Regulatory Issues in Pharmacogenomics

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
• Guidance Documents
• 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 Should Attend:

• Quality Assurance
• Regulatory Affairs
• Document control managers
• Contractors
• IT Managers
• Quality Control
• Geneticists
• Pharmacokinetic-Drug Metabolism / Pharmacokinetic-Pharmacodynamic Personnel
• VP of PKDM / PKPD
• VP of IT
• Doctors

Course Director: ANGELA BAZIGOS ‎

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.