Aptiv Solutions Creates Adaptive Trials Center

Aptiv Solutions has created an Adaptive Clinical Trials Innovation Center comprised of thought leaders and experts in adaptive trial design, methodology and implementation. The leaders of the Innovation Center include: Reinhard Eisebitt, executive vice president and head of Innovation Center, Judith Quinlan, senior vice president of Trial Design Implementation, Andrew Grieve, senior vice president of Clinical Research Methodology, Vladimir Dragalin, senior vice president of Software Development and Consultingm, and Gernot Wassmer, senior vice president and principle software architect of ADDPLAN.

Mr. Eisebitt has 25 years of experience in the CRO industry. He co-founded ClinResearch, a CRO that specializes in the planning, execution and reporting of adaptive clinical trials, and co-founded the software company ADDPLAN, which created the first commercial adaptive trials software.

Ms. Quinlan has experience in both the pharmaceutical and CRO industries having held various leadership positions at GlaxoSmithKline, where she managed adaptive designs within her business areas, and was also involved in multiple initiatives to promote adaptive designs across GSK. She joined Aptiv from Cytel, Inc., where she was vice president of Adaptive Clinical Trial Services.

Mr. Grieve has more than 30 years of experience in the pharmaceutical industry, where he promoted the use of Bayesian methods and was involved in the development and implementation of Bayesian adaptive designs. He recently joined the company from King’s College London, where he was Professor of Medical Statistics.

Mr. Dragalin is an adaptive designs expert with 25 years of experience in developing the methodology of adaptive designs, and has 12 years of pharmaceutical industry experience having held positions at GlaxoSmithKline, Wyeth, Pfizer. Prior to joining Aptiv he led the Quintiles Center for Statistics in Drug Development.

Mr. Wassmer co-founded the software company ADDPLAN, the first commercial software package for the design, simulation, and analysis of adaptive clinical trials. He has 20 years of experience in clinical trial consulting for academia and industry and is adjunct professor of Medical Statistics at University of Cologne.

The Innovation Center team is collaborating with pharmaceutical and biotech companies, as well as regulatory authorities, to provide consulting on best practices for the use of adaptive designs. This team will work with clients to assist with the trial design, simulation and execution, develop adaptive trials software tools, and work with project teams in clinical operations, data management and statistics groups.

“We are pleased to have attracted such talented experts who have both industry and CRO experience in the design, simulation and execution of adaptive trials,” said Patrick K. Donnelly, chairman and chief executive officer of Aptiv Solutions. “Aptiv Solutions is leading the industry in the use of adaptive clinical trials, which can build significant efficiency into the clinical development process, enabling sponsors to make the correct development decisions sooner and get the right products to market faster.”