Personalized Medicine
Personalized Medicine Mission Health is one of the few community health systems in the U.S. to develop a Personalized Medicine Program (PMP), a program typically available at major medical centers and institutions only. Personalized Medicine offers a scientific, individually-guided approach for improving the health of our population – an approach with the potential to replace the trial-and-error drug treatment method currently used to manage cancer and other chronic diseases. Personalized Medicine builds on the knowledge and advances in genomic medicine to provide patients and their healthcare providers information to minimize toxic drug treatment side effects and maximize drug effectiveness. This program supports every service line across the hospital system (cardiology, cancer, neurology, psychiatry, pain management, pediatrics, etc.) and throughout our regional physician practices. Mission’s Personalized Medicine program was established in 2013 with the recruitment of Director Dr. Lynn Dressler, a national leader in the field. The program has since grown to include a full-time clinical pharmacist trained in personalized medicine; a part-time research nurse to coordinate research studies; a full-time program coordinator, and a part-time pediatric pharmacist. The program currently has two major concentrations: cancer care and non-cancer conditions. To further this program, Mission requires funding for several initiatives, including the following.
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Personalized Cancer Care: Targeted Therapy & Beyond In cancer care, experts in the Personalized Medicine Program evaluate a patient’s tumor for mutations, and aim to match a drug that kills cells with that specific mutation. This approach to cancer drug treatment is called targeted therapy. Targeted therapy has completely transformed cancer treatment, providing many cancer patients with treatment options that didn’t exist 10 years ago. Targeted therapy uses the genetic make-up from the patient’s tumor to identify and implement specific drug treatments with the highest level of effectiveness for the cancer patient. In this way, the drug with the highest probability of effectiveness targets the mutated c ells and leaves normal cells intact. The PMP cancer team also studies and predicts responses to new types of treatments, including immunotherapy, which boosts the patient’s immune system to help fight the cancer. The PMP team provides consultation, education and training, and offers access to state-of-the-art, clinically useful testing and application to enhance the care of our cancer patients. Several initiatives have been planned to offer patients and providers access to cutting-edge tests, and to evaluate the impact of testing. Many projects will look at targeted therapy; others will look at novel technologies to detect recurrences early. Before we can implement these projects clinically, they require additional efforts, including performing feasibility studies, especially to help cover the cost of testing. These efforts include: Cancer Genomics Demonstration Project ($110,000 annually; $5,500 per patient) This project will provide a feasibility demonstration to develop a common infrastructure for identifying patients who will benefit from more expansive genomic tumor testing. The expansion of this comprehensive tumor profiling project will help identify alternate treatments for patients with late-stage or metastatic disease, especially those unresponsive to standard therapy. Additionally, comprehensive tumor testing occasionally identifies unusual mutations for which there are an FDA-approved or investigational drugs that could be used to fight the cancer. The pilot demonstration project will provide patients and clinicians the opportunity to familiarize themselves with this cutting-edge testing and ensure a smooth, streamlined process for patient care. Primary funding for this pilot covers the costs of testing 20 patients (10 adult cancer patients and 10 pediatric cancer patients) who would not otherwise have access to this testing. Personalized Medicine
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Personalized Medicine Testing to Identify Best Drugs for Supportive Care ($116,783 annually; $2,920/patient) Cancer patients are typically given a variety of drugs to ease the side effects of cancer treatment (pain, nausea and vomiting), and to support them through a cancer diagnosis (drugs to treat anxiety and depression). This project will evaluate feasibility and barriers as they relate to providing more effective and supportive care for cancer patients. The project will test patients before chemotherapy or targeted therapy to identify potential genetic variations that may help the physician select appropriate, supportive medications at the time of diagnosis. With this information we can enhance care and quality of life of our cancer patients. Funding for this pilot will cover the cost of testing for inherited variations for 40 adult cancer patients. Personalized Medicine Non-Invasive Testing to Evaluate Progression of Disease ($110,000 annually; $5,500/patient) This project will examine the feasibility and barriers in investigative testing of a cancer patient’s blood for DNA mutations. These investigative blood tests will identify DNA mutations that may be circulating in the body, potentially indicating progression of disease. These tests resemble evaluation of a patient’s tumor, however, in these tests the patient’s blood is evaluated. This is a non-invasive way of assessing tumor progression in patients already diagnosed with cancer. While these tests are available clinically, they are not yet a best practice or standard-ofcare. The pilot study will test the feasibility of these tests for patients at risk for tumor progression. Funding for this project covers the cost of testing. Family History, Cancer and Chronic Diseases ($100,000 annually; $1,000/patient) While physicians and patients know that certain diseases are hereditary, there is no uniform or consistent method for collecting and sharing disease information between and among patients and their healthcare providers. This project will evaluate the usefulness of electronic tools to help patients and families easily access and share information with their physician, and to store patient medical records for use by the patient’s healthcare team. A component of this tool is a patient questionnaire that collects family health history and lifestyle behaviors, and then provides risk assessment for diseases like cancer, diabetes and cardiovascular disease. Funding for this study supports development of a pilot study to test software in select primary care and specialist practices in western North Carolina.
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Personalized Medicine in Non-Cancer Patients Mission’s Personalized Medicine Program also helps patients with non-cancer conditions. Each of us inherits small variations in our DNA. Some of variations, when present in certain genes, can affect how we respond to a drug, and explain why some of us have negative drug side effects. Other variations may help predict if drug treatment for a specific condition will be effective for that individual patient. Genetic testing for drug response is a new and promising field of study; it can help a broad number of patients with varying conditions, such as older adults taking multiple medications, patients taking medications to treat anxiety and depression, and cardiology patients getting a cardiac stent, among others. This new field of medicine helps predict patient response to a drug before drug administration, therefore assisting in accurate drug dosage and preventing severe side effects. Several initiatives are planned to provide patients and providers access to these predictive tests. Many initiatives require additional efforts before implementation. Most of the funding outlined below will help us conduct pilot or feasibility studies to familiarize clinicians and patients with the tests, help them interpret results, and provide a foundation for adoption and use. Personalized Medicine Testing in Primary Care Practices ($57,500 annually; $1,437/patient) This demonstration project will assess the feasibility and barriers to providing personalized medicine testing in a primary care practices. Testing is most beneficial when performed before administering a drug, and ideally before severe drug side effects prompt an emergency room visit. Given these factors, testing in the primary care environment is necessary. However, three major factors have been identified in preventing test adoption by primary care physicians: 1) cost of testing, 2) knowledge of personalized medicine testing, and 3) comfort with test interpretation and application. This pilot study will examine the actual barriers to providing testing in primary care settings when these three major factors are addressed. Thus, the Personalized Medicine team will provide education and training on interpretation of test results. The pilot study will cover the cost of testing eligible patients (>65 years old with Medicare on multiple medications). Funding from the North Carolina Biotechnology Center will offset a portion of testing costs, but additional funding is required to support an additional year of pilot testing (allowing 40 additional patients to participate).
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Personalized Medicine Testing to Enhance the Drug Management of Patients with Behavioral Health Issues ($71,850 annually; $1,437 per patient) Personalized Medicine testing can inform the management of patients with depression and anxiety, which accounts for a large percentage of drug therapy. The use of testing to guide drug therapy for behavioral issues, however, is still in its early stages. A pilot study evaluating feasibility, logistics and barriers for said drug therapy is necessary to assess the likelihood of physician uptake and patient satisfaction. In this pilot, we will work with our behavioral health teams in psychiatry and primary care settings to provide patient testing in outpatient clinics, guide care, and ultimately, improve outcomes and lower cost of care. Funding is required to cover testing and infrastructure costs. Approximately 50-75 patients will be part of this pilot study.
Personalized Medicine Testing to Enhance Drug Management in Patients with Cardiovascular Disease ($71,850 annually; $1,437 per patient) Personalized Medicine testing can guide drug selection for patients with acute coronary syndrome, especially those requiring cardiac catheterization. Testing is also beneficial for patients on or about to start statins that lower cholesterol and minimize heart attack risk. Working with regional cardiologists, this pilot study will assess and identify infrastructure needs and feasibility in providing tests for high-risk cardiology patients. Most patients do well on standard drugs used for post-cardiac stent treatment. However, up to 25% of the population inherits genetic variations that prevent the patient from benefiting from these drugs, and these patients are at risk for suffering another cardiac event (i.e., a heart attack due to clotting because the drug isn't working properly). Before a patient begins drug therapy, testing can be performed to determine if standard cardiac drugs are effective. Providing tests for all our cardiac stent patients requires substantial funding for a pilot study examining logistics, cost, and feasibility. Approximately 50-75 patients will be part of this pilot study.
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Education and Training in Personalized Medicine To maximize the benefits of personalized medicine, a thorough understanding of testing, benefits, application and limitations is crucial for patients and providers. Funding is necessary to offer ongoing education, materials and programs about genomic and personalized medicine to patients and families, as well as training for our health care teams. This type of understanding empowers patients, if they choose, to play a more active role in their healthcare, and helps providers to stay on top of new developments in healthcare. A variety of educational program modalities are proposed – from one-day conferences to online education modules, and inperson interactive discussions to town hall meetings.
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Provision of Education Forums for Patients and the Community ($15,000 annually) Knowledge of personalized medicine testing can empower patients, as testing often begins with a patient request to his physician. Funding for this project is necessary to cover the costs of developing educational materials, videos, brochures and conferences for patients, families and community members. These efforts also include travel to multiple regions in Western North Carolina (WNC) to offer education tailored to various populations at convenient regional locations. Provision of Education and Training for Health Care Providers ($25,000 annually) A principal barrier in patient testing and improving patient outcomes is physician comfort with and knowledge of the personalized medicine field. Many physicians need additional training to improve their test interpretation and application skills, and thus, enhance patient care. To address this gap, the Personalized Medicine Program has developed educational conferences for front-line providers, including the first Personalized Medicine Conference for Primary Care Physicians (held in 2015), and a conference for pharmacists (spring 2017). Funding is necessary to provide educational materials and offset the costs of these conferences. Funding is also necessary to develop more efficient and creative training methods for busy regional clinicians; proposed ideas include internet seminars (webinars) and easily-accessible electronic modules, all of which provide Continuing Education credits. Funding to cover travel expenses for in-person physicians and nurses, and pharmacist services in rural areas of WNC, is also essential.
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Due to the financial constraints of many patients, personalized medicine testing, for both cancer and non-cancer patients, is not readily available to those who would benefit most. A fund to provide access to testing and to cover testing costs is proposed for both cancer and non-cancer patients in-need.
To enhance care, the Personalized Medicine Program recently opened a clinic for adult patients and their physicians for test consultation, testing, and interpretation. Using this program model, we hope to extend similar efforts to the pediatric population, as well.
Testing for a patient’s response to drugs before drug administration is not only clinically sensible, but meets best practices and FDA recommendations, and provides key information to enhance patient drug management. Testing also shows promise in optimizing the patient experience and quality of life, and decreasing the cost of care (by way of reduced hospital stays, emergency room visits and hospital re-admissions resulting from drug toxicity or ineffectiveness). Replacing the trial and error approach to drug treatment and management of chronic diseases with a scientific, individually-guided approach is key to improving the health of our population.
Provide Access to Patients in Financial Need ($55,000 annually; $450/non-cancer patient; $5,500/cancer patient) This projects provides a safety net so patients in-need can access personalized medicine testing services (approximately 30 patients per year). Use of these project funds will be carefully considered within our patient financial services program.
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