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T H I R D   Q U A R T E R   2 0 1 5
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From the Director
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Welcome to our third Tufts CSDD Quarterly Update of 2015, presenting an overview of current research, recent publications, upcoming staff presentations, and other CSDD news. As you can see, there's a lot going on at the Tufts Center.
 
The start of a new academic year means a return to teaching, and the course I teach each fall at the Tufts School of Medicine on Principles of Drug Development is well underway. The students include doctoral candidates in Tufts' Sackler School of Biomedical Sciences, physicians enrolled in Tufts' clinical research graduate program, as well as students from other departments and Tufts campuses. The course covers the drug development pathway, from translational medicine to approval, and includes lectures on the history of U.S. drug regulation, pharmaceutical economics, human research protection, pharmacovigilance, development of vaccines and devices, chemistry manufacturing and controls, reimbursement and access, and special programs for special populations, including orphan diseases, neglected diseases, and pediatric indications. Although the course is offered as an elective, I'm always gratified to see the interest level and commitment to learn about this complex yet critically important area.
 
I'm also delighted to announce that on November 9-11, my colleague Dr. Liming Shao, Professor and Director of the Shanghai Center for Drug Discovery and Development (SCDDD) at Fudan University, and I will be presenting the first joint academic training program on pharmaceutical and biopharmaceutical development to be held in Shanghai, China. The jointly run course is part of the formal collaboration, mentioned in this space in previous Quarterly Updates, between SCDDD and Tufts CSDD. The training program is intended for individuals in industry who want a broader understanding of the landscape for pharmaceutical innovation, as well as for students interested in entering the R&D based industry. Dr. Shao and I are very excited to present the course and to offer an opportunity for advanced training in this rapidly growing and dynamic area in China.
 
Feel free to contact me directly with your thoughts and perspectives. And as always, I thank you for your support. 
 
Sincerely, 
 KenKsignature
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
  • Challenges Facing Biosimilar Uptake
  • Current Landscape for Personalized Medicines
  • Estimating the Cost of Building a Biologics Development and Manufacturing Facility
  • Evaluating the Impact of Canadian Market Reforms and Initiatives on Clinical Trial Activity and Performance
  • Impact of Reimbursement on Innovation
  • Mapping Direct and Indirect Study Conduct Costs
  • Examining Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings 
  • Pandemic & Bioterror Medical Countermeasures (MCMs)


 

Email us if you are interested in participating in one of our Multi-Company Working Groups, or if you would like additional information about sponsoring research at CSDD.

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Recent CSDD Publications    
 
Cohen JP. Biosimilars: Improving patient access to biologics while bending the cost curve. In Vivo 2015;33(6):14-18.

Cohen JP. Biosimilars: the big picture. The Medicine Maker 2015;(8):20-21.

Cohen JP, Dong J, Lu CY, Chakravarthy R. Restricting access to florbetapir: Medicare coverage criteria for diagnostics and drugs are inconsistent. BMJ 2015;351:h3333.

DiMasi JA, Hermann JC, Twyman K, Kondru RK, Stergiopoulos S, Getz KA, Rackoff W. A tool for predicting regulatory approval after phase II testing of new oncology compounds. Clinical Pharmacology & Therapeutics [Published online before print August 1, 2015].

Getz KA, Lamberti MJ. The unintended inefficiencies of outsourcing practice. Pharmaceutical Outsourcing [Published online before print September 2, 2015].

Kaitin KI, Guest Editor. (Includes: Kaitin KI, editorial. The quest to develop new medicines to treat Alzheimer's disease: Present trends and future prospects; pp 1618-1621) Clinical Therapeutics 2015;37(8).

Lamberti M, Grote F, Abramson M, Getz K. Outsourcing Strategies and Practices to Improve Efficiency and Performance. Applied Clinical Trials [Published online before print, August 11, 2015].

Milne C-P. Prospects for personalised medicines in the Asia-Pacific Region. Pharma Focus Asia 2015;(22).

Milne C-P, Cohen JP, Felix A, Chakravarthy R. Impact of postapproval evidence generation on the biopharmaceutical industry. Clinical Therapeutics 2015;37(8):1852-1858.

Stergiopoulos S, Getz K. Evaluating AE reporting of two off-patent biologics to inform future biosimilar naming and reporting practices. Drug Safety 2015;38(8):687-692.
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Latest Tufts CSDD Reports

Tufts CSDD Impact Reports  
Tufts CSDD R&D Management Report
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Faculty & Staff Presentations   
Selected presentations given or scheduled to be given by Tufts CSDD staff

SEPTEMBER
Kenneth Kaitin: Marcus Evans Evolution Summit 2015 (keynote), Las Vegas, NV, September 20-21

Kenneth Kaitin & Christopher Milne: Japanese Mansfield Scholars Program, Boston, MA, September 22

Joshua Cohen: World Congress Rare Disease Summit, Boston, MA, September 28-29


OCTOBER
Christopher Milne: FDA Public Meeting on REMS (panelist), Silver Springs, MD, October 5-6

Kenneth Getz: 2015 PCORI Annual Meeting, Crystal City, VA, October 6-8

Kenneth Getz: Site Solutions Summit, Amelia Island, FL, October 11

Kenneth Kaitin: Brookings Institution Defining and Measuring Innovation Workshop, Washington, D.C., October 14

Christoper Milne: Q1 Productions, Complimentary vs. Companion Diagnostics, Alexandria, VA, October 14-15

Mary-Jo Lamberti: Patient Recruitment and Retention Summit, Boston, MA, October 21-22

 
NOVEMBER
Kenneth Getz: Baptist Hospital 21st Century Clinical Trials Program, Miami, FL, November 6

Kenneth Getz: CTTI Conference on Best Recruitment Practices, Washington, D.C., November 9-10

Christopher Milne: HealthTech.com, Re-Entering Anti-Bacterial Drug Development, Boston, MA, November 17-18

Kenneth Getz: Partnerships Europe, Hamburg Germany, November 17-19

Joseph DiMasi: Harvard University Drug Development Boot Camp, Boston, MA, November 18-19


DECEMBER
Christoper Milne: Q1 Productions, Complimentary vs. Companion Diagnostics, San Diego, CA, December 7-8

Kenneth Getz: MRCT Annual Meeting, Boston, MA December 15
I N   T H I S   I S S U E
Louis Lasagna Library Fund
Dr. Louis Lasagna
Tufts CSDD sincerely thanks the following recent donors to the Louis Lasagna Library Fund:
  • Dr. Bobby W. Sandage
  • Mr. Gilbert Cohen
  • Ms. Cathy Clay
  • Mr. Jules Kirsch
  • Dr. Eric Cohen
  • Mr. Walter Robb
FYI. . .
Tufts CSDD welcomed Mr. Tom Brinton and Mr. Michael Wilkinson to the staff as Research Analysts.
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Congratulations to Ken Getz, who was recently inducted as a fellow in the Drug Information Association.
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Registration is open for the 2016 Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, taking place February 1-5, 2016 at the Ritz-Carlton Hotel in Boston, MA. For more info and to register, visit our website.
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 Tufts CSDD in the News
Over the past quarter, Tufts CSDD faculty have been featured and Center research cited in articles, reports, and editorials published in over 30 news sources, including The Washington Post, Newsweek, The Boston Herald, International Business Times, Reuters, The Detroit News, Politico, and The Wall Street Journal.

Quote of the Quarter
 "I believe the whole patient-centric movement really signals a pretty profound change, but I also have this fear that if we don't implement this correctly, we'll lose our patience," said Ken Getz, director of sponsored research at Tufts [CSDD]. ..."Unless these patient-centered approaches deliver a return on investment, many of these initiatives will go away," Getz at Tufts said.


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 Sponsored Research Programs, 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
 
Josephine Awatin, BS
Research Analyst

Tom Brinton, BS
Research Analyst

Ranjana Chakravarthy, BA
Research Analyst

Michael Wilkinson, BA
Research Analyst

Sandra Peters, MLIS
Information Services Librarian
 
Tufts CSDD
617.636.2170 | csdd.tufts.edu