Jim Bolognese named 2017 American Statistical Association Fellow

James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow of the American Statistical Association (ASA). Jim will be officially honored by the ASA at the Joint Statistical Meetings in Baltimore, Maryland this summer.

The American Statistical Association (ASA) is the world’s largest community of statisticians. It uses the title of Fellow of the American Statistical Association as its highest honorary grade of membership. The designation of ASA Fellow has been a significant honor for nearly 100 years.

Jim commented “I'm very honored, gratified, and humbled by this recognition. In thinking back over my last 41 years as a consulting statistician on medical research projects, I owe a significant debt of thanks to the many excellent collaborators with whom I've had the honor and privilege to work. Without them continually challenging me, this recognition would not have been possible."

Jim is receiving the honor in recognition of excellence in consulting, collaboration, and leadership on statistical aspects of drug development research programs and their impact on medical care; for innovative research in the design and analysis of adaptive clinical trials, and decision analysis in early-phase trials; as well as for exemplary service to the profession and to ASA.

Cyrus Mehta, President of Cytel commented "What strikes me most about Jim is his love of ideas, quickness, and creativity as a key member of our strategic consulting and software development groups. He draws upon a wealth of experience gained from 41 years of consulting on all aspects of clinical drug development - trial design, implementation, operations and pharmacology. As a result, no matter what type of project is placed before him, he can immediately propose a way forward. No wonder our clients all love to work with Jim and repeatedly request that he be assigned to their projects."

Jim's contribution to development of statistical knowledge in drug development includes extensive published research in peer reviewed journals, with a particular focus on early and Phase 2 trials. Recent publications include:

Optimizing adaptive design for Phase 2 dose-finding trials incorporating long-term success and financial considerations: A case study for neuropathic pain. Contemporary Clinical Trials, 57, pp.69-86. 

A randomized, phase 2 study investigating TRV130, a biased ligand of the μ-opioid receptor, for the intravenous treatment of acute pain. Pain, 157, no. 1 264-272. 

Methodological extensions of phase 2 trial designs based on program-level considerations: Further development of a case study in Neuropathic pain. Therapeutic Innovation & Regulatory Science.

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