Regulatory Issues in Pharmacogenomics

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Sep 30, 2014
90 Minutes
Product Description

Regulatory Issues in Pharmacogenomics

Pharmacogenomics (a portmanteau of pharmacology and genomics) is the study of the role of genetics in drug response. It deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with drug absorption, metabolism, distribution and elimination, as well as drug receptor target effects. Pharmacogenomics may be used interchangeably with the term pharmacogenetics, which focuses on the effects of candidate genes in drug response. Pharmacogenomics aims to develop rational means to optimize drug therapy, relating to the patients' genotype, to ensure utmost efficacy with minimal adverse effects. This approach promises the advent of "personalized medicine"; where drugs and drug combinations are optimized for each individual's unique genetic makeup.

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 reimbursement of the genomic tests. In this audio session, expert Angela Bazigos will describe—the agency expectations, how to correctly submit pharmacogenomics data for faster approval by the agency, and what to expect from the regulatory agencies in the near future.

Angela will begin by giving an overview of Pharmacogenomics and how it is used in drug development. She will then identify the agencies that regulate pharmacogenomics data, and explain what the regulations are. Know the four key challenges of pharmacogenomics in a regulated industry and get suggestions for overcoming those challenges to get approval from the FDA and other regulatory agencies.

Topics covered in the session:

  • 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

Get answers to your questions in a Q&A segment after the session by the speaker

Who should attend

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

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About Our Speaker

Angela Bazigos - Pharma Conferences

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...   More Info
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