Dismantling Barriers to Adaptive Design Adoption to Be Key Theme of Pre-Disruptive Innovations Conference

1. Dismantling Barriers to Adaptive Design Adoption to Be Key Theme of Pre-Disruptive
Innovations Conference
Reston, Virginia, September 3, 2013 – Aptiv Solutions, a global biopharmaceutical and medical device
development services company and leader in adaptive clinical trials, will chair the Adaptive Trial Designs
Summit in Boston, MA on September 18.Presentations by scientists at Merck, Biogen Idec, Tufts,
Harvard, Aptiv Solutions, and former regulatory officials will address how to overcome barriers to the
adoption of adaptive designs.
Adaptive clinical trialsallow pre-planned modifications to improve utility, such as terminating studies
early to spare patients from ineffective treatments or in Phase II trials adding patients to effective
dosages for a more accurate determination of the dose–response relationship. Coupled with new
industry initiatives to increase efficiency, adaptive designs can make structural improvements to the
drug development process. However, despite industry-wide acknowledgement of the promise of
adaptive designs, only 20 percent of clinical trials are adaptive. Low adoption can be attributed
significantly to internal organization resistance and perceived regulatory barriers, according to a recently
released Tufts Center for the Study of Drug Development (CSDD) report.
The success story of overcoming barriers to adoption of adaptive designs at Merck will be the subject of
a talk by Jerald Schindler, VP of Late Development Statistics at Merck. He will recount his strategic
approach to achieve broad organizational support for adaptive trial designs and the value this has
generated.
Additional talks will address:
Regulatory obstacles to use of adaptive design, Simon Day, Director of Clinical Trials Consulting
and Training Limited
Product development decision-making with adaptive design, Stacy Lindborg, Senior Director of
Biostatistics at Biogen Idec and Steven Zelenkofske, SVP Clinical and Medical Affairs & CMO at
Regado Biosciences
Sophisticated adaptive designs and how to approach them, Judith Quinlan, Senior VP Aptiv
Solutions Innovation Centre
Independent data monitoring committees, Lee Jen Wei, Professor at Harvard University
A panel discussion on combining adaptive design with industry initiatives to drive clinical
efficiency
AboutAptiv 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

2. professionals in North America, Eastern & Western Europe, Israel, and Japan. Visit the website at
www.aptivsolutions.com.