Scientific advances in such fields as genomics, proteomics, and imaging hold the promise of leading to an era of personalized medicine, where diagnoses will be more precise and treatments more targeted. Personalized medicine can also increases patient safety, as patient profiles indicate which drugs are suited for which people, at what dose, and which patients might suffer from adverse drug reactions.
Many challenges remain before the promises of personalized medicine are realized. The pharmaceutical industry will have to shift from a business model that emphasizes blockbuster drugs to one producing many specialized medications for subgroups of patients. Regulatory agencies will have to determine if existing policies are adequate. For example, the FDA will have to craft methods for evaluating diagnostics and companion drugs simultaneously. Health care providers will need to consider how best to apply the new science to their patients. A system of secure electronic health records for individual patients must be developed. Parallel with these changes, social, ethical, and legal issues must be openly discussed.
[2012] Cracking Your Genetic Code
Advances in human genomics and bioethics are the focus of the special program Cracking Your Genetic Code that aired on March 28, 2012 on PBS. The film was produced by NOVA in association with The Hastings Center.
[2011] Personalized Medicine: Prescriptions and Prospects
Published by The Food Drug and Law Institute in partnership with AAAS, and Edited by Joanne Hawana and Deborah Runkle, this book discusses the scope, impact and reach of personalized medicine. Specific focus is given to issues related to bioethics, reimbursement, professional and patient education, regulation, and public policy.
[2009-2010] Colloquia Series on Personalized Medicine
The colloquia addressed the scientific discoveries, business models, and regulatory changes that are necessary to develop new personalized treatments and their companion diagnostics. Other sessions focused on electronic health records, reimbursement, education of patients and their care givers, and such ethical, legal, and policy issues as privacy, patients’ responsibility for their own health, and direct to consumer testing, among others.
[2008] Personalized Medicine: Promises and Challenges
A roundtable discussion and a legal, regulatory and policy seminar took place at a one-day event addressing an interdisciplinary audience on the broad implications of personalized medicine.