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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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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?
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.
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.
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.
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.
FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.
Bristol-Myers R&D leaders Brian Gavin and Sean Connolly offered insight into the company's immunology focus for autoimmune diseases, which increasingly is driven by a search for biomarkers that point to the best use of the big pharma's drugs.
The UK firm believes its siRNA stabilisation chemistryis represented in several late-stage RNAi studies and that market leader Alnylam requires a license that could have a material impact on Silence's market capitalization.
The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.
US FDA recently heard from range of stakeholders on the issue of 3D-printing anatomical models during a meeting at the agency's Maryland headquarters. James Coburn, a senior engineer at FDA's device center, spoke to Medtech Insight following the meeting about what he learned and next steps for this rapidly evolving technology.
Industry, health-care providers and FDA discussed major issues in using additive manufacturing for making anatomical models at the agency's headquarters last month. The findings will be presented in a white paper from the Radiological Society of North America to help FDA figure out how to regulate the technology.
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