The Biotechnology Industry Organization (BIO) represents a diverse portfolio of companies throughout the continuum of personalized medicine. These companies include those that develop therapeutic and diagnostic products, as well as research tools companies that drive innovation in this area. With broad member representation from across the drug, biologic, diagnostic and research tool industries, BIO is uniquely positioned to serve as industry’s key voice on personalized medicine issues. As part of an effort to better utilize BIO’s advantageous position, the Personalized Medicine and Diagnostics (PMDx) Working Group was created in September 2011. The primary goal of the PMDx working group is to identify and provide solutions for the challenges and barriers facing the personalized medicine industry.
While this effort will significantly bolster BIO’s ability to serve the needs of its members in the personalized medicine industry, the organization is not new to taking on critical issues in this space. Traditionally, BIO has addressed these issues in the context of the now inactive Research Tools and Molecular Diagnostics (RTMD) Working Group. The PMDx Working Group will continue to serve the needs of our diagnostic and research tools companies, but endeavors to better leverage BIO’s diverse membership through an organizational structure that reflects the entire spectrum of personalized medicine. The formation of the PMDx group provides a unique forum that is composed of the various stakeholders in the industry; resulting in the creation of policy that positively impacts the personalized medicine industry as a whole.
Personalized medicine holds the promise of improving patient outcomes, decreasing adverse reactions to therapeutics, and fostering the more efficient use of expensive medical resources. BIO is committed to helping its members ensure that the development of these important products is driven by the pace of scientific innovation, and not inappropriate policy barriers. Recent activities by the group include responding to FDA’s Draft Guidances on In Vitro Companion Diagnostics and Research Use Only (RUO and Investigational Use Only (IUO) products, exploring alternative payment models for novel molecular diagnostics, and addressing coding issues for genetic tests. For more information about the group, please contact BIO’s Director for Diagnostics and Personalized Medicine Policy, Paul Sheives at [email protected].