Personalized medicine will change the way medicine is practiced.  Patients will benefit from new therapies while experiencing fewer side effects and; physicians will be armed with more precise tools; and medicine will be practiced in a more efficient and effective manner.  Further, this greater precision in treatment will reshape drug and biologic development, dramatically advance our understanding of the pathogenesis of disease, eliminate waste from our healthcare system, and improve the overall quality and efficiency of care.  However, the policy challenges are daunting, and it will take cooperation among all stakeholders to bring these benefits to fruition. 

Though personalized medicine holds the potential to be a game changer in patient care, none of this promise will be realized unless there are adequate business models to support product development.  Currently, economic and regulatory disincentives are impeding the development of novel molecular diagnostic products.  The strength of patents in this area is too uncertain, the regulatory environment is too fractured, and the reimbursement system lacks adequate specificity and certainty to stimulate robust business investment.  Given these conditions, payers, healthcare providers and patients have yet to collaborate to determine how to best capitalize on the benefits available to them.  The Personalized Medicine Coalition (PMC) and the Biotechnology Industry Organization (BIO) are committed to bringing stakeholders together to eliminate these barriers to innovation and encourage patient access, in order to ensure that our healthcare system benefits from all personalized medicine promises to offer. 

To answer these challenges, PMC and BIO have partnered to create a series of “PMC/BIO Solutions Summits” to convene stakeholders with the charge to discuss potential solutions to these important barriers.  In the first of this series, the summit discussions will help articulate:

• Opportunities to streamline the personalized medicine research and development process through payer collaboration.
• The infeasibility of large scale randomized controlled clinical trials and the challenges of subject recruitment and return on investment for testing personalized medicine diagnostics. 
• Alternative models for meeting evidentiary standards in patient populations or indications where randomized controlled clinical trials are not feasible.
• Payer concerns regarding and the depth of clinical data adequate to meet those requirements.
• Gaps in education around the value of personalized medicine diagnostics to payers, patients and healthcare providers.
• Strategies and tactics for the demonstration of healthcare cost savings from adoption of personalized medicine diagnostics, and for inclusion of personalized medicine diagnostics in physician practice guidelines.
• Challenges, recent changes and improvements needed in the current payment system for novel molecular diagnostics.
• Potential approaches to incentivize industry in the development of innovative personalized medicine diagnostics (e.g., patent reforms, regulatory exclusivity models, and changes to the reimbursement system).
• Mechanisms to include patients and physicians in the discussion about coverage and reimbursement that often play out without input from these important stakeholders.