|F O U R T H Q U A R T E R 2 0 1 2|
Welcome to our fourth Tufts CSDD Quarterly Update of 2012, providing an overview of current Center research, publications, courses, presentations, and other news. It's been a busy and productive quarter. We have had several prominent peer-reviewed publications, our November R&D Roundtable on development strategies for companion diagnostics was well-attended and led to a very lively discussion, our update study on the cost of new drug development is moving forward nicely, and our Multi-Company Project Series continues to generate enormous interest and excitement among the participating companies.
As I mentioned in our previous Quarterly Update, I've been working with colleagues at Tsinghua University Law School in Beijing, along with U.S. co-rapporteurs Susan Winkler (former FDA chief of staff and current president and CEO of the Food and Drug Law Institute) and Richard Kingham (senior partner at Covington & Burling) on an initiative to develop recommendations for reform of the Chinese drug law. I'm happy to report that on November 29th, after 5 months of collaborative effort, we made our formal presentation to the Chinese SFDA, who seemed very amenable to working with Tsinghua and the industry in reforming the process. China, with its prodigious rate of economic growth, is poised to become one of the world's leading pharmaceutical markets. Our hope is that our recommendations will lead to harmonization of Chinese drug regulations with those of Europe, the United States, and other major markets.
Presentation at Tsinghua University Law School in Beijing
With 2013 right around the corner, I can't help but marvel at all that we have accomplished over the past year here at the Tufts Center: 32 publications to date (including 18 peer-reviewed and two book chapters); four lively and productive R&D Management Roundtables; six influential Tufts CSDD Impact Reports; our 39th annual Postgraduate Course; and an extraordinary number of staff presentations at conferences, companies, academic institutions, and government symposia. I'm proud to say that Tufts CSDD remains at the forefront of efforts to assess the dynamics of biomedical innovation and improve the efficiency and productivity of pharmaceutical R&D.
On behalf of the entire staff of the Tufts Center, I wish you and yours a very happy and peaceful holiday season, and, as always, I thank you for your support.
Kenneth I Kaitin, Ph.D.
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.
Onocology drugs get faster approvals than non-oncology drugs in U.S., Vol. 14, Issue 5, September/October 2012
Approval times for new oncology drugs in the United States during the last decade were shorter than approval times for non-oncology products, while the reverse was the case in the European Union, according to a study recently completed by the Tufts Center for the Study of Drug Development. [View press release]
One in five procedures generates extraneous clinical trials data, Vol. 14, Issue 6, November/December 2012
One out of every five procedures performed during later stage clinical trials collects extraneous data and costs drug developers more than $1 million per trial, a newly completed study by the Tufts Center for the Study of Drug Development has found. [View press release]
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Tufts CSDD R&D Management Report: October 2012
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.
The Technical and Support Services Outsourcing Landscape, Vol. 7, Issue 4
Drug sponsors and their contract service providers are using more sophisticated, integrated, and coordinated relationship structures to deliver greater speed and efficiency, a trend that is expected to accelerate, 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.
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
- Benchmarking Risk-Based and Other Optimized Monitoring Practices
- Comparative Economic Study of Fully-Loaded Sponsor Versus Contract Clinical Service Provider Costs
- Evaluating the Use of Comparators and Co-Therapies in Clinical Studies
- Assessing the Adoption and Impact of Adaptive Clinical Trial Designs
- Measuring Progress in Neglected Disease Drug Development
- Identifying Predictors of Successful Transition in Late Stage Clinical Trials in Oncology
|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.
OUR NEXT ROUNDTABLE:
Managing Protocol Design to Improve Clinical Study Efficiency
February 21, 2013, Boston, MA
Protocol design strategies, such as decreasing the prevalence of unused protocol data, reducing protocol complexity, and limiting the number of protocol amendments, can decrease costs and streamline timelines. This roundtable will open with a presentation of recent Tufts CSDD findings on the incidence and cost of protocol amendments and unused protocol data, and will follow with a discussion on specific strategies to reduce protocol complexity and improve clinical study performance and cost.
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
|Tufts CSDD Recent Publications |
Getz KA, Kaitin KI. Open innovation: the new face of pharmaceutical research and development. Expert Review of Clinical Pharmacology 2012;5(5):481-483
Getz, KA, Stergiopoulos, S, Kaitin KI. Evaluating the completeness and accuracy of MedWatch data. American Journal of Therapeutics Online Publish Date: 2012 September 24
Lamberti MJ, Costello M, and Getz K. Global supply chain management. From tactical to strategic: Tracking the evolution of global clinical supply chain management. Applied Clinical Trials 2012;26(9):36-42
Kaitin KI. Translational research and the evolving landscape for biomedical innovation. Journal of Investigative Medicine 2012;60(7):995-998
Kaitin KI, Cohen JP. Weighing access and affordability. Pharmaceutical Technology 2012;36(11):30
Milne C-P. New drugs for predicted cancer epidemic: Who will lead the way? Regulatory Rapporteur 2012;9(10):10-11
Stergiopoulos S, Getz KA. Mapping and characterizing the development pathway from non-clinical through early clinical drug development. Pharmaceutical Medicine 2012;26(5):297-307
|Staff Presentations |
Selected presentations given or scheduled to be given by Tufts CSDD staff:
Stella Stergiopoulos: Opal Conference on Global Clinical Trials: Preferred CRO Partnerships, Philadelphia, PA, October 1-2, 2012
Mary Jo Lamberti: Biotech Supply Chain Academy Conference, Foster City, CA, October 8, 2012
Christopher Milne: Regulatory Affairs Professionals Society (RAPS) Annual Meeting, Seattle, WA, October 28-30, 2012
Joshua Cohen: Town Hall Meeting on Colorectal Cancer Drugs (sponsored by Indiana University), Chicago, IL, October 30, 2012
Ken Getz: ACRP New England, Waltham, MA, November 2, 2012
Mary Jo Lamberti: Investigator Site Panel on Clinical Supplies, Wilmington, DE, November 2, 2012
Joshua Cohen: Cambridge Healthcare Institute Meeting on Pricing and Reimbursement of Cancer Drugs, Philadelphia, PA, November 5, 2012
Ken Getz: IIR Partnerships. Hamburg, Germany, November 8, 2012
Mary Jo Lamberti: BioResearch Central Summit (keynote), Kansas City, KS, November 15, 2012
Joseph DiMasi: Office of Health Economics, London, UK, November 27, 2012
Joseph DiMasi: Pharma Integrates 2012, London, UK, November 28, 2012
Christopher Milne: American Conference Institute meeting on Orphan Drugs and Rare Diseases (keynote), Boston, MA, November 28-29, 2012
Kenneth Kaitin: Building a 21st Century Regulatory Framework and Agency, Tsinghua University Pharmaceutical Law Institute, Beijing, China, November 29, 2012
|Selected excerpts from recent articles
November 19, 2012
Sponsors Waste Millions Collecting 'Non-core' Data Says Study
Part of the problem is that drug firms are unsure as to what data they will be asked for by regulators according to Ken Getz, assistant professor at Tufts CSDD, who said: "The impetus to collect these data is strong, and until now there has been no systematic assessment of this practice."
October 5, 2012
Proposal for San Francisco to Negotiate Drug Prices Makes Waves
"Companies have a good point in that if they just arbitrarily lower the prices of drugs, it will cause problems for innovation later down the road," says Joshua Cohen, a health economist at Tufts [CSDD].
October 4, 2012
Cancer Drugs Cross Finish Line Faster in U.S.
"Oncology drug development continues to be challenging," says Christopher-Paul Milne, DVM, MPH, JD, director of research at Tufts CSDD, pointing to the difficulty in enrolling sufficient numbers of patients with specific genetic anomalies in clinical trials of targeted therapies and the longer period needed to evaluate a treatment response.
October 1, 2012
Three Ways to the Future
...Observes Ken Kaitin, director of Tufts [CSDD], "most other companies are saying that spending 20 years and hundreds of millions of dollars on developing new CNS drugs, only to see them fail in the later stages of the pipeline, is a risk they are not willing to take."
The Boston Globe
October 1, 2012
MIT Economist Pitches Cancer Megafund
Only about half of the treatments that make it to final testing are submitted to the Food and Drug Administration for approval, said Kenneth I. Kaitin, director of [CSDD]. Getting to that point takes about 8½ years, he said."Promising research that could potentially lead to new products is not being pursued, simply because of a lack of funding,'' said Kaitin...
September 26, 2012
Clearing the Final Hurdles to the FDA
Although results of each clinical trial are unique and open to multiple explanations, there are some common themes among the phase III stumbles for oncology drugs, says Kenneth Kaitin, director of Tufts [CSDD].
September 23, 2012
Pharma Companies Partner with Academic Researchers
Professor and Director of [Tufts CSDD] Kenneth Kaitin comments: "The research complexities associated with the most challenging diseases and medical conditions means that few companies have the resources required to discover new molecules and then take them through clinical development and, ultimately, product launch. They are finding, however, that academic medical centers can provide a valuable way to bridge the gap between discovery and clinical development."
September 19, 2012Drug Companies' Lobbyist May Push to Expand U.S. Payments
A Part D model in other parts of Medicare, such as those that cover payments for physicians and hospital care, would help drugmakers, said Joshua Cohen, senior research fellow at Tufts [CSDD].
PharmalotSeptember 19, 2012Not All Tests Can Be Companion Diagnostics
According to Joshua P. Cohen, Ph.D., Senior Research Fellow, Tufts [CSDD] ... "Personalized medicine will progress the same way a toddler learns to walk," he says. "The important thing is companies are collaborating at earlier stages in the drug development process to develop therapeutics and tests in tandem. In this respect, they are following FDA guidance on personalized medicine and co-development of test and therapeutic. Ultimately, the more co-developed product combinations companies launch the better off patients will be. Moreover, it is a win-win situation in that other stakeholders, such as payers, providers, and the pharmaceutical industry stand to benefit as well."
September 13, 2012
Tailoring Treatment for Cancer
Indeed, pharmaceutical companies are actively pursuing personalized medicine, with as many as half the U.S. drug companies developing personalized medicine programs, according to Christopher-Paul Milne, DVM, MPH, JD, director of research at [CSDD]. ... "I haven't heard that companies are backing off their commitments to push forward with personalized medicine, especially as they are increasing their efforts to demonstrate the value of their products compared to competitor products or other therapeutic options," Milne says.
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
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