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Personalized Medicine - Pharmacogenomics Model in Clinical Trials

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by

Stephanie Lock

on 24 April 2014

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Transcript of Personalized Medicine - Pharmacogenomics Model in Clinical Trials

Challenges
Long term sample storage & handling
Electronic genetic data transmission
Possible genetic discrimination
Return of study information
Public view & understandings
Ethics
Regulations perspectives
What is pharmacogenomics (PGx)?
Study of how genes
(DNA and RNA)
affect a person’s response to drugs.
Hypothesis developed after protocol initiation
and not described in original protocol

PGx analysis has no influence on trial design
as

analysis is retrospectively defined

PGx analysis generally not included in CSR,
and can be conducted at some point after CSR is authored

Analysis conducted on optional, future-use samples.

What is pharmacogenetics (PGt)?
Personalized Medicine: Pharmacogenomics Model in Clinical Trials
How?
Right drug
Right dose
Right time

- Mayo Clinic Proceedings, 2014
One Size Fits All
Applications of PGx
in terms of clinical endpoints
Pharmacokinetics
Efficacy
Safety
Where are we now in terms of PGx?
Study of how
DNA
sequence affect a person's response to drugs
However, both terms are often used interchangeably
Biomarker Validation Strategy
Companion Diagnostics Development
Phase
Where can we go from here?
Developed hypothesis described in protocol
(can be exploratory)
PGx can influence trial design
(eg. stratification based on gene status)
PGx analysis included in CSR
Analysis conducted utilizing samples collected from
all or majority of patients in the trial
Phase
Informed Consents
Trial Design & Protocol Development
optional vs. mandatory participation
genomic endpoint are already known vs. will only be defined over the course of the trial according to emerging clinical issues
samples will be analyzed within the context of the trial only vs. will also be retained for future research
BMD
CDx
DRA
OTM
Cost vs Savings
Time
Vendors & Key Personnels
Resources
Observational
Exploratory
Preliminary safety & PK data
Defined endpoint based on genomics
Identify responder subgroups
Determine optimal dose
In terms of utilization in...
Genomic Data and Sample Coding Categories
Full transcript