Archive for the ‘Personalized Medicine’ Category
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Genomics is what makes personalized medicine possible.
Personalized medicine is a new and better approach to health care based on each persons unique genetic makeup.
Personalized medicine, because it is based on each patients unique genetic makeup, is beginning to overcome the limitations of traditional…
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Personalized medicine: Precise genomic solutions for disease
This story is part of the American Cancer Societys Cutting-Edge Cancer Science series, which is exploring some of the most promising areas of cancer research in depth.
This is part 1 of a 3-part feature exploring what personalized medicine means for cancer patients. Part 2 covers where personalized cancer stands today and part 3 reviews personalized medicine for cancer prevention.
The type of cancer a person has and how it gets treated is no longer just about where in the body the cancer started, such as in the breast or lungs or the colon. More so now than ever, when doctors decide how to attack a cancer, they are arming themselves with a wealth of knowledge about the specific molecular and genetic makeup of their patients tumor.
Many researchers and cancer centers are already embracing this personalized approach to cancer care. Though still in early stages, this field of work is moving and improving at a rapid pace, and just got a boost from President Barack Obama, with his announcement of a $215 million investment to launch the Precision Medicine Initiative. The initiative aims to speed up progress toward personalized medicine for all.
Delivering on the promise of personalized medicine, though, is going to take a massive effort from not just researchers and doctors, but also from health insurers, pharmaceutical companies, and government agencies, among others.
Personalized vs. Precision Medicine
The terms personalized medicine and precision medicine are often used interchangeably. While experts are not in agreement as to whether the two terms mean the same thing, the definitions of personalized medicine and precision medicine seem to be merging. Even President Obama, in his remarks about the Precision Medicine Initiative, commingled the two: Precision medicine in some cases, people call it personalized medicine gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen.
The meaning of the terms and source of the forthcoming breakthroughs is essentially the ability to tailor treatments, as well as prevention strategies, to the unique characteristics of each person.
The presidents initiative, and the terms themselves, extend beyond cancer, and are meant to encompass all health issues. Cancer, though, is a major focus of the Precision Medicine Initiative, especially its nearer-term goals.
Taking Steps Toward Personalized Medicine
A lot of work has already been done to make cancer care more personalized, partly because cancer is so complex that it has forced scientists to dig deep into the inner workings of human cells to figure out cancers causes.
Decades of advances in basic science, technology, therapeutics, and the understanding of the genetic causes of cancer have coalesced in recent years to make personalized cancer care possible.
What researchers have learned over time is that cancer can arise from any number of genetic malfunctions, and often is due to a combination of errors, that ultimately lead to the out-of-control cell growth that causes tumors to grow and spread.
This knowledge has allowed doctors to sometimes move cancer treatment from a broad-brush approach using radiation, surgery, and chemotherapy to wipe out cancer and taking out normal healthy cells in the process to a more targeted technique.
Targeted therapy took off in the late 1990s and early 2000s, with the advent of drugs that interfere with the essential functions of cancer cells in order to get them to die off such as by stopping cancer cells from dividing or keeping tumors from making the new blood vessels they need to grow.
Targeted drugs gave doctors the ability to start customizing treatments, to a certain degree, to the patient. But researchers discovered that like radiation and chemo targeted therapies arent one size fits all. Every patient has a unique set of factors driving their cancer. In other words, there are multiple targets in each patient that may need to be hit. This is where tumor profiling comes in.
Better Treatments, Fewer Side Effects
The idea of analyzing an individual patients tumor to determine what combination of drugs will work best is what personalized cancer care is all about. With this level of specificity also comes greater potential to decrease toxic side effects. The overall toxicity to patients should be reduced because you are more likely to use the best collection of drugs the first time around, says William Phelps, Ph.D., the director of preclinical and translational cancer research at the American Cancer Society.
When it comes to cancer, personalization can take several different forms currently. It might mean:
The ability to look at the genetic makeup of a persons tumor in a relatively quick and low-cost manner has been one of the most important contributors to progress in personalized cancer care. A major technological advance that has made my work possible was the tumbling down in cost and time of sequencing patients tumors, says Ross Cagan, Ph.D., director of the Mount Sinai Center for Personalized Cancer Therapeutics.
Lower cost, though, does not yet mean affordable for everyone.
A 2011 National Research Council report on precision medicine explains why these advances matter, by contrasting breast cancer treatment today and 25 years ago. Twenty-five years ago, women had few treatment options basically hormone therapy or chemo, both of which could have significant side effects.
Today, many patients have treatment options based on the particular markers in their tumors. These patients can get better, more specific treatments, which might also have fewer side effects.
This is one of the major goals of personalized medicine give cancer patients the treatments that are most likely to work on their particular cancer with fewer harmful side effects.
READ PART 2: Personalized Cancer Care: Where it Stands Today
Personalized Medicine: How the Human Genome Era Will Usher in a Health Care Revolution
Personalized medicine has the potential to transform healthcare through earlier diagnosis, more effective prevention and treatment of disease, and avoidance of drug side effects. The challenge for policymakers will be to deal intelligently and comprehensively with the array of issues that will affect quality of healthcare under this new paradigm.
On February 10, 2005, NHGRI Director Dr. Francis Collins, the senior advisor on genomics in the Federal government, outlined his vision for the future of genomics-based medicine to the Personalized Medicine Coalition (PMC) at the National Press Club. He also explored the numerous policy issues that must be addressed to realize the full potential of this new area of medicine.
To view the integrated presentation of both video and Power Point slides, go to:
For Web browsers other than IE or Netscape, go to the lecture webcast on the PMC Web site at:
Last Updated: March 17, 2012
Youre one of a kind. Its not just your eyes, smile, and personality. Your health, risk for disease, and the ways you respond to medicines are also unique. Medicines that work well for some people may not help you at all. They might even cause problems. Wouldnt it be nice if treatments and preventive care could be designed just for you?
The careful matching of your biology to your medical care is known as personalized medicine. Its already being used by health care providers nationwide.
The story of personalized medicine begins with the unique set of genes you inherited from your parents. Genes are stretches of DNA that serve as a sort of instruction manual telling your body how to make the proteins and perform the other tasks that your body needs. These genetic instructions are written in varying patterns of only 4 different chemical letters, or bases.
The same genes often differ slightly between people. Bases may be switched, missing, or added here and there. Most of these variations have no effect on your health. But some can create unusual proteins that might boost your risk for certain diseases. Some variants can affect how well a medicine works in your body. Or they might cause a medicine to have different side effects in you than in someone else.
The study of how genes affect the way medicines work in your body is called pharmacogenomics.
If doctors know your genes, they can predict drug response and incorporate this information into the medical decisions they make, says Dr. Rochelle Long, a pharmacogenomics expert at NIH.
Its becoming more common for doctors to test for gene variants before prescribing certain drugs. For example, children with leukemia might get the TPMT gene test to help doctors choose the right dosage of medicine to prevent toxic side effects. Some HIV-infected patients are severely allergic to treatment drugs, and genetic tests can help identify who can safely take the medicines.
By screening to know who shouldnt get certain drugs, we can prevent life-threatening side effects, Long says.
Pharmacogenomics is also being used for cancer treatment. Some breast cancer drugs only work in women with particular genetic variations. If testing shows patients with advanced melanoma (skin cancer) have certain variants, 2 new approved drugs can treat them.
Even one of the oldest and most common drugs, aspirin, can have varying effects based on your genes. Millions of people take a daily aspirin to lower their risk for heart attack and stroke. Aspirin helps by preventing blood clots that could clog arteries. But aspirin doesnt reduce heart disease risk in everyone.
NIH-funded researchers recently identified a set of genes with unique activity patterns that can help assess whether someone will benefit from taking aspirin for heart health. Scientists are now working to develop a standardized test for use in daily practice. If doctors can tell that aspirin wont work in certain patients, they can try different treatments.
One NIH-funded research team studied a different clot-fighting drug known as clopidogrel (Plavix). Its often prescribed for people at risk for heart attack or stroke. Led by Dr. Alan Shuldiner at the University of Maryland School of Medicine, the team examined people in an Amish community. Isolated communities like this have less genetic diversity than the general population, which can make it easier to study the effects of genes. But as in the general population, some Amish people have risk factors, such as eating a high-fat diet, that raise their risk for heart disease.
Many of the Amish people studied had a particular gene variant that made them less responsive to clopidogrel, the scientists found. Further research revealed that up to one-third of the general population may have similar variations in this gene, meaning they too probably need a different medicine to reduce heart disease risks.
The findings prompted the U.S. Food and Drug Administration (FDA) to change the label for this common drug to alert doctors that it may not be appropriate for patients who have certain gene variations. Two alternative drugs have since been developed. If people have these gene variants, they know they have options, says Shuldiner. This is a great example of how study results made it onto a drug label and are beginning to be implemented into patient care.
Getting a genetic test usually isnt difficult. Doctors generally take a sample of body fluid or tissue, such as blood, saliva or skin, and send it to a lab. Most genetic tests used today analyze just one or a few genes, often to help diagnose disease. Newborns, for example, are routinely screened for several genetic disorders by taking a few drops of blood from their heels. When life-threatening conditions are caught early, infants can be treated right away to prevent problems.
The decision about whether to get a particular genetic test can be complicated. Genetic tests are now available for about 2,500 diseases, and that number keeps growing. Your doctor might advise you to get tested for specific genetic diseases if they tend to run in your family or if you have certain symptoms.
While there are many genetic tests, they vary as to how well they predict risk, says Dr. Lawrence Brody, a genetic testing expert at NIH.
For some diseases, such as sickle cell anemia or cystic fibrosis, inheriting 2 copies of abnormal genes means a person will get that disease. But for other diseases and conditions, the picture is more complex. For type 2 diabetes, testing positive for some specific gene variants may help predict risk, but no better than other factorssuch as obesity, high blood pressure and having a close relative with the disease.
The latest approach to personalized medicine is to get your whole sequenced. Thats still expensive, but the cost has dropped dramatically over the past decade and will likely continue to fall. Since your genome essentially stays the same over time, this information might one day become part of your medical record, so doctors could consult it as needed.
You can start to get a sense of your genetic risks by putting together your familys health history. A free online tool called My Family Health Portrait from the U.S. Surgeon General can help you and your doctor spot early warning signs of conditions that run in your family.
But personalized medicine isnt just about genes. You can learn a lot about your health risks by taking a close look at your current health and habits. Smoking, a poor diet, and lack of exercise can raise your risks for life-threatening health problems, such as heart disease and cancer. Talk to your health care provider about the steps you can take to understand and reduce your unique health risks.
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Personalized Medicine News — ScienceDaily
Currently, much of medical practice is based on “standards of care” that are determined by averaging responses across large cohorts.
The theory has been that everyone should get the same care based on clinical trials.
Personalized Medicine is the concept that managing a patient’s health should be based on the individual patient’s specific characteristics, including age, gender, height/weight, diet, environment, etc.
Potential applications of personalized medicine Personalized medicine aims to identify individuals at risk for common diseases such as cancer, heart disease, and diabetes.
The simple family history has long been used by physicians to identify individuals at increased risk and to advise preventive measures such as lifestyle modifications (changes in diet, cessation of toxic habits, increased exercise) earlier screening, or even prophylactic medications or surgery.
Scientific advancements offer the potential to define an individual’s risk based on their genetic make-up.
Fields of Translational Research termed “-omics” (genomics, proteomics, and metabolomics) study the contribution of genes, proteins, and metabolic pathways to human physiology and variations of these pathways that can lead to disease susceptibility.
It is hoped that these fields will enable new approaches to diagnosis, drug development, and individualized therapy.
Pharmacogenetics Pharmacogenetics (also termed pharmacogenomics) is the field of study that examines the impact of genetic variation on the response to medications.
This approach is aimed at tailoring drug therapy at a dosage that is most appropriate for an individual patient, with the potential benefits of increasing the efficacy and safety of medications.
Gene-centered research may also speed the development of novel therapeutics.
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Personalized medicine – ScienceDaily
TheCenter for Personalized Medicine (CPM)is helping doctorsdeliver the best possible patient care by developing laboratory testing solutions that accurately, quickly and deeply inform cliniciansof the latest treatment and careoptions based on their patients’unique tumor profiles.
The CPM brings together a multidisciplinary expert teamin the areas of oncology, pathology, laboratory and information technology, bioinformatics, medical informaticsand health care delivery to perform cutting edge research and createthe highest quality, evidence-based genomic tests available using advanced molecular diagnostic technologies. The team is developing a comprehensive OmniSeq Programto implement personalized genomic medicine in routine cancer care.
This is the future of medicine, not just in oncology but across all diseases. Candace Johnson, PhD, President & CEO of RPCI
In cancer, personalized medicine uses advanced laboratory technologies to detect alterations in tumor DNA to match a patient to the treatments that will work best for their specific tumor, help avoid unnecessary treatment, find out how well treatment is working over time or make a prognosis.
FDA’s Role in the Precision Medicine Initiative
Most medical treatments are designed for the “average patient” as “one-size-fits-all-approach,” that is successful for some patients but not for others. Precision medicine, sometimes known as “personalized medicine” is an innovative approach to disease prevention and treatment that takes into account differences in peoples genes, environments and lifestyles.
Advances in precision medicine have already led to powerful new discoveries and several new FDA-approved treatments that are tailored to specific characteristics of individuals, such as a persons genetic makeup, or the genetic profile of an individuals tumor. Patients with a variety of cancers routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.
To advance these developments, President Obamas Precision Medicine Initiative seeks to identify genetically-based drivers ofdisease in order to develop new, more effective treatments. FDAs role is to ensure the accuracy of genetic tests, many of which are derived from next generation sequencing, a rapid and fairly inexpensive technology that collects data on a persons entire genome.Researchers are combing through segments of this data to look for genetic variants, potentially meaningful differences that might eventually result in a treatment.
However, the vast amount of information generated through next generation sequencing (NGS) poses novel regulatory issues for FDA.Recognizing these challenges, FDA is at work on a workable regulatory platform that will encourage innovation while ensuring accuracy. To get there, weve been issuing discussion papers, holding workshops and collaborating with our stakeholders.
In addition, FDA has created precisionFDA, a community research and development portal that allows for testing, piloting, and validating existing and new bioinformatics approaches to NGS processing.
Cancer Genetics, Inc. (CGI) is an oncology-focused diagnostics company. We develop tests that can help doctors diagnose cancers and help them select the best treatment for each patient. Our laboratories provide testing for major cancer centers, oncology clinics, and pharmaceutical companies.
Personalized medicine aims to provide each individual patient with the therapy they are most likely to respond to. By assessing each patient and their tumors unique genetic information, we can help doctors provide the most accurate diagnosis, prognosis, and treatment selection available.
Today only 25% of initial cancer treatments are successful. This is in part due to the traditional approach to treatment, which has tended to give each patient with the same disease the same treatment. Because personalized medicine takes into account each tumors and each individuals unique genetic makeup, we are able to provide more individualized treatment and help improve success rates in cancer treatment.
Our groundbreaking work in the area of genetics-based testing is good news for patients because it makes personalized medicine possible. Every person is different and every cancer is different. Genetic-based testing identifies a persons cancer at a molecular level. With that kind of precise information, diagnosis is more specific and your doctor can recommend a treatment plan that is personalized to your needs.
Talk to your doctor to see if genetic-based testing is right for you. And if you or someone you know has been diagnosed with cancer, connect with networks, services and research that can support, inform and guide you.
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Personalized Medicine | Cancer Genetics Inc.
WASHINGTON — Personalized medicine holds great promise, but several issues need to be addressed before it can succeed, according to experts in drug and therapy development.
These roadblocks include designing trials to adequately test new therapies, reimbursement rates, and challenges with implementing ambitious programs, such as President Obama’s Precision Medicine Initiative (PMI). Experts gathered to discuss these issues at a recent panel hosted by Pharmaceutical Research and Manufacturers of America (PhRMA).
Conventional research paradigms, such as randomized control trials, are often inadequate for assessing new therapies, the experts noted. For instance, some new therapies are specific for genetic mutations that give rise to a disease or its symptoms, but are frequently only found in small subpopulations of patients. One example is that only 4% of U.S. patients with cystic fibrosis carry the “broken gene” targeted by ivacaftor (Kalydeco), an agent that targets abnormal chloride trafficking in cystic fibrosis.
“The [patient] populations get smaller and smaller and smaller, and it’s just impossible to have sufficient number of patients to provide sufficient rigor and statistical robustness to come to a conclusion about whether treatment A works better than treatment B,” pointed out Steve Averbuch, MD, vice president for translational clinical development and pharmacodiagnostics at Bristol-Myers Squibb in New York City.
Averbuch said new trial designs, patient registries, and crowd-sourcing platforms will be necessary to advance personalized medicine. He cited the Lung Map trial and the I-Spy II breast cancer clinical trials as examples of successful new approaches to research.
Another obstacle is inadequate reimbursement. Personalized medicine receives broad-based support from the community, patients, industry, and the FDA, noted Amy Miller, PhD, executive vice president of the Personalized Medicine Coalition in Washington, “and yet… there’s a breaking point when it gets to [the Centers for Medicare & Medicaid Services] when coverage and payment for the necessary diagnostics doesn’t necessarily keep pace with the enthusiasm that we see on the therapeutic side.”
A third issue is a lack of agreement on terminology. Personalized medicine and precision medicine are often used interchangeably, Miller pointed out, adding that the former is preferred by patients. But Averbuch noted that legislators prefer precision medicine, particularly when discussing related policy.
What is the difference? Alan Balch, PhD, CEO of the Patient Advocate Foundation and National Patient Advocate Foundation in Washington, said he views precision medicine as the precise “mechanism of treatment” under the broader healthcare schematic of personalized medicine.
Finally, there are programs like PMI, which have lofty goals but face stumbling blocks in the real world. The $215 million NIH study has received bipartisan support from Congress. PMI seeks to enroll 1 million participants into its voluntary national research cohort.
All participants would be required to contribute “core data” including their individual electronic health record (EHR) data, the results of a baseline health exam, a completed survey, and a new blood specimen, according to the PMI Working Group report released in September.
PMI has some key barriers it needs to address:
“In order for this cohort to work, we need [EHR] to really, truly function for people,” said Kathy Hudson, PhD, deputy director for science outreach and policy for the NIH in Bethesda, Md.
One possible solution would be for PMI to adopt the “Blue Button” model, a downloadable file of claims data, that has been effectively employed by the U.S. Department of Veterans Affairs, she stated.
Regarding the safety of this data, Hudson said that hackers are interested in obtaining Social Security numbers. If the PMI working group can help create unique research identifiers that separate an individual’s private health information from Social Security identifiers and other valuable financial information, Hudson said, “I think we’ll be able to go a long way in terms of protecting privacy.”
The PMI working group is also collaborating with lawmakers to develop ways to penalize parties that use information from the cohort in ways that participants did not intend, Hudson said.
Yet, there’s no perfect guarantee of privacy, she acknowledged.
Lastly, it will be important for the FDA to respond to new developments in the precision medicine space with speed and accuracy, particularly the regulation of new diagnostic tests.
Elizabeth Mansfield, PhD, deputy office director for personalized medicine at FDA said, “FDA really has to be nimble here to work out a way to allow the technologies that are going to back this up to evolve as rapidly as they can, and yet still be safe and effective.”
Mansfield said the agency had met to discuss the initiative several times with the NIH and other stakeholders, and seemed confident that it was up to the challenge.
And there’s more promising news for personalized medicine: Hudson highlighted the “tangible benefits” of PMI.
While developing carefully tailored therapies based on molecular targets and potential environmental influences will take time, researchers could still use data from the very large PMI cohort to validate genetic variants that are already known to effect a drug’s response, she explained.
This would give physicians and patients more certainty as to which drugs will or won’t work for them, she added.
Balch noted that post-market surveillance data could be used to discover new populations that could benefit from a drug. A therapy that targets one population may also have a positive response in other sub-populations with the same genetic marker.
For industry, “that’s really where the scalability is,” he said.
Partners HealthCare Personalized Medicine (formerly known as the Partners HealthCare Center for Personalized Genetic Medicine or PCPGM) is a division of Partners HealthCare, an integrated health care system founded by Brigham and Womens and Massachusetts General Hospital, both Harvard-affiliated teaching hospitals, and the largest independent hospital recipients of National Institute of Health (NIH) research funding in the United States.
Partners Personalized Medicine was founded in 2001 by Partners HealthCare and Harvard Medical School (HMS) as the Harvard-Partners Center for Genetics and Genomics. The center was launched before completion of the Human Genome Project as an early commitment to, and in recognition of, the potential for genomic knowledge to dramatically improve health care. This mission, to better understand and harness the unique genetic and genomic makeup of individuals to improve their health, continues today.
As a part of the Partners HealthCare system, and through its affiliation with Harvard Medical School, Partners Personalized Medicine is uniquely positioned to leverage the talent and resources of Partners HealthCare system and impact the research and clinical activities of one of the largest and most transformative health care systems in the country.
Partners Personalized Medicine brings together scientists, clinicians, genetic counselors and information scientists from Partners hospitals and Harvard Medical School who collaborate to:
In this way, the Partners Personalized Medicine plays a crucial role in helping to ensure that the Partners HealthCare system fulfills its mission of delivering high quality and efficient patient care, advancing clinical care through research discoveries, and educating the next generation of scientists and care givers who can bring that care to our local and global community.
Partners Personalized Medicine comprises four areas that work together and with you to provide you with industry leading personalized medicine services:
The investigative and clinical work of Partners Personalized Medicine is backed by a world-class,information technology infrastructure that includes GeneInsight Suite and GIGPAD. These and other applications developed by and utilized by the divisionare critical to managing the data intensive and rapid pace of genetic testing and research.
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About | Partners HealthCare Personalized Medicine
Dr. Lang Li, Associate Director of the IIPM, namedDirector ofIU Center for Computational Biology and Bioinformatics. Read more…
IIPM Member Dr. Janet Carpenter named Indiana University Distinguished Professor.Read more…
Posted on August 12, 2014 IIPM Member receives Conquer Cancer Foundation grant Dr. Costantine Albany, IIPM member, has received a Conquer Cancer Foundation grant. Read more…
Posted on July 25, 2013 Educational Conference on Personalized Medicine and Pharmacogenomics “Pharmacogenomics in Clinical PracticeWhat you need to know” Thursday, September 5, 2013 from 8:30am 3:00pm The Indiana Institute of Personalized Medicine is offering a didactic and case-study oriented educational conference focusing on pharmacogenomics and its application in clinical practice.The IIPM, led by Dr. Flockhart and a select group of clinicians and pharmacogenomic experts, will conduct a CME and ACPE qualified program addressing the use of pharmacogenomics in clinical practice. The program will be held at the IU Health Neuroscience Center Auditorium at 355 West 16th Street Indianapolis IN 46202. Read more…
To assist with the recognition of these medications, Dr. Malaz A. Boustani and an interdisciplinary team developed the Anticholinergic Cognitive Burden (ACB) list as a practical tool that identifies the severity of anticholinergic effects on cognition of both prescription and over-the-counter medications. Read more…
The 11th Annual Personalized Medicine Conference will be held the third Wednesday and Thursday of November at the Joseph B. Martin Conference Center at Harvard Medical School, Boston Massachusetts. We look forward to seeing you there!
The Personalized Medicine Conference is an annual two-day event co-hosted and presented by Partners HealthCare Personalized Medicine, Harvard Business School, and Harvard Medical School in association with the American Association for Cancer Research; American Medical Association; American Society for Human Geneticsand Personalized Medicine Coalition. Widely considered the most prestigious event in the field, this conference attracts hundreds of national and international thought leaders across multiple disciplines as speakers, panelists, and attendees.
Taking place atHarvard Medical School in Boston, Massachusetts. Enjoy your stay.
Plan your travel
Thelatest session descriptions, program speakers, and times to plan your schedule
View this year’s agenda
A cross-industry, cross-disciplinary panel committed to personalized medicine
View the list
Scott WeissPartners Personalized Medicine
Robert Higgins Harvard Business School
Raju KucherlapatiHarvard Medical School
Be part of the conversation as Personalized Medicine moves into the 2nd decade
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By Margaret A. Hamburg, M.D.
The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients.
Today cancer drugs are increasingly twinned with a diagnostic devicethat can determine whether a patient will respond to the drug based on their tumors genetic characteristics; medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patients own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.
But these examples are not science fiction. They are very real achievements that demonstrate the era of personalized medicine where advances in the science of drug development, the study of genes and their functions, the availability of increasingly powerful computers and other technologies, combined with our greater understanding of the complexity of disease, makes it possible to tailor treatments to the needs of an individual patient. We now know that patients with similar symptoms may have different diseases with different causes. Individual patients who may appear to have the same disease may respond differently (or not at all) to treatments of that disease.
FDA has been playing a critical role in the growth of this new era for a number of years. Even before I became FDA Commissioner the agency was creating the organizational infrastructure and putting in place the regulatory processes and policies needed to meet the challenges of regulating these complex products and coordinating their review and oversight. It has been my pleasure to serve at FDA during this next exciting period and to help ensure that the agency continues to prioritize this evolution by anticipating, responding to, and encouraging scientific advancements.
I am very pleased to be able to present a new report by FDA as part of our ongoing efforts in this field. Paving the Way for Personalized Medicine: FDAs Role in a New Era of Medical Product Development describes many of the exciting developments and looming advances in personalized medicine, lays out the historical progress in this field, and examines FDAs regulatory role: from ensuring the availability of safe and effective diagnostic devices, to addressing the challenges of aligning a drug with a diagnostic device, to post-market surveillance.
Outside collaboration and information sharing is essential for this field to flourish. On Tuesday, the American Association for Cancer Research and AdvaMedDX held a fruitful daylong conversation on personalized medicine to treat cancer. I was one of the speakers, participating in a conversation with Dr. Francis Collins, the head of the National Institutes of Health. Our discussion focused in part on current status of drug and diagnostic co-development and the challenges and potential of whole genome sequencing, where data can be collected on a patients entire genetic makeup at a reasonable cost in a reasonable amount of time.
FDA is committed to fostering these cooperative efforts, as it will require the full force of government, private industry, academia and other concerned stakeholders to maximize our efforts and fully realize the promise of personalized medicine. Our new report outlines that commitment, and helps chart the way forward so that more people can live long and prosper.
Margaret A. Hamburg is the Commissioner of the Food and Drug Administration
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By analyzing your genes, doctors can identify certain drugs that may be dangerous or completely ineffective for you, and they can calculate personalized dosages that match your DNA. Image courtesy of Jane Ades, NHGRI.
NIH research is working hard to solve the puzzle of how genes and lifestyle connect to affect our lives and our health. Today, researchers can scan and compare entire genomes very quickly. These studies have already turned up disease signatures for type 2 diabetes, heart disorders, prostate cancer, Crohns disease, Parkinsons disease, and age-related macular degeneration. More disease-related gene variants are identified every few months.
The Human Genome Project and thousands of follow-on studies are helping scientists to develop gene-targeted treatments. A poignant example is the case of a woman with lung cancer that had spread to her brain. Diagnosed in 2002, this 44-year-olda vegetarian who had never smokedunderwent various therapies to stave off what seemed inevitable. Then came a miracle: she learned of a clinical trial testing a new drug, getfitinib, that for some tumors appeared to work as a genetic smart weapon. Her tumor was one of those, and she is alive today because of medical research.
Thanks to NIH-funded basic research that gave us genetic engineering and launched the $40 billion biotech industry, DNA is a household name. Virtually every biomedical research lab and pharmaceutical company throughout the world uses the power of the genomic revolution every day to demystify diseases and find new cures. Within 5 years, the complete DNA instruction bookor whole genomeof an individual will read out for less than $1,000, making genetic analysis a routine part of medical care.
These colored bands on a computer screen represent the various building blocks of DNA that make up just a small portion of the human genome.
One recent study provides a glimpse of how whole-genome sequencing might eventually be used in the clinic. Scientists evaluated the entire genome of a 40-year-old man to determine his risk for dozens of diseases and his likely response to common drugs. They pinpointed gene variants linked to several diseases in the mans family, including vascular disease and early sudden death. They also found variants linked to conditions not known to be in his family, such as thyroid and parathyroid diseases. Other gene variants predicted the patients likely responses to certain heart medicationsinformation thats especially relevant since hes at risk for cardiovascular disorders.
Remarkable advances in the field of pharmacogenomicshow individuals react differently to medicinesindicate that we are moving away from one-size-fits-all medicine. Scientists can now identify glitches in our DNA scripts that reveal what drugs may be dangerousor completely ineffectivefor certain people. This information will help doctors calculate precise dosages that match a persons DNA.
Collectively, research results in this important area of biomedicine are prompting the U.S. Food and Drug Administration (FDA) to consider changing the labeling requirements for important medicines taken by millions of Americans. Already, pharmacogenomic information is contained in about 10% of labels for drugs approved by the FDA to treat a range of conditions including HIV/AIDS, cancer, seizures, and cardiovascular disorders.
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Personalized Medicine – National Institutes of Health (NIH)
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August 5, 2015
The increasing national focus on personalized or ‘precision’ medicine is misguided, distracting from broader investments to reduce health inequities and address the social factors that affect population health, two leading public health scholars argue in the New England Journal of Medicine.
“There is now broad consensus that health differences between groups and within groups are not driven by clinical care, but by social-structural factors that shape our lives,” write Sandro Galea, MD, DrPH, dean of the Boston University School of Public Health, and Ronald Bayer, PhD, professor of Sociomedical Sciences and co-director of the Center for the History and Ethics of Public Health at Columbia University’s Mailman School of Public Health. “Yet seemingly willfully blind to this evidence, the United States continues to spend its health dollars overwhelmingly on clinical care.
“It is therefore not surprising that even as we far outpace all other countries in spending on health, we have poorer health indicators than many countries, some of them far less wealthy than ours.”
Bayer and Galea say that while investments in precision medicine may ultimately “open new vistas of science” and make contributions to “a narrow set of conditions that are primarily genetically determined,” enthusiasm about the promise of this research is premature. Leaders of the National Institutes of Health (NIH) have praised President Barack Obama’s recent initiative to devote $215 million to personalized medicine, an emerging practice of medicine that uses an individual’s genetic profile to guide decisions in regard to the diagnosis and treatment of disease.
“Without minimizing the possible gains to clinical care from greater realization of precision medicine’s promise, we worry that an unstinting focus on precision medicine by trusted spokespeople for health is a mistakeand a distraction from the goal of producing a healthier population,” they write.
Arguing that clinical intervention will not remedy pressing health problems that arise from environmental conditions and inequities in income and resources, they cite a 2013 report by the National Research Council and the Institute of Medicine that found Americans fared worse in terms of heart disease, birth outcomes, life expectancy and other indicators than their counterparts in other high-income countries. The report concluded that “decades of research have documented that health is determined by far more than health care.”
They call for greater public investments in “broad, cross-sectional efforts” to minimize the socioeconomic and racial disparities in the U.S. that contribute to poor health.
Bayer and Galea say the NIH’s most recent Estimates of Funding for Various Research, Condition and Disease Categories report shows that total support for research areas including the words ‘gene,’ ‘genome’ or ‘genetic’ was about 50 percent higher than funding for areas including the word ‘prevention.’ And investment in public health infrastructure, including local health departments, lags substantially behind that of other high-income countries.
In explaining why they felt compelled to speak out, Galea and Bayer said they are wary that that specialized medicine will push larger public health initiatives aside.
Enthusiasm for personalized medicine is premature …
Companion Diagnostics are the Key to Personalized Medicine for Cancer
Personalized medicine — also known as targeted medicine or precision medicine — is a rapidly-evolving area of healthcare in which treatment for a medical condition such as cancer is tailored to the individual patient and his or her biology. There should be no one-size-fits-all approach to medicine. The goal of personalized medicine is to prescribe the right medicine to the right patient at the right time and avoid the trial-and-error treatment paradigm.
If, for example, a woman has ovarian cancer caused by a genetic mutation, personalized medicine may enable her to be treated with a chemotherapy shown to be effective in individuals with that specific mutation.1
Companion diagnostics are the medical tests that make personalized medicine possible. Designed to be paired with a specific drug, companion diagnostics help healthcare professionals determine which patients could be helped by that drug and which patients would not benefit, or could even be harmed.
Unlike other laboratory developed tests, companion diagnostic tests are reviewed and approved by the U.S. Food and Drug Administration (FDA), which is the gold standard for ensuring safety, effectiveness and quality. FDA approval gives physicians confidence they are receiving the highest quality test result on a consistent basis.
BRACAnalysis CDx is an FDA-approved companion diagnostic that helps to identify women with advanced ovarian cancer with germline BRCA1/2 mutations who have completed three or more lines of chemotherapy and might benefit from treatment with Lynparza (olaparib).
Myriad myChoice HRD is a tumor tissue test that measures deficiencies in the DNA-repair mechanism of cancer cells and may help identify more of the cancer patients who are most likely to benefit from certain types of DNA-damaging chemotherapy agents.
Personalized medicine is the future of healthcare, not just for cancer, but for disease in general. Companion diagnostics will be critical tools that all physicians will need in their toolbox as healthcare moves forward. In addition to cancer, companion diagnostics hold promise in the treatment of other chronic diseases such as rheumatoid arthritis, other autoimmune disorders and diabetes.
Welcome to DNA Stat. We specialize in personalized medicine services, specifically in the pain management and pharmacogenomics arena. We take pride in both our research and unsurpassed customer service, providing clients with genetic & pharmacogenomics testing which is the fastest growing field in the medical industry today.
Pain management and pharmacogenomics is vitally important as we progress into the 21st century as it is a realization and acknowledgement that one size does not fit all when it comes to medications. What might work for one individual flawlessly could mean an adverse reaction and a trip to the emergency room for another. Genetic Testing is the tool used to determine the difference before the medication is ingested. In this way, we are spearheading and defining personalized medicine services and enabling people to recover and maintain their illnesses and conditions worry-free. By eliminating the guess work, patients can recover more fully and quicker than ever before.
We know that the medical industry can be daunting to most people. Fortunately, the genetic & pharmacogenomics testing at DNA Stat comes down to a simple Buccal swab of the cheek. No needles involved, no fear, no blood no problem. Within three weeks, the patients doctor will have in his or her hands a Pharm D Report which is the roadmap to prescribing better medications and better treatments for their patient. DNA Stat, the leader in genetic& pharmacogenomics testing, is changing the way the world sees medicine one patient at a time.