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Big Data Peeps At Your Medical Records To Find Drug Problems

Big Data Peeps At Your Medical Records To Find Drug Problems | healthcare technology | Scoop.it

It's been tough to identify the problems that only turn up after medicines are on the market. An experimental project is now combing through data to get earlier, more accurate warnings.


No one likes it when a new drug in people's medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke.


To do a better job of spotting unforeseen risks and side effects, the Food and Drug Administration is trying something new — and there's a decent chance that it involves your medical records.


It's called Mini-Sentinel, and it's a $116 million government project to actively go out and look for adverse events linked to marketed drugs. This pilot program is able to mine huge databases of medical records for signs that drugs may be linked to problems.


The usual system for monitoring the safety of marketed drugs has real shortcomings. It largely relies on voluntary reports from doctors, pharmacists, and just plain folks who took a drug and got a bad outcome.


"We get about a million reports a year that way," says Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research. "But those are random. They are whatever people choose to send us."

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Personalized Immunotherapy for Leukemia Named Breakthrough Therapy

Personalized Immunotherapy for Leukemia Named Breakthrough Therapy | healthcare technology | Scoop.it

A University of Pennsylvania-developed personalized immunotherapy has been awarded the U.S. Food and Drug Administration’s Breakthrough Therapy designation for the treatment of relapsed and refractory adult and pediatric acute lymphoblastic leukemia (ALL). The investigational therapy, known as CTL019, is the first personalized cellular therapy for the treatment of cancer to receive this important classification.


In early-stage clinical trials at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia, 89% of ALL patients who were not responding to conventional therapies went into complete remission after receiving CTL019.


The investigational treatment pioneered by the Penn team begins by removing patients' T cells via an apheresis process similar to blood donation, then genetically reprogramming them in Penn’s Clinical Cell and Vaccine Production Facility. After being infused back into patients’ bodies, these newly built “hunter” cells both multiply and attack, targeting tumor cells that express a protein called CD19. Tests reveal that the army of hunter cells can grow to more than 10,000 new cells for each single engineered cell patients receive.


source: http://www.dddmag.com/news/2014/07/personalized-immunotherapy-leukemia-named-breakthrough-therapy



more related articles on this :

http://www.chop.edu/service/oncology/pediatric-cancer-research/t-cell-therapy.html


http://online.wsj.com/articles/novartis-wins-breakthrough-status-for-new-leukemia-treatment-1404758105


http://www.novartis.com/newsroom/media-releases/en/2014/1816270.shtml



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FDA Helping to Advance Treatments Tailored to Patients

FDA Helping to Advance Treatments Tailored to Patients | healthcare technology | Scoop.it

Personalized medicine is the tailoring of a medical treatment to the individual characteristics, needs and preferences of a patient. Many recent advances involve using a patient's genetic information to guide his or her treatment.


Developing a truly personalized approach to patient care will require fundamental advances in the understanding of the biological, anatomical and physiological mechanisms that underlie disease, and how they are affected by environmental, genetic, social and cultural factors.


To describe its unique responsibilities and its efforts in facilitating the advancement of personalized medicine, the Food and Drug Administration (FDA) has released a new report entitled "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development 


FDA's commitment to personalized medicine dovetails with its focus on advancing regulatory science, which is the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.


Here are some examples from the report of how FDA is using regulatory science to help speed the development of promising new personalized medicine therapies.


Virtual patient: Advances in medical imaging and the power of computers to create virtual, anatomically correct models of the human body have enabled the use of patient-specific computer simulations in clinical practice and medical device development. This has facilitated the creation of personalized, custom-built medical devices. FDA's Center for Devices and Radiological Health (CDRH) is developing a publicly available digital library of such models and simulations. This space for collaboration and sharing will help advance the personalization of medical device development and use.


Clinical Trial Designs and Methods: FDA is working to refine clinical trial design and statistical methods of analysis to address issues that often arise in the development of targeted therapeutics. The agency is also looking specifically at clinical trials for the development of cancer drugs. For example, FDA is participating in the "I-SPY 2 Trial," a groundbreaking clinical trial model that will help scientists quickly test the most promising drugs in development for women with rapidly growing breast cancers.


Biology of cancer: FDA's National Center for Toxicological Research (NCTR) conducts research to improve the understanding of cancer's underlying biology. A research project focused on the KRAS oncogene, for example, established that many tumors carry subpopulations of KRAS mutant cells, which can contribute to an acquired resistance to some cancer treatments.


Identification of genetic risk factors for vaccine reactions: FDA's Center for Biologics Evaluation and Research is involved in research collaborations that focus on identifying genetic risk factors associated with negative reactions to vaccines.


Genetics and cardiovascular risk: In collaboration with researchers at the University of Maryland, scientists at NCTR are conducting research to identify genetic factors that interact with common lifestyle factors—such as diet and drug exposure—to contribute to cardiovascular disease.


Personalized medicine for heart devices: Researchers at CDRH have made major advances in understanding the underlying biology of heart disease. They have used new methods to analyze electrocardiograms to identify the causes of heart disease and to predict which patients will benefit from specific cardiovascular treatments. These new methods are being used by outside research groups and may be used to design more efficient clinical trials in the future.


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Could health apps save your life? That depends on the FDA

Could health apps save your life? That depends on the FDA | healthcare technology | Scoop.it

The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will soon have its hands full with consumer health apps and devices.


The vast majority of the health apps you’ll find in Apple’s or Google’s app stores are harmless, like step counters and heart beat monitors. They’re non-clinical, non-actionable, and informational or motivational in nature.


But the next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels.

More clinical apps

The FDA is charged with keeping watch on the safety and efficacy of consumer health products. Lately, that includes more clinical apps as well as devices you might buy at the drugstore, like a home glucose testing kit.


“It’s these apps that the FDA says it will regulate,” David Bates of Brigham and Women’s Hospital and Physicians Organization told VentureBeat in June. These apps will have to go through the full 510(k) process,” he said.


Dr. Bates chaired a group to advise the FDA on how to review health apps for approval, and on how the FDA should advise developers.

“It was intended to help them think through the risk factors involved with these products and then give guidance on how to stay within the guidelines,” he said.


“The device makers were asking from some guidance from The FDA on what types of things would be accepted and what wouldn’t,” Bates said.

Bates believes the FDA wants to use a light regulatory touch when looking at new medical devices. “The FDA definitely wants innovation to continue in clinical devices,” he said. “In general the FDA knows that the vast majority of apps are just informational.”


The FDA’s final guidance focuses on a small subset of mobile apps that present a greater risk to patients if they do not work as intended.


Health apps go mainstream

The big software companies (Apple, Google, and Samsung) have brought attention to, and lent credibility to, apps and devices that do more than count steps. These companies are building large cloud platforms designed to collect health data from all sorts of health apps and devices.


more at http://venturebeat.com/2014/07/21/health-apps-are-changing-so-must-the-fda/


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What is the Future for Genetic Testing and Personalized Medicine?

What is the Future for Genetic Testing and Personalized Medicine? | healthcare technology | Scoop.it

Personalized medicine, or the ability for the medical profession to tailor therapy to particular individuals’ genetic characteristics, has been a long desired but ever elusive goal for the life sciences.  However, the prospects for personalized medicine appear to be improving in recent years.  These changes come in the wake of a variety of medical advances, including human genomic testing and cancer drugs targeted for individuals with specific genetic profiles.


As public attention to understanding the human genome has increased, the topic has garnered substantial controversy and regulation in this sector is poised to increase.  The Food and Drug Administration (FDA) has already indicated its intent to regulate—most recently in a report clarifying its future role in personalized medicine and in warning letters to direct-to-consumer genetic testing companies.


The FDA maintains it has the authority to regulate personal genetic data because it defines that data as a medical device under Section 201(h) of the Food Drug & Cosmetics Act.  The agency also points to its role as the federal body charged with providing guidance on medical device claims and protecting consumers.


Some health scholars and consumers have weighed in on the propriety of regulation.  In a study of consumer attitudes toward regulating direct-to-consumer genetic testing, researchers found many consumers wanted unfettered access to genetics testing services without government regulation, but favored oversight to ensure that the information provided was high quality.

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