tools for pharmacogenomics carry the promise of achieving improved drug safety, earlier attrition rates, decreased drug development costs, a reduced drug development cycle, and resuscitation of failed drugs. Delivering on these promises will lead the way toward longer patent life and greater profits for new drugs. The challenge-and opportunity-for pharmaceutical companies is to figure out how to deploy the appropriate pharmacogenomics strategy into the drug sales model to facilitate maximum return.
Successful Pharmacogenomics Business Models is a new Cambridge Healthtech report that provides a theoretical framework to evaluate pharmacogenomics initiatives within pharmaceutical companies.
The objective of the framework is to
- determine the situation where pharmacogenomics is viable within the current and future large pharmaceutical drug development model;
- determine requirements for success for each viable pharmacogenomics strategy;
- understand the implications for the pharmaceutical and diagnostics industries.
A key perceived risk in adopting pharmacogenomics is a decrease in market share due to smaller patient populations. Successful Pharmacogenomics Business Models examines how an appropriate pharmacogenomics strategy can actually open up additional revenue streams and contribute significantly to the bottom line by extending the patent protection period for a drug by reducing the time to market, saving costly Phase III trials through early attrition, and diminishing overall healthcare costs by improving safety profiles and Phase IV surveillance.
The report evaluates numerous factors driving the pharmacogenomics market, and addresses key issues shaping the adoption of pharmacogenomics testing including the following:
- The rapidly decreasing cost of SNP genotyping as a catalyst for pharmacogenomics adoption.
- A detailed analysis of the measurements used by pharmaceutical companies-cost-minimization, cost-benefit, cost-effectiveness and cost-utility-to evaluate pharmacogenomic testing.
- An evaluation of the factors impacting the strategic, commercial and operational aspect of delivering pharmacogenomics to the marketplace.
- The factors influencing the integration of pharmacogenomics into clinical trials, including an FDA proposal to address the following issues: the implications of existing regulations as they pertain to required or requested pharmacokinetic and pharmacogenetic/genomic data from the FDA; clarification on governance of pharmacogenomics tests in laboratories; whether a test is defined as clinical (drug specific) or non-clinical (research only); and future directions the FDA will take to drive the implementation of applied pharmacogenomics.
- An evaluation of successful pharmacogenomic business models.
- A scenario forecasting for the adoption of pharmacogenomics in industry based on two key variables-time to adoption and available capital to address hurdles in the industry.
- A discussion of the issues of payer/provider support and physician adoption.
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