The widespread adoption of personalized medicine will require the harmonization of many components: advances in technology; changes in healthcare infrastructure and medical practice convention; improvements in the efficiency and quality of healthcare delivery; diagnostic and therapeutics business models for genetically defined markets; attempts by government and private payers to justify a new genre of tests and drugs; a different approach to regulatory oversight; and, of course, the ethical and legal issues that go along with the extensive use of genetic information in medical records. Personalized medicine is, in fact, a systems-level challenge, in which no single component or stakeholder can hope to push through a coherent and encompassing policy for adoption on its own. The need for a nationwide, multi-industry policy consensus for the next generation of medicine has led to the creation of the Personalized Medicine Coalition - an independent, non-profit organization of over 20 leading pharmaceutical, diagnostic, biotechnology and information technology companies, as well as major academic institutions and governmental agencies. The Coalition provides a structure for achieving consensus positions on crucial public policy issues and serves as a forum for debate and education in personalized medicine.
Keywords: bioethics; education; healthcare policy; intellectual property; personalized medicine; regulatory policy; reimbursement; systems engineering.