|F I R S T Q U A R T E R 2 0 1 4|
From the Director
Welcome to our first Tufts CSDD Quarterly Update of 2014. At the time of this writing, 2014 is just two months old, but already we're engaged in a full slate of new research projects and moving forward on a host of other CSDD programs.
This year's CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation - our 41st annual program! - went off without a hitch, despite a mid-week snowstorm that brought much of the mid-Atlantic region to a standstill. Having been involved with the course for the better part of four decades, I'm thrilled that we've been able to keep the agenda timely and fresh. For example, this year's course featured new lectures on vaccines and immunotherapeutics, social media and the pharmaceutical industry, and CMC and quality in drug development. As in previous years, the students were highly engaged and enthusiastic, and clearly appreciated the high caliber of the lectures, faculty interaction, and especially the small group activities. We are indebted to our extraordinary faculty for contributing their time and expertise to make the CSDD Postgraduate Course an outstanding and perennially popular program.
Also in February, we held our first quarterly R&D Management Roundtable of 2014 - part of our CSDD Executive Forum. The topic was "New Initiatives for Boosting Clinical Success," which generated a very animated and productive discussion. Our next roundtable, scheduled for May 15th, will focus on "Strategic Alliances and Integrated Partnerships." If you've not had an opportunity to attend one of our R&D Management Roundtables, I encourage you to register. I think you'll find the events stimulating and different. An overview of our roundtable series is provided in this Quarterly Update.
Finally, I'm pleased to welcome Ron Evens, PharmD, FCCP, to the CSDD staff as an Adjunct Research Professor and Biotechnology Consultant. Ron, who is based in Napa, California, and is president of MAPS 4 Biotec, Inc., has a wealth of experience in biotechnology product development trends as well as the shifting landscape for biopharmaceutical developers. We're thrilled that he will be sharing that expertise with us as we continue to examine this dynamic sector of the life sciences industry.
As always, we'd like to hear your thoughts and perspectives. Feel free to contact me directly. And thank you for your support.
Kenneth I Kaitin, PhD
Professor and Director
Spotlight: Tufts CSDD Executive Forum
The Tufts CSDD Executive Forum, which features our quarterly R&D Management Roundtables, is now in its sixth year. The program offers a unique opportunity for senior industry leaders to exchange ideas and discuss experiences on a wide range of strategic and operational R&D issues. Roundtables are hosted by CSDD staff at our offices in Boston. Attendance is limited to 25 - 30 participants. Roundtables typically begin with a presentation of current and relevant CSDD research findings, to help set the stage. This is followed by illuminating company presentations. Most importantly, there is ample time provided for open discussion exploring new strategic initiatives, challenges and successes, and the identification and implementation of best practices.
Our February 20th R&D Management Roundtable focused on a scoring algorithm for predicting clinical success post phase two for oncology drugs. CSDD and Janssen Pharmaceuticals collaborated to create the algorithm, which was based on a dataset of clinical and operating attributes of successful and terminated drug candidates. A discussion of the algorithm, as well as other initiatives to boost clinical success rates, generated a lively and fruitful exchange of ideas and action items.
We're very excited about our next roundtable, scheduled for May 15th, which will focus on risk-sharing partnerships and integrated alliances. It's sure to be an exciting and enlightening discussion. We hope to see you at one of our upcoming roundtables. For a full description, see our website.
Research Participation 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 the Effectiveness of Investigative Site Management Practices
- Evaluating the Impact of Integrated Outsourcing Relationships on Performance and Quality
- Measuring the Adoption of eClinical Solutions and Standards
- Social Media in Clinical Research Standard Practices and Policies
- Challenges Facing Biosimilar Uptake
- Impact of Reimbursement on Innovation
- Mapping Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings
- Mapping the US Generic Manufacturing Landscape
- Personalized Medicine Landscape
- Profiling New R&D Innovations Driving Performance and Efficiency
- Quantifying the Use of ePRO in Clinical Trials
|Latest CSDD Publications |
Cohen JP, Felix AF. Are payers treating orphan drugs differently? Journal of Market Access & Health Policy 2014;2:1-5.
Cohen JP, Felix AF. Complying with state and federal regulations on essential drug benefits: implementing the Affordable Care Act. American Journal of Managed Care 2014;20(2):31-36.
DiMasi JA. Pharmaceutical R&D performance by firm size: approval success rates and economic returns. American Journal of Therapeutics 2014;21(1):26-34.
DiMasi JA, Kim J, Getz KA. The impact of collaborative and risk-sharing innovation approaches on clinical and regulatory cycle times. Therapeutic Innovation & Regulatory Science 2014. [Published online before print February 5, 2014]
Getz KA. Adoption of adaptive trial designs poised to accelerate. Applied Clinical Trials 2013;22(11):16-18.
Getz KA, Stergiopoulos S. Therapeutic area variability in the collection of data supporting protocol end points and objectives. Clinical Investigation 2014;4(2):125-130.
Millier A, Cohen JP, Toumi M. Economic impact of a triptan Rx-to-OTC switch in six EU countries. PLoS ONE 2013;8(12):e84088.
Milne C-P, Davis J. The Pediatric Studies Initiative: after 15 years have we reached the limits of the law? Clinical Therapeutics 2014:36(2):156-162.
Selker HP, Oye KA, Eichler H-G, Stockbridge NL, Mehta CR, Kaitin KI, McElwee NE, Honig PK, Erban JK, D'Agostino RB. A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials. Clinical Pharmacology & Therapeutics 2013;95(2):147-153.
|Staff Presentations |
Selected presentations given or scheduled to be given by Tufts CSDD staff:
Mary Jo Lamberti: CROWN Clinical Operations Summit, Philadelphia, PA, January 22-24
Kenneth Getz: Patients as Partners, The Conference Forum, Philadelphia, PA March 3-4
Kenneth Kaitin: International Conference on Pharmaceutical Medicine (ICPM), Berlin, Germany, March 20-21
Joshua Cohen: CBI Conference on Personalized Medicine, Washington, D.C., March 21
Kenneth Getz: IIR Annual Partnerships Conference, Las Vegas, NV, March 31-April 2
Kenneth Kaitin: CBI R&D Open Innovation and Portfolio Optimization Conference, Philadelphia, PA, April 8-9
Kenneth Getz: ACRP Annual Meeting, San Antonio, TX, April 27-28
Christopher-Paul Milne: Companion vs. Complementary Diagnostics, CHI Executive Summit, Philadelphia, PA, April 30
Christopher-Paul Milne: Marcus Evans 7th Evolution Summit, Palm Beach, FL, May 7-9
Christopher-Paul Milne: New Trends in Regulatory Science, University of Copenhagen, Denmark, May 19
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Tufts CSDD's Outlook 2014
is now available on our website. Published each January, the report highlights near-term pharmaceutical and biopharmaceutical development trends. Feel free to download
your electronic copy today!
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Welcome to Dr. Ronald Evens, who formally joined the CSDD staff as an Adjunct Research Professor and Biotechnology Consultant in February.
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In the first quarter of 2014, CSDD staff have been quoted and their research cited in over 30 news sources, including The Washington Post, Forbes, The Pink Sheet Daily, Scrip Intelligence, FierceBiotech, and The Burrill Report.
"A key success factor for the [FDA's new Breakthrough Designation] program will be whether it serves the goal of helping drug sponsors and the FDA work together to cut development time, while encouraging the utilization of new development tools and methodologies, such as targeted diagnostics and adaptive clinical trial designs," says [Christopher-Paul Milne, Tufts CSDD's director of research].
CSDD RESEARCH STAFF
Kenneth I Kaitin, PhD
Professor and Director
Christopher-Paul Milne, DVM, MPH, JD
Director of Research, Assistant Professor
Joshua P. Cohen, PhD
Joseph A. DiMasi, PhD
Director of Economic Analysis, Assistant Professor
Kenneth A. Getz, MBA
Director of CSDD Sponsored Research Program, Associate Professor
Ronald Evens, PharmD, FCCP
Adjunct Research Professor and CSDD Biotechnology Consultant
Richard I. Shader, MD
Medical Consultant and Professor Emeritus, Molecular Physiology and Pharmacology
Mary Jo Lamberti, PhD
Senior Research Fellow
Stella Stergiopoulos, BA
Senior Project Manager
Ranjana Chakravarthy, BA
Abigail Felix, BA
Jesse Moskowitz, BS
Paulami Naik, MSPH
Sandra Peters, MLIS
Information Services Librarian