ComplianceOnline, Online Event
Why Should You Attend:
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.
An up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
Areas Covered in the Seminar:
- Types of biomarkers and their regulatory implications.
- Overviews of emerging regulatory aspects for all classes of biomarkers.
- Specific guidances for biochemical, genomic and imaging biomarkers.
- Elements constituting context of use for a biomarker.
- The qualification process for biomarkers.
- Context, structure and format of regulatory submissions for qualification of biomarkers.
- Definition and use of a Companion Diagnostic Device.
- Applicable standards when imaging is used to assess a primary endpoint.
- Definition of clinical, investigative and research use in the context of PET drugs.
- Clinical evaluation of pharmacogenomics.
Date: August 14, 2012
Time: 10:00 AM-11:00 AM PDT
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
||Orest Hurko, is a Senior Clinical Consultant with the Biologics Consulting Group, Inc. in Alexandria Virginia. He was the founding director of Investigative Medicine for the Neurology CEDD in GSK and Discovery/Translational Medicine in Wyeth, responsible for biomarker development in oncology, neuroscience, inflammation, cardiovascular and bone disease as well as women’s health. He has published extensively on the application of biomarkers in drug development, most recently in Nature Reviews Drug Discovery. He currently serves on the Data and Publications Committee of the Alzheimer Disease Neuroimaging Initiative, and the faculties of the Pharmaceutical Education & Research Institute, Inc., the University of Dundee and the annual International Conference on Drug Development sponsored by the University of Texas in Austin.