Biomarkers for Drug Development: The Emerging Regulatory Landscape (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Aug 14, 2012||End Date/Time: Aug 14, 2012|
Why Should You Attend:
Biomarkers have long been advocated by the FDA as a way of making development more efficient. However, detailed guidances are only now being issued. Over the last eighteen months the FDA has explained its current thinking on biomarkers in a series of final and draft guidances. Though not formally labeled as a series by the Agency, it is useful to consider a number of recent guidances as a group.
This session will cover the emerging regulatory aspects for all classes of biomarkers: biomarkers of (1) efficacy, (2) toxicity, (3) dose-selection, & (4) patient-selection. The utility of each of these four classes of biomarkers varies according to the degree of validation, the business model of the company using them, and the terms under which regulatory approval is sought.
This training will enable industrial scientists and clinicians to understand the recent guidances on biomarkers and companion diagnostics and allow them to prepare detailed roadmaps ensuring proper qualification and implementation of biomarkers to a standard that will be accepted by the FDA in registration packages for either small molecule drugs or biologicals.