S E C O N D   Q U A R T E R   2 0 1 2


Welcome to our second Tufts CSDD Quarterly Update of 2012, offering a snapshot of current research activities, publications, presentations, educational programming, and other news of the quarter. As you'll see, it's been a busy and productive Spring for us here at the Tufts Center.


On May 17th, I chaired our quarterly Tufts CSDD Executive Forum roundtable, and I couldn't have been more pleased with the candid and dynamic discussion. The topic was Academic-Industry Partnerships: Opportunities and Pitfalls. There were outstanding presentations describing the partnership models of Eli Lilly, Pfizer, Merck, and Novartis. The group also heard a review of Tufts CSDD's recent study on the status of academic-industry relationships, and an insider's view from Tufts Medical Center on partnering with industry.


Several observations from the roundtable stood out for me. The first was that although all the represented companies are committed to partnering with academic institutions to gain access to novel science and new research opportunities, each company has developed its own approach for designing and managing the process. The result is a mélange of partnership models coming out of industry, each with its own goals and strategic underpinnings. Another observation was that there is a critical need to bring more academic scientists into these discussions. Although the roundtable benefitted greatly from hearing the perspectives of the technology transfer office and the business development group at Tufts University School of Medicine and Tufts Medical Center, respectively, more academic institutions need to add their voice to the discussion of how to best design and manage successful academic-industry partnerships. I believe this is where Tufts CSDD, by providing a neutral forum for these critical discussions, can play a unique and vital role. Note that our next Tufts CSDD R&D Management Report will present highlights of the roundtable.


On another note, I'm pleased to announce that Tufts CSDD will be well represented at the upcoming Drug Information Association Annual Meeting, June 25-28 in Philadelphia. Joe DiMasi, Mary Jo Lamberti, and Stella Stergiopoulos will all be speaking in or chairing sessions. Also, Ken Getz and I will, once again, be chairing a special joint CSDD-DIA executive-level program entitled Pioneering Partnerships. In the first of the two sessions, we will be looking at Collaborative Research with Members of the Payer Community. In the second session, we will focus on Challenges of Precision Medicine: Diagnostics, Reimbursement, and Partnership Co-Development. The sessions will be held on Tuesday, June 26, at 10am and 12pm. If you plan to attend the DIA Annual Meeting, I encourage you to look into this special program.


As always, we're interested in hearing your thoughts and perspectives on these and other issues. Don't hesitate to contact us with your comments. I thank you for your support.




Kenneth I Kaitin, PhD
Professor and Director
Tufts CSDD Publications and Reports

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.
Cover for April/May 2012 Impact Report

User fee era in U.S. currently poses mixed regulatory burden for sponsors
Vol. 14, Issue 3, May/June 2012
Drug sponsors experienced a mixed regulatory burden under the FDA Amendments Act, which was also the fourth iteration of the Prescription Drug User Fee Act (PDUFA IV), according to new research from 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.



Cover for April 2012 R&D Management reportManaging the Transition from Nonclinical to Early Clinical Development  

Vol. 7, No. 2, April 2012

Drug companies looking to increase the efficiency and productivity of their R&D pipelines are turning to a host of techniques and approaches aimed at shortening the time from nonclinical to early clinical development - with promising results - 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 Integrated Outsourcing Relationship Models on Quality and Performance
  • Comparative Economic Study of Fully-Loaded Sponsor Versus Contract Clinical Service Provider Costs  
  • Evaluating the Use of Comparators and Co-Therapies in Clinical Studies   

Sponsored Research 

  • Approval Success Rates for Cancer Drugs
  • Comparison of Patient Access to Cancer Drugs in the United States and Europe 
  • Generics and Biosimilars Initiative: Regulatory and Economic challenges facing biosimilars


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 ForumExecForumbroch

The Tufts CSDD Executive Forum 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.   



The Changing Landscape for Technical Services Outsourcing 

September 13, 2012, Boston, MA  

In a recent analysis, Tufts CSDD documented an increased reliance by companies on technical services outsourcing - including clinical supplies, heart assessment, and others - to boost efficiency and productivity. This roundtable will open with a presentation of Tufts CSDD findings, followed by companies describing their strategies for improving the return on relationships with technical services outsourcing providers.

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.  

This year's program is nearly at capacity, so act fast if you are interested in joining us for this unique learning experience.


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

Tufts CSDD Recent Publications   


DiMasi JA, Grabowski HG. R&D Costs and Returns to New Drug Development: A Review of the Evidence. In: The Oxford Handbook of The Economics of the Biopharmaceutical Industry, eds. PM Danzon, S Nicholson. Oxford: Oxford University Press; 2012:21-46 


Getz K, Hallinan Z, Simmons D, Brickman MJ, Jumadilova Z, Pauer L, Wilenzick M, Morrison B. Meeting the Obligation to Communicate Clinical Trial Results to Study Volunteers. Expert Review of Clinical Pharmacology 2012 Mar;5(2):149-156  


Malins A, Milne C-P. Application of Biopharmaceutics Classification System in Drug Development. Pharma Focus Asia 2012;(16):24-31 


Milne C-P, Joshi N. Biopharmaceutics Classification System (BCS): Optimization Through Harmonization.  DIA India 5th Annual Conference Magazine April 2012 

Milne C-P, Malins A. White paper: Academic-Industry Partnerships for Biopharmaceutical Research & Development: Advancing Medical Science in the U.S. Boston: Tufts Center for the Study of Drug Development. April 2012 


Reichert JM. Marketed Therapeutic Antibodies Compendium. MAbs 2012 May;4(3):413-415   


Shader RI, Milne C-P. The Use of Generic Drugs in Pediatric Psychopharmacology. In: Pharmacotherapy of Child and Adolescent Psychiatric Disorders. 3rd ed, eds. DR Rosenberg, S Gershon. Hoboken, NJ: Wiley; 2012:39-50  


Wilson AW, Neumann PJ. The Cost-Effectiveness of Biopharmaceuticals: A Look at the Evidence. MAbs 2012 Mar/Apr;4(2):281-8

Zuckerman R, Milne C-P. Market Watch: Industry Perspectives on Personalized Medicine. Nature Reviews Drug Discovery 2012;11(3):178 

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

Christopher-Paul Milne: Food & Drug Law Institute Annual Conference, Washington, DC, April 24-25, 2012

Kenneth I Kaitin: Marcus Evans Evolution Summit, Meeting Chair and Keynote Speaker, Chicago, IL, April 30-May 2, 2012

Stella Stergiopoulos
: Drug Delivery Formulation 2012 Summit, San Francisco, CA, April 30-May 2, 2012

Kenneth I Kaitin: Bill and Melinda Gates Foundation Symposium on Measuring Value and Creating a Measurement Culture, Seattle, WA, May 3, 2012

Ken Getz: Alliance for Multispecialty Research Annual Meeting, Keynote, Coral Gables, FL, May 4, 2012 


Kenneth I Kaitin: Lysosomal Storage Disorders Patient Group Meeting, Boston, MA, May 6, 2012 


Ken Getz: MassBIO, Cambridge, MA, May 15, 2012 


Joseph DiMasi: American Thoracic Society 2012 International Conference, San Francisco, CA, May 18-23, 2012


Kenneth I Kaitin: Danske Bank Symposium on Emerging Markets, Copenhagen, Denmark, May 23, 2012 


Christopher-Paul Milne: NextLevel Pharma Conference, Singapore, May 23-24, 2012   


Ken Getz: BioCentral Conference, Kansas City, KS, June 6, 2012   


Kenneth I Kaitin: Science Shaping Our World (SHOW), Boston, MA, June 7, 2012  


Joshua Cohen: Harvard Medical School's Annual Conference, Cambridge, MA, June 15, 2012 


Kenneth I Kaitin, Joseph DiMasi, Ken Getz, Mary Jo Lamberti, Stella Stergiopoulos: Drug Information Association 2012 Annual Meeting, Philadelphia, PA, June 24-28, 2012

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

Ken Kaitin, Joe DiMasi, Ken Getz, Mary Jo Lamberti, and Stella Stergiopoulos will be presenting and chairing sessions at this year's Drug Information Association annual meeting, to be held June 25-28 in Philadelphia.

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 Tufts CSDD in the News
Selected excerpts from recent articles

The Lancet
May 17, 2012
Skies Darken Over Drug Companies
"Only three out of ten compounds in the marketed portfolio of pharma companies generate revenues equal to or greater than the average cost to develop a new drug," explains [Tufts CSDD director] Kaitin. "Unfortunately for industry, many of these top selling products are those that have already lost or about about to lose patent protection." ..."Actually, I'm optimistic about the future of the research-based industry. The talent and the commitment are there, and the need for new medicines is never-ending."


May 17, 2012 

Top Drug Lobbyist Says U.S. Losing Research Jobs Overseas 

Efforts by the U.S. to keep companies may have little benefit as most of the growth in the pharmaceutical sector will be in emerging markets, said Christopher-Paul Milne, associate director for [Tufts CSDD]. ... "It is a global industry and has been and it is going to continue to further globalize," Milne said. 

Tampa Bay Online
May 11, 2012
Promising USF Drug Falls Short in Trials

The demand for drugs to treat depression and other central nervous system disorders is high, but they're more difficult than most to move through the approval process, said Joseph DiMasi, of [Tufts CSDD].


The New York Times  

May 1, 2012

Pfizer Races to Reinvent Itself  

"The question is how do you remain successful and sustain your operations if you're investing less and less in R&D?" said Kenneth I. Kaitin, a professor and director of [Tufts CSDD]. "The answer to that is to try to find a new way and a more efficient mechanism for discovering and developing drugs."


Wall Street Journal

Apr 24, 2012

Simpler Language, More Access to Results Sought for Clinical-Trial Volunteers

"People who agree to participate in clinical research want to know that their involvement informed medical knowledge about disease and how to treat it," says lead author Kenneth Getz, an assistant professor at [Tufts CSDD].

Innovation News Daily

Apr 23, 2012

Prescription for Worry? Drug Firms Outsource Research to Universities

Traditionally, universities performed very early-stage, basic research and the drug industry took it from there. Now they're meeting more in the middle, said Sherer and Christopher Milne, associate director at [Tufts CSDD]. ... "This is the way research is going to be done going forward," Milne said.


The Wall Street Journal

Apr 23, 2012

Services Match Patients with Clinical Trials

Kenneth Getz, a senior research fellow at [Tufts CSDD], says matching services can play an important role in increasing trial participation but cautions that patients "often don't have even a rudimentary understanding of how to evaluate this information" and should consult with their doctors or nurses before pursuing a trial.  


Forbes India

Apr 9, 2012

How Open Source Drug Discovery is Helping India Develop New Drugs

"In drug research, the network effect is multiplying. The medicines of the future will come from innovation networks, which will be comprised of numerous stakeholders, says Kenneth Kaitin, professor and director, [Tufts CSDD]. .... Although India may currently lack the infrastructure for moving forward with some of these open source initiatives, I think the brain power and commitment are there..."

Genetic Engineering & Biotechnology News

Apr 9, 2012

Studies Suggest that When it Comes to Drug Development Success, Size Matters

"The distribution of disease categories does differ between large and small molecules. In particular, large molecule development is more concentrated in oncology and immunology, while small molecule development is more concentrated on cardiovascular and CNS conditions," Joseph A. DiMasi, Ph.D., director of economic analysis for Tufts CSDD, told GEN. 


FierceBiotech IT

Apr 9, 2012

Big Pharmas Back Open Source Drug Discovery with Money and Molecules

Ken Kaitin, director of [Tufts CSDD], said it's only a matter of time before the network model taking hold in biopharma results in new medicines... 


Mar 30, 2012

SME Biotech Companies Are Playing A More Critical Role In R-and-D For Neglected Tropical Diseases Than Previously Thought; NTDs Affect More Than One Billion People Worldwide

NTDs are a group of diseases that mostly affect the poor in developing countries, and have historically been given less attention by both the private and public sectors. A 2010 study by Joshua Cohen and Andrew Wilson of [Tufts CSDD], and Maria Staroselsky Dibner of the Lahey Clinic in Massachusetts found that only three percent of the 1,393 new drug approvals between 1975 and 1999 were for NTDs. 



Mar 28, 2012

In Cancer Science, Many "Discoveries" Don't Hold Up

"If you can write it up and get it published you're not even thinking of reproducibility," said Ken Kaitin, director of [Tufts CSDD]. "You make an observation and move on. There is no incentive to find out it was wrong."


Cancer Discovery

Mar 22, 2012  

The Science of Biosimilars

"Creators of biosimilars must reverse-engineer the conditions that will nudge their cells to make protein drugs with all the right structural properties. Some differences have a significant effect on a protein drug's efficacy and toxicity. Some don't. "The hard part is knowing what is clinically relevant," says Janice Reichert, PhD, research assistant professor at [Tufts CSDD]."  


The Oregonian

Mar 21, 2012

Oregon Patients Caught Between Insurers, High Cost for Specialty Drugs 

At issue are medications often known as "biologics" that target cancer, HIV, multiple sclerosis, hemophilia, hepatitis C, lupus and other chronic or progressive diseases. Specialty drugs generally impact a small population, and therefore cost a lot to recoup research costs, says Dr. Christopher-Paul Milne, associate director of [Tufts CSDD].



Mar 16, 2012

New Institute Aims to Help Academics Make Medicines

The launch of the new institute comes at a time when pharmaceutical companies around the globe are scrambling in search of a new model for research and development, says Kenneth Kaitin, who heads [Tufts CSDD].



Mar 16, 2012

Study Shows CNS Drugs Take Longer Than Others to Develop, Receive Approval

"Although I expected that CNS drug development and approval times were longer than average, I was somewhat surprised at the extent to which they were longer," said Joseph A. DiMasi, PhD, director of economic analysis, [Tufts CSDD], and principal investigator. "I also found it surprising that non-CNS drugs were two-and-one half times more likely to receive a priority review rating from the FDA than were CNS drugs."


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
Medical Consultant and Professor Emeritus, Molecular Physiology and Pharmacology

Tufts CSDD
617.636.2170 | csdd.tufts.edu