Precision Medicine is Happening Now
The proof is $142 million dollars recently awarded to Mayo Clinic from National Institutes of Health (NIH)
When President Obama introduced his Precision Medicine Initiative® (PMI) during the 2015 State of the Union address, his vision was to empower medical professionals with the information and resources they need to tailor treatments to the individual patient based on his or her unique characteristics.
Simplified, if you are sick, your doctor takes your blood and sends it to a lab for testing. He or she will then compare the results of that test along with your medical history to those of other patients who have had the same illness. If a match is found, your doctor can more easily identify treatments that “worked” for other patients and create an individualized treatment plan with the expectation that it will also work for you.
The idea of Individualized Medicine sounds straightforward, but implementing it will require cooperation at all levels of government and from those doing clinical research. It will also require the availability of precise biospecimens.
The Precision Medicine Initiative is a major step towards developing that cooperation, and over the last two years it has started taking form, as recently demonstrated by the large sum awarded to Mayo Clinic by National Institutes of Health. The $142 million dollar award will help Mayo Clinic build the world’s largest research-cohort biobank for the PMI Cohort Program. This award also signifies the “all of government” commitment that has been made to PMI, and it highlights the importance of Biobanking and other Bioservices in executing the program.
An Idea That’s Time Has Come
Over a decade ago, my friend (and now business partner), Jim Sperzel, and I drew up a business plan on a piece of notebook paper as we traveled from Munich to Tutzing, Germany. What we were envisioning was a first of its kind biobank that could provide the Diagnostic Industry with IRB-approved, patient biospecimens to help expedite the pace of research. Our company, ProMedDx, grew out of that business plan, and today it is a small-scale version of what the PMI Cohort Program aims to become.
As our company grew and our capabilities expanded, we realized we were in possession of a very large, very rare collection of precision biospecimens. We also knew that as medicine became more individualized the research community would show greater demand for a reliable resource of precise biospecimens from large cohorts of diagnosed patients. That is exactly what has happened.
We weren’t as prophetic as we would like to believe. The need for a program such as the PMI is not new, but it has become more critical to the future of human health worldwide. At ProMedDx, we know there are quantifiable benefits to understanding the individual behind the illness. In depth information allows healthcare professionals to practice more precise care more efficiently and with improved patient outcomes. Ultimately, Precision Medicine will reduce the time and expense of healthcare. It all begins with quality biospecimens.
Precise Biospecimens are the Key to More Precise Medicine
For Precision Medicine to work, doctors and nurses engage a process of analyzing patient medical history and genomic testing to guide them in making diagnosis and treatment decisions. This interpretive analysis of large-scale patient data and analytical tools is a dynamic process that becomes more precise each day as the assay of patient data and technology progresses. Precise biospecimens are the “fuel” that continuously feeds this process.
Biopharmaceutical companies also play an important role in the success of Precision Medicine, as they focus on the development of drugs that target specific genetic differences/changes. To achieve this, they must analyze large volumes of biospecimens in their research labs to study the effects of singular and combination compounds at a cellular level. Accessibility to biospecimens from diverse cohorts of diseased and treatment naive individuals makes their work possible.
Furthermore, laboratories that provide genomic insight use proprietary panels of next-generation sequencing tests. Such tests require precise processing & handling of the specimens prior to analysis. The technology is meticulous, and slight variations in handling of the biospecimen can limit—and in some cases prevent—an accurate analysis.
As you can see from these examples, today’s science cannot be optimized using legacy biologics whose source or handling is not known.. Just as precision automobiles require premium grade gasoline to fuel their performance engines, researchers need precision biosamples to fuel their investigation. Ultimately, this is the goal of the Precision Medicine Initiative: The government wants to build a biobank of “premium” biospecimens and information.
The Future of the Precision Medicine Initiative
The National Institutes of Health will award $142 million to the Mayo Clinic over a five-year period to establish the world’s largest research-cohort biobank for the PMI Cohort Program. The PMI Cohort Program aims to extend precision medicine to all diseases by building a national research cohort of one million or more U.S. participants. The award will support the collection, storage and distribution of biological samples known as biospecimens for use in research.
According to a Press Release from NIH, laboratory analyses of the biospecimens, including chemical and genetic tests, will be a key component of the core PMI Cohort Program data set. These data, combined with other information provided by volunteers such as lifestyle and health questionnaires, medication history, electronic health records, physical exams, environmental exposures, and real-time physiology tracked through mobile health technologies will give researchers a more efficient way to study individual differences in health and disease.
“This range of information at the scale of 1 million people will be an unprecedented resource for researchers working to understand all the factors that influence health and disease,” said NIH Director Francis S. Collins, M.D., Ph.D. “The more we understand about individual differences, the better able we will be to tailor the prevention and treatment of illness.”
Mayo Clinic was chosen for its size, expertise and capabilities to provide the infrastructure to store, analyze and make available to researchers more than 35 million biospecimens and associated data. Mayo Clinic will be using state-of-the-art laboratory automation and robotics for efficient processing and retrieval, and its Biobank staff will follow a detailed set of policies to safeguard the collection against contamination or loss and to protect participant confidentiality.
Here at at ProMedDx, we have a long, defined history of supporting Precision Medicine, so we are anxiously watching to see how the PMI program evolves. In fact, Jim and I are once again putting pen to paper to see how we can expand our own services to support the initiative and provide our clients with innovative solutions. Meanwhile, our portfolio of services is already growing to provide immediate support to researchers in the fields of Lung, Colorectal, Breast, Prostate, Ovarian, Metabolic and Neurological disease studies.