Welcome to Tufts CSDD's fourth Quarterly Update of 2014, presenting an overview of current CSDD research, recent publications, staff presentations, and other news.

It's been a busy and exciting quarter, punctuated with the release on November 18th, at a media event held at Tufts School of Medicine, of our newest estimate of the cost of drug development. After making some brief opening remarks, I introduced the study's lead author, Dr. Joseph DiMasi, who went through the methodology and the results of his analysis for the media folks in attendance, as well as for the many participants who called in to the simultaneous webcast. The new estimate of $2.56 billion - fully capitalized and including the cost of failures - represents a 145% increase in constant dollars over our previous estimate published in 2003. Not surprisingly, our new study has generated considerable discussion, and continues to be covered by news sources around the world. I'm extremely proud that CSDD is the sole source of this profoundly important series, and that our estimates are relied on and used by developers, regulators, investors, and policy-makers worldwide.

CSDD Director Ken Kaitin with Dr. Yonghao Gui (left), Dean of Shanghai Medical College of Fudan University, and Dr. Liming Shao (right), Professor and Director of Fudan's Shanghai Center for Drug Discovery and Development 

In other news, I had the honor in early November to visit Fudan University in Shanghai, China, where I received an academic appointment as Consulting Professor. I also gave lectures to students in the College of Medicine and the School of Pharmacy. But the main purpose of my trip was to kick-off a new collaboration between Tufts CSDD and Fudan's newly created Shanghai Center for Drug Discovery and Development, run by Professor and Director Liming Shao. The goals of the collaboration are to conduct joint research on 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. For our first joint activity, Dr. Shao and I will be co-chairing a panel on biotech development at the 17th Shanghai International Forum on Biotechnology and the Pharmaceutical Industry in June 2015. I'm extremely excited about this new collaboration, and I look forward to sharing our activities with you in future Quarterly Updates.

It's been a productive and fulfilling year for us here at the Tufts Center, and I'm looking forward to an equally successful 2015. On behalf of the entire CSDD staff, I wish you and yours a happy, healthy, and peaceful holidays season. And as always, I thank you for your support. 

Research Opportunities 

Multi-Company Working Group Studies

• 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 

Sponsored Research

• Challenges Facing Biosimilar Uptake
• Current Landscape for Personalized Medicines
• Impact of Reimbursement on Innovation
• 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

Getz KA, Lamberti MJ, Kaitin KI. Taking the pulse of strategic outsourcing relationships. Clinical Therapeutics. 2014;36(10):1349-1355.

Kaitin KI. Integrated partnerships and the transformation of pharmaceutical research and development. Clinical Therapeutics. 2014;36(10):1346-1348.

Stergiopoulos S, Getz KA. Social listening to enhance clinical research. Global Forum. 2014;6(5):17-20.

• CNS Drugs Take Longer to Develop, Have Lower Success Rates, Than Other Drugs, November/December 2014, Vol. 16, No. 6  

Tufts CSDD R&D Management Report:

• New Directions in Clinical Study Outsourcing Practices, October 2014, Vol. 9, No. 4

NOVEMBER

Mary Jo Lamberti: Partnerships in Clinical Trials, Barcelona, Spain, November 4-6

Mary Jo Lamberti: CDISC International Interchange, Bethesda, MD, November 12

Joseph DiMasi: R&D Cost Study Forum, Boston, MA, November 18

Joseph DiMasi: Drug Development Boot Camp, Boston, MA, November 19-20

Joshua Cohen: Tufts Global Health Research and Innovation Day, Boston, MA, November 20

Christopher Milne: Novartis Symposium, Bogota, Columbia, November 21

DECEMBER

Joshua Cohen: IBC Vaccine Development & Production Summit, Boston, MA, December 8

Kenneth Getz: Princess Margaret Cancer Centre, Toronto, Canada, December 12

Joshua Cohen: Northeastern Global Health Lectures, Boston, MA, December 19

JANUARY

Kenneth Getz: Clinical Development Summit, Austin, TX, January 12-13, 2015

Kenneth Kaitin: MassBio Policy Leadership Breakfast (panel), Boston, MA, January 28, 2015.

FEBRUARY

Mary Jo Lamberti: SCOPE (Summit for Clinical Operations Executives), Orlando, FL, February 24-26, 2015