As personalized medicine becomes increasingly important to our health care system, both as a specific area of clinical research and as a paradigm shift in our approach to treating patients, a number of different groups are working to ensure that patients, policymakers, and the general public can easily understand what this complex and innovative field is all about, and why it matters to the future of health and medical care.
One such group is the Personalized Medicine Coalition, an education and advocacy organization that promotes the understanding and adoption of the concept of personalized medicine, as well as the products and services it produces. In support of this objective, the Coalition has produced a number of helpful fact and information sheets to clarify key personalized medicine concepts for a lay audience and break down some critical areas by the numbers. Read on for an overview of some of the most important points covered.
Personalized medicine: the people
One of the most important concepts that the Personalized Medicine Coalition strives to make clear is just how broad a community is working on, involved in, and impacted by the development of personalized medicine. Implicated stakeholders include the following:
Patients and consumers—As the ultimate end users, patients and consumers are among the key drivers of personalized medicine. They also help support its development by participating in clinical trials and genetic testing, and working proactively with their health care providers to manage disease risks and treatment.
Health care providers—This group leverages their knowledge about a patient’s genetic profile, as well as critical new technologies, to provide an individualized, custom approach to all aspects of disease, including prevention, detection, diagnosis, management, and treatment.
Biopharmaceutical companies—These enterprises use our growing understanding of how genetic variation impacts individual responses to drugs and treatments to research and develop specially targeted therapies.
Diagnostic companies—The genetic information that we possess is only as valuable as the tools and tests we have to analyze and interpret it. This is the area that diagnostic companies focus on: improving our understanding of how disease works at the molecular level, and thereby improving our ability to predict a patient’s likely response to drug therapy.
Academic researchers—Basic and clinical research is an essential part of discovering new insights into the molecular and genetic aspects of disease; these insights are what allow us to develop more precise diagnostic methods and more targeted drugs.
IT/Information companies—Digital tools and resources have had a huge impact not only on how research is conducted, but also on how patient information is collected and stored. New electronic methods protect privacy and confidentiality while making critical information available to inform clinical decision-making.
Advocacy groups—Education and advocacy are instrumental in helping pave the way for the acceptance of new innovations like personalized medicine. Advocacy groups educate consumers and providers alike, participate in research, and lobby for vital policy and regulation changes to facilitate research and development activities.
Payors—This stakeholder group works to incentivize personalized medicine through new business models; reimbursement of personalized treatment protocols like targeted therapies and molecular diagnostics is just one method that can help push the pace of innovation and adoption.
Personalized medicine: the diseases
A great many diseases and health conditions are the subject of personalized medicine research and development. Some of the most notable examples of diseases that have been significantly impacted by personalized medicine include the following:
Breast cancer—The targeted therapy trastuzumab is one of the earliest and most widely used examples of personalized medicine. Research had revealed that in about 30% of breast cancer patients, a protein called HER2 was overexpressed, and this protein did not respond to standard therapy. Following the approval of trastuzumab in 1998 for HER2-positive tumors, further studies showed that disease recurrence was reduced by 52% when trastuzumab was combined with chemotherapy.
Cardiovascular disease—Before genetic diagnostic testing was widely available, it was less certain if whether a heart transplant would be rejected by the recipient; if it was, recipients typically had to undergo a highly invasive, post-transplant heart biopsy. Today, however, a simple blood test is all that doctors need to determine the probability of transplant rejection in a potential recipient prior to the procedure.
Personalized medicine: the numbers
Did you know the following facts and figures about personalized medicine?
In 2006, 13 prominent personalized medicine treatments, drugs, and diagnostic products were commercially available. In 2014, that number reached 113.
Biomarker data is a highly valuable resource for treatments in all stages of clinical development. In preclinical development, 60% of all treatments rely on biomarker data, as do 50% of treatments in early clinical development and 30% of treatments in late clinical development. However, this decreasing progression is likely to change with greater reliance of biomarker data in late stage clinical trials as diagnostic predictive value becomes proven.
If women with breast cancer tumors received pre-treatment genetic tests, chemotherapy use could be reduced by 34%. If doctors used a genetic test to determine the proper dose of the blood thinner warfarin for each individual patient, 17,000 strokes each year could be prevented.