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The Pursuit of Better Medicines through Genetic Research

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The Pursuit of Better Medicines through Genetic Research Terri Arledge, DVM US Department Head Drug Development Genetics – PowerPoint PPT presentation

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Title: The Pursuit of Better Medicines through Genetic Research


1
The Pursuit of Better Medicines through Genetic
Research
Terri Arledge, DVM US Department Head Drug
Development Genetics
2
  • Genetic research goals and initiatives at GSK
  • Industry group addressing ethical, legal and
    regulatory issues with genetic research into drug
    response (pharmacogenetics)
  • Research sponsors perspectives on family consent
    and suggested points to be considered

3
Genetic Research Goals at GSK
  • Identify susceptibility genes for common diseases
  • Use results of genetic research to discover new
    medicines acting on new targets (e.g., new genes
    associated with human disease pathway)
  • Improve safety and efficacy of medicines by
    understanding the genetic basis for /- drug
    response in individuals
  • Promote education and informed discussion about
    genetic research

4
Primary Genetic Research Initiatives
Genetic Research
Understanding drug response
Understanding diseases
New treatments
Targeting treatments
5
Identification of Disease Susceptibility Genes
  • Susceptibility genes confer a risk of - but do
    not cause - disease
  • GSK Clinical Genetics Networks
  • Large, international studies among academic
    institutions, genome screening centers and
    genetic epidemiology centers
  • Protocols with well-characterized, standardized
    patient assessment criteria
  • Detailed family history, clinical information
    and DNA from affected and unaffected siblings
    and parents
  • Informed consent and information coding
  • Identify gene loci responsible for disease
    susceptibility
  • Examples -- Asthma, Depression, COPD, Early
    Onset Heart Disease, Osteoarthritis

6
Pharmacogenetic Research
  • Pharmacogenetics How genetic differences among
    patients influence their responses to medicines
  • GSKs Pharmacogenetic research in drug
    development trials
  • Participation is voluntary - separate consent
    for genetic research
  • Blood sample for DNA analysis and information
    coding
  • Correlate drug response with genotype
    information using pooled data

7
Pharmacogenetic research
Section of SNP profile
Section of SNP profile
Patients without a
side effect
Patients with a
side effect
side effect
SNP Print
Predictive of no
side effect
Predictive of a
side effect
8
Pharmacogenetics Working Group
Mission To advance the understanding and
development of pharmacogenetics by openly
addressing and disseminating information on
non-competitive topics such as ethical, legal and
regulatory issues. Proposed Activities Sponsor
symposia, prepare publications, interface with US
and European regulators and address elements of
pharmacogenetic research protocols and consents
9
A Sponsors Perspectives on Family Consent
  • Distinction among types of research
  • Implications for Study Participants
  • Implications for the Feasibility of Research

10
Points to Consider regarding Family Consent
  • Scientific rationale for collecting family
    history data
  • Justification for the degree of detail
  • Degree of confidence that subject is a credible
    source of family history
  • Implementation of safeguards (data collection
    environment, access and release of data)

11
Recommendations regarding Family Consent
  • Responsibility for assessing family consent
    issues should remain with local investigators,
    ethics committees and research sponsors
  • Education and guidance materials - not
    prescriptive, sweeping measures - should be
    developed for use by researchers, ethics
    committees and sponsors
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