Regulatory Issues in Pharmacogenomics

Pharmacogenomics (a portmanteau of pharmacology and genomics) is the study

of the role of genetics in drug response.

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Presenter
Angela Bazigos

Contents

What is Pharmacogenomics (PGX)

How is it used in drug development
Why Regulate PGx
Who Regulates Industry Activity in this Area

How is PGx Regulated? (Guidance Documents)

How does FDA harmonize with other agencies that regulate PGX
How to ensure your genomic data is accepted by the FDA and
other regulatory agencies

Key Challenges in PGx

Biomarker Validation
Getting Drug / Diagnostic (Rx/Dx) development in sync
Uncertainties over reimbursement

Informed Consent
What is the outlook for the FDA and PGX
Q&A
Appendix Warfarin case study

What is Pharmacogenomics
(PGX)

What is Pharmacogenomics
Pharmacogenomics

is the study of how

an individuals genetic inheritance affects
the bodys response to drugs
The term Pharmacogenomics comes
from the words Pharmacology (the
Science of Drugs) and Genomics (the
study of genes and their function and is
thus the intersection of pharmaceuticals &
genetics

What is PGX
Pharmacogenomics

allows us to identify
sources of an individuals profile of drug
response and predict the best possible
treatment option for this individual.

How is PGX Used in Drug

Development

How is PGX used in Drug

Development

Interindividual Variability in
Drug Response
Disease
Asthma
Hypertension
Solid Cancers
Depression
Diabetes
Arthritis
Schizophrenia

Drug Class
Rate of Poor Response
Beta-agonists
40-75%
Various
30%
Various
70%
SSRIs, tricyclics
20-40%
Sulfonylureas, others
50%
NSAIDs, COX-2 inhibitors 30-60%
Various
25-75%

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