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Head of Nation’s Leading Patient Advocacy Organization Addresses Personalized Medicine and E-Health at BIOVISION Global Conference

Nancy Davenport-Ennis, founder and CEO of the National Patient Advocate Foundation, recently addressed attendees at the BIOVISION conference in Lyon, France on personalized medicine and e-health technology and engaged healthcare stakeholders from across the globe on the future of e-health and the impact technology integration will have on the lives of patients.

“As we continue to make strides in technology and digitize healthcare, we are on the cusp of a digital revolution that will enhance patient access to treatment information, change the paradigm of the patient-provider relationship and create a social contract with those who serve our country,” stated Davenport-Ennis. “Health information technology also stands to significantly reduce costs and provide more coordinated care for patients.”

The Veterans Health Information Systems and Technology Architecture (VistA) program serves as a practical illustration of the social contract to service members. This 160 module program of financial and clinical support is used on the battlefield and for veterans nationally. VistA is one of the most widely used Electronic Health Records (EHR) programs in the United States. The e-health session also included a review of the role of telemedicine and Personal Health Records.

Davenport-Ennis addressed policy advances made in the U.S., including the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2010. The HITECH Act dedicates $25.9 billion to health information technology in rural settings and community clinics. The Act also increases efforts in all 50 states to pass security legislation protecting consumers’ Personal Health Information from employers and insurers.

Her presentation also highlighted patient requirements to protect Personal Health Information in conformity with the Genetic Information Nondiscrimination Act (GINA) law passed in 2009, while also acknowledging some of the remaining challenges to infrastructure, processes and training within the e-health environment.

Additional presenters included Najeeb Al-Shorbaji of the World Health Organization, Roberto Santoro of Italy, President of the European Society of Concurrent Enterprising Network, Brigitte Trousse, President of France Living Lab , and Veronique Thouvenot , Head of Head of Millennia2015 “Women and eHealth” International Working Group.

Source: PR Newswire

ASU Scholars Advocate Innovation in Regulatory, Payment Pathways for Personalized Medicine

Two innovative programs designed to improve the availability of emerging medical technologies that can help patients receive more effective, efficient and personalized health care are advanced in a commentary written by a team of scientists and policy experts, including seven from Arizona State University, and published today in Science Translational Medicine.

The March 13 article, “Regulatory and Reimbursement Innovation,” explores the benefits of coverage with evidence development (CED) and parallel review for the regulation and reimbursement of molecular diagnostics. Molecular diagnostics include tests that aid in better prediction, diagnosis, prognosis and treatment of disease through the use of DNA, RNA and proteins.

The U.S. Food and Drug Administration (FDA) requires certain diagnostic tests to provide reasonable assurances of safety and effectiveness before they can be marketed. The Centers for Medicare and Medicaid Services (CMS) determines whether such products are “reasonable and necessary” before they can be covered by Medicare. The FDA and CMS currently are reviewing CED and parallel review for more widespread use, according to the article.

One of the co-authors, ASU Regents’ Professor Gary Marchant, Faculty Director of the Center for Law, Science & Innovation (LSI) at ASU’s Sandra Day O’Connor College of Law, said these tests are expected to improve health outcomes by giving providers optimal treatment choices for their patients.

“It’s a new paradigm of health care,” said Marchant, who founded LSI’s Program on Personalized Medicine, Law & Policy, the nation’s first law-school program that fosters the discipline’s study through collaborative, multidisciplinary evaluation of critical issues. “And it’s a critical time for both of these innovative programs, because agencies of the federal government are actively considering expanding them.

“These tests produce complex algorithms that can help your physician direct your health care, where you should go for treatment and what medications can – and cannot – help you,” he said. “People are dying unnecessarily, and we need to get these diagnostics out more quickly and with better data.”

Regulatory and reimbursement roadblocks hinder the tests’ development and slow their integration into routine care decisions, according to lead author, LSI Research Director Rachel Lindor. A graduate of the law school’s J.D. program who is now completing her M.D. degree at Mayo Medical School, Lindor began researching these issues during an externship in 2011 at the U.S. Department of Health and Human Services.

An LSI-hosted workshop in April 2012, “Potential Solutions to Regulatory and Reimbursement Barrier for Molecular Diagnostics: Parallel Review and Coverage with Evidence Development,” followed. It drew notable experts from government, industry and academia to brainstorm solutions to these barriers; their input led to the now-published article.

“Overall, the group seemed to agree that both of these policies were good in theory, but there were pieces of each that made people skeptical they would actually work,” Lindor said. “We came up with a few changes at the workshop that we thought would make them more attractive for developers who may have products coming up through the pipeline.”

Parallel review enables developers to meet with both CMS and FDA early in a product’s review process, in order to clarify the agencies’ evidentiary expectations and reduce inefficiencies. CED allows CMS to temporarily cover new products not yet supported by sufficient evidence to meet its “reasonable and necessary” coverage threshold while additional data are evaluated.

“Our recommendations on CED focused on trying to streamline the process so developers wouldn’t see it as a hurdle to getting paid for their products – things like smoothing out the way that FDA and CMS work together when they review the same product and shortening the time it takes for CMS to actually start a CED,” Lindor explained. “The group was also concerned about CMS’ hints that CED may be used by local Medicare contractors, so one of our recommendations was that CMS provide some more logistics on how exactly that would work.”

Lindor said tweaks to the parallel review program could make it more amenable to diagnostic test developers and speed the tests’ access to insurers, care providers and patients.

“Our group recommended that CMS give developers some assurance that there will be some benefits to participating, which could be done by shortening the time it takes to go through the process, or by providing more flexibility about what type of payment decisions would come from the review,” Lindor said. “We also recommended that the policy be made available to a broader range of products than it’s open to now.”

Dr. Denis Cortese, Director of ASU’s Health Care Delivery and Policy Program, and a co-author of the article, said “The primary goals of these two programmatic recommendations are to more quickly and accurately determine the appropriate role for new medical technologies in medical practice and patient care.”

Another co-author, Dr. George Poste, Chief Scientist of ASU’s Complex Adaptive Systems Initiative, said molecular diagnostics have enormous potential to increase diagnostic accuracy and increase the efficacy and safety of drugs in multiple diseases.

“Current ambiguities in regulation and reimbursement policies for these new tests are a major barrier to corporate investment and R&D innovation,” Poste said.

Study: Regulatory and Reimbursement Innovation

Source: EurekAlert!

Veracyte Announces UnitedHealthcare Coverage Policy For the Afirma® Gene Expression Classifier

Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced that UnitedHealthcare, one of the nation’s largest private health insurers, has issued a positive medical coverage policy for the Afirma® Gene Expression Classifier for use in assessing thyroid nodule fine needle aspirate (FNA) biopsies that are indeterminate – not clearly benign or malignant following traditional cytology review. The new medical coverage policy will apply to the insurer’s nearly 27 million commercial members, effective April 1, 2013. Veracyte’s genomic test is already covered for approximately 40 million Medicare patients nationwide.

The Institute for Systems Biology and AB SCIEX Partner to Help Make Medical Care More Predictive and Personalized

Medical care is expected to become more personalized and better able to help prevent the onset of diseases in the future, thanks to groundbreaking research into P4 medicine underway by world-renowned scientists at the Institute for Systems Biology, including National Medal of Science award winner Leroy Hood, MD, PhD., and ISB proteomics research director, Robert Moritz, PhD., and now supported by a new collaboration with AB SCIEX, a global leader in analytical technology.

ISB and AB SCIEX have signed a multi-year agreement to collaborate on the development of methods and technology in proteomics mass spectrometry with the goal to redefine biomarker research and complement genomics through fully comprehensive quantitative proteomics analysis. This will help advance the development of a new approach to medical care.

ISB’s concept of P4 medicine promises to provide deep insight into disease mechanisms on the path to develop medical care that is predictive, personalized, preventive and participatory (the four “P”s) – a pioneering vision that requires a combination of analytical tools, workflows, databases, collaborations and computational strategies.

“With breakthroughs in translating research into clinical relevance, P4 medicine is expected to enable the creation of a virtual cloud of billions of data points around each individual as the basis for straightforward predictions about health and disease,” said Dr. Hood, ISB president and co-founder. In December, he was named a recipient of the National Medal of Science, which is the highest honor the President of the United States can bestow on a scientist, in recognition of visionary work for the advancement of science.

Led by Dr. Hood, ISB’s groundbreaking research is being accelerated by SWATH™ Acquisition, a data-independent acquisition (DIA) mass spectrometry workflow that can quantify virtually all detectable peptides and proteins in a complex sample – all in a single analysis.

“Quantifying enormous numbers of protein analytes at the same time is a critical need to accelerate P4 medicine and the democratization of proteomics, a revolution that is akin to the sequencing of the genome and the democratization of DNA,” added Dr. Hood. “SWATH is a game-changing technique that essentially acts as a protein microarray and is the most reproducible way to generate comprehensive quantitation of the entire proteome. It generates a digital record of the entire proteome that can be mined retrospectively for years to come.”

ISB’s know-how in systems biology and informatics will support the development of SWATH libraries, similar to its highly regarded SRMAtlas project for the human proteome, pioneered by Rob Moritz and his collaborators, and the proteomes of other clinically-relevant organisms. “With complete proteome-wide libraries, ISB provides the basis to support comprehensive SWATH analysis,” said Dr. Moritz, ISB Proteomics Research Director.

Committed to an open policy of sharing data and methods, ISB will make the SWATH libraries available to the global scientific community to accelerate the use of SWATH for other biological research. Utilizing the depth in proteomics technology development and underpinned by the extensive proteomics computational resources in data interpretation tools, standards initiatives and database development under the leadership of Dr. Moritz, ISB will develop new SWATH technologies and tools to enable the community to quickly adopt comprehensive quantitative proteome analysis.

“Having the proteomics data standardized across laboratories and across samples really enables us to quantitate entire proteomes at a level that hasn’t been done before,” said Dr. Moritz. “We aim to define markers that can predict whether a patient will respond to a certain treatment or not, and applying SWATH will play a big part in taking our advancements to another level. Not only can we now complement the breadth of genomics, but we will have the much-needed libraries and software development going forward to make data-sharing quite easier and standardized.”

As a trusted partner with academic researchers, AB SCIEX has formed this strategic alliance with Dr. Hood, Dr. Moritz and their distinguished ISB colleagues through the AB SCIEX Academic Partnership Program to help broaden the availability of new technologies to researchers delving into omics research around the world.

“What ISB does with SWATH will set a new benchmark in proteomics research,” said Rainer Blair, President of AB SCIEX. “Our collaboration with ISB will help drive SWATH into the mainstream of analytical science and make comprehensive, reproducible and simplified omics data more accessible to biologists around the world.”

ISB will be using the AB SCIEX TripleTOF® 5600± System and an Eksigent ekspert™ nano-LC 400 System as the instrument platforms on which to conduct the protein identification and quantitation. The TripleTOF 5600+ System provides the high speed necessary for SWATH Acquisition. TripleTOF technology combines high speed and high sensitivity with high resolution and accurate mass. ISB also plans to use SelexION™ technology, a recent advancement in differential ion mobility, in the future to advance its research.

Source: Institute for Systems Biology

NCBiotech Weighs Personalized Medicine Sector

The North Carolina Biotechnology Center has approved a $100,000 grant to explore the state’s readiness for a Center of Innovation (COI) to help capitalize on the growing field of personalized medicine.