Aptiv Solutions will be presenting and exhibiting at the DIA 2013 49th Annual Meeting taking place June 23-27, 2013, at the Boston Convention and Exhibition Center in Boston, Massachusetts. Stop by our booth #1419 and learn from our experts during the following sessions at DIA 2013:
Monday June 24, 2013, 11:00 am–12:30 pm (Track 02B) Portfolio Management Symposium This symposium will address adopting an adaptive design strategy at a portfolio level in order to provide significant value to the critical decisionmaking required to deliver an optimized pipeline of products. We will also look at the substantial challenges faced by generic companies in maximizing the value of their portfolio planning and aligning available and projected resources and strategic goals.
Chairperson: Gregg Schneider, Director, R&D Financial Management, Otsuka Pharmaceutical
Sarah Arbe-Barnes, PhD, Senior Vice President, Translational Sciences, Aptiv Solutions, United Kingdom
Vladimir Shnaydman, PhD, President, ORBee Consulting
Tuesday, June 25, 2013, 1:45–3:15 pm (Track 15) Looking Closer into the Utility of Adaptive Approaches This symposium will discuss the advantages and disadvantages of a few methodologies that are directly related to implementation of adaptive designed trials. A weighted average approach on the type I error and type II error will be introduced and will be compared with the standard approach where type I error is fixed and type II error is to be minimized. As for randomization, a hybrid randomization algorithm will be presented, which will be contrasted with conventional randomization to illustrate the pros and cons among the algorithms. Finally, adaptive dose finding designs including penalized D-optimal design, CRM design and Bayesian adaptive designs will be compared. In addition, the tradeoff between the desire to maximize information and various constraints will be discussed while gaining information under ethical/cost constraints in adaptive dose finding studies.
Chairperson: Sue-Jane Wang, PhD, MA, MS, Associate Director, Adaptive Design and Pharmacogenomics, Office of Biostatistics, Office of Translational Science, FDA
Speakers: Andrew Peter Grieve, DrSc, PhD, MSc, Senior Vice President Clinical Trial Methodology, Aptiv Solutions, Germany
Valerii Fedorov, MSc, Vice President, Quintiles Inc.
Representative Invited, Product Manager, Medidata Solutions Worldwide
Wednesday, June 26, 2013, 4:00–5:30 pm (Track 09) Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors This forum will present targeted, real-world case studies from biotechnology and pharmaceutical sponsors as well as a CRO on the development of novel combination products with a particular focus on global regulatory strategy and implementation.
Chairperson: Kevin B. Johnson, PhD, MBA, Global Head, Regulatory Affairs, Novella Clinical
Speaker: Cynthia Joan Nolte, PhD, Director, Medical Device Regulatory Services, Aptiv Solutions
OneMedForumNY 2013, June 26th-27th at the Metropolitan Club in New York City, will feature 60 private and public companies with sector-altering technology and a growing reputation. Technologies at the benchtop level will present alongside revenue-positive market-stage companies. OneMedForum NY2013 is a gathering of leading investors and management of some of the most promising emerging life science companies in Asia and North America. Through panels, workshops, and up-close programming with top industry leaders, attendees explore strategies for company growth finance with healthcare investors looking for outsized returns.