RESTON, Va.--(BUSINESS WIRE)--Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces its participation in a prestigious conference on adaptive clinical trials, held at the University of Tokyo on May 10th 2013. The keynote lecture will be delivered by Professor Gernot Wassmer, Aptiv Solutions’ Senior Vice President Clinical Trial Innovation, and a second lecture will be delivered by Laurent Spiess, Aptiv Solutions’ Vice President Adaptive Trials.
The conference entitled ‘Practice of Adaptive Clinical Trials’ features a number of key experts from several Japanese universities as well as representatives from the Japanese pharmaceutical industry, the Japanese CRO industry and the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Leaders from these four groups will discuss the current status of adaptive trial adoption in Japan and how this could evolve over time.
Professor Wassmer’s keynote lecture is entitled ‘Lessons learned from Phase II adaptive dose-finding trials’. Adaptive dose finding trials are recognized by both industry and regulatory agency experts as the area where adaptive design can have a major impact on the product development process, not only in terms of trial efficiency but also in terms of enhanced probability of success by guiding selection of the appropriate dose for Phase III pivotal trials.
“Poor design of Phase II studies is a major reason for failure in later Phase III trials. Traditional dose-finding trials leave much room for improvement and Phase II dose-finding is the key area regulatory agencies see as benefitting most from adaptive designs,” says Professor Wassmer.
In a second lecture, Spiess will provide an overview of adaptive design incorporating a number of case studies that demonstrate the benefits of adaptive trials as well as the regulatory agency guidance available from the FDA and EMA.
“We are both honored and very excited to be part of this prestigious event at Tokyo University,” says Pat Donnelly, Chairman and CEO of Aptiv Solutions. “Adaptive design trials are rapidly gaining acceptance in the US and Europe, and it’s exciting to see the discussion continually advancing in Japan and other key countries.”
About Aptiv Solutions
Aptiv Solutions is a global development services company that is focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has more than 850 professionals in North America, Eastern & Western Europe, Israel, and Japan. Visit the website at www.aptivsolutions.com.
