This year marks the 15th anniversary of the completion of the Human Genome Project. In the decade and a half that has passed since, the genomic revolution has spurred an immeasurable level of excitement and support surrounding the promise of personalized medicine, setting high expectations for a new era of health care and rapidly transforming…… Continue reading this entry
Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align with current theories of disease and treatment. These points highlighted one of the many engaging panels of the 2017 … Continue reading this entry
Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle. Advocates of personalized medicine contend that it results in better care for the patient, as therapy is targeted specific to an individual, and that … Continue reading this entry
The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter data. That was the key takeaway from a panel discussion at the Business of Personalized Medicine Summit on March … Continue reading this entry
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers. What do I Need to Know? 1. What is an HTC/P? Under the Public Health Service Act (PHSA) and implementing regulations, the FDA regulates … Continue reading this entry