This training provides 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.
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.
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.
Learning Objectives:
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.
Who Will Benefit:
This webinar will provide valuable assistance to pharmaceutical and biotechnology personnel with responsibility for the implementation of biomarkers in clinical development programs and registration packages, including:- Translational Medicine scientists developing biomarkers
- Clinical Scientists designing Phase 2 and Phase 3 trials
- Preclinical scientists developing biomarker assays
- Administrative managers in charge of Clinical Research
- Regulatory Compliance Associates and Managers
Course Provider
Orest Hurko,
