From the Director

Welcome to our first Tufts CSDD Quarterly Update of 2014. At the time of this writing, 2014 is just two months old, but already we're engaged in a full slate of new research projects and moving forward on a host of other CSDD programs.  

This year's CSDD Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation - our 41st annual program! - went off without a hitch, despite a mid-week snowstorm that brought much of the mid-Atlantic region to a standstill. Having been involved with the course for the better part of four decades, I'm thrilled that we've been able to keep the agenda timely and fresh. For example, this year's course featured new lectures on vaccines and immunotherapeutics, social media and the pharmaceutical industry, and CMC and quality in drug development. As in previous years, the students were highly engaged and enthusiastic, and clearly appreciated the high caliber of the lectures, faculty interaction, and especially the small group activities. We are indebted to our extraordinary faculty for contributing their time and expertise to make the CSDD Postgraduate Course an outstanding and perennially popular program.

Also in February, we held our first quarterly R&D Management Roundtable of 2014 - part of our CSDD Executive Forum. The topic was "New Initiatives for Boosting Clinical Success," which generated a very animated and productive discussion. Our next roundtable, scheduled for May 15th, will focus on "Strategic Alliances and Integrated Partnerships." If you've not 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. An overview of our roundtable series is provided in this Quarterly Update.

Finally, I'm pleased to welcome Ron Evens, PharmD, FCCP, to the CSDD staff as an Adjunct Research Professor and Biotechnology Consultant. Ron, who is based in Napa, California, and is president of MAPS 4 Biotec, Inc., has a wealth of experience in biotechnology product development trends as well as the shifting landscape for biopharmaceutical developers. We're thrilled that he will be sharing that expertise with us as we continue to examine this dynamic sector of the life sciences industry. 

• New Breakthrough Therapy Designation Program Aims to Cut Clinical Trial Time, January/February 2014, Vol. 16, No. 1
• Drug Sponsors Tread Cautiously Using Social Media to Aid Clinical Research, March/April 2014, Vol. 16, No. 2

Tufts CSDD R&D Management Report: 

• Enhancing Product Value through Comparator and Co-Therapy Clinical Trials, January 2014, Vol. 9, No. 1

Research Participation Opportunities 

Multi-Company Sponsored Working Groups

• Assessing the Effectiveness of Investigative Site Management Practices
• 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
• Mapping the US Generic Manufacturing Landscape
• Personalized Medicine Landscape 
• Profiling New R&D Innovations Driving Performance and Efficiency
• Quantifying the Use of ePRO in Clinical Trials

Cohen JP, Felix AF. Are payers treating orphan drugs differently? Journal of Market Access & Health Policy 2014;2:1-5.

Cohen JP, Felix AF. Complying with state and federal regulations on essential drug benefits: implementing the Affordable Care Act. American Journal of Managed Care 2014;20(2):31-36.

DiMasi JA. Pharmaceutical R&D performance by firm size: approval success rates and economic returns. American Journal of Therapeutics 2014;21(1):26-34.

DiMasi JA, Kim J, Getz KA. The impact of collaborative and risk-sharing innovation approaches on clinical and regulatory cycle times. Therapeutic Innovation & Regulatory Science 2014. [Published online before print February 5, 2014]

Getz KA. Adoption of adaptive trial designs poised to accelerate. Applied Clinical Trials 2013;22(11):16-18.

Getz KA, Stergiopoulos S. Therapeutic area variability in the collection of data supporting protocol end points and objectives. Clinical Investigation 2014;4(2):125-130.

Millier A, Cohen JP, Toumi M. Economic impact of a triptan Rx-to-OTC switch in six EU countries. PLoS ONE 2013;8(12):e84088.

Milne C-P, Davis J. The Pediatric Studies Initiative: after 15 years have we reached the limits of the law? Clinical Therapeutics 2014:36(2):156-162.

Selker HP, Oye KA, Eichler H-G, Stockbridge NL, Mehta CR, Kaitin KI, McElwee NE, Honig PK, Erban JK, D'Agostino RB. A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials. Clinical Pharmacology & Therapeutics 2013;95(2):147-153.

January

Mary Jo Lamberti: CROWN Clinical Operations Summit, Philadelphia, PA, January 22-24

March

Kenneth Getz: Patients as Partners, The Conference Forum, Philadelphia, PA March 3-4

Kenneth Getz: IIR Annual Partnerships Conference, Las Vegas, NV, March 31-April 2

April

Kenneth Kaitin: CBI R&D Open Innovation and Portfolio Optimization Conference, Philadelphia, PA, April 8-9

Kenneth Getz: ACRP Annual Meeting, San Antonio, TX, April 27-28

May

Christopher-Paul Milne: Marcus Evans 7th Evolution Summit, Palm Beach, FL, May 7-9

Christopher-Paul Milne: New Trends in Regulatory Science, University of Copenhagen, Denmark, May 19