Personalized Medicine Is…
Personalized medicine is a multi-faceted approach to patient care that not only improves our ability to diagnose and treat disease, but offers the potential to detect disease at an earlier stage, when it is easier to treat effectively. The full implementation of personalized medicine encompasses:
Risk Assessment:
Genetic testing to reveal predisposition to disease
Prevention:
Behavior/Lifestyle/Treatment intervention to prevent disease
Detection:
Early detection of disease at the molecular level
Diagnosis:
Accurate disease diagnosis enabling individualized treatment strategy
Treatment:
Improved outcomes through targeted treatments and reduced side effects
Management:
Active monitoring of treatment response and disease progression
Explore the People, Places, Products and Policy working toward a shared goal of harnessing breakthroughs in science and technology to improve patient care.
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What is Personalized Medicine?
Personalized medicine is the tailoring of medical treatment to the individual characteristics of each patient. The approach relies on scientific breakthroughs in our understanding of how a person’s unique molecular and genetic profile makes them susceptible to certain diseases. This same research is increasing our ability to predict which medical treatments will be safe and effective for each patient, and which ones will not be.
Personalized medicine may be considered an extension of traditional approaches to understanding and treating disease. Equipped with tools that are more precise, physicians can select a therapy or treatment protocol based on a patient's molecular profile that may not only minimize harmful side effects and ensure a more successful outcome, but can also help contain costs compared with a "trial-and-error" approach to disease treatment.
Personalized medicine has the potential to change the way we think about, identify and manage health problems. It is already having an exciting impact on both clinical research and patient care, and this impact will grow as our understanding and technologies improve.
Personalized Medicine Is Impacting Patient Care in Many Diseases. For Example…
…in Breast Cancer: One of the earliest and most common examples of personalized medicine came in Herceptin® (trastuzumab). About 30% of patients with breast cancer have a form that over-expresses a protein called HER2, which is not responsive to standard therapy. Herceptin was approved for patients with HER2 positive tumors in 1998 and further research in 2005 showed that it reduced recurrence by 52% in combination with chemotherapy.¹
…in HIV/AIDS: Selzentry® (maraviroc) is a personalized medicine targeted for the treatment of a specific strain of HIV known as "CCR5-tropic." Selzentry was developed in conjunction with the Trofile™ assay, a molecular diagnostic test that determines if a patient is carrying the CCR5-tropic variation of the virus. Using this test, health care providers can identify which patients will benefit from this drug, therefore choosing the best treatment options for patients who may be resistant to or intolerant of other available therapies.
…in Cardiovascular Disease: Dosing of the drug Coumadin® (warfarin), used to prevent blood clots, is typically adjusted through multiple rounds of trial and error, during which the patient may be at risk of excessive bleeding or further blood clots. However, genetic tests detecting variation in the way individuals metabolize the drug can help predetermine the right dose for a patient the first time. In 2007, the FDA updated the label for Coumadin to recommend that a patient's genetic makeup be considered when deciding what dose to administer.²
Who Is Personalized Medicine?
The people and groups engaged in personalized medicine and helping to drive it forward
The realization of personalized medicine relies on the input and contributions of a broad community of stakeholders, all working together toward a shared goal of harnessing breakthroughs in science and technology to improve patient care.
Participating in genetic testing and clinical trials and working with health care providers to proactively manage disease risk and/or treatment strategies
Employing an understanding of the patient’s genetic profile and utilizing new technologies to individualize the approach to disease prevention, detection, diagnosis, treatment, and management
Developing targeted therapies and conducting innovative research based upon an understanding of genetic variation and its effects on the safety and effectiveness of the candidate drug
Developing tools and tests to analyze and interpret genetic information, improving the understanding of disease at the molecular level and a patient’s likelihood to respond to drug therapy
Conducting basic and clinical research to uncover new insights into human genetics and the molecular basis of disease, enabling greater precision in diagnosis and more targeted drug development
Creating electronic tools and resources to collect and store patient health information, making it available to inform clinical decisions and improve safety while protecting patient privacy
Advancing personalized medicine in patient care by educating consumers and providers, accelerating research, and supporting necessary changes in policy and regulation
Exploring new business models to incentivize the practice of personalized medicine through appropriate reimbursement of molecular diagnostics, targeted therapies, and other personalized treatment protocols
Accelerating the Adoption of Personalized Medicine
As the ecosystem of stakeholders works to advance personalized medicine, collaboration with government regulators and policymakers is necessary to encourage widespread use of these new tools and technologies. The regulatory process must evolve in response to advances that are targeted to smaller patient populations based on genetic profiles, and policies and legislation must be enacted that provide incentives for innovative research and adoption of new technologies. Together, progress in the research, clinical care, and policy enabling personalized medicine has great potential to improve the quality of patient care and to help contain health care costs.
¹ Personalized Medicine Coalition, "The Case for Personalized Medicine," May 2009, (Accessed 12 May 2011); Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in her2-positive breast cancer. N Eng J Med 2005; 353:1659-72; Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Eng J Med 2005; 353:1673-84.
² Personalized Medicine Coalition, "The Case for Personalized Medicine," May 2009, (Accessed 12 May 2011); U.S. Food and Drug Administration press release. FDA Approves Updated Warfarin (Coumadin®) Prescribing Information. August 16, 2007; (Available online) (Accessed 12 May 2011).