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PERSONALIZED MEDICINE: DESCRIPTION
Personalized medicine is characterized by a deeper understanding of the human genome and other biological factors, and translation of this knowledge to clinical practice. Advances in information technology and bioinformatics are transforming health care from what was a reactive population-based treatment mode to a more modern preventative, and personalized one.
This evolution presents valuable opportunities and challenges for the industry involving therapeutics, diagnostics, and research tools. As an example, advances in personalized medicine can lead to the identification of sub-populations with varying treatment responses as well as adverse event profiles to innovative therapies.
This may result in more efficient health care, but at the same time, challenges the “blockbuster” model of pharmaceutical product development. Yet the same technologies that may disrupt the blockbuster model could help provide future opportunities involving more efficient clinical trial design and execution. As a result, it has the potential for reducing the cost of drug development and accelerating the drug development timeline. In addition, advances in information technology may combine with advances in genomic and biologic sciences to alter the model by which patients and providers interact.
Some predict a health care model in which patients are consumers who are increasingly well informed and intimately involved in health care decisions. This can be empowering, but also presents challenges, such as validating information for accuracy, privacy and security, and an evolution in cost-effective applications. Policy discussions will influence the nature of the regulatory, reimbursement, intellectual property, and commercial environment. Additionally, policymakers will determine the nature and extent of funding and incentives necessary for the advancement of personalized medicine. We help our clients succeed in this evolving market by combining our scientific, policy and legal expertise to give the most current advice on policy trends that will affect their business.