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Personalized Medicine

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Personalized Medicine: A Patient Primer On Best Practice

Personalized medicine is focused on meeting patients’ needs, but it also has the potential to transform the delivery and financing of health care. In Vivo probes the path toward meeting both goals in an in-depth nterview with Eleanor Perfetto, SVP for strategic initiatives at the National Health Council, the DC-based patient advocacy organization whose members include groups representing 133 million patients nationwide.

Personalized Medicine Leadership Pricing Debate

Personalized Medicine: What's Your Strategy?

Free content: Personalized medicine is upending the business of health care. In March, In Vivo will focus on exploring this new landscape. There is no single "right" route for companies to follow, but pharma, payers and other stakeholders need to find a path because the forces driving personalized medicine are global, and unstoppable.

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One Size No Longer Fits All: The Personalized Medicine Trial Landscape

Success rates are higher for clinical trials that incorporate selective pharmacogenomics and pharmacogenetics (PGX) biomarkers, according to data from Informa's Trialtrove. Given the challenges of designing and administering trials to secure regulatory approval in areas of unmet medical need, the data provide some basis for optimism in realizing the promise of targeted, personalized therapies that improve health outcomes for individual patients.

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Flatiron Aims To Accelerate, Personalize Cancer Research

Flatiron Health was formed to exploit a previously untapped source of real-world data on the treatment and clinical outcomes of cancer patients. The company is now working with most of the major players in the oncology sector as well as with the FDA to maximize the benefits of such data analytics.

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Companion Diagnostics: The Expanding Reach Of Personalized Medicine

Personalized medicine is becoming the hallmark of care in oncology, but its use is also increasing in other therapeutic areas including inflammation, respiratory, infectious diseases and central nervous system disorders, as scientific understanding of these diseases advances. The expansion of companion diagnostics beyond oncology has impacts on dealmaking, clinical practice and the R&D pipeline.

Personalized Medicine Innovation Diagnostics

How Immuno-Oncology Is Turning Biomarker Development On Its Head

Immuno-oncology’s challenge is to orchestrate a biomarker program in a highly competitive drug development landscape knowing that prior to having significant clinical experience, the program is unlikely to yield the kinds of binary measurements used to define and select a patient population for a targeted therapy.

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Revisiting Cell Screening To Find New Cancer Drug Combos

Evidence is slowly building of the potential of high-throughput screening of individual patient tumors to test their sensitivity and response to hundreds of combinations of cancer drugs, first in leukemia and hopefully for treating other cancers.

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ANGLE Targets A Rich CTC Niche In Liquid Biopsy

A multibillion-dollar market is on the way for liquid biopsy, which allows the measurement of markers present in biological fluids, a repeatable method of disease diagnosis that could replace some invasive biopsies and allow clinicians access to tissues that have been inaccessible with current methods. Within this dynamic field, ANGLE PLC is coming closer to clinical application market readiness with its circulating tumor cell harvesting technology, as CEO Andrew Newland explains.

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Precision Medicine's Progress: Reports From The Front Lines

A roundtable of industry experts discuss how advances in biomarkers and personalized medicine will impact pharma R&D decisions and ultimately benefit patients (free with registration).

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Which Path Forward For Foundation Medicine?

Now backed by Roche, can Foundation Medicine continue to innovate in the delivery of molecular information in oncology and outpace the twin threats posed by the commoditization and regulation of genomic data?

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Making The Most Of A Maturing Myriad Genetics

Five and a half years after its decision to spin off its pharmaceutical business and a year and a half away from having the US Supreme Court break its monopoly on BRCA gene testing, Myriad Genetics is no longer an exception among molecular diagnostics companies. It must find its way along a more crowded path.

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When Illumina Buys Roche: The Dawning Of The Era Of Diagnostics Dominance

With current technology and resources, a well-funded in vitro diagnostics company can create and pursue a strategy of information gathering and informatics application to create medical knowledge, enabling it to assume the risk and manage certain segments of patients. But few if any pharma or diagnostics firms appear poised to take advantage.

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Personalized Medicine Takes Aim At Common Diseases

While oncology steals the limelight, some firms are harnessing the technologies and R&D strategies of precision medicine to develop combination drug/diagnostic products for large-population, non-oncology diseases.

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Scant Intersection Between Patient-Centered Outcomes Research And Personalized Medicine’s Needs

On its face, comparative effectiveness research and its new cousin, patient-centered outcomes research, would seem to support, if not enable, personalized medicine. But as currently established in the US, there is little conceptual overlap. That’s largely because much CER and patient-centered outcomes research steer clear of anything that smacks of the development of cost data, which personalized medicine may need to truly make its value proposition.

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Delivering Cancer Diagnostics Tools

Pharma is keenly interested in new cancer diagnostics tools, which in many cases are aimed at selecting the best therapy for a specific patient, measuring response to therapy and predicting or more sensitively measuring relapse. These technologies are often the same as those used in pharma's drug development efforts. But deciding with whom and how to ally for the development and distribution of tests is difficult, showing just how uncharted, and bumpy, is the current diagnostics terrain.
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Personalized Medicine In 2010: Welcome To The Establishment

Evidence of progress for molecular diagnostics and instrumentation, the mainstays of the personalized medicine toolkit, was considerable in 2010. Much of the activity centered on sequencing, although its general utility in clinical diagnostics has not yet been demonstrated and whether measurements of gene expression can form the basis for a plethora of molecular tests also remains an open question. In abbreviated form, we list some of the important dealmaking activities and trends of the year.
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More on Personalized Medicine from Scrip, Pink Sheet & Medtech Insight.

Cautious Roche Stresses: 'It's Not Only About APHINITY'

Roche is suddenly sounding less optimistic about its Phase III APHINITY trial of Perjeta in the neoadjuvant breast cancer setting – stressing that 2017 will also bring three other key readouts for the company.

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3D Printing Opens A Legal Brave New World

Attorneys at Reed Smith have released a white paper that attempts to tackle the legal uncertainties facing 3D printing of medical devices. They tackle issues including product liability, intellectual property and quality management. Also: Listen to our podcast interview with one key contributor to the report.

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Argos Nears Phase III Results For Precision Cancer Immunotherapy

With pivotal data expected in 2017 in metastatic kidney cancer, Argos hopes its drug will bridge the hot points of immuno-oncology and personalized medicine with a drug that extract’s RNA from a patient’s tumor and primes the dendritic cells to teach the immune system how to kill the cancer.

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Opinion: Will EU Medtech Regs Lead You To Sell Your Home?

The EU’s medtech regulations are creating a huge and costly compliance machine. Amanda Maxwell, in the UK, comments on why you should be worried.

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FDA And The Transition: Reading The LDT Leaves

FDA’s decision to hold off on finalizing its guidance on oversight of lab-developed tests is an acknowledgement of the new US political dynamics after the Nov. 8 elections. It may also be an important signal of where early attention will fall at FDA after the transition: on the devices, not drugs.

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Kura Oncology's Troy Wilson On Precision Medicine For Cancer

Since using a reverse-merger last year to go public, Kura Oncology has resurrected an abandoned Janssen cancer candidate and raised $46.5m in an IPO. CEO Troy Wilson spoke with Scrip about the firm's efforts toward precision medicine in cancer.

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