Welcome to our fourth Tufts CSDD Quarterly Update of 2013. In it you will find an overview of current Center research, recent publications, staff presentations, and other news. As 2013 comes to a close, I look back with pride over all that the Center has accomplished this past year: 33 publications (including 19 peer-reviewed articles, two book chapters, and one white paper); four dynamic and productive CSDD Executive Forum Roundtables; an extraordinary number of staff presentations at conferences, companies, academic institutions, and government-sponsored events; numerous staff honors; and an astonishing number of references to CSDD research in the general media and trade press, as well as published interviews with and quotes by Center staff.

2013 also saw the rollout of the Louis Lasagna Library Fund, created to help sustain the Center's Louis Lasagna Library of Drug Development Science and Policy. A unique repository for relevant literature, one-of-a-kind documents, and authoritative reports, the Louis Lasagna Library collects, maintains, and disseminates information crucial to all stakeholders involved in the development, regulation, and utilization of new medicines. The Louis Lasagna Library Fund was created to ensure that the Louis Lasagna Library continues to serve as a crucial resource not just for the Tufts community, but for external interests worldwide.

This past year, we also celebrated an important CSDD milestone; in February we held our 40th annual Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation. This perennially popular, CME-accredited, 5-day program, which I have the privilege to co-direct with my colleague Dr. Richard Shader, is designed to provide a fundamental overview of the pharmaceutical development landscape. I believe that the continued relevance and popularity of the program is a testament to the vision and commitment to education of the course's founder, Dr. Louis Lasagna. Plans are well underway for our 41st program, scheduled for February 3-7, 2014 in Boston, and I'm pleased to report that enrollment has been robust.

It's been a wonderfully productive and fulfilling year for us here at CSDD, and I'm looking forward to an equally successful 2014. On behalf of all of us at the Tufts Center, I wish you and yours a very happy, healthy, and peaceful holiday season. And as always, I thank you for your support.

• Biotech Products in Big Pharma Clinical Pipelines Have Grown Dramatically, November/December 2013, Vol. 15, No. 6  

Tufts CSDD R&D Management Report:

• Outsourcing to Maximize Clinical Trial Operating Efficiency, October 2013, Vol. 8, No. 4

Research Participation 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
• Impact of Reimbursement on Innovation
• Mapping Product-Specific Adverse Event Reporting in Institutional and Ambulatory Settings  
• Personalized Medicine Landscape 

Getz KA. Leveraging pharmacists as a channel to raise clinical research literacy among patient communities. Applied Clinical Trials 2013;22(10):30-33. 

Getz KA, Campo R. Drug development study designs have reached the danger zone. Expert Review of Clinical Pharmacology 2013;6(6):589-591.

Kaitin KI, Honig PK. Guest editors. (Includes: Kaitin KI and Honig PK, editorial. Reinventing bioinnovation, pp 279-283) Clinical Pharmacology and Therapeutics 2013;94(3).

Lamberti MJ, Naik P, Stergiopoulos S, Kim J, Getz KA. Characterizing the global market for Contract R&D Services. Chimica Oggi [Chemistry Today]: Monograph Supplement Series CROs/CMOs­ 2013;31(4):9-13.

Milne CP. Prospects for rapid advances in the development of new medicines for special medical needs. Clinical Pharmacology & Therapeutics 2013. [Published online before print on October 30, 2013]

November

Joshua Cohen: NSURE Paradigm - Facilitating Prescription to Over-the-Counter Switches, Brookings Institution, Washington, DC, Nov. 4, 2013

Christopher-Paul Milne: Analytical Life Science & Diagnostics Association (ALDA) Service Executives Annual Meeting, Boston, MA, Nov. 12, 2013

Kenneth Kaitin: Northeastern University's Open Classroom Public Forum, Boston, MA, Nov. 20, 2013

December

Christopher-Paul Milne: Pharma Value and Growth through Academic-Industry Partnering, Copenhagen Business School, Denmark, Dec. 3, 2013

Joseph DiMasi: Janney Montgomery Scott Annual Investor Meeting, New York, NY, Dec. 4, 2013

January

Kenneth Kaitin: American Course in Drug Development and Regulatory Science (ACDRS-UCSF), Washington, DC, Jan. 7, 2014

Mary Jo Lamberti: CROWN Clinical Operations Summit, Philadelphia, PA, Jan. 22-23, 2014

February

Ken Getz: SCOPE Conference, Miami, FL, Feb. 4-6, 2014

Kenneth Kaitin: PhRMA's Annual Patient Advocacy Retreat, Annapolis, MD, Feb. 10, 2014

Ken Getz: R&D Leadership Summit, Boca Raton, FL, Feb. 10-11, 2014

Ken Getz: Clinical Trials Canada, Ontario, Canada, Feb. 27, 2014

Mary Jo Lamberti: Patient Adherence & Advocacy Summit, Philadelphia, PA, Feb. 27-28, 2014