Transcript Impact of Pharmacogenomics on the Pharmaceutical Industry

IMPACT OF
PHARMACOGENOMICS ON
THE PHARMACEUTICAL
INDUSTRY
Viktoriya Buchko
American Institute of Chemical Engineers
August 6, 2008
Pharmacogenomics
= drug therapy + genetic diagnostic test
OVERVIEW

Relevance: realization in 5-10 years
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Especially because of the passage of Genetic
Information Non-discrimination Act (GINA) 2008
Objectives:
Increase safety and effectiveness of drugs
 Efficiency and economical concerns
 Do not exacerbate health disparity concerns

METHODOLOGY
0.1% genetic difference
 Limit market size
 Use biomarkers or other diagnostic tests

BENEFITS
Short-term
 Reduce side effects
 Reduce trial-and-error dosing
Long-term
 Improve health care system
 Reduce health disparities
CURRENT PHARMACEUTICAL DRUG
DEVELOPMENT MODEL
2-3 years
3-5 years
Compound
ID’ing
Preclinical Studies
-lab & animal testing
-toxicity research
-safety
3-7 years
Clinical Trials
I: 20-30 healthy
2-3 years
Examination
-New Drug App.
volunteers
safety & dosage
II: 100-300 patient volunteers
efficacy & side effects
III: 1000-15000 patient volunteers
long-term use & ADRs
DIFFICULTY IN DRUG DEVELOPMENT
Increased R&D costs, yet fewer new drugs
approved
 9% of candidates filed for NDA
 1/10 on market considered market success
 Competition from generics, “me-too” drugs

PHARMACOGENOMIC SOLUTIONS
Decrease development time
 Faster approach to drug candidate identification
 Methods for approval

New niches, such as anti-obesity drugs
 Rescue drugs

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Less risk
CONCERNS WITH PHARMACOGENOMICBASED BUSINESS MODEL
High-risk for large pharmaceutical companies
 Identifying genetic basis
 Post-marketing surveillance studies
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POLICY ACTION
TO FACILITATE PHARMACOGENOMICS

Genetic test standardization
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
Integration of clinical and genomic data


Laboratory Test Improvement Act (S. 736)
Genomics and Personalized Medicines Act (S. 976)
Mitigate ethical concerns
Distributive justice
 Selection & prioritization of drugs
 Enact the Institutional Review Board

POLICY ACTION
TO FACILITATE PHARMACOGENOMICS

Incentive for coupling diagnostic and drug
treatment

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S. 976 calls for Nat’l Academy of Sciences for analysis
Mandate Phase IV clinical trials
KEY FINDINGS
Segmenting drug development industry
 Cooperation of large pharmaceutical companies
with smaller biotech companies
 Immediate relevance in Mendelian one-genebased diseases
 Genetic tests as diagnostics most pertinent in allor-nothing benefit
 Genetic test to be first used in complement to a
drug already on the market
 New uses for current drugs

CONCLUSIONS
With passage of GINA 2008, greater security in
genetic testing will allow for the realization of
personalized medicine.
 Must increase regulatory control to keep pace
with the developing pharmacogenomic-based
drugs.
 Increase public awareness, including that of
physicians, of the possibilities of safer, more
efficacious drug treatments.

QUESTIONS
BIDIL: TO REDUCE HEART FAILURE IN SELFIDENTIFIED BLACK INDIVIDUALS
PROOF
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
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Twice the fatality rate in
black individuals than
other Americans
Reduce disparity through
minority recruitment
Reduce mortality rate by
43%, 1st hospitalization rate
by 33%
CRITICISM


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Statistic valid for 45-64 year
olds, where only 6% of
mortality population is
accounted for
Commercial tactic to obtain
new patent
Self-identification is not
proof of genetic basis
Assessment of disparities in population targeting
 Level of significance to determine variation
within group
 Off-labeling present?
 Follow-up genetic studies
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IMPLICATIONS OF GENETIC TESTING
Access predictive info
 Constraints
 Issues with direct-to-consumer genetic tests
 Method of administration
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