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Aug. 6, 2020
 
 
ONCOLOGY
 
 
Delivering on the promise of precision cancer medicine and why it matters even more during a pandemic
MedCity News
While many of us have avoided exposure to COVID-19 by sheltering in place, patients with advanced cancer have faced difficult choices about moving ahead with immune-compromising, but potentially life-saving treatments, and leaving the safety of their homes to receive infusions at hospitals or treatment centers.
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Cancer diagnostic delays due to COVID-19 may lead to high excess mortality
medwireNews
Two modelling studies published in The Lancet Oncology show the impact cancer diagnostic delays due to COVID-19 could have in England, with some scenarios suggesting over a 1000 people could die unnecessarily.
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5 developments in oncology targets
Drug Target Review
According to new research published in Developmental Cell, the PRC1 protein is an essential component in cell division. Acting as a viscous glue, the protein creates resistance as cells pull chromatids to either end of the single dividing cell.
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GENOMICS
 
 
Bringing RNA into genomics
MIT News
The human genome contains about 20,000 protein-coding genes, but the coding parts of our genes account for only about 2% of the entire genome. For the past two decades, scientists have been trying to find out what the other 98% is doing.
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Scientists create comprehensive database of bacterial genomes
NutraIngredients.com
An international team of scientists has collated all known bacterial genomes from the human gut microbiome into one 'unparalleled' large database. To understand the role that bacterial species play in human biology, scientists usually isolate and culture them in the lab before they sequence their DNA.
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Genomic surveillance reveals multiple introductions of SARS-CoV-2 into Northern California
AAAS
Genome sequencing of severe acute respiratory syndrome coronavirus 2 outbreaks is valuable for tracing the sources and perhaps for drawing lessons about preventing future outbreaks.
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EMERGING MEDICAL TECHNOLOGIES
 
 
NIH delivering new COVID-19 testing technologies to meet US demand
National Institutes of Health
The National Institutes of Health is investing $248.7 million in new technologies to address challenges associated with COVID-19 testing. NIH’s Rapid Acceleration of Diagnostics initiative has awarded contracts to seven biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September.
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Histology image analysis via AI classifies cancer types, predicts genetic alterations
Clinical OMICs
The ability to accurately identify cancer — and classify cancer types — using machine learning would provide a tremendous advance in cancer diagnostics for both physicians and patients. But that is just one role of many that machine learning can play in cancer.
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Ready player one: The marriage of video games and medical technology
Verdict Medical Devices
From occupational therapy to clinician training, gaming is becoming an increasingly popular way to help make medical procedures and information more fun and engaging. Chloe Kent takes a closer look into these projects to find out how video games are being used in medical settings.
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BIOTECH/DIAGNOSTICS/PERSONALIZED MEDICINE
 
 
New multi-analyte blood test may open up new potentials in personalized medicine
News-Medical.Net
Similar to blood sugar, various biomarkers could in future be identified using just a few drops of blood. Researchers at Ruhr-Universität Bochum are developing a multi-analyte test strip for this purpose that will open up new potentials in personalized medicine by facilitating the continuous measurement of various parameters.
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The road to COVID-19 testing: The role of a Canadian biotech pioneer
Medical Xpress
Canadians are updated daily on the multi-faceted devastation caused by SARS-CoV-2 and on the results of COVID-19 testing from across the country. Few people may be aware that these tests are based on a method innovated by the first-ever biotech company, Cetus, co-founded in California by Canadian-born and educated Ron Cape. He was Cetus's first president in 1971, and then chairman and CEO.
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RENEGERATIVE MEDICINE
 
 
Researchers discover stem cells in the optic nerve that enable preservation of vision
Medical Xpress
Researchers at the University of Maryland School of Medicine have for the first time identified stem cells in the region of the optic nerve, which transmits signals from the eye to the brain. The finding, published this week in the journal Proceedings of the National Academy of Sciences, presents a new theory on why the most common form of glaucoma may develop and provides potential new ways to treat a leading cause of blindness in American adults.
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3-D printed organs aid vaccine testing
StarTribune
As shortages of personal protective equipment persist during the coronavirus pandemic, 3-D printing has helped to alleviate some of the gaps. But Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, and his team are using the process in a more innovative way: creating tiny replicas of human organs — some as small as a pinhead — to test drugs to fight COVID-19.
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MANAGED HEALTHCARE NEWS
 
 
Performance transparency will make the payer-provider relationship less adversarial
Fierce Healthcare
As more and more payers move the majority of their provider contracts to value-based payment models, there’s little doubt that the relationship between the two parties will continue to be adversarial. It’s hard not for it to be, as reimbursement discussions are normally part of the vicious cycle. The big question is whether it would be less combative with more transparency, and if so, how?
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Commercial high deductible plans may not impact member outcomes
Xtelligent Healthcare Media
Contrary to expectations, there may not be a correlation between deductible costs and member outcomes for commercial high deductible plans, according to a study published in JAMA Open Network. The study looked at commercial and Medicare Advantage plans over a span of more than a decade.
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FDA: NEW TREATMENTS AND TECHNOLOGY
 
 
FDA addresses endotoxin levels in investigational cancer treatments
Regulatory Focus
Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the U.S. Food and Drug Administration. The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug.
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Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: Use as an endpoint to support accelerated approval
FDA
This guidance is intended to assist sponsors in designing trials to support marketing approval of drugs and biological products for the treatment of high-risk early-stage breast cancer in the neoadjuvant setting. The main focus of the guidance is to discuss the use of pathological complete response in high-risk early-stage breast cancer as a potential endpoint to support approval under the accelerated approval regulations.
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ACCOUNTABLE CARE ORGANIZATIONS
 
 
CMS to begin recouping COVID-19 Medicare loans
Healthcare Dive
The Medicare Accelerated and Advance Payment Programs speeds Medicare payments to providers in times of emergency, based on historical payments. It's been a godsend in lessening the immediate financial pressure on providers, but the tight repayment window sparked calls from providers for further relief from the administration.
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Wide support for House bill to boost CMS alternative pay models
Medscape
A newly introduced House bill designed to strengthen the Medicare Shared Savings Program and other Advanced Alternative Payment Models of the Centers for Medicare & Medicaid Services has gained the support of 13 national health stakeholder groups, it was announced on July 24.
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NAMCP UPDATES
 
 

In late 2018, the National Association of Managed Care Physicians (NAMCP) decided to create the Value Based Care Council (VBCC). The VBCC mission supports empowering medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. The goal is to improve the integration of cost, quality, and access in the clinical decision making process so as to enhance the effectiveness and efficiency of extracting value from the associated spend in order to optimize outcomes.

Pursuant to the above, and in response to an unmet need in the marketplace, the VBCC developed a short form in order to enhance the effectiveness and efficiency with which value propositions can be shared between industry and the medical leadership of various payers throughout the country. This same short form provides a concise and consistent manner with which value propositions can be shared and provides the ability to align expectations prior to actually conducting conversations or having a meeting regarding a product or service.

The Product Value Proposition Customer Engagement Short Form can be found on the NAMCP website (www.namcp.org) in the Value Based Care Council subsection of the Councils tab, under tools and resources. Please contact Will Williams at wwilliams@namcp.org with questions or for additional information.


Jazz Pharmaceuticals is excited to announce the approval of ZEPZELCA™ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. ZEPZELCA is a second-line therapy that has been studied in both platinum-sensitive and -resistant SCLC patients. Please click here for more information.


Takeda Pharmaceuticals is part of, "The Fight Is In Us", an initiative to maximize the individual and societal benefit of COVID-19 plasma. The campaign will focus on recruiting COVID-19 survivors to donate their plasma at licensed blood and plasma donor centers.
  • If you’ve recovered from #COVID19, your immune system has antibodies that could be used as a treatment. See if you can help others by donating plasma www.TheFightIsInUs.org. #TheFightIsInUS

  • The antibodies that helped you or someone you know fight off COVID-19 may be able to help others. Visit www.TheFightIsInUs.org to see if you qualify to donate plasma. #TheFightIsInUs
You are a survivor, now you could be a hero. Plasma from recovered #COVID19 patients could play a key role in creating a potential therapy for coronavirus. Learn how you can donate at www.TheFightIsInUs.org #TheFightIsInUs


Biodesix, Inc., a leading diagnostic company in lung disease, recently announced a partnership with Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to bring a COVID-19 Droplet Digital PCR (ddPCR) test to the FDA for an Emergency Use Authorization (EUA) approval to support the escalating need for testing in the U.S. Two studies published this month, ahead of peer review, reported that ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2 (the virus that causes COVID-19) compared to existing test methods that are performed using qPCR. Biodesix currently has a focus on lung disease and offers other diagnostic testing for lung cancer utilizing the ddPCR platform.Click here for more information.


"Modeling Cost-Effectiveness of On-Demand Treatment for Hereditary Angioedema Attack" was recently published in the Journal of Managed Care Pharmacy's February 2020 issue. Hereditary angioedema (HAE) is a rare disease that causes painful and potentially fatal episodes of swelling (attacks). HAE attacks can be unpredictable and the need to treat sudden attacks promptly and effectively is critical to minimize risk of hospitalization, morbidity, and mortality. A cost-effectiveness model was evaluated that considers evaluation of on-demand medications, healthcare utilization and patient well-being. For access to the publication, please click here.


Biodesix, Inc. announced initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc. The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO®) (avelumab). Development efforts will now focus on transferring the test into Biodesix's CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex™ artificial intelligence (AI) platform. Click here to read the full press release.


The NAMCP Medical Directors Institute recently held the first meeting of its Executive Leadership Council (ELC) at the recent Fall Managed Care Forum. The NAMCP Medical Directors Institute decided in late 2018 to create the Value Based Care Council (VBCC) with a mission to empower medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. Click here to view an overview of the genesis, formation, and work of NAMCP's Value Based Care Council. Please click here to view the press release.


LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced the first patient enrolled in "A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression" (RECOVER). The study will evaluate Vagus Nerve Stimulation Therapy (VNS Therapy) for Treatment-Resistant Depression (TRD) in accordance with the U.S. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination as part of its Coverage with Evidence Development Program. The first patient was enrolled by Dr. Azfar Malik in St. Louis. Click here to read the full press release.


Biodesix, Inc. this week highlighted findings from multiple studies demonstrating the significance and clinical utility of its VeriStrat® blood-based proteomic test as a predictive biomarker for patient survival outcomes and as a diagnostic tool to improve the clinical management of patients with non-small cell lung cancer (NSCLC). This information is vital to implementing optimal treatment strategies for patients and supports disease state monitoring. To date, VeriStrat testing has helped more than 50,000 patients in determining the best treatment for their lung cancer. Click here to see the full press release.
 
 
Genomics Biotech and Emerging Medical Technologies Institute eBrief
 
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