Rather than developing blockbuster drugs that target broad populations, in an era of personalized medicine, industry must discover and develop tailored therapies for smaller markets and the development of new therapeutics based on genomics and proteomics will require an entirely new level of tailoring.
There are many benefits associated with the pursuit of personalized medicine, among them the ability to understand risks and benefits at the level of the individual, the expanded use of biomarkers to identify unpromising drugs early in the R&D process and to run smaller, accelerated clinical trials that can be modified in mid-stream as evidence emerges.
By targeting subpopulations, the market for personalized medicine may follow the niche orphan drug structure. Currently, orphan drug status is awarded to therapeutics that target rare diseases or conditions, where the target population is less than 200,000 people. With the FDA offering funding grants for clinical research in rare diseases, this could be further incentive for personalized medicine companies wishing to gain commercial success.
Personalized medicine may breathe new life into drug programs that were abandoned during the development process or withdrawn from the market due to safety concerns.
Recommendations for Moving Forward
Articulate the benefits of products in the pipeline to payers and regulators as early as possible in the R&D process to win their support and avoid the time and expense of developing a drug or diagnostic that cannot be commercialized.
To help make the business case for reimbursement, develop health economic models that project the potential cost savings of
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