RESTON, Va.--(BUSINESS WIRE)--Aptiv Solutions, a global biopharmaceutical and medical device development services company and leader in adaptive clinical trials, will present at three symposia at DIA 2013, the annual conference of the Drug Information Association, held at the Boston Convention and Exhibition Center, June 23-27.
Adopting an Adaptive Design Strategy to Manage Portfolio Risk and
Monday June 24, 2013 from 11:00 a.m. to 12:30 p.m.; Room 104C
Sarah Arbe-Barnes, Ph.D., Senior Vice President Translational Research, will discuss the benefits of adopting an adaptive design strategy across a product portfolio in the Portfolio Management Symposium. In May, the Tufts Center for the Study of Drug Development published a report that demonstrated $100 to $200 million in savings from portfolio-level application of adaptive designs. The study found that more than 20% of clinical trials now employ adaptive designs and indicated further growth.
Optimal Choice of the Type I Error Rate in Drug Development
Tuesday, June 25, 2013 from 1:45 to 3:15 p.m.; Room 157AB
Raina Duan, Ph.D., Director of Biostatistics, will present a provocative analysis of medical statistics’ arbitrary selection of Type I and II error rates, which may adversely affect drug development and have implications for adaptive trial designs. The presentation, developed in collaboration with Prof. Andy Grieve, Senior Vice President, Clinical Research Methodology and former president of the Royal Statistical Society, is part of the Statistical Science and Quantitative Thinking track’s symposium, chaired by Sue-Jane Wang, Ph.D., Associate Director, Adaptive Design and Pharmacogenomics at the FDA.
Human Factors Evaluations Throughout Combination Product
Development Optimizes Performance and Streamlines Regulatory Review
Wednesday, June 26, 2013, from 4:00 to 5:30 p.m.; Room 253C
Cynthia Nolte, Ph.D., Director, Medical Device Regulatory Services, will discuss two case studies demonstrating the value of human factors evaluations throughout the development process for combination products. The presentation is part of the symposium on Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors.
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.