Patient-Centered medicine, now mandated by the FDA through passage of the 21s Century Cures Act, demand that drug and device developers consider the needs of patients far earlier in the development process. Similarly, Personalized medicine describes the disruptive evolution in healthcare in which our increasing understanding of the human genome and other biological factors, translation of that understanding to clinical practice, and advances in information technology and bioinformatics are transforming healthcare from a reactive population-based treatment model to a predictive, preventative, personalized, and participatory treatment model.
Both of these evolutions in drug development provide both opportunities and challenges for the spectrum of biotechnologies, including therapeutics, diagnostics, and research tools. For example, advances in personalized medicine can lead to the identification of sub-populations with differing treatment responses and adverse event profiles to various therapies. This can result in more efficient health care, but simultaneously will challenge the “blockbuster” model of pharmaceutical product development. Yet the same technologies that may disrupt the blockbuster model may provide opportunities for more efficient clinical trial design and execution, potentially reducing the cost of drug development and accelerating the drug development timeline. Additionally, advances in information technology capabilities may interact with advances in genomic and biologic sciences to alter the model by which patients and providers interact. Similarly, newly-realized Patient-Centered health care model, in which patients are consumers who are increasingly more informed and involved in healthcare decisions has changed the way companies must approach drug and diagnostic development through early patient engagement and tailoring both preclinical studies and clinical trials to demonstrate a clear benefit to the patient. This can be empowering but also presents challenges, such as validation and accuracy of information, privacy and security, and an evolution in cost-effectiveness modeling and applications.
Policy discussions will influence the nature of the regulatory, reimbursement, IP, and commercial environment. We help our clients succeed in this evolving market by leveraging our scientific and policy expertise to provide strategic reports on policy trends that will affect their business, position their business strategies in the dynamic policy environment, and seek public-private partnership opportunities to meet their business objectives.