This presentation will begin by giving an overview of Pharmacogenomics and how it is used in drug development. It will then identify the agencies that regulate Pharmacogenomics data, and explain what the regulations are. It will then go into detail of the four key challenges for Pharmacogenomics in a regulated industry and offer suggestions for overcoming those challenges to get approval from the FDA and other regulatory agencies.
Submission of Pharmacogenomics data as part of a drug or biologic submission, impacts the approval of the submitted product. Complying with FDA requirements on the subject will help with approval of the submitted product. In addition, regulations are coming into place, for the re-imbursement of the genomic tests.
This presentation will describe the agency expectations, describe how to correctly submit Pharmacogenomics data for faster approval by the agency, and what to expect from the regulatory agencies in the near future.
Areas to be Covered:
What is Pharmacogenomics (pgx)
How is it used in drug development
Why talk about regulation
Who regulates industry activity in this area
How does the FDA harmonize with other agencies that regulate pgx
Key Challenges for Regulated Industry
Validating Biomarkers and submitting genomic data to FDA
Getting Rx/Dx development in synch
Uncertainties about re-imbursement
Ensuring adequate consent for use of samples, including genomic testing
How to ensure that your pgx data is accepted by the FDA and other regulatory agencies
What is the outlook for the FDA and pgx
Who will Benefit:
Document control managers
Pharmacokinetic-Drug Metabolism / Pharmacokinetic-Pharmacodynamic Personnel
VP of PKDM / PKPD
VP of IT