development, being conducted by director of economic analysis Joseph DiMasi, is well under way.
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CSDD director Kenneth Kaitin will brief the Department of Defense's Chemical, Biological and Medical Systems group on April 16th at the Aberdeen Proving Grounds in Maryland.

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 Tufts CSDD in the News
Selected excerpts from recent articles

Cancer Network

Feb 22, 2012

Challenges to the FDA Review Process: Cost Considerations and Long-Term Benefit Benchmarks 

[Podcast with Christopher-Paul Milne and Kenneth I Kaitin of Tufts CSDD]:


CM: "We are getting a lot of overlap now with drug-device combinations as well as new drug delivery vehicles. ... [The FDA] is not only going to have to enhance their in-house capacity, but they are going to have to improve the policy network so that they can extend their expertise outreach too."


KK: "Reimbursement has not traditionally been an issue in the oncology space ... Now I think we are beginning to see that that is eroding."


MIT Technology Review

Mar/Apr 2012

Foundation Medicine: Personalizing Cancer Drugs  


Some [insurance companies] already balk at paying for well-established tests, says Christopher-Paul Milne, associate director of [Tufts CSDD], who calls reimbursement "one of the biggest impediments to personalized medicine." 


Medical Marketing and Media

Feb 16, 2012

Drugmakers look outside labs to offset R&D risk


Dr. Kenneth Kaitin, a professor and director at [Tufts CSDD] told MM&M ... that there is no blanket solution to keeping a lid on [industry R&D] investment, but that strategic partnerships can be a smarter way for pharmaceutical companies to explore a research area as opposed to going through the turmoil and cost of a merger or acquisition. ... Kaitin said, academic partnerships have been a prime example of the benefits of this approach: companies get access to science without the cost of staff, rent or heat, and gain the ability to walk away from project without baggage, because "if the technology doesn't work, you don't own it."


The American

Feb 2, 2012

Red Tape and Pink Slips: Obama's Imaginary Regulatory Reform


In a study published last year, Joseph DiMasi and Laura Faden of [Tufts CSDD] persuasively debunked the myth that drug companies purposely produce duplicative me-too drugs. They ... found that the process is best viewed as "a race in which several firms pursue investigational drugs with similar chemical structures or with the same mechanism of action before any drug in the class obtains regulatory marketing approval."   


Market Watch.com

Jan 31, 2011

Transparency Life Sciences, LLC Launched as World's First Drug Development Company Based on Open Innovation

"Our research at the Tufts Center highlights the urgent need to remove bottlenecks and inefficiencies in clinical development and to reduce the high and rising cost of R&D," added Kenneth Getz of [Tufts CSDD]. "Bold new approaches are needed to upend the long-outdated pharmaceutical R&D paradigm."


MIT Technology Review

Jan/Feb 2012

Technological Healing 


Despite some progress in matching cancer drugs to tumors, pharmacogenomics "has had limited impact on clinical practice," says Joshua Cohen of [Tufts CSDD], who led a 2011 study of the field. Several dozen diagnostics are in use to assess whether patients would benefit from a specific drug, he estimates. ... But insurers still doubt the value of most such tests.



Jan 18, 2012

CRAs spend less than half their time in on-site monitoring tasks, says Tufts 


[Tufts CSDD] senior project manager Mary Jo Lamberti told Outsourcing-pharma.com ...: "The first step in more efficiently managing CRA time is to gather baseline data so that CRA managers are making informed decisions." This approach has been adopted by regulators according to Dr Lamberti who added that "[The US] FDA and EMA are already looking at ways of reducing CRA work burden. The Tufts CSDD study can help inform these discussions."



Jan 9, 2012 

New study finds medical sales jobs may be boosted by better drug development


Kenneth I Kaitin, Tufts CSDD director, said companies need to improve their research and development productivity over the next five years in order to stay competitive in the global market. "The good news is that many companies are embracing new approaches to drug development that have the potential to improve R&D productivity, including novel partnership agreements with academic medical centers and other drug companies," Kaitin added.



Jan 2012

2011 in Reflection 


"Partnerships have become an increasingly important mechanism for mitigating development risk and reducing overall R&D spending," says Ken Kaitin, Director of [Tufts CSDD]. "I expect the number and extent of these partnerships to grow."


Jan 6, 2012

HHS ruling on Plan B introduces new risk for drugmakers


"The message to the industry is clear," says Kenneth Kaitin, director of [Tufts CSDD]. "If you're developing a drug or considering developing a new medicine in an area that might be politically charged, you should think again."


The Wall Street Journal

Dec 27, 2011

Families of Ill Children Try Drug Development

Drug companies drop promising compounds for many reasons, says Kenneth Getz, senior fellow at [Tufts CSDD]. ... "Historically, drug development has been a very insular and secretive activity," says Mr. Getz. "The reasons for discontinuing development [may never be] fully disclosed to the patient community," he says.



Dec 6, 2011

Novartis to shut brain research facility

"Standard approaches to developing drugs for mental health have not reaped significant benefit in the past two decades," says Ken Kaitin, director of [Tufts CSDD]. "But it is a dilemma for the companies because there is a large and growing market for these products."  



Nov 30, 211  

Pfizer targets miniblockbuster prospects as Lipitor patent expires 


The shelf lives of new blockbusters might be shorter than previous big-sellers like Lipitor, as multiple drugs against the same targets compete and beat out others for market share. "We won't see drugs with the [financial] longevity of Lipitor," Ken Kaitin, director of [Tufts CSDD], told Nature News. 


Kenneth I Kaitin, PhD 
Professor and Director

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
Research Assistant Professor

Janice M. Reichert, PhD
Research Assistant Professor

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

Tufts CSDD
617.636.2170 | csdd.tufts.edu