S E C O N D Q U A R T E R 2 0 1 5
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From the Director
Welcome to our second Tufts CSDD Quarterly Update of 2015. I'm writing from Shanghai, China, where I will be co-chairing a symposium on the growth of the Chinese biotech sector, at the 17th Shanghai International Forum on Biotechnology & Pharmaceutical Industry. I'm sharing duties with my colleague Dr. Liming Shao, Professor and Director of the Shanghai Center for Drug Discovery and Development (SCDDD) at Fudan University. As mentioned in a prior Quarterly Update, SCDDD and Tufts CSDD have entered into a formal collaborative agreement, the goals of which are to conduct joint research on drug development trends in China and the U.S., to offer a drug development training program in China similar to CSDD's annual Postgraduate Course, to co-sponsor symposia, and to have an intern exchange program. I'm thrilled to be kicking off our collaboration with this highly relevant symposium, which will examine challenges and opportunities for a rapidly growing and dynamic biotechnology sector here in China.
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Professor Liming Shao at the Shanghai symposium on drug development.
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| | Professor Kaitin presenting the keynote address in Shanghai. |
 It's been an exceedingly busy quarter at CSDD, with numerous ongoing projects, multi-company working groups, roundtables, workshops, and presentations. Of particular note was an informative and timely one-day summit that we held May 12th in Washington, DC, entitled "Re-engineering Clinical Trials to Improve Drug Development and Performance. The program was co-hosted by Tufts CSDD and ICON plc, and was chaired by Associate Professor and Director of CSDD Sponsored Programs, Ken Getz. The goal of the summit was to explore innovative approaches and insights to "fixing the clinical trial conundrum," and featured FDA Deputy Commissioner Dr. Robert Califf, who presented the agency's assessment of major opportunities for improving R&D quality and efficiency, as well as FDA initiatives under consideration to better accommodate the evolving R&D environment. Tufts CSDD is pleased to be at the forefront of efforts to explore, measure, and improve R&D efficiency and the clinical trial process. Finally, I am delighted to report that our recently launched Louis Lasagna Library Fund, created to help sustain the Center's unique Louis Lasagna Library of Drug Development Science and Policy, is off to a great start. We are extremely grateful to all those who have contributed in support of the library (noted to the right), and I encourage all to consider making a donation. Information is on our website. As always, feel free to contact me directly with your thoughts and perspectives, and thank you for your support. Sincerely,
Kenneth I Kaitin, PhD
Professor and Director |
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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- Assessing Health Care Provider Perceptions of, and Referral Experiences with, Clinical Research
- Benchmarking Clinical Supply Logistics
- Benchmarking Site Selection and Management Practices
- Evaluating the Return on Investment of Patient Centric Initiatives
- Quantifying the Cost of Implementing Protocol Amendments and Evaluating Steps to Reduce Amendments
Sponsored Research - Benchmarking Real World Data Usage in Clinical Trials
- Challenges Facing Biosimilar Uptake
- Current Landscape for Personalized Medicines
- Impact of Reimbursement on Innovation
- Mapping Direct and Indirect Study Conduct Costs
- Mapping Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings
- Pandemic & Bioterror Medical Countermeasures (MCMs)
- Personalized Medicine Landscape
- Public/Private Sector Contributions to R&D
- Sizing and Segmenting the High Throughput Screening Market
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Cohen JP. Implementing the Affordable Care Act: Remaining Hurdles. Clinical Therapeutics 2015;37(4):717-719.
DiMasi JA, Grabowski HG, Hansen, RW [response to editorial]. The cost of drug development. New England Journal of Medicine 2015;372(20):1972.
Getz KA. Charting a course for the patient centricity movement. Clinical Researcher 2015;29(2):36-40.
Getz KA. Establishing return-on-investment expectations for patient-centric initiatives. Therapeutic Innovation & Regulatory Science [Published online before print: April 15, 2015].
Getz KA. The transformative promise of patient centric R&D. Pharmaceutical Business Review [Published online before print: May 7, 2015].
Krumholz-Bahner S, Garibbo M, Getz KA, Widler BE. An overview and analysis regarding the use of adjudication methods in EU and US drug approvals. Therapeutic Innovation & Regulatory Science [Published online before print: April 22, 2015].
Lamberti MJ, Kush R, Kubick W, Henderson C, Hinkson B, Kamenju P, Getz KA. An examination of eClinical technology usage and CDISC standards adoption. Therapeutic Innovation & Regulatory Science [Published online before print: May 19, 2015].
Lu CY, Cohen JP. Can Genomic Medicine Bend the Cost Curve? Molecular Diagnosis & Therapy 2015;19(2):71-77.
Nelson AM, Martin IG, Getz KA. Generational value differences affecting public perceptions of and willingness to participate in clinical trials. Therapeutic Innovation & Regulatory Science [Published online before print: May 5, 2015].
Stergiopoulos S, Brown CA, Grampp G, Felix T, Getz KA. Identifying and quantifying the accuracy of product name attribution of US-sourced adverse event reports in MedWatch of somatropins and insulins. Therapeutic Innovation & Regulatory Science [Published online before print: April 15, 2015].
For more information on publications from Tufts CSDD's faculty staff, please contact our Information Services Librarian Sandra Peters.
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Latest Tufts CSDD Reports Personalized medicine gains traction but still faces multiple challenges , May/Jun 2015, Vol. 17 No. 3 [View press release] Tufts CSDD R&D Management Report Assessing the FDA's Breakthrough Therapy Designation , Apr 2015, Vol. 10 No. 2 [View press release]
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Tufts CSDD Impact Reports: 100th Issue!
 The July/August edition of the Tufts CSDD Impact Report marks the 100th issue of our marquee subscription publication. For 17 years, Tufts CSDD has been providing timely analyses and critical insight through this one-of-a-kind publication. Tufts CSDD Impact Reports continue to be an essential resource keeping drug developers, regulators, academic professionals, and other stakeholders ahead of the game.
The biopharma landscape is constantly changing. Stay ahead of the curve with Tufts CSDD Impact Reports. Check out the July/August issue and subscribe today.
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Faculty & Staff Presentations
Selected presentations to be given by Tufts CSDD faculty and staff:
JUNE Joshua Cohen: Pharmaceutical Executive Roundtable on Pharmacoepidemiology, New York, NY, Jun 4 Joseph DiMasi: American Diabetes Association 75th Annual Meeting, Boston, MA, Jun 5 Joseph DiMasi: Bates White Life Sciences Symposium, Washington, DC, Jun 8-9 Christopher Milne: PharmAccess Leaders Forum, Brussels, Belgium, Jun 8-10 Ronald Evens: AAPS, NBC Conference, San Francisco, CA, Jun 9 Kenneth Kaitin: Symposium on Biotechnology Development (co-chair and keynote), 17th Shanghai International Forum on Biotechnology & Pharmaceutical Industry, Shanghai, China, Jun 10 Joseph DiMasi: Special Libraries Association 2015 Annual Meeting, Boston, MA, Jun 14 Kenneth Kaitin, Kenneth Getz, Mary Jo Lamberti, Stella Stergiopoulos: DIA Annual Meeting, Washington, DC, Jun 15-18 SEPTEMBER Kenneth Getz: OCT New England, Boston, MA, Sep 16-17
Kenneth Kaitin: 2015 Evolution Summit, Las Vegas, NV, Sep 20
Mary Jo Lamberti: Global Innovation Clinical Research and Operations Forum, Cambridge, MA, Sep 23-24
OCTOBER Mary Jo Lamberti: Patient Recruitment and Retention Summit, Boston, MA, Oct 21-22 |
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Louis Lasagna Library Fund
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Tufts CSDD sincerely thanks the following recent donors to the Louis Lasagna Library Fund:
- Dr. Harris A. Berman
- Dr. Han Broekman
- Dr. Henry G. Grabowski
- Dr. Robert Helms
- Mr. Peter Barton Hutt
- Dr. Stacy Melanson
- Dr. Walter Pickett
- Dr. Jeffrey W. Sherman
- Mr. Peter Thomson
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Congratulations to Ken Getz, who received a recognition award for raising public awareness about clinical research from the Association of Clinical Research Professionals.
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Only a few seats remain for the 2015 Tufts CSDD Leadership Course, July 7-8 at the DoubleTree by Hilton Hotel in Boston, MA. For more info and to register, visit our course page.
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Tufts CSDD is on Twitter, LinkedIn and Facebook!
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Over the past quarter, Tufts CSDD faculty have been featured and Center research cited in more than 50 news sources, including Bloomberg Business, The Financial Times, Forbes, The Des Moines Register, The Hill, Politico, The Sacramento Bee, US News and World Report, and The Wall Street Journal.
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['Clearly, advertising and education campaigns will be necessary for biosimilars, notes Joshua Cohen, research associate professor, Tufts CSDD'.] "Even if the FDA has done its job regarding safety, efficacy, and quality, there will be some skeptics. There's a diffusion curve for any new product, and it will be hard to get early adopters. Some doctors will play a waiting game and look for more data on each biosimilar."
-Joshua P. Cohen, Tufts CSDD
Pharmaceutical Executive
April 8, 2015
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CSDD RESEARCH STAFF
Kenneth I Kaitin, PhD
Professor and Director Christopher-Paul Milne, DVM, MPH, JD Director of Research and Research Associate Professor
Joseph A. DiMasi, PhD
Director of Economic Analysis and Research Associate Professor
Joshua P. Cohen, PhD
Research Associate Professor Kenneth A. Getz, MBA Director of CSDD Sponsored Research Program, Research Associate Professor Ronald Evens, PharmD, FCCP Adjunct Research Professor 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
Research Analyst
Josephine Awatin, BS
Research Analyst
Sandra Peters, MLIS
Information Services Librarian
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