F I R S T Q U A R T E R 2 0 1 3
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Welcome to our first Tufts CSDD Quarterly Update of 2013. In it you'll find an overview of our current research activities, recent publications, upcoming programs, and other news.
It's been a very busy and productive start to the year. Most notably, in early February we celebrated the 40th anniversary of CSDD's perennially popular Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation. I'm proud to say that over the past four decades, this highly regarded program has remained true to the vision of its creator (and CSDD founder), Dr. Louis Lasagna. Dr. Lasagna's goal was to create a unique learning experience where drug developers and clinical investigators could receive in-depth instruction in the design and evaluation of clinical studies, and a broad understanding of the regulatory, economic, and scientific issues that affect the development of new medicines. I firmly believe, however, that the course's formidable popularity over the years is a result of the fact that the program is continually evolving and adapting to the changing landscape for biomedical innovation. For example, our current program includes lectures on electronic health records, companion diagnostics, and pharmacoeconomics. Moreover, the course is designed to meet the needs of a host of disciplines, reflecting today's multifunctional nature of drug development. Students this year came from large and small pharma companies, CROs, academia, government agencies, and law firms, and covered a range of disciplines, including clinical, regulatory, discovery research, operations, CMC, sales, and legal. Of course, the success of the program is due in large part to the enormously talented and committed faculty, to which I offer my sincerest thanks for helping to make this 40th anniversary program a memorable event.
There are lots of other CSDD happenings to talk about. I encourage you to take a look at the rest of this update, and contact us if you'd like more information. We're always interested in your thoughts and perspectives on our research, programs, and other activities. And, as always, I thank you for your support.
Sincerely,
Kenneth I Kaitin, PhD
Professor and Director
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Tufts CSDD's 40th Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation
 
Tufts CSDD's 40th annual  Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation took place on February 4-8 at the Ritz-Carlton in Boston. The early feedback for our 40th Anniversary course has been fantastic, with participants calling it "an unprecedented learning opportunity" and "one of the best they've attended in many years." Tufts CSDD's comprehensive professional development program consists of focused lectures, breakout sessions, and live simulations guided by top faculty from across industry, regulatory, and academic arenas. It's become an industry mainstay and requisite learning for anyone currently in or looking for a career in drug development.
Mark your calendars for Tufts CSDD's 41st annual Postgraduate Course, taking place February 3-7, 2014. To sign up for email updates, contact Jonathan Hsieh at 617-636-0840 or via email.
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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 Sector Trends
- Prescription Drug Policy
- R&D Management and Operations
Visit our website for more information or to purchase the recently available Outlook 2013 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.
RECENT REPORTS:
 89% of Trials Meet Enrollment, but Timelines Slip, Half of Sites Under-Enroll
Vol. 15, Issue 1, Jan/Feb 2013
While nine out of 10 clinical trials worldwide meet their patient enrollment goals, reaching those targets typically means that drug developers need to nearly double their original timelines, according to new research from the Tufts Center for the Study of Drug Development, benchmarking patient recruitment and retention practices.
[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 leaders convene with CSDD research staff to discuss current drug development challenges and strategic initiatives within the research-based industry.
RECENT REPORTS:
 The Technical and Support Services Outsourcing Landscape
Vol. 8, Issue 1, Jan 2013
Companion diagnostics, which are central to the creation of personalized medicines, have captured the interest of many drug companies, but face a number of hurdles that could impede development, 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.
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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 Sponsored Working Groups
- Assessing Investigative Site Experiences with Clinical Supplies
- 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
Sponsored Research
- Assessing the Adoption and Impact of Adaptive Clinical Trial Designs
- Benchmarking the Incidence and Cost of Core Protocol Procedures Conducted Excessively
- Identifying Predictors of Successful Transition in Late Stage Clinical Trials in Oncology and CNS
- Measuring Progress in Neglected Disease Drug Development
- Review and Analysis of Recently Approved Personalized Medicines and Those in Late-Stage Development
- Reasons for Failure and Probability of Success for Therapeutic Subgroups
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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.
OUR NEXT ROUNDTABLE:
 Partnerships, Alliances, Consortia and Other Risk-Sharing CollaborationsMay 16, 2013, Boston, MA
Throughout the pharmaceutical industry, companies are entering into innovative risk-sharing collaborations and creating integrated networks to improve product development and share risk. This roundtable will review alliance and network relationship management strategies that enhance partnership value and increase return on investment.
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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Tufts CSDD Leadership for Drug Development Teams July 9-10, 2013, Boston, MA
Now in its 12th year, the Tufts CSDD's Leadership for Drug Development Teams course draws on the real experiences of front-line professionals across the spectrum of R&D - from drug discovery and pre-clinical research to clinical development, regulatory affairs, CMC, and marketing. Our curriculum is continuously updated to address the rapidly changing challenges of life science R&D.
Registration will open next week, check our website for more details as they become available.
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Tufts CSDD Recent Publications
DiMasi JA. Pharmaceutical R&D performance by firm size: Approval success rates and economic returns. American Journal of Therapeutics Online Publish Date: 2013 January 23. Getz KA. The perils and promise of risk imbalance. Inside Outsourcing, 2012 Dec;10-16. Getz KA, Lamberti MJ, Carnan E, Fulton ML. Assessing global CRA workload and utilization. ACRP Monitor. 2013;27(1):11-18. Lamberti MJ, Getz KA. The scoop on drug shortages. Pharmaceutical Executive. 2013;33(1):24-27. Lamberti MJ, Brothers C, Manak D, and Getz KA. Benchmarking the study initiation process. Therapeutic Innovation & Regulatory Science, 2013;47(1):101-109. Martell RE, Sermer D, Getz K, Kaitin KI. Oncology drug development and approval of systemic anticancer therapy by the U.S. food and drug administration. The Oncologist. 2012;17(12). Tilles SA, Borish L, Cohen JP. Management of hereditary angioedema in 2012: scientific and pharmacoeconomic perspectives. Annals of Allergy, Asthma & Immunology. 2013;110(2):70-74. |
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Staff Presentations
Selected presentations given or scheduled to be given by Tufts CSDD staff:
Christopher Milne: Pew Workshop on FDA Performance and Predictability, Washington, DC, January 29, 2013 Christopher Milne: SCOPE (Summit for Clinical Ops Executives), Miami, FL, February 4-6, 2013 Joseph DiMasi: IOM/ASCO Workshop on Implementing a National Cancer Clinical Trials System for the 21st Century, Washington, DC, February 11-12, 2013 Ken Getz: R&D Leadership Summit, Aventura, FL, February 11-12, 2013 Joshua Cohen: International Conference on Drug Development, Austin, TX, February 26-27, 2013 Ken Getz, Mary Jo Lamberti and Stella Stergiopoulos: DIA Euro Meeting, Amsterdam, Holland, March 4-6, 2013 |
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We are proud to announce that Director of Sponsored Research Programs Ken Getz was promoted to Associate Professor at Tufts University School of Medicine, as of January 1, 2013. . . . . . . . . .
Welcome to Ms. Christina Coffin, who joined the Tufts Center staff as a Library Assistant in December. Christina can be reached at christina.coffin@tufts.edu. . . . . . . . . . Tufts CSDD is on Twitter, LinkedIn and Facebook!
Stay informed about upcoming events and courses, promotional specials on our various publications, the latest press releases and more! Follow us today:
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Selected excerpts from recent articles PharmaVOICE February 2013 (pp 40-43) Outsourcing for Efficiency "The emergence of open innovation models, where scientists worldwide openly share knowledge, and novel partnerships and alliances hold significant promise to transform the nature, pace, and cost of new drug development -- to the benefit of patients, as well as to drug sponsors, their development partners, and investors," Dr. Kaitin [of Tufts CSDD] says.
KOMUFebruary 6, 2013 Prescription Switching: Just What the Doctor Ordered? Joshua Cohen [at Tufts CSDD] said while he couldn't classify the ties between drug manufacturers and PBMs as a conflict of interest, he does note a lack of transparency. "The problem," he adds, "is we are not sure how evidence-based the process is. Therefore we do not know if the goals are being reconciled efficiently and properly."
Nature Medicine February 6, 2013 Biomedical Briefing "The entire site selection process is very, very inefficient, and site performance is volatile and unpredictable," says study author Ken Getz, director of sponsored research at Tufts CSDD... "In this current environment, where companies are constantly looking for ways to operate more efficiently, the findings suggest that investigative site selection and management is probably one of the most important areas where they should focus." The Sacramento Bee February 2, 2013 Clinical Trials on Rise, but Many Lack Participants "Over the years, it's gotten harder and harder to attract research volunteers," said Ken Getz [of Tufts CSDD] and founder of CISCRP. "People hear about clinical research with passing interest at best and most not until they come to the point that they need a clinical trial." ... "People don't understand why research is important to health care," he said. "They don't understand the broader context." Nature Reviews: Drug Discovery February 2013 (pp 87-90) 2012 FDA Drug Approvals: FDA Drug Approval Bonanza Sees Cancer and Orphan Drugs on Top Again [According to Christopher] Milne, [Director of Research at Tufts CSDD], nearly all of the newly approved cancer drugs received fast-track or priority review, designations that are reserved for therapies that offer major advances in treatment. New cancer drugs, therefore, are still hitting unmet need. "I don't think we are seeing saturation yet," says Milne. PharmaTimes Online January 17, 2013 More Effort Needed to Address R&D Inefficiencies: Tufts CSDD Director "While patent expirations, reduced cash flow and weaker pipelines are prompting the research-based pharmaceutical industry to embrace new paradigms of drug development, companies still need to hone their efforts towards streamlining the [drug development] process," warns [Tufts CSDD] director Kenneth Kaitin. Critical Values January 2013; 6(1) pp 34-36 The New Blockbuster: New Companion Diagnostics are Making their Mark in the Cancer Market First "A decade ago, the register of the top 15 selling drugs was the pharmaceutical industry's equivalent of the Hollywood A-list... But a look at today's top 15 list [includes] biologics such as Herceptin and Gleevec, which, while still quite profitable, have a much smaller prescription population...These biologics, along with their growing number of companion diagnostics,' says Joshua Cohen [of Tufts CSDD]..., "are proving that the traditional blockbuster drug definition is changing, and fast." FierceBiotech January 16, 2013 Pharma Fumbles in Recruitment Game as Clinical Trials Miss Goals "Patient recruitment and retention are among the greatest challenges that the clinical research enterprise faces today, and they are a major cause of drug development delays," said Ken Getz, director of sponsored research at Tufts CSDD. FierceBiotech January 8, 2013 Tufts: Billions Wasted in Pharma RD Despite New Biz Models Ken Kaitin, director of [Tufts CSDD], delivered this sobering assessment...: "You can't change your R&D model and find new leads for compounds to bring into the clinic and plug them into the old process for developing new products and expect that your company is going to do better."
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SENIOR RESEARCH STAFF
Kenneth I Kaitin, PhD
Professor and Director
Christopher-Paul Milne, DVM, MPH, JD
Director of Research and Assistant Professor
Joseph A. DiMasi, PhD
Director of Economic Analysis and Assistant Professor
Joshua P. Cohen, PhD
Assistant Professor
Kenneth A. Getz, MBA
Director of Sponsored Research Programs and Associate Professor
Richard I. Shader, MD
Medical Consultant and Professor Emeritus, Molecular Physiology and Pharmacology |
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