Lois Hinman

TL;DR: A selection of case studies from the first 5 years of the US Food and Drug Administration's voluntary exploratory data submission programme, which also involves collaboration with the European Medicines Agency, are discussed, and general lessons are highlighted.

TL;DR: This article describes a systematic framework that was developed by Pharmaceutical Research and Manufacturers of America committees and tested at a workshop and could be applied to create an appropriately individualized evidentiary standard for any biomarker purpose.

TL;DR: This session provided an opportunity to allow an exchange of ideas between the FDA and industry and to identify critical issues that need further discussion in this important and evolving field.

TL;DR: Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit-risk paradigm for new drugs.

TL;DR: The survey results showed that, while the industry has made some attempt to incorporate PG/PD studies into drug development, application has been inconsistent and several validPG/PD markers have since emerged in drug labels.