F O U R T H   Q U A R T E R   2 0 1 5
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From the Director

Dr. Kenneth Kaitin Welcome to Tufts CSDD's fourth Quarterly Update of 2015, presenting an overview of current research, recent publications, staff presentations, and other news.  

I recently returned from Shanghai, China, where my colleague Dr. Liming Shao, Professor and Director of the Shanghai Center for Drug Discovery and Development (SCDDD) at Fudan University, and I presented our first joint "Fudan SCDDD-Tufts CSDD Training Course for Drug R&D" on November 8-10. The academic program is part of the formal collaboration between SCDDD and Tufts CSDD, described in this space in previous Quarterly Updates. I could not have been more pleased with the level of interest and engagement shown by the 10 students, all from local Chinese companies, who completed the inaugural program. Dr. Shao and I are excited to expand the scope and reach of the course for 2016, and we continue to work on other aspects of our collaboration, including joint research projects and co-sponsored symposia.

Dr. Kaitin _ Shao and graduates
Drs. Kaitin and Shao (center), with the 2015 graduates of the Fudan 
SCDDD-Tufts CSDD Training Course for Drug R&D.
In other news, I'm pleased to report that CSDD continues to be a source of information, insight and perspective to political leaders focused on efforts to balance the need for maintaining economic incentives for research-based companies to develop new drugs and biologics, with the equally important need to ensure that those medicines are affordable and accessible to the patients who need them. On November 20th, I had the privilege of briefing Representative Joseph P. Kennedy III (D-MA), who serves on the Committee on Science, Space and Technology, on issues related to biomedical innovation, government incentive programs, drug pricing, and reimbursement. And on December 15th, I was invited to meet, once again, with Massachusetts Senate President Stan Rosenberg, to discuss R&D challenges and their impact on biomedical investment and innovation in Massachusetts. In my opinion, balancing the need to incentivize innovation with the need to ensure patient access to valuable new treatments is one of the most important challenges facing political leaders today. We at CSDD are proud to offer our scholarly analyses and unique perspective to this critical discussion.
It's been a highly productive and fulfilling year for us here at the Tufts Center, and I'm looking forward to an equally successful 2016. On behalf of the entire CSDD team, I wish you and yours a very happy and healthy holiday season, and may the new year bring joy, prosperity, and peace. As always, I am grateful for your support. 

Kenneth I Kaitin, Ph.D.
Professor and Director
CSDD Workshop: Manufacturing Strategy for Diverse Biologic Pipelines of the Future 
On October 29th, Tufts CSDD held a highly interactive biologics manufacturing workshop, which included senior leaders from industry, the U.S. Biomedical Advanced Research and Development Authority, and the U.S. Department of Defense. Chaired by Center director Ken Kaitin, and Boston Oncology CEO Dr. Abdullah Baaj, the workshop explored manufacturing strategies, performance benchmarks, and manufacturing best practices.

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
  • Biopharmaceutical Industry New Drug Development Competitive Dynamics
  • Challenges Facing Biosimilar Uptake
  • Current Landscape for Personalized Medicines
  • Developing standard clinical study performance metrics for a large network of academic health systems
  • Dissemination of Prescribing Information
  • 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
  • Identifying gaps in the patient recruitment and retention process
  • 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)
  • PBM Exclusion Lists
  • Personalized Medicines and Companion Diagnostics 
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.
Recent CSDD Publications   
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 2015;98(5):506-513.

Lamberti, M, Kush, R, Kubick, W, Henderson, C, Hinkson, B, Kamenju, P, Getz, K. An Examination of eClinical Technology Usage and CDISC Standards Adoption. Therapeutic Innovation & Regulatory Science 2015;49(6):869-876.

Milne C-P, Cohen JP, Chakravarthy R. Where is personalized medicine in industry heading? Nature Reviews Drug Discovery 2015;14(12):812-813.
Latest Tufts CSDD Reports


Tufts CSDD Impact Report: 

Tufts CSDD R&D Management Report:

Faculty & Staff Presentations 
Selected presentations given or scheduled to be given by Tufts CSDD staff:
Joseph DiMasi: Seminar Series on Pharmaceutical Economics and Policy, UCLA, Los Angeles, CA, December 3.

Christopher Milne: Complimentary versus Companion Diagnostics, Q1 Productions, San Diego, CA, December 7-8.

Kenneth Kaitin: Novartis Open Forum on Academic-Industry Partnerships, Cambridge, MA, December 16.

Kenneth Getz: Novartis Patient Centricity Day, East Hanover, NJ, January 19.

Kenneth Kaitin: Healthcare in America Program, Alpert Medical School, Brown University, Providence, RI, January 20.

Kenneth Getz: Crown Conference, Philadelphia, PA, January 27.

Joshua Cohen: Uptake of Biosimilars, 11th Summit of Biosimilars, CBI, Alexandria, VA, January 28-29.
Kenneth Kaitin: International Conference on Drug Development, University of Texas, Austin, TX, February 22.

Kenneth Getz & Christopher Milne: SCOPE Conference, Miami, FL February 23-25.

Kenneth Getz: Patients as Partners, Philadelphia, PA, March 14-15.

Kenneth Getz: Clinical Trial Collaborations, Boston, MA, March 21-22.

Mary Jo Lamberti: Procurement and Outsourcing Congress, Philadelphia, PA, March 22-23.

Joshua Cohen: PBM Formulary Exclusions Summit, CBI, Atlanta, GA, March 28-29.

Kenneth Kaitin: Suffolk District Medical Society Annual Meeting, Boston, MA, March 30.
I N   T H I S   I S S U E
Louis Lasagna Library Fund
Dr. Louis Lasagna
We sincerely thank the following recent donors to the Louis Lasagna Library Fund in support of Tufts CSDD's Louis Lasagna Library of Drug Development Science and Policy:
  • Joan C. Cohen
  • Roger Cohen
  • Nancy K. DuRie 
  • Ronald and Hikaru Hua
  • Terry S. Kleiman 
  • Josef von Rickenbach
  • Amy Wax
FYI. . .
Registration for Tufts CSDD's 43rd Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation (February 1-5, 2016) is underway. Enrollment is limited, so register today.
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Congratulations to Ken Getz who received a Lifetime Achievement Award from InformaHealth on November 18th at the Partnerships in Clinical Trials conference in Hamburg, Germany.
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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 50 news sources, including The Wall Street Journal, The LA Times, CNN Online, the Boston Globe, Forbes, and Agence France-Presse.
 Quote of the Quarter
"Drug companies are going to have to do a better job at communicating to the public about what goes into their prices - and that's scaring some investors."

-Kenneth Kaitin, Professor and Director of Tufts CSDD

The Boston Globe
October 18, 2015


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 and 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

Tom Brinton, BS
Research Analyst

Michael Wilkinson, BA
Research Analyst
Sandra Peters, MLIS
Information Services Librarian
Tufts CSDD
617.636.2170 | csdd.tufts.edu