From the Director

Welcome to our first Tufts CSDD Quarterly Update of 2015. And what an incredible kick-off to the year it's been here in New England! Despite several punishing blizzards, over nine feet of accumulated snow, numerous university and business closures, and the near paralysis of public transportation, CSDD has remained engaged in a full slate of research projects and has moved forward on a host of new programs. 

Our 42nd annual CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation, held the first week of February, went off without a hitch, despite a major snowstorm at the beginning of the week that brought much of the region to a standstill. We had nearly full attendance, and only a few faculty on the first day needed to give their presentations via Skype. Despite the challenges, the class was attentive, engaged, and eager to learn. Every year I'm amazed how the course agenda, which covers a broad range of topics and is organized to meet the needs of students with very varied backgrounds and experiences, comes together so nicely to create such a rich and novel learning experience. We are indebted to our outstanding faculty and all the many wonderful students we've had over the years for helping to make the Tufts CSDD Postgraduate Course a superb and enduring benchmark for educational programming on pharmaceutical innovation.

Also in February, we held our first quarterly R&D Management Roundtable of 2015 - part of our CSDD Executive Forum. The topic, "FDA's Breakthrough Therapy Designation-A Three-Year Assessment," generated a very animated and productive discussion. The program included a presentation of new CSDD metrics on BTD approvals, talks on company experiences with BTD development programs, and a featured presentation by Dr. Sarah Pope Miksinski, Acting Division Director for the Division of New Drug Quality Assessment 2 in the Office of New Drug Quality Assessment within the Center for Drug Evaluation and Research, on the FDA's current thinking on BTDs. Our next roundtable, to be held May 14th, will focus on "Diagnostic-Therapeutic Co-development Strategies and Best Practices." If you haven't had an opportunity to attend one of our R&D Management Roundtables, I encourage you to register. I think you'll find the events stimulating and different. For more information on the series, visit our website.

Finally, I'm pleased to note that our Director of Research and Associate Professor Chris Milne is expanding Tufts CSDD's global reach through a three-month research and teaching fellowship at Kyushu University in Japan. During his stay, Chris will be teaching undergraduate and graduate level courses and will be managing several CSDD-Kyushu collaborative research projects. We're excited to make this new connection with colleagues in Japan.

As always, thank you for your support. 

Chakravarthy R, Cotter K, DiMasi JA, Milne CP, Wendel N. White paper: Public and Private Sector Contributions to the Research & Development of the Most Transformational Drugs of the Last 25 Years. Boston: Tufts Center for the Study of Drug Development. January 2015.

Cohen JP. Roadblocks preventing personalized medicine from reaching its Potential. Biomarkers in Medicine 2015;9(1):5-8.

Getz KA, Kaitin KI. The impact of bad protocols. In: Schuler P, Buckley B, eds. Re-engineering Clinical Trials: Best Practices for Streamlining Drug Development. Amsterdam: Academic Press; 2015:105-116.

Getz KA, Kaitin KI. Why is the pharmaceutical and biotechnology industry struggling? In: Schuler P, Buckley B, eds. Re-engineering Clinical Trials: Best Practices for Streamlining Drug Development. Amsterdam: Academic Press; 2015:3-15.

Grabowski, HG, DiMasi JA, Long G. The roles of patents and research and development incentives in biopharmaceutical innovation. Health Affairs 2015;34(2):302-310.

Milne C-P, Bryan C, Garafalo S, McKiernan M. Complementary versus companion diagnostics: apples and oranges? Biomarkers in Medicine 2015;9(1):25-34.

Milne C-P, Kaitin KI. Meeting unmet medical needs: the disparity dilemma. Pharmaceutical Executive 2015;35(2):26-28.

Stergiopoulos S, Surgeon L. The facilitated clinical trial protocol review: is the theory being put into good practice? Chimica Oggi [Chemistry Today] 2014;32(6):52-56.

• High turnover, protocol noncompliance plague the global site landscape, January/February 2015, Vol. 17, No. 1
• Biosimilars entering the U.S. market are likely to face multiple challenges, March/April 2015, Vol. 17, No. 2

Tufts CSDD R&D Management Report: 

• Anticipating and Managing a Changing Site Landscape January 2015, Vol. 10, No. 1

MARCH
Kenneth Getz: R&D Leadership Summit, Miami, FL, March 5-6

Kenneth Kaitin: U.S. Biomedical Advanced Research and Development Authority (BARDA) Distinguished Speaker Series, Washington, DC, March 11 

Mary Jo Lamberti: Forecasting and Optimization of the Clinical Supply Chain Summit, Philadelphia, PA, March 16-17

Kenneth Getz: Patients as Partners, Philadelphia, PA, March 16-17   

Kenneth Getz: Oracle Industry Connect, Washington, DC, March 24-26

APRIL
Joseph DiMasi: IVAL Hepatocyte Technology Conference, Malden, MA, April 14  

Kenneth Kaitin: Clinical Research Forum Annual Meeting, Washington DC, April 17 

Kenneth Getz: Partnerships in Clinical Research, Boston, MA, April 22-23

Kenneth Getz: ACRP Annual Meeting, Salt Lake City, UT, April 25-27

MAY
Kenneth Getz: Chief Medical Officers East, Boston, MA, May 4-5   

Kenneth Kaitin: Convergence Forum, Chatham, MA, May 15 

Joseph DiMasi: National Bureau of Economic Research (NBER) Productivity Seminar, Cambridge, MA, May 26   

Kenneth Getz: OCT East, Boston, MA, May 27-28   

JUNE
Joseph DiMasi: American Diabetes Association 75th Annual Meeting, Boston, MA, June 5   

Joseph DiMasi: Bates White Life Sciences Symposium, Washington, DC, June 8-9   

Christopher Milne: NextLevel Pharma, Pharma Access Leaders Forum, Brussels, June 8-10

Kenneth Kaitin: 17th Annual Shanghai BioForum, Co-chair of Global Pharmaceuticals Innovation Strategy Symposium, Shanghai, China, June 9 

Joseph DiMasi: Special Libraries Association 2015 Annual Meeting, Boston, MA, June 14