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Welcome to our third Tufts CSDD Quarterly Update of 2012, providing an overview of current Center research, publications, presentations, courses, and other news of the quarter. Summer is typically a busy time at the Tufts Center, and this one was no exception. As you'll see below, it's been an active and productive quarter.
A particularly interesting project that I'm working on is the China Drug Administrative Law (DAL) Initiative, the goal of which is to review and make recommendations regarding China's current DAL to inform potential reforms. Three U.S. rapporteurs (Susan Winckler, President and CEO of the Food and Drug Law Institute, Richard Kingham, Partner at Covington & Burling, LLP, and me) are working closely with Chinese colleagues in Tsinghua University's Pharmaceutical Law Institute to assess and contrast the regulatory process in China with that in the U.S. and the E.U. The U.S. trade association PhRMA is supporting the effort. We held our first joint meeting in Beijing in July, and we will present our final report in early December 2012. I look forward to sharing some of the details of our deliberations with you in future reports.
I'm very pleased to announce several important promotions within the Tufts Center that became effective July 1st. Christopher Milne, formerly associate director, is now our Director of Research. Ken Getz is now Director of CSDD Sponsored Research Program. And Robert Chung has become our new Director of Administration and Development. On an additional note, on July 2nd we bid farewell to Janice Reichert, who had been with the Center for 13 years. During that time, Jan tracked trends in biotechnology product development and managed our research efforts in the expanding area of protein therapeutics.
As always, we're interested in hearing your thoughts and comments on CSDD research, programs, and other activities. Feel free to contact us with your ideas, and I thank you for your support.
Sincerely,
Kenneth I Kaitin, Ph.D.
Professor and Director
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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, where senior leaders across the pharmaceutical spectrum gather with CSDD faculty to discuss current drug development challenges and strategic initiatives within the research-based industry.
 RECENT REPORT: Making Academic-Industry Partnerships Work for Both PartiesVol. 7, No. 3 Drug developers are forging new ways to work with academic medical centers to create the next generation of breakthrough medicines, which is changing the way drug companies do science, according to a panel of leaders from academia and industry recently convened by the Tufts Center for the Study of Drug Development. [ View press release] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Tufts CSDD Impact Reports RECENT REPORT: U.S. offers patients faster, greater access to cancer drugs than Europe
Vol. 14, Issue 4, July/August 2012
Cancer patients in the United States get faster access to more oncology drugs to treat their disease than patients in Europe, according to a newly completed study by the Tufts Center for the Study of Drug Development. [View press release]
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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
- Comparative Economic Study of Fully-Loaded Sponsor Versus Contract Clinical Service Provider Costs
- Evaluating the Use of Comparators and Co-Therapies in Clinical Studies
- Quantifying the Cost of First Time in Human Preparations
Sponsored Research
- Comparison of Patient Access to Cancer Drugs in the United States and Europe
- Measuring the Value and Impact of Adaptive Clinical Trial Designs
- Reasons for Investigational Drug Failure
Email us for additional information about sponsoring research at Tufts CSDD or participating in one of our Multi-Company Working Groups.
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Upcoming Programs and Events
 Tufts CSDD Executive Forum
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. UPCOMING ROUNDTABLES
The Changing Landscape for Technical Services Outsourcing September 13, 2012, Boston, MA
In a recent analysis, Tufts CSDD found that companies are increasing their reliance on technical services outsourcing - including clinical supplies, heart assessment, and others - to boost efficiency and productivity. Tufts CSDD will kick-off this roundtable with a presentation of the results of its recent analyses. Companies will then share and discuss strategies for improving the return on relationships with technical services outsourcing providers. Development Strategies for Companion Diagnostics November 1, 2012, Boston, MA Partnership, co-development agreements, and collaborations are rapidly becoming the new face of pharmaceutical innovation. Transformational strategies 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. For more information or to register for upcoming roundtables, visit our website or contact Stella Stergiopoulos at 617-636-0322 or via email.
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40th Annual Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation  February 4-8, 2013, Boston, MA
For the past 40 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.
For more information or to register, visit our website.
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Tufts CSDD Recent Publications
Cohen JP. Evaluating the Impact of Medicare Part D on Quality Metrics. Expert Review of Pharmacoeconomics & Outcomes Research 2012 Jun;12(3):271-273 Getz KA. Outsourcing Landscape. Applied Clinical Trials 2012; 21(5) Getz KA, Kaitin KI. Transforming Pharmaceutical R&D Through Integrated and Open Partnerships. Global Forum 2012 Jun;4(3):16-21 Getz KA, Lamberti MJ, Mathias A, Stergiopoulos S. Resizing the Global Contract R&D Services Market. Contract Pharma 2012 Jun;14(5):54-62 Lamberti MJ, Mathias A, Myles JE, Howe D, Getz K. Evaluating the Impact of Patient Recruitment and Retention Practices. Drug Information Journal Online Publish Date: 2012, July 13 Milne C-P. Defining conflict of interest. Pharmaceutical Technology 2012; 36(3):38 Milne C-P. Innovation Boom Towns. Pharmaceutical Technology 2012;36(6):30 Milne C-P, Malins A, Namita J. The Biopharmaceutics Classification System: Canary in the Coal Mine for Regulatory Science. American Pharmaceutical Review Online Publish Date: 2012, July 17 Orfali M, Feldman L, Bhattacharjee V, Harkins P, Kadam S, Lo C, Ravi M, Shringarpure DT, Mardekian J, Cassino C, Coté T. Raising Orphans: How Clinical Development Programs of Drugs for Rare and Common Diseases are Different. Clinical Pharmacology & Therapeutics 2012 Aug;92(2):262-264 |
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Staff Presentations
Selected presentations given or scheduled to be given by Tufts CSDD staff
Kenneth Kaitin: Clinical Trials Methods Course in Neurology, Vail, CO, July 21, 2012 Kenneth Kaitin: Norrie Disease International Conference, Boston, MA, August 10, 2012 Kenneth Kaitin: Indiana University Clinical and Translational Science Institute, Indianapolis, IN, August 14, 2012 Kenneth Kaitin: IIR Clinical Business Expo, Boston, MA, September 19-20 Joshua Cohen: Cambridge Healthcare Institute's 4th Annual ADAPT Conference on Personalized Medicine, Washington, DC, September 19-22, 2012 Ken Getz: Contract Pharma, New Brunswick, NJ, September 20, 2012 Ken Getz: Outsourcing in Clinical Trials New England, Boston, MA, September 25, 2012 Ken Getz: Barnett Conference on Protocol Complexity, Boston, MA, October 9, 2012 Ken Getz: Site Solutions Summit, Palm Beach Gardens, FL, October 13, 2012 Kenneth Kaitin: Marcus Evans Evolution Summit, Munich, Germany, October 14-16, 2012 Ken Getz: Cambridge Healthtech Institute, Bethesda, MD, October 22, 2012 Christopher-Paul Milne: Annual Meeting of the Regulatory Affairs Professionals Society (RAPS), Seattle, WA, October 28, 2012 |
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Tufts CSDD hosted its 11th annual Leadership for Drug Development Teams course on July 10-11 at the Nine Zero Hotel in Boston. Led by Merle Kummer of Kummer Cosulting, we enjoyed a class packed to capacity with a highly engaged and energized group of attendees. Find out about our 2013 course here.
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Welcome to Ms. Jennifer Kruse who officially joined the Tufts Center staff in May 2012 as our new Staff Assistant. She can be contacted at jennifer.kruse@tufts.edu.
Welcome Jennifer!
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Selected excerpts from recent articles
The Boston Globe
June 11, 2012
Computers May Predict Drugs' Side Effects
Kenneth Kaitin, director [of CSDD, notes], "One of the major challenges for the industry is that compounds enter clinical testing without a very good understanding of how the drugs work and what the side effects are going to be, so you're essentially entering blind."
Bulletins-electroniques.com
(France)
June 15, 2012
Translational Research: The Renewal of Pharmaceutical Research
Kenneth I Kaitin is interviewed by the Office for Science and Technology for the French Embassy regarding translational research. The goal, he says, was to provide funding for academic institutions to conduct research that could be utilized by pharmaceutical companies for the creation of new drugs.
Bloomberg Business Week
June 15, 2012
Potential partnerships with industry leaders such as Pfizer could mean more resources for academic researchers. Ken Kaitin states that this partnership model "represents the most significant change in the innovative landscape we've seen in three decades."
The Burrill Report
July 13, 2012
"This study is groundbreaking in that it links, for the first time, clinical trial economics to protocol complexity," says Ken Getz, [of CSDD], who served as principle investigator. "The results have been eye-opening for participating companies and will no doubt serve as a jumping off point for pharmaceutical and biotechnology companies to examine ways to reduce the number of non-core procedures to improve clinical trial efficiency and substantially reduce study budgets."
The Tampa Tribune
July 16, 2012
USF to Explore Genetics Frontier
"Creative chaos" is the way Chris Milne [of CSDD] described the progress of personalized medicine. ..."Most doctors didn't learn about genetics at this level of detail in medical school," he said. ..."This is an exciting time in medicine, but it's a confusing time as we make a new paradigm "incorporating genomic information," Milne said.
PharmaExec.com
July 18, 2012
Paring the Fat in Clinical Trials
"What we found was that nearly one out of four procedures can be classified as non-core, costing sponsors approximately 20 per cent of every study budget on the collection of data that was not material or may never be used," study coordinator and Tufts senior research fellow Ken Getz told Pharm Exec. ...."
Chemical & Engineering News
July 23, 2012
"..In that case, the main problem is that the test doesn't tell physicians what they need to do, says Joshua P. Cohen, a health economist at [CSDD] who has studied market access to personalized medicine. It tells them which patients are at risk for uncontrolled bleeding, he adds, but it doesn't tell them what dose they should prescribe..."
Institutional Investor
August 1, 2012
"The FDA is trying not to be an impediment," says Christopher-Paul Milne, ... director of research at [CSDD]. ... "Not so long ago the FDA would say, 'The economic problems of the industry are not our problem," Milne notes. "Now they're saying, 'If there's a productivity problem, we have to go back and revamp the way we [look at] clinical development.'"
Nature Medicine
August 6, 2012
"It's a tradeoff," says Cohen [of CSDD]. "While patients in Europe don't have as many [therapeutic] options available to them, the options they do have are basically free."
August 6, 2012
Nurses on Trial
In the U.S. there are no requirements that physicians run clinical trials, but according to Ken Getz, "there is a general sense that MDs can be trusted most." Ken Getz also says that there is some evidence that the gender of a principal investigator affects who chooses to participate in a clinical trial.
JAMA
August 8, 2012
Oncology Drugs Enter the US Market Faster Than in Europe but Cost More
The evidence-based approach adopted by European systems appears to improve the affordability of drugs that are considered to be cost-effective, said Joshua P. Cohen, PhD, a research assistant professor at Tufts... Cohen added that although more oncology drugs are available in the United States, "it is not clear if greater access leads to better health outcomes."
Clinical Trials Advisor
August 16, 2012
Side-by-Side Industry-Academic Partnerships are Wave of Future
"To meet the dual challenges of drug discovery - developing new compounds faster and at less cost - drug makers should consider forming more integrated partnerships where company staff and academic scientists work side-by-side." "It's the best way to ensure benefit on investment," Kenneth Kaitin, director of [CSDD], told CTA.
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SENIOR RESEARCH STAFF
Kenneth I Kaitin, PhD
Professor and Director
Christopher-Paul Milne, DVM, MPH, JD
Director of Research, Assistant Professor
Joseph A. DiMasi, PhD
Director of Economic Analysis, Assistant Professor
Joshua P. Cohen, PhD
Assistant Professor
Kenneth A. Getz, MBA
Director of CSDD Sponsored Research Program, Assistant Professor
Richard I. Shader, MD
Medical Consultant and Professor Emeritus, Molecular Physiology and Pharmacology |
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