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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 interview 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: An Infographic

Free content: There were 132 personalized medicines on the market in 2016, compared with just five in in 2008, according to the Personalized Medicine Coalition. And 27% of new molecular entities approved by the FDA in 2016 can be can be classified as a personalized medicine. That's a big jump from 2005, when personalized medicines accounted for just 5% of NME approvals. A look at some other key numbers in this rapidly growing field.

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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.

Personalized Medicine Research and Development Strategies Research & Development

Singulex And Qiagen Partner In Personalized Medicine

Singulex and Qiagen have entered a strategic alliance whereby Qiagen will be able to offer its clients companion diagnostic development services based on Singulex’s Single Molecule Counting technology.

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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?

Medical Device BioPharmaceutical Business Strategies

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.

Medical Device BioPharmaceutical Strategy

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.

BioPharmaceutical Medical Device Strategy

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.

Medical Device BioPharmaceutical Clinical Trials

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.
Platform Technologies Research and Development Strategies

More on Personalized Medicine from Scrip, Pink Sheet & Medtech Insight.

Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

In Vitro Diagnostics Personalized Medicine

Blueprint Lays Out Path To Early Approval In Small GIST Population

Blueprint Medicines will pursue an accelerated path to approval for its newly designated breakthrough therapy BLU-285 in the treatment of gastrointestinal stromal tumors in a small subset of patients.

Clinical Trials Personalized Medicine

AstraZeneca's OlympiAD Trial Kick-Starts PARP In Breast Cancer

The OlympiAD monotherapy study paves the way for AstraZeneca's Lynparza in breast cancer, as well as other PARP inhibitors down the line, but the ASCO presentation raises questions about trial design and whether combinations are needed to boost efficacy.

Clinical Trials Personalized Medicine

Loxo's Larotrectinib Requires Paradigm-Change In Clinical Practice

The TRK inhibitor won over ASCO with deep and durable responses across 17 cancer types, but diagnostics will be the true test of the tumor-agnostic approach – and the focus of Loxo's commercial strategy.

Clinical Trials Personalized Medicine

Cancer Treatment Complexity And Costs Increased Substantially Over Two Decades

A QuintilesIMS Institute study of global oncology trends illustrates the benefits and downside of therapeutic advances – more therapeutic options with better targeting, but also significantly higher complexity in setting a therapeutic course, which is complicated by rising costs.

Cancer Research & Development

Sysmex Buys OGT To Add Cytogenics Capability

Oxford Gene Technology announced May 31 that it will become a wholly owned subsidiary of Sysmex, the Japanese in vitro diagnostics company that will gain entry into the cytogenetics market with OGT's fluorescence in situ hybridization and array comparative genomic hybridization products.

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