The 21st International Molecular Medicine Tri-Conference is the industry’s Preeminent Event on Molecular Medicine, focusing on Drug Discovery, Genomics, Diagnostics and Information Technology.

Laboratory-developed tests, which are developed, validated and performed by clinical laboratories, have come under increased scrutiny by the FDA. Cambridge Healthtech Institute's Laboratory-Developed Tests DVD will cover the latest developments from the FDA and the positions and recommendations put forward by medical and industry professional societies; the challenges of meeting CLIA regulations in the new age of genomics; and the complexities of implementing NGS assays into clinical laboratories.

In these presentations selected from the Strategies for Companion Diagnostic Development workshop at the Fourth Annual ADAPT Congress 2012, global IVD leaders and experienced consultants address the potential downstream effects of early decisions in the development cycle of companion diagnostics, what are the strategies to achieve successful commercialization of IVD products, how collaborative partnerships drive results and are models for successful development, and when and how a companion diagnostic should be included in drug trials.

Presentations selected from the Clinical Assay Development workshop at the Fourth Annual ADAPT Congress 2012 discuss how discovery and research assays are increasingly being converted into clinically useful assays that are used in clinical trials to improve patient outcome and to support drug development. Regulatory issues and the dedication of resources to develop assays are addressed, as well as strategies to overcome the challenges of using commercial assays on clinical samples; analytical validation studies to determine clinical utility; and the benefits of working with a diagnostics organization with both experienced IVD manufacturing and an extensive CLIA laboratory infrastructure.