StemCell Therapy

The blood-brain barrier in healthy people is a powerful shield that protects neurons from harmful invaders. But in people with multiple sclerosis (MS), that shield malfunctions, allowing B cells from the immune system to pass into the brain and destroy healthy tissues.

Scientists at the University of Montreal Hospital Research Centre (CRCHUM) have identified a new target that they suggest could be exploited to slow down the flow of B cells into the brains of people with MS. They reported the discovery in the journal Science Translational Medicine.

B cells produce a substance called activated leukocyte cell adhesion molecule (ALCAM) that allows them to migrate into the brain via blood vessels, the researchers found. Blocking ALCAM in mouse models of MS reduced the flow of B cells into the brain and slowed the progression of the disease, they reported.

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RELATED: How new gene discoveries could guide precision medicine in multiple sclerosis

B cells are a major culprit in progressive MS, the most severe form of the disease, and there are drugs on the market designed to deplete them, including Roches Ocrevus. Novartis is in phase 3 trials of Arzerra (ofatumumab), a drug that eliminates B cells by binding to the surface protein CD20. Arzerra is approved to treat chronic lymphocytic leukemia, but Novartis has been gunning for a bigger market opportunity. In September, it released new phase 3 data showing that Arzerra reduced MS relapse rates by more than 50% when compared to Sanofis Aubagio.

Meanwhile, several academic teams are looking to genetics as a path to personalized MS treatment strategies. In October, researchers at Johns Hopkins reported that newly discovered variants in the genes C1, CR1 and C1QA are associated with vision loss in progressive MS. They believe further research into these complement genes could lead to the development of new MS therapies.

Blocking ALCAM could also offer a promising strategy for thwarting B cells in MS, said University of Montreal Professor Alexandre Prat, Ph.D., in a statement. "The molecule ALCAM is expressed at higher levels on the B cells of people with multiple sclerosis, he said. By specifically targeting this molecule, we will now be able to explore other therapeutic avenues for the treatment of this disease."

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Halting the progression of multiple sclerosis by blocking harmful B cells - FierceBiotech

LONDON, Nov. 14, 2019 Lifebit Biotech, a leading innovator in bioinformatics and cognitive software solutions, and Medley Genomics, a company focused on using advanced data analytics to support better diagnosis and treatment of complex diseases, announced today their partnership agreement. The Lifebit-Medley partnership aims at removing the barriers impeding progress in precision medicine where advanced biomedical analysis tools, like HotNet2, must be deployed over distributed and complex data to arrive at breakthrough insights.

Lifebit CEO, Dr Maria Chatzou Dunford, said, We are thrilled to announce our partnership with Medley Genomics, which allows us to bring advanced tools to the biomedical research community, advancing knowledge by powering the investigation of new diagnostic and therapeutic opportunities. Any company or researcher can now discover disease driver genes and novel pathways by utilising the high performance HotNet2 at enterprise scale and over distributed cohorts of patient data without needing to move the data.

Developed by Medley co-founder Dr Ben Raphael, HotNet2 assesses the complex heterogeneous genomic landscape across patient cohorts, including the long tail of disease relevant genes, by building significantly mutated gene subnetworks based on mutational frequencies and known interaction networks. Because HotNet2 comes with many dependencies, installation was complex without Lifebit CloudOS. To increase the power of analysis, experimental setups need to include as many samples as possible. Unless users have endless resources to spend on sequencing and data generation, they would need to combine disconnected data from various public and private sources, presenting a major obstacle to progress.

With Lifebit CloudOS, HotNet2 now runs over distributed data using federated capabilities, providing immediate access to infinite compute resources, said Dr Patrice Milos, Medley Genomics CEO. Increasingly our customers are applying HotNet2 to define subgroups within their patient disease cohorts and to reveal novel biological pathways. Our partnership with Lifebit enables us to reach countless more researchers across our shared communities helping them to simplify their work processes and ultimately bring important discoveries to patients faster.

By deploying HotNet2 with Lifebit CloudOS, analyses are seamlessly executed and distributed data is united through federated analysis data is never transferred and security is assured. This is critical as analyses can run at sample-level within the users cohort or across different patient cohorts, without compromising the data by moving them outside their secure environment. Detailed reports can be generated at scale, including visualizations for each run, and instantly shared for true collaboration across teams. The HotNet2 solution is available to anyone via the Lifebit CloudOS Marketplace.

About Lifebit

Leading life sciences organisations are accelerating their research and discoveries with Lifebit. Lifebit CloudOS is the federated, integrated solution for fully FAIR omics and biomedical analysis, allowing anyone to streamline and scale analyses faster, cheaper, and securely in their own data environments. Lifebit AI-Engine has deep-learned the biology behind drug response and is helping pharmaceutical companies repurpose drugs, validate targets and optimise vaccines by reasoning about omics data like humans would. Headquartered in London, UK, Lifebits ecosystem of employees, partners, and customers spans 15 countries. Visitlifebit.aiLifebit press contact:[emailprotected]

About Medley Genomics

Medley Genomics Inc., based in Providence, Rhode Island, US, provides cutting edge algorithms and software to deliver on the promise of individualization of therapy. The companys approaches provide deep insight into the heterogeneity of disease as well as defining unique disease mechanisms across disease cohorts. Applied first in oncology, these insights are necessary for optimizing targeted and combination therapies, personalized cancer vaccines and immunotherapies to effectively treat the total disease burden and offer hope of lasting cures for patients. Visit Medleygenomics.com Medley press contact:[emailprotected]

Source: Medley Genomics

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Lifebit, Medley Genomics Partner to Deliver Solution Supporting Diagnostic and Therapeutic Discoveries - HPCwire

TOKYO & BASEL, Switzerland & MANNHEIM, Germany--(BUSINESS WIRE)--NEC Corporation (NEC; TOKYO: 6701), a leader in IT and network technologies, and VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that the companies have signed a strategic clinical trial collaboration agreement and an equity investment agreement to develop novel personalized neoantigen cancer vaccines.

Under the terms of the collaboration agreement, which is non-exclusive to both parties, NEC will provide funding for a Phase I clinical trial. NEC and VAXIMM will co-develop personalized cancer vaccines using NECs cutting-edge artificial intelligence (AI) technology, which is utilized in its Neoantigen Prediction System, and VAXIMMs proprietary T-cell immunotherapy technology. The vaccines are planned to be evaluated in a Phase I clinical trial in various solid tumors. VAXIMM will be responsible for conducting the clinical trial, which is expected to be initiated in 2020.

NEC has the option for development and commercialization rights to the program worldwide, except for China and other Asian territories outside of Japan.

Osamu Fujikawa, Senior Vice President, NEC Corporation, said: Cancer is consistently one of the most serious healthcare challenges, with millions of new cases diagnosed worldwide annually. NECs core technology is well positioned for the development of personalized medicine, and we are strongly committed to delivering effective treatments for cancer patients. We are delighted to be working with VAXIMM in order to develop an optimal immunotherapy for each individual patient.

Heinz Lubenau, PhD, Chief Operating Officer and Co-Founder of VAXIMM, said: We are excited to enter this alliance with NEC and to have their strong support of VAXIMM. NECs novel AI technology will enable not only the identification but also the prioritization of neoantigens from each patient, facilitating the optimal potential treatment for each individual. Once the list of neoantigens is available, we will be able to apply our technology to quickly produce a personalized vaccine. Individualized therapy is at the cutting edge of cancer treatment today, and, with this collaboration, we are able to further contribute to this approach.

Notes:

About NECs AI Drug Development BusinessFor more information, please visit https://www.nec.com/en/global/solutions/ai-drug/

About NEC's Neoantigen Prediction SystemNECs neoantigen prediction utilizes its proprietary AI which is combined with NEC OncoImmunity ASs bioinformatics pipelines making it the leading neoantigen prediction system in the field. NEC comprehensively evaluates candidate neoantigens, which allows it to effectively prioritize numerous candidate neoantigens identified in a single patient.

Press release:NEC acquires Norwegian bioinformatics company, OncoImmunity AShttps://www.nec.com/en/press/201907/global_20190729_01.html

About NEC CorporationFor more information, visit NEC at http://www.nec.com.

About VAXIMMFor more information, please see http://www.vaximm.com.

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NEC and VAXIMM Announce Collaboration to Advance Personalized Neoantigen Cancer Vaccines - Business Wire

Which genetic changes predispose to disease? How do characters in a novel relate to each other? Which wine and cheese go well together?

Turns out, theres an app for that and its about to become far more versatile as University of Toronto researchers work to release it to a wider community with the support of the Chan Zuckerberg Initiative.

CalledCytoscape, the software in question is already an essential tool for viewing networks in biology, including gene networks that hold clues about how different genes co-operate to sustain health and how these networks change in disease. But like most research software, its currently a desktop application that has to be installed and updated, and doesnt work on phones or tablets.

Today, the Chan Zuckerberg Initiative announced it is providingU of TsGary BaderandHannesRst, both researchers at the Donnelly Centre for Cellular and Biomolecular Research, with US$150,000 each to create a cloud-based Cytoscape and Open MS.Co-founded by Facebook chief executive Mark Zuckerberg and his spouse, Priscilla Chan, the initiative seeks to harness technology to accelerate progress in science.

The future of data analytics should be that it is easier to do, easier to share information and it should be easier for people to collaborate, says Bader, a professor of computational biology who is cross-appointed to the department of molecular genetics in the Faculty of Medicine and the department of computer science in the Faculty of Arts & Science, andholds the Ontario Research Chair in Biomarkers of Disease.

Just as web-based cloud computing has transformed how we listen to music and store data, Bader, whose team is developing the web-based Cytoscape Explorer, says that freedom fromhaving to keep track of files and e-mail them back and forth will boost creativity and speed up science.

Because your document lives on the cloud, the latest version is already there, and you can access it anytime, anywhere. It makes it easier to see what everyone else is doing and youre exposed to more ideas that changes the way you do things in a positive way.

Initially designed for genomics researchers, Cytoscape incorporates the basic principles of network theory and can be easily adapted for other applications. Besides biology, it has been used in business, social studies and marketing, as well as mapping how characters in an epic science fiction novel relate to each other.

We are building the foundation for other people to do research,saysHannesRst,an assistant professor of computational biology at the Donnelly Centre(photo by Jovana Drinjakovic)

Bader even adapted the softwareto find optimal wine and cheese combinations for a dinner party.

Research analytics have been slow to move to the cloud because it is difficult to obtain funding purely for software development unless it promises to reveal new insights. Yet cloud analytics are desperately needed to support increasingly collaborative research often involving teams scattered around the world.

We are building the foundation for other people to do research, says Rst, an assistant professor of computational biology who is also cross-appointed to the departments of molecular genetics and computerscience, and whose team is developingOpenMS, a free tool for biomarker analysis.

With more than one million downloads since launching in 2001, Cytoscapes popularity is only likely to grow with the move to the cloud.

We really think that making this available on the web will allow users who never previously discovered the software, and never used it on the desktop, to easily access it, says Bader, who joined the Cytoscape team in the early 2000s and is leading the newly funded project with Dexter Pratt, a software engineer in the group of Trey Ideker, a professor at the University of California, San Diego, and a co-founder of Cytoscape.

If scientists knew what healthy looked like at the molecular level, they might be able to spot disease as it begins to develop and potentially halt it.

Molecular profiling of human tissue blood, for example produces vast amounts of complex data calling for sophisticated analysis tools such as OpenMS, a leading free software for the analysis of data produced by mass spectrometry, which identifies and counts molecules based on their unique mass-to-charge ratio.

Composed of a set of algorithms that can be rearranged into different workflows, Open MS can be tailored to individual user data. Butin its current form, it requires a certain level of coding knowledge, discouraging uptake among users without programming experience.

The cloud version will have no such obstacles.

We want to make OpenMS user-friendly, using a graphic user interface where users can click on buttons to start their analysis instead of typing commands on the command line, says Rst, who holds the Canada Research Chair in Mass Spectrometry-based Personalized Medicine.

Programming-savvy users will be able to inspect and modify the source code to their needs.

To set up OpenMS on the cloud, Rst will take advantage of so-called Docker containers, which are sets of code that enable standardized software packaging so that it runs the same way on any platform.

The software will be hosted on Niagara, a supercomputer cluster at U of T and part of ComputeCanada, the high-performance computing infrastructure established by the federal government.

The overarching goal of Rsts research is to identify early biomarkers of diabetes and cancer.

We want to take peoplesbody fluids and generate a metabolic profile that we can track over time how people change, he says.

His team recently acquired a state-of-the-art mass spectrometry instrument worth $1 million, with support from the Canada Foundation for Innovation and U of Ts Faculty of Medicine. The instrument, referred to among lab members as the space ship for its futuristic look, can detect trace amounts of biomolecules for more accurate profiling.

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With the help of Chan Zuckerberg Initiative, U of T researchers develop data tools to accelerate science - News@UofT

More powerful than the march of mighty armies is an idea whose time has come

Victor Hugo

The intellectual legacy of Rosamund Snow

Rosamund Snow was a social scientist with type 1 diabetes; she was an academic at the University of Oxford and a Patient Editor for The BMJ. She led the field in questioning conventional approaches to patient and public involvement in research and in mainstreaming a patient-led way of doing research.

Rosamunds PhD was entitled The role of patient expertise inside and outside the health system. She addressed, from the patients perspective and using critical social science methodology, what it was like to attend a diabetes clinic. [1] This work led to a widely-cited academic paper What happens when patients know more than their doctor? which addressed knowledge imbalances between educated patients and non-specialist GPs. [2] She was critical of partnership approaches to research priority-setting, which she viewed as both tokenistic and paternalistic (she claimed that patients had been accused, for example, of proposing the wrong kind of research questions). [3] At The BMJ, she led a radical re-engineering of processes for including the patient voice in the journal. She co-authored (with me) another highly-cited paper addressing the question of whether evidence-based medicine is biased against the patient. [4]

Tragically, Rosamund died on 2nd February 2017. Her parents made a significant financial donation to help create an institute in her memory; this funding is being used to pump-prime the initiative with some doctoral fellowships. The applications are still open until January 2020. [5]

Patient involvement in researcha brief history

There is a well-described mismatch between the research that is done on a particular condition and the research that patients themselves would like to see done. [4,6] Formal research priority-setting partnerships aim to reduce this mismatch by involving patients in the selection of topics for research. [7, 8] The National Institute for Health Research (NIHR) has strongly supported patient and public involvement (PPI) in research, produced national benchmarks for PPI,funded INVOLVE (www.invo.org.uk) which promotes patient involvement in all aspects of biomedical research, and written up some exemplar case studies.[9, 10, 11] Co-design and co-delivery of research with patients and communities using partnership models is increasingly popular. [12,13]

While these and similar approacheshave merits, all are designed and run by researchers (with greater or lesser efforts to achieve democratic governance); they are not led by patients. [14] Sarah White distinguishes nominal involvement of patients and the public (undertaken to confer legitimacy on a project), instrumental involvement (to improve its delivery and/or efficiency), representative involvement (to avoid creating dependency) and transformative involvement (to enable citizens to influence their own destiny). [15] Arguably, most of what is called patient involvement in medical research is nominal or instrumental in nature.

Transformative involvement of patients: a question of power

Social scientists have highlighted the persistence of power imbalances when well-meaning clinicians and scientists seek to involve patients in research. [16] In a paper called Beware Zombies and Unicorns, Mary Madden and Ewen Speed cautioned against aligning with an uncritical (instrumental) agenda for PPI and called for models of patient-led research that address fundamental questions about who holds the power and sets the agenda in research. [17] Helga Nowotny, past President of the European Research Council, has highlighted the need to democratise expertise when undertaking science with citizens (everyone is an expertin different aspects of the problem). [18] Such partnerships, run democratically and with careful attention to the processes of governance and power-sharing, would align well with Simon Locks call for a Peoples Research Council. [19]

A different kind of knowledge

Researchers in all fields become patients (and vice versa). Patient-led research may therefore include conventional forms of objective knowledge such as randomised controlled trials or bench science in the researchers own illness. More uniquely, patients bring experiential knowledgethe subjective, lived-body knowledge of what it is like to live with a particular illness or condition.

Experiential knowledge can be systematically explored through phenomenology (the study of what we can discern through our consciousness and senses [20]) and auto-ethnography (the study of ones own experience in an unfamiliar world [21]). Experiential knowledge is complementary to knowledge generated in the laboratory or the clinical trial, potentially producing multiple realities as accounts of the patient experience clash with textbook descriptions of disease or the unsurfaced assumptions of clinicians and researchers. [22]

Another kind of knowledge that is unique to the patient experience (and ripe for research) is the collective knowledge generated by online communities. The growth of the social web has enabled the emergence of large (and increasingly research-aware) communities of individuals with a particular disease. Some of these communities share ideas for research and self-organise to undertake self-experimentation, self-surveillance and even analysis of their own genomic data. [23, 24]

Governing patient-led research: scientific rigour and ethics

If patient groups are to undertake and/or commission research, academic input (to match patients priorities and questions with appropriate theories and methodologies, and to support analysis and writing up) and capacity-building (training patients in research methods and techniques) are surely essential to ensure that patient-led research is scientifically defensible (and hence has credibility with clinicians and policymakers). [25,26]

The question of what counts as scientific rigour may itself be contested if the term is defined narrowly using the traditional scientific criteria of objectivity and distance. Martha Nussbaum, for example, has vigorously challenged the (arguably, flawed and gendered) view of science as necessarily dispassionate, uninvolved and emotionless; she considers emotion to be a dimension of scholarship without which science is impoverished and uncreative. [27]

Patient-led research raises both similar and different ethical challenges to conventional research. A comparison of patient-led research with standard research, for example, revealed six areas that are of potential relevance to ethical oversight: institutionalization, state recognition and support, incentive structures, openness, bottom-up approach, and self-experimentation. [23]

The productive role of conflict

In the best research programmes, the (productive) conflicts generated when patients experiential knowledge meets conventional research paradigms not only informs the wider research agenda, but transforms conventional researchers into more creative scientists who prioritise different questions and study them in imaginative and flexible ways. Vololona Rabeharisoa distinguishes between conventional researchers in the lab and patient groups, which she calls researchers in the wild. [22] Citing her own empirical work on the research interactions in rare diseases, she comments:

We witnessed the trajectory of scientists who had started on the bench as biologists, then, as they exchanged with patient organizations, oriented themselves towards the clinic, and then returned to the bench with new research questions stemming from their observations, enriched by patients observations.

Notwithstanding the potential for such creative conflict, a significant challenge for patient-led research is that it is often (understandably) underpinned by cognitive passionsthat is, deeply-held, emotionally-charged perspectives on a condition. While such passions give energy and focus to a patient-led research agenda, they may mean that patients find it difficult to approach research into their own condition with the equipoise expected in science. However, while one high-profile patient-scientist conflict seemed to generate negative tension (chronic fatigue syndrome [28]); there are many counter-examples of conflicts that were highly productive, including in rare diseases,HIV/AIDS, mental health,and breast cancer. [22,29,30,31]

In short, there are many questionsboth scientific (in the broad sense) and philosophicalthat could be taken forward by an institute for patient-led research.

Whilst substantial additional funds will need to be raised to create a full-blown institute, a preliminary vision for such an institute is set out in Box 1.

Such an institute would:

Trish Greenhalgh is professor of primary care health sciences at the University of Oxford.

Twitter: @trishgreenhalgh

References:

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Trish Greenhalgh: Towards an institute for patient-led research - The BMJ - The BMJ

The use of liquid biopsy and ctDNA is a promising tool designed to improve diagnostic, prognostic and predictive values in many types of tumors. We believe that ctDNA could be a powerful tool to help detect disease earlier and provide information and clarity when additional treatment is not needed.

DANBURY, Conn. (PRWEB) November 14, 2019

A promising new non-invasive diagnostic tool designed to detect womens cancers, even at the earliest stages of disease development or their recurrence, is attracting interest and attention.

Researchers at Danbury Hospitals Rudy L. Ruggles Biomedical Research Institute (Ruggles Research Institute), now part of Nuvance Health, and the Icahn School of Medicine at Mount Sinai have shown that an early detection tool for gynecological cancers, developed by the team, may also be used to determine whether chemotherapy and other invasive treatments are required for patients following an initial diagnosis. According to a just published study in the journal Cold Spring Harbor Molecular Case Studies, researchers believe that circulating tumor DNA (ctDNA) biomarkers can provide an additional source of information that could help avoid both misdiagnoses and prevent overtreatment.

Ovarian cancer is among the most lethal cancers, with 70 percent of women experiencing a recurrence of the disease within 18 months. This poor outcome often follows a grueling treatment regimen which can include surgeries, multiple rounds of platinum-based chemotherapy, radiation, CT and PET scans, biopsies, blood draws and other tests and treatments that affect patients physical and emotional health, well-being and quality of life.

Often described as a silent killer, the majority of women are diagnosed at the later stages of the disease. Further, diagnosing ovarian cancer presents unique challenges for physicians as symptoms are often non-specific, such as abdominal bloating, indigestion, changes in appetite, and back pain. Researchers from the Ruggles Research Institute and the Icahn School of Medicine at Mount Sinai believe that liquid biopsy, using personalized ctDNA biomarkers based on an individuals specific tumor genetic signature, would lead to greater diagnostic accuracy.

The case study focused on a patient who initially presented with an unexplained whole-body rash and multiple uninformative dermatologic examinations, biopsies and treatments which eventually led to a diagnosis of ovarian cancer and surgery. Within a day following her debulking surgery, the rash which the patient had endured over a three-month period resolved. The patient received chemotherapy and she was clinically diagnosed as cancer free. Surprisingly and unexpectedly, one year later the rash reappeared, prompting speculation of tumor recurrence and a concern to initiate aggressive secondary treatment. However, the gynecologic oncology research team sought to use cutting-edge molecular techniques to better examine if her cancer had truly recurred. Using genomics-based testing and bio-banked tumor and blood samples which had been stored from the patient throughout the course of her care, researchers developed exquisitely sensitive and patient-specific ctDNA biomarkers which could detect even traces of her cancer if they were present in her bloodstream. Using these markers, they could demonstrate that no traces of cancer were detectable despite the presence of the patients unexplained rash. No additional treatment or chemotherapy would be prescribed. Now, two years after the patients original surgery, and with additional negative ctDNA findings, the patient remains healthy with no evidence of disease recurrence.

According to Dr. John Martignetti, Director of the Laboratory for Translational Research at the Ruggles Biomedical Research Institute and an expert in human genetics and genomic sciences who led the research team, these results from a preliminary single-case study are encouraging.

The use of liquid biopsy and ctDNA is a promising tool designed to improve diagnostic, prognostic and predictive values in many types of tumors, he said, Based on these results, as well as our longitudinal precision medicine study which includes biobanking of tumor and blood samples from our patients, we believe that ctDNA could be a powerful tool for not only helping to detect disease earlier but just as importantly, to provide information and clarity on when additional treatment is not needed.

Catch up on the latest news at Danbury Hospital.

CONTACTAmy ForniManager, Public Relations203-739-7478Amy.Forni@nuvancehealth.org

Andrea RynnDirector, Public & Government Relations203-739-7919Andrea.Rynn@nuvancehealth.org

About John Martignetti, MD, PhDThe Rudy L. Ruggles Biomedical Research Institutes Laboratory for Translational Medicine is headed by Dr. John Martignetti. He has assembled a research group here at the institute and with his clinical and research colleagues here and at the Mount Sinai Health System has established a state-of-the-art precision medicine program linking gynecologic/oncology patient clinical care and genomic information to improve treatment and surveillance.

About the Rudy L. Ruggles Biomedical Research InstituteRudy L. Ruggles Biomedical Research Institute at Western Connecticut Health Network, now part of Nuvance Health, aims at advancing the health of our community by performing innovative translational research with the goal of improving the current standard of patient care. The Rudy L. Ruggles Biomedical Research Institute includes a team of renowned scientists known for their groundbreaking work and expertise in various research disciplines that include Cancer and Lyme disease. The research institute encourages scientific collaboration/partnerships with other research organizations in an effort to pioneer discovery and foster creative thinking. Research institute's leadership and management team are committed to promoting excellence in research by attracting highly qualified researchers, residents and physicians to the institution.

About Nuvance HealthNuvance Health is a family of award-winning nonprofit hospitals and healthcare professionals in the Hudson Valley and western Connecticut. Nuvance Health combines highly skilled physicians, state-of-the-art facilities and technology, and compassionate caregivers dedicated to providing quality care across a variety of clinical areas, including Cardiovascular, Neurosciences, Oncology, Orthopedics, and Primary Care.

Nuvance Health has a network of convenient hospital and outpatient locations Danbury Hospital, New Milford Hospital, Norwalk Hospital and Sharon Hospital in Connecticut, and Northern Dutchess Hospital, Putnam Hospital Center and Vassar Brothers Medical Center in New York plus multiple primary and specialty care physician practice locations, including The Heart Center, a leading provider of cardiology care, and two urgent care offices. Non-acute care is offered through various affiliates, including the Thompson House for rehabilitation and skilled nursing services, and the Home Care organizations. For more information about Nuvance Health, visit our website.

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Danbury Hospital Researchers On Track Developing Tool For More Precise Diagnosis Of Gynecologic Cancers - PR Web

Third Quarter Revenue Grew 34% Over the Prior Years Quarter and 25% Year to Date

Acquired BioPharma Business in Partnership with Ampersand

Diagnostic Test Volume Grew 16% for the Quarter and 22% Year to Date

Conference Call and Webcast Wednesday November 13, 2019 at 4:30 pm ET

PARSIPPANY, NJ, Nov. 13, 2019 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. (formerly Interpace Diagnostics Group, Inc.) (Nasdaq: IDXG), a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications, announced today that it has changed its name to Interpace Biosciences, Inc. to better reflect its new business model that combines its traditional esoteric molecular diagnostic business with its recent acquisition of the BioPharma business of Cancer Genetics (CGIX), now known as Interpace Pharma Solutions, that uses its proprietary test systems and platforms to support drug discovery and development valued by pharmaceutical and biotechnology companies. Interpace Biosciences will continue to trade on NASDAQ as IDXG.

Interpace Biosciences recognized $7.7 million in Net Revenue for the quarter and $20.0 million year to date. Our Diagnostics business had volume growth of 16% for the quarter and 22% year to date. Medicare and contracted reimbursement remained strong and continued to grow across both products.

On July 15, 2019 Interpace closed on the acquisition of the BioPharma business of Cancer Genetics and accordingly from that date forward the BioPharma business is being reported in the results of operations of Interpace Biosciences. Further, on October 16, 2019 Interpace Biosciences closed on the $13 million second tranche round of financing with Ampersand Capital Partners (Ampersand) and on October 24th we completed settlement with Cancer Genetics under the Net Working Capital Adjustment as planned. We are now moving forward together as one company!

Certainly part of our rationale in acquiring the BioPharma business was risk diversification of our customer base and revenue stream but more importantly it was to take advantage of the synergies between these two businesses as cancer therapeutics move toward earlier stage treatment, require customized services and obligate many therapeutic companies to match their targeted therapies with companion diagnostics. Today, Interpace Pharma Solutions is involved in over 225 clinical trials including approximately 47 immuno-oncology trials. Focusing on the Pharma Solutions business, contracts are growing and bookings have been recorded through September 30, 2019 worth over $18 million that are expected to be recognized over the next year or more. Our near-term growth plans are to add additional business development personnel in key unserved markets, expand our immuno-oncology franchise and accelerate global expansion as recently indicated by our partnership with Genecast in Bejing, China.

We think that the combination of the Interpace Diagnostics and Interpace Pharma Solutions businesses, now under the Interpace Biosciences umbrella, is a great platform to leverage our broad based and synergistic capabilities, and deliver consistent growth. The addition of Ampersand as a significant financial and strategic partner and investor in Interpace Biosciences we believe provides validation of our model and plans as well as the basis for supporting future synergistic growth. Interpace Biosciences has demonstrated its ability to not only acquire meaningful assets but to also cost effectively integrate assets while continuing to grow.

During the third quarter we continued to drive volume growth across our products and completed the acquisition of the BioPharma business of Cancer Genetics (CGIX). We are especially pleased to be partnering with Ampersand Capital Partners, one of the best known and most successful funds in the laboratory services space, said Jack Stover, President & CEO Of Interpace. The transition process is happening on schedule and our goal, as previously stated, is to reach adjusted EBITDA breakeven before the end of next year, Stover said.

THIRD QUARTER 2019 FINANCIAL PERFORMANCE

For the Third Quarter of 2019 as Compared to the Third Quarter of 2018

-- Net Revenue was $7.7 million which included revenues of both our Diagnostics and Pharma Solutions business for part of the quarter, an increase of 34%; -- Gross Profit was 37%, a decrease compared to 52% primarily due to the acquisition of the BioPharma business and the reduction in the estimate of amounts to be collected resulting from our transition to a new billing and collections contractor. -- Sales & marketing expenses increased $0.7 million to $2.8 million; -- G&A Expenses were $4.5 million as compared to $2.1 million again related principally to our BioPharma acquisition and certain non-cash charges; -- Acquisition-related costs were $0.8 million in the current quarter with no such costs in the prior year; -- Loss from Continuing Operations was $(7.3) million as compared to $(3.0) million; -- Net Loss per basic and diluted share was $(0.19) versus $(0.11); -- Adjusted EBITDA was $(4.2) million as compared to $(1.0) million; and -- Net cash used in operations for the quarter was $(4.8) million as compared to $(1.8) million.

For the Nine Months Ended September 30, 2019 as Compared to the Nine Months Ended September 30, 2018

-- Net Revenue increased to $20.0 million, a 25% improvement; -- Gross Profit decreased to 48% from 53%; -- Sales & Marketing expenses increased $2.0 million or 33%; -- G&A expenses were $9.8 million as compared to $6.0 million due principally to costs associated with the BioPharma acquisition; -- Acquisition-related costs were $2.4 million with no such costs in the comparable period for the prior year; -- Loss from Continuing Operations was $(16.0) million as compared to $(8.0) million; -- Net Loss per Share was $(0.43) as compared to $(0.29); -- Adjusted EBITDA was $(7.7) million as compared to $(3.4) million; and -- Net cash used in operations was $(12.6) million as compared to $(6.8) million.

Cash and cash equivalents were $2.4 million as of September 30, 2019 before the closing of the second tranche financing with Ampersand on October 16th, 2019. From the proceeds received from the second closing with Ampersand, approximately $3.75 million was used to repay the balance in the revolving credit line, $6.02 million was used to repay the note to Cancer Genetics and the balance was used for general corporate purposes including the integration of the BioPharma business. Further, on September 20, 2019, the Company entered into an Equity Distribution Agreement with Oppenheimer & Co. Inc., as sales agent, pursuant to which the Company may, from time to time, issue and sell shares of its common stock with an aggregate offering price of up to $4.8 million.. To date, no shares have been sold under this Agreement.

Adjusted EBITDA (in the attached schedule), which we believe is a meaningful supplemental disclosure that may be indicative of how management and our Board of Directors evaluate Company performance, is defined as income or loss from continuing operations, plus depreciation and amortization, non-cash stock based compensation, interest and taxes, and other non-cash expenses including asset impairment costs, non-recurring acquisition and transition expenses, loss on extinguishment of debt, goodwill impairment, change in fair value of contingent consideration and warrant liability.

RECENT BUSINESS HIGHLIGHTS

Secured Additional Financing via Ampersand Capital Partners and Acquisition of BioPharma Business

Closed on a $13 million Convertible Preferred Stock investment by Ampersand constituting the second tranche of the overall $27 million Convertible Preferred Stock financing provided by Ampersand to Interpace in connection with Interpaces July 15, 2019 acquisition of the BioPharma Business of Cancer Genetics, Inc. (CGIX).

Reimbursement Expansion Announced

In September we announced that we contracted with 3 independent Blue Cross Blue Shield (BCBS) plans in the South and Southwest totaling nearly 5 million covered lives; -- Announced diagnostic contract agreement with BCBS plans of Michigan and California; -- Announced agreement with SelectHealth to provide ThyGeNEXT and ThyraMIR in Utah and Idaho to more than 850,000 members; and; -- Announced that THyGeNEXT and ThyraMIR are now covered by Independence Blue Cross for its nearly 2.5 million members in Philadelphia and Southeastern PA.

Clinical Validation Announcements

-- Announced the publication of two peer-reviewed journal articles and one textbook chapter supporting the clinical utility of ThyGeNEXT when used alone and in combination with ThyraMIR; -- Presented new data on the performance of ThyGeNEXT and ThyraMIR at the American Thyroid Assn Annual Meeting in October; -- Presented new data on the performance of PancraGEN at the American College of Gastroenterology in October; and -- Presented at the World Congress on Thyroid Cancer in Rome on detail outcomes of a study using our thyroid assays in combination with microRNA testing.

Other

-- Entered into a strategic partnership with Genecast to partner biopharma solutions in China; -- Interpace named one of the 50 Most Admired Companies of the Year by Silicon Review; and -- Entered into agreement with Predictive Oncology to evaluate diagnosis of thyroid cancer via AI-driven analyses.

UPDATED NET REVENUE GUIDANCE

Interpace is adjusting its 2019 annual Net Revenue guidance to between $28 and $32 million as we continue to transition the BioPharma business and prepare for our first full year together. Interpace Biosciences is also confirming top-line revenue guidance of $50 million for 2020.

CONFERENCE CALL INFORMATION Interpace will hold a conference call and Webcast on Wednesday, November 13, 2019, at 4:30 pm ET to discuss financial and operational results for the third quarter ended September 30, 2019. Details are as follow:

Date and Time:Wednesday, November 13, 2019 at 4:30 pm ET Dial-in Number (Domestic):(877) 407-0312 Dial-in Number (International):+1 (201) 389-0899 Confirmation Number:13690534 Webcast Access:https://webcasts.eqs.com/interpacedia20190513/en

The webcast replay will be available on the Companys website approximately two hours following completion of the call and archived on the Companys website for 90 days.

About Interpace Biosciences

Interpace Biosciences is a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Interpace Diagnostics is a fully integrated commercial and bioinformatics business unit that provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management.

Interpace Pharma Solutions provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries and advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.For more information, please visit Interpaces current website at http://www.interpacediagnostics.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Companys future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including believes, estimates, anticipates, expects, plans, projects, intends, potential, may, could, might, will, should, approximately or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Companys control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Companys actual results to be materially different from those expressed or implied by any forward-looking statement, including that there is no assurance that the acquisition of the BioPharma business will be successfully integrated with the Company, that the potential benefits of the acquisition, including future revenues, will be successfully realized, that other potential acquisitions will be successfully consummated, that the Company will be able to maintain its Nasdaq listing and that the Company will be able to meet its revenue projections. Additionally, all forward-looking statements are subject to the Risk Factors detailed from time to time in the Companys most recent Annual Report on Form 10-K, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Contacts: Investor Relations Edison Group Joseph Green (646) 653-7030 jgreen@edisongroup.com

Non-GAAP Financial Measures

In addition to the United States generally accepted accounting principles, or GAAP, results provided throughout this document, Interpace Biosciences has provided certain non-GAAP financial measures to help evaluate the results of its performance. We believe that these non-GAAP financial measures, when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors in analyzing the Companys ongoing business and operating performance. We believe that providing the non-GAAP information to investors, in addition to the GAAP presentation, allows investors to view the Companys financial results in the way that management views financial results.

In this document, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management to measure cash flow of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation and amortization, acquisition related expenses, transition expenses, non-cash stock based compensation, interest and taxes, and other non-cash expenses including asset impairment costs, bad debt expense, loss on extinguishment of debt, goodwill impairment and change in fair value of contingent consideration, and warrant liability. The table below includes a reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure.

INTERPACE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except per share data)

Three Months Ended Nine Months Ended September 30, September 30, -------------------- --------------------- 2019 2018 2019 2018 -------- -------- --------- -------- Revenue, net $ 7,725 $ 5,753 $ 20,005 $ 16,062 Cost of revenue 4,835 2,763 10,489 7,590 - ------ - ------ - ------- - ------ Gross Profit 2,890 2,990 9,516 8,472 Sales and marketing 2,757 2,048 8,127 6,135 Research and development 857 510 2,032 1,528 General and administrative 4,492 2,084 9,790 5,981 Acquisition related expense 838 - 2,534 - Acquisition related amortization expense 995 813 2,621 2,439 Total operating expenses 9,939 5,455 25,104 16,083 Operating loss (7,049 ) (2,465 ) (15,588 ) (7,611 ) Accretion expense (111 ) (248 ) (331 ) (248 ) Other income (expense), net (135 ) (288 ) (12 ) (143 ) - ------ - ------ - ------- - ------ Loss from continuing operations before tax (7,295 ) (3,001 ) (15,931 ) (8,002 ) Provision for income taxes 9 7 19 21 - ------ - ------ - ------- - ------ Loss from continuing operations (7,304 ) (3,008 ) (15,950 ) (8,023 ) Loss from discontinued operations, net of tax (58 ) (34 ) (51 ) (129 ) Net loss $ (7,362 ) $ (3,042 ) $ (16,001 ) $ (8,152 ) - ------ - ------ - ------- - ------ Basic and diluted (loss) income per share of common stock: From continuing operations $ (0.19 ) $ (0.11 ) $ (0.43 ) $ (0.29 ) From discontinued operations (0.00 ) (0.00 ) (0.00 ) (0.00 ) - ------ - ------ - ------- - ------ Net (loss) income per diluted share of common stock $ (0.19 ) $ (0.11 ) $ (0.43 ) $ (0.29 ) - ------ - ------ - ------- - ------ Weighted average number of common shares and common share equivalents outstanding: Basic 38,196 28,215 37,169 28,002 Diluted 38,196 28,215 37,169 28,002

Selected Balance Sheet Data (Unaudited) ($ in thousands)

September December 30, 31, -------- -------- 2019 2018 -------- -------- Cash and cash equivalents $ 2,358 $ 6,068 Total current assets 20,581 17,721 Total current liabilities 17,296 8,492 Total assets 74,673 48,442 Total liabilities 37,915 15,504 Total preferred stock 13,161 - Total stockholders equity 23,597 32,938

Selected Cash Flow Data (Unaudited) ($ in thousands)

For the Nine Months Ended September 30, --------------------- 2019 2018 --------- -------- Net loss $ (16,001 ) $ (8,152 ) Net cash used in operations $ (12,556 ) $ (6,800 ) Net cash used in investing activities (13,921 ) (388 ) Net cash provided by (used in) financing activities 22,767 (9 ) - ------- - ------ Change in cash and cash equivalents (3,710 ) (7,197 ) Cash and equivalents, Beginning 6,068 15,199 Cash and equivalents, Ending $ 2,358 $ 8,002

GAAP to Non-GAAP Reconciliation (Unaudited) ($ in thousands) Quarters Ended Nine Months Ended September 30, September 30, ---------------------- ----------------------- 2019 2018 2019 2018 -- ----- - -- ----- - -- ------ - -- ----- - Loss from continuing operations (GAAP Basis) ($ 7,304 ) ($ 3,008 ) ($ 15,950 ) ($ 8,023 ) Acquisition related expense 838 - 2,534 - Transition expenses 836 - 836 - Depreciation and amortization 1,074 870 2,823 2,580 Stock-based compensation 211 525 1,247 1,564 Bad debt expense - - 499 - Taxes - 7 - 21 Accretion expense 111 248 331 248 Mark to market on warrant liability 10 325 -35 259 Adjusted EBITDA (Non-GAAP Basis) ($ 4,224 ) ($ 1,033 ) ($ 7,715 ) ($ 3,351 ) -- ----- - -- ----- - -- ------ - -- ----- -

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Interpace Diagnostics Changes Name to Interpace Biosciences; Announces Plans for Next Phase of Growth and Third Quarter 2019 Financial Results -...

ByKristin Hanson

This article was originally published on Nov. 8 on giving.jhu.edu

Between 2001 and the beginning of 2018, more than 1,500 U.S. military service members lost limbs in the line of duty. Although technology has improved the prosthetic devices these people can use, a stubborn obstacle remains: the fragility of human skin.

"Skin was never meant to hold this kind of pressure," says Lee Childers, the senior scientist for the Extremity Trauma and Amputation Center of Excellence at Brooke Army Medical Center in San Antonio, Texas.

"Think about it like a blister on your foot. It's painful, but you can still get by," he continues. "In an amputation, it's a blister on your residual limb. You can't use your prosthesis until the blister is completely healed. If it's your leg [that is affected], you can't walk for two or three weeks. Think about how that would impact your life."

What if there were a way to make the skin at an amputation site tougher, like the palm of your hand or the sole of your foot? Luis Garza, an associate professor of dermatology at Johns Hopkins and leader of the Veteran Amputee Skin Regeneration Program, is developing a cell therapy that could enable prosthetics wearers to use their devices longer.

"This is an example of personalized medicine," Garza says. "We're taking each person's own cells, growing them up, and inserting them back in."

Garza's postdoctoral research focused on skin stem cells. In 2009, he and his department chair, Sewon Kang, began having conversations about how that work could help the increasing numbers of veterans coming back from war with amputations. Garza and his team received grants from the U.S. Department of Defense, National Institutes of Health, and Maryland Stem Cell Fund that have moved the program forward in the past decade.

Garza's team spent the summer of 2019 testing "normal" subjectsthose without amputationsto perfect the procedure, including the dose, content, method, and frequency of the injections. During one appointment, members of Garza's team took biopsies of skin from a subject's scalp and sole. The cells went to a lab where they were grown under an FDA-approved protocol and passed through quality control tests.

In a second appointment, subjects completed a questionnaire and underwent baseline measurements of their skin's thickness and strength. Garza's team then injected a site on the subjects' skin with the stem cells grown from their cells in the lab.

Image caption: Luis Garza, associate professor of dermatology at Johns Hopkins, leads the Veteran Amputee Skin Regeneration Program.

"We're hoping that these stem cell populations will engraft in the new skin," Garza says.

The subjects returned to Hopkins several months later to go through the questionnaire and measurements once more, and Garza's team documented changes.

Confident in the results they gleaned from the normal subjects, Garza's team enrolled its first subject with an amputation in August. Moving from the normal population to the amputation-affected population quickly unearthed some aspects of the therapy Garza didn't anticipate.

"When we talked with him, he said 'I don't want to mess with my one remaining footdo you have to take skin from there?' And we said, 'Actually, no, we could do your palm,'" Garza says.

His team then tested the biopsy and growth of palm cells from subjects in the normal population. "We're moving away from having our product informed purely by biology to letting our therapy development be shaped by the user."

Although federal grants have supported much of the program's progress, private philanthropy has played a role, too. Corporations like Northrop Grumman, foundations like the Alliance for Veteran Support, and grateful patients with and without ties to the armed forces have contributed nearly $300,000. Those gifts have enabled the program to persevere through gaps between federal grants.

Private funds will be increasingly important as the project enters its next phase: extension to military medical centers around the country. Garza's team must prove that the safeguards to protect cells on their round-trip voyage from a test site to Hopkins are effective. They also must secure approval by local institutional review boards for clinical studies.

"Soldiers are used to getting orders, but you can't order someone to be part of a [medical] study," Garza says. "There are hard medical ethics questions around how to make this open to them but ensure they don't feel obligated. We've been working on that for a year, and we probably have another six months or so to go."

Childers stands ready for whenever the program's extension is a go. He will lead the study at Brooke Army Medical Center and feels motivated by the prospect of helping many of the veterans he works with every day.

"We do everything we can to serve those who serve us. This can enable people to return to duty and be redeployed if they choose," he says. "This is game-changing technology that will have an impact for our service members, but also others who live with amputation."

That population includes the hundreds of thousands of Americans who've undergone amputations for complications of diabetes, who must use a wheelchair, or who wear ankle or foot orthoses for help with walking, among others.

"Having the ability to transform skin anywhere you want to target on the body will have gigantic implications across the entire spectrum of our society in many ways," Childers says.

There's a lot of work to be done before such benefits reach the public, Garza cautions. With continued support from donors and the military community, though, he's optimistic about the program's future.

"The challenges are pretty big, but I think within five years, it could happen," he says. "That's the hope."

Disclaimer: The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of the Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force and Department of Defense or the U.S. Government.

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Serving those who serve - The Hub at Johns Hopkins

NEW YORK, Nov. 13, 2019 /PRNewswire/ --

KEY FINDINGSThe global metabolomics market is predicted to showcase growth at a CAGR of 11.84% during the projected period. The surging chronic diseases, along with the prevalence of cancer, are the major factors influencing the growth of the global market of metabolomics.

Read the full report: https://www.reportlinker.com/p05826891/?utm_source=PRN

MARKET INSIGHTSThe report includes the segmentation on the basis of application, indication, and product & service.The use of metabolomics in studying cancer would be instrumental as it would result in new biomarkers for cancer, which are further used in the diagnosis of the disease.

Also, advancements in personalized medicine aids in a scientific understanding of diseases like cancer and genetic diseases.The development of methodologies has always been given preference when it comes to research activities in nutrition.

This is set to result in huge market growth opportunities in the global metabolomics market. The metabolomics incurs huge costs in terms of instrumentation, and this factor can limit the market growth.

REGIONAL INSIGHTSThe global market with regard to metabolomics is analyzed on the basis of North America, Europe, Asia Pacific, and the Rest of the World.The North American market region is projected to garner the largest market share by the end of the forecast period.

The region has a large presence of several end-users.The market region of Asia Pacific is estimated to record the highest CAGR for the metabolomics market.

The growth is attributed to the presence of economically diverse countries in the region.

COMPETITIVE INSIGHTSThe market has the presence of key players that aid in the growth and revenue of the market. Some of the key players include, Bruker Corporation, Danaher Corporation (Sciex), Bio-Rad Laboratories, Inc., Biocrates Life Sciences Ag, Creative Proteomics, Apical Scientific Sdn Bhd, etc.

Our report offerings include: Explore key findings of the overall market Strategic breakdown of market dynamics (Drivers, Restraints, Opportunities, Challenges) Market forecasts for a minimum of 9 years, along with 3 years of historical data for all segments, sub-segments, and regions Market Segmentation cater to a thorough assessment of key segments with their market estimations Geographical Analysis: Assessments of the mentioned regions and country-level segments with their market share Key analytics: Porter's Five Forces Analysis, Vendor Landscape, Opportunity Matrix, Key Buying Criteria, etc. Competitive landscape is the theoretical explanation of the key companies based on factors, market share, etc. Company profiling: A detailed company overview, product/services offered, SCOT analysis, and recent strategic developments

Companies mentioned1. AGILENT TECHNOLOGIES, INC.2. APICAL SCIENTIFIC SDN BHD3. BIOCRATES LIFE SCIENCES AG4. BIO-RAD LABORATORIES, INC.5. BRUKER CORPORATION6. CREATIVE PROTEOMICS7. DANAHER CORPORATION (SCIEX)8. HUMAN METABOLOME TECHNOLOGIES, INC.9. KORE TECHNOLOGY LIMITED10. LECO CORPORATION11. METABOLON INC.12. PERKINELMER, INC.13. SHIMADZU CORPORATION14. THERMO FISHER SCIENTIFIC INC.15. WATERS CORPORATION

Read the full report: https://www.reportlinker.com/p05826891/?utm_source=PRN

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The region has a large presence of several end-users.The market region of Asia Pacific is estimated to record the highest CAGR for the metabolomics...

CHF 32 Million in Milestone Revenues

Multiple Upcoming Catalysts

Execution Across Clinical and Preclinical Neurodegenerative Development Pipeline

LAUSANNE, Switzerland, Nov. 13, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, today provided a business and clinical update and reported its consolidated financial results for the third quarter of 2019.

Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: AC Immune, together with our leading pharmaceutical partners, is advancing one of the industrys broadest, most diversified development pipelines targeting neurodegenerative diseases. This quarter, we continued to demonstrate strong progress across our pipeline of potentially best-in-class small molecule, antibody, and vaccine therapeutics, as well as our cutting-edge diagnostic agents. This resulted in milestones achieved totaling CHF 32 million which were comprised of CHF 30 million from Eli Lilly and Company and EUR 2 million (CHF 2.2 million) from Life Molecular Imaging.

Prof. Pfeifer continued, We anticipate multiple catalysts in 2019 and 2020, highlighted by expected Phase 2 data for semorinemab, our anti-Tau antibody partnered with Genentech/Roche, which we anticipate will be the first Phase 2 data available for a Tau-targeted therapy in Alzheimers disease (AD). We also anticipate achieving further progress across our development pipeline with both early and late stage data readouts that we believe will build substantial value for the Company.

AC Immunes unique, multi-pronged approach is designed to address the full spectrum of neurodegenerative diseases. By selectively targeting misfolded pathological proteins both intracellularly and extracellularly, and by creating state-of-the-art diagnostic imaging agents that enable early detection of multiple disease pathologies and tracking of disease progression, AC Immune is pioneering a personalized medicine approach to deliver the right therapy to the right patient at the right time.

Research & Development Highlights

Analysis of Financial Statements for the Three and Nine Months Ended September 30, 2019

About AC ImmuneAC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in Precision Medicine for neurodegenerative diseases. The Company is utilizing two proprietary discovery platforms, SupraAntigenTMand MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen Pharmaceuticals Inc.

As a strategic leader in the field of neurodegenerative diseases, AC Immune has developed a five-point Roadmap to Successful Therapies for Neurodegenerative Diseases that recognizes the importance of treating earlier, targeting Tau, focusing on more homogeneous patient populations, precision medicine and exploring neuroinflammation as a target.

For further information, please contact:

Forward-looking statementsThis press release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immunes strategies or expectations. In some cases, you can identify these statements by forward-looking words such as may, might, will, should, expects, plans, anticipates, believes, estimates, predicts, projects, potential, outlook or continue, and other comparable terminology. Forward-looking statements are based on managements current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions Item 3. Key InformationRisk Factors and Item 5. Operating and Financial Review and Prospects in AC Immunes Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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Balance Sheets

Statements of Income/(Loss)

Statements of Comprehensive Income/(Loss)

Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share

(a) Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards fair value recognized for the portion of the equity award which is vesting over the period.

(b) Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.

(c) Effective interest expense for the period relates to the accretion of the Companys convertible loan in accordance with the effective interest method.

(d) Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

For the three and nine months ended September 30, 2019, adjustments increased net income and decreased net income by CHF 0.6 million and CHF 0.9 million compared with decreases to the net losses by CHF 1.9 million and CHF 3.0 million for the comparable periods in 2018, respectively. The Company recorded CHF 0.9 million and CHF 2.0 million for the three and nine months, respectively, for share-based compensation expenses. There were foreign currency remeasurement gains of CHF 0.3 million and remeasurement losses of CHF 0.3 million, respectively, related to foreign currency fluctuations. The Company recorded nil and CHF 1.4 million for amortization of effective interest for the three and nine months ended September 30, 2019, respectively. Finally, the Company recognized nil and a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature.

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AC Immune Q3 2019 Financial Results and Business Update - Yahoo Finance

Personalized Medicine Market Overview:

The recent report added by Verified Market Research gives a detailed account of the drivers and restraints in the Personalized Medicine Market. The research report, titled [Personalized Medicine Market Size and Forecast to 2026] presents a comprehensive take on the overall market. Analysts have carefully evaluated the milestones achieved by the Personalized Medicine Market and the current trends that are likely to shape its future. Primary and secondary research methodologies have been used to put together an exhaustive report on the subject. Analysts have offered unbiased outlook on the Personalized Medicine Market to guide clients toward a well-informed business decision.

The comprehensive research report has used Porters five forces analysis and SWOT analysis to give the readers a fair idea of the direction the Personalized Medicine Market is expected to take. The Porters five forces analysis highlights the intensity of the competitive rivalry while the SWOT analysis focuses on explaining strengths, weaknesses, opportunities, and threats present in the Personalized Medicine Market. The research report gives an in-depth explanation of the trends and consumer behavior pattern that are likely to govern the evolution of the Personalized Medicine Market.

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Personalized Medicine Market: Regional Segmentation

For a deeper understanding, the research report includes geographical segmentation of the Personalized Medicine Market. It provides an evaluation of the volatility of the political scenarios and amends likely to be made to the regulatory structures. This assessment gives an accurate analysis of the regional-wise growth of the Personalized Medicine Market.

Personalized Medicine Market: Research Methodology

The research methodologies used by the analysts play an integral role in the way the publication has been collated. Analysts have used primary and secondary research methodologies to create a comprehensive analysis. For an accurate and precise analysis of the Personalized Medicine Market, analysts have bottom-up and top-down approaches.

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Table of Content

1 Introduction of Personalized Medicine Market

1.1 Overview of the Market 1.2 Scope of Report 1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Personalized Medicine Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Personalized Medicine Market, By Deployment Model

5.1 Overview

6 Personalized Medicine Market, By Solution6.1 Overview

7 Personalized Medicine Market, By Vertical

7.1 Overview

8 Personalized Medicine Market, By Geography8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France 8.3.4 Rest of Europe 8.4 Asia Pacific 8.4.1 China 8.4.2 Japan 8.4.3 India 8.4.4 Rest of Asia Pacific 8.5 Rest of the World 8.5.1 Latin America 8.5.2 Middle East

9 Personalized Medicine Market Competitive Landscape

9.1 Overview 9.2 Company Market Ranking 9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview 10.1.2 Financial Performance 10.1.3 Product Outlook 10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Verified Market Research has been providing Research Reports, with up to date information, and in-depth analysis, for several years now, to individuals and companies alike that are looking for accurate Research Data. Our aim is to save your Time and Resources, providing you with the required Research Data, so you can only concentrate on Progress and Growth. Our Data includes research from various industries, along with all necessary statistics like Market Trends, or Forecasts from reliable sources.

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Tag: Personalized Medicine Market Size, Personalized Medicine Market Growth, Personalized Medicine Market Analysis, Personalized Medicine Market Forecast, Personalized Medicine Market Outlook, Personalized Medicine Market Trends, Personalized Medicine Market Research, Personalized Medicine Market Report

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Personalized Medicine Market Size 2019 By Top Key Players, By Type and Application, Forecast to 2026 - Markets Gazette 24

Data Bridge Market Research Adds Gene Editing Tools Market Industry Trends and Forecast to 2026 new report to its research database. The report spread No of pages:350 No of Figures:60 No of Tables:220 in it.

This report proves to be a useful guide for the individuals related to Gene Editing Tools market as it accommodates data such as advancement patterns, competitive scene examination, and key locales improvement status. Few of the major competitors currently working in theThermo Fisher Scientific Inc.; CRISPR Therapeutics; Editas Medicine; National Human Genome Research Institute; Intellia Therapeutics, Inc.; Merck KGaA; Horizon Discovery Ltd.; GeneCopoeia, Inc.; ERS Genomics; Takara Bio Inc.; New England Biolabs; GenScript among others.

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Global Gene Editing Tools Market is expected to register a healthy CAGR of 17.63% in the forecast period of 2019-2026. The report contains data from the base year of 2018 and the historic year of 2017. This rise in market value can be attributed to the growing preferences in demands for personalized medicine.

The examination is an ideal blend of both quantitative and qualitative data featuring key market augmentations, challenges that industry and rivalry are trying alongside segmentation and new opportunities accessible and pattern in the Gene Editing Tools Market.

Research strategies and tools used of Gene Editing Tools Market:

This Gene Editing Tools market research report helps the readers to know about the overall market scenario, strategy to further decide on this market project. It utilizes SWOT analysis, Porters Five Forces Analysis and PEST analysis.

Breakdown of Gene Editing Tools Market:

The Gene Editing Tools market report performs segmentation which is done on the basis of type, end-user, and manufacturers and applications to fully and deeply research and reveal market profile and prospects.

Understands the Latest Trend of Gene Editing Tools:

Global Gene Editing Tools Market By Product (CRISPR/Cas9, ZFNs, TALENs, Viral Systems, Transposon Systems, Others), Application (Veterinary Medicine, Cell Line Engineering, Bioremediation, Food & Brewing Development, Food Waste Management, Bio Sensing Development, Others), Disease Application (Sickle Cell Disease, Heart Disease, Diabetes, Alzheimers Disease, Obesity, Others), End-User (Biotech & Pharma Companies, CROs, Academic & Research Institutes, Food Industry, Others), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026

Regional Insights of Gene Editing Tools:

Regional analysis helps the market players to take an exhaustive assessment of the Gene Editing Tools market region wise so that it becomes easy for them to distinguish and investigate the developing pattern and hidden opportunities all over the world.

The Gene Editing Tools market covers regions such as- South America, North America, Europe, Asia-Pacific, Middle East, and Africa.

Chapter Details of Gene Editing Tools

Part 01: Executive Summary

Part 02: Scope of The Report

Part 03: Gene Editing Tools Market Landscape

Part 04: Gene Editing Tools Market Sizing

Part 05: Gene Editing Tools Market Segmentation By Product

Part 06: Five Forces Analysis

Part 07: Customer Landscape

Part 08: Geographic Landscape

Part 09: Decision Framework

Part 10: Drivers and Challenges

Part 11: Market Trends

Part 12: Vendor Landscape

Part 13: Vendor Analysis

View Detailed Table of Content @ https://www.databridgemarketresearch.com/toc/?dbmr=global-gene-editing-tools-market

What does this report offer? -:

Developing patterns alongside critical drivers, difficulties and conceivable outcomes.

Fortifies decision making capabilities of market players.

Statistics of the market in form of graphs, pictures, pie-charts and tables.

Detailed knowledge of Gene Editing Tools market.

Competitive Evaluation:

The Gene Editing Tools research report highlights the import market Dynamics of the Industry, Definitions and Software of this Series and Also business arrange of this Market. Future prospects of this industry and Market scenario. Also, Prime strategical tasks on the current Market including improvements, mergers, acquisitions and Partnership, etc.

Analysis of the Market with Analytical tools

The report additionally accompanies an investigation of the business focused scene combined with a profoundly nitty gritty SWOT examination also.

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Gene Editing Tools Market Continuous Excellent Growth | Intellia Therapeutics, Inc.; Merck KGaA; Horizon Discovery - Eastlake Times

Wei Jian Gohs startup Craft Health makes personalized medicine and nutrition possible. The startup is one Im very envious of as Ive had a lot of ideas in this area for years. Ideas are nothing however and the Singapore based Craft Health team is executing on a series of innovations that could make personalized nutrition and medicine more accessible and widespread. Craft Health is taking a very straightforward and logical idea to market: one pill does not fit all. If were both adults and we take a painkiller we may each take one, as prescribed. But I may be twice as heavy as you or my body could have a completely different in many different ways. Craft Health wants to enable the customization of pills and doses to the individual. Whats more the company wants to make their custom 3D printed pills commonplace. On top of that, the team have spotted a huge application which no one is working on in 3D printing: 3D printed nutrition and supplements. Craft Health is a very exciting startup to me that could really unlock many exciting outcomes for people in all sorts of scenarios. I love that it was started by pharmacists to enable them to better help patients. Im very bullish on the Singaporean startup so we interviewed Wei Jian Goh who is a co-founder and the CEO of the startup.

What is Craft Health?

Craft Health is a personalized nutrition and medicines platform, leveraging onto 3D printing technologies. Our vision is to simplify the process of pill taking for consumers or patients.

Where do you hope to be in five years?

We aim to be at the forefront of the intersection for 3D printing technologies and formulations, supplying the Craft Health solutions to both nutraceuticals and pharmaceutical industries.

CraftHealths CO-Founders, both Pharmacists, Wei Jiang Goh and Seng Han Lim.

What do you do?

Using 3D printing, we are able to print different shapes, layers or geometries to provide accurate dosing of active ingredients such as nutraceuticals or active pharmaceutical ingredients. We also compartmentalize individual active ingredients to reduce the risk of cross contamination or interactions. .

At the same time, we are also formulation scientists and have formulated different bases for various controlled release profiles.

These include immediate release (active ingredients are released within 10 minutes of consumption), sustained release (active ingredients are slowly released between 4-6 hours after consumption), amongst others.

We are also developing our very own 3D printer, using the paste extrusion technique where no heat nor UV curing is used. We are looking at how we can automate the 3D printing process in a scalable manner.

In short, we are able to personalize the nutrition or medicines to the consumer/patient.

How does it work?

Craft Health uses a proprietary blend of generally regarded as safe (GRAS) materials that are already found in the pills that are commercially available. We take the non-active ingredients of these pills and change their ratio in order to achieve different formulations of controlled release. For example, we have formulations for immediate release (release of active ingredients within 10 minutes after consumptions) and sustained release (release of active ingredients slowly over a period of 4 -6 hours). The active ingredient is blended into our proprietary formulations.

The active ingredients and our proprietary formulation for the selected release profile are blended and formed into a paste. The semi-solid paste is then extruded into the shape of a pill using a 3D printer. We are able to print multiple active ingredients, each with their selected release profiles, within the same pill in this way.

What would determine the individual supplements?

The individual supplements would be determined by the individual, on the basis of what they want (self-selection) and what they need (depending on their response for nutritional questionnaires and even nutrigenomics)

Would it depend on me, or me at one point, my blood work?

This would depend largely on the extent of personalization you require, from filling up a simple questionnaire to nutrigenomics.

Who are your customers?

Craft Health is targeting nutraceuticals and pharmaceutical companies to

1. License our technologies and 3D printed formulation solutions

2. Supply our 3D printed pills through the Craft Health Platform

What benefits would they have?

Nutraceuticals: Increase the product range to consumers, especially discerning consumers who are increasingly concerned about what supplements they take. Supplements can be in various combinations personalized to the individual, and also release profiles.

Pharmaceuticals: Rapid prototyping for reformulation exercise to extend existing patent life spans of therapeutics, or a low volume, high mix approach to clinical trials where small volumes batches and dosing can be titrated quickly, depending on the trial results.

Why did you start this company?

Craft Health is founded by two Singaporean pharmacists, who went on to pursue our PhDs in 3D printing and formulation work.

When we were practising as pharmacists, we saw many instances where patients go home with bags of medicines, typically from common conditions such as hypertension, diabetes and high cholesterol. This is further exacerbated by complicated dosing regimens such as before/after food requirements. We thought that there should be a better solution to this, something that can simplify the process of medicine taking and this, was the inspiration for Craft Health.

Who has funded you?

Craft Health has recently closed their seed fund raising round led by Mistletoe Singapore, and participated by National University of Singapore (NUS) Graduate Research Innovation Programme (GRIP) and one angel, NUS Adjunct Associate Professor Neo Kok Beng.

What does it feel like to be the first company in 3D printed nutrition?

We believe we are the first company in 3D printed nutrition in South East Asia. It is a humbling experience as we learn about the various nuances of consumer preferences in this region.

Do you think that 3D printed nutrition is for everyone? or just a select group of athletes?

We believe the early adopters will be those that require highly specialized nutrition. These include athletes where age, gender, sports type and even the stage of training matters. Eventually we see 3D printed nutrition for everyone, whether for maintaining good health or to optimize their performance.

When do you hope to launch a customer?

We are an early stage start up, having incorporated in May 2019. Currently we are in the research and development phase, where we are expanding our database of various formulations, developing our in-house 3D printer and also actively looking for collaborations and partnerships. Our target launch for our initial pilot for 3D printed supplements would be late 2020.

What magical sauce do you have that would stop me from copying you?

We believe we are one of the few companies that are developing the complete supply chain for 3D printed healthcare: From developing our very own 3D printers specializing in 3D printing nutraceuticals and pharmaceuticals, to developing our proprietary database of various formulations for controlled release of different active ingredients, whether supplements or pharmaceuticals. Therefore, we are able to offer a one stop solution for 3D printed healthcare.

Discuss this article and more on the 3DPrintBoard or comment below to tell us what you think.

See the article here:
Interview with Wei Jian Goh of Craft Health on Personalized Medicine and Nutrition - 3DPrint.com

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NEC and VAXIMM announce collaboration to advance personalized neoantigen cancer vaccines - Pharmaceutical Business Review

PARSIPPANY, NJ, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Interpace (IDXG) announced today that it will report its third quarter 2019 financial results on Wednesday, November 13, 2019 at 4:30 p.m. ET. Interpace will host a conference call and webcast to discuss the Companys financial results and provide a general business update.

All listeners should confirm they are dialing in for the Interpace conference call with the operator who will promptly place them into the call. A webcast replay will be available on the companys website (www.interpacediagnostics.com) approximately two hours following completion of the call and will be archived on the companys website for 90 days.

About Interpace, Inc.

Interpace is a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Interpaces Diagnostic Business is a fully integrated commercial and bioinformatics business unit that provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has four commercialized molecular tests and one test in a clinical evaluation process (CEP): PancraGEN for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDXthat differentiates lung cancer of primary vs. metastatic origin. In addition, BarreGEN for Barretts Esophagus, is currently in a clinical evaluation program whereby we gather information from physicians using BarreGEN to assist us in positioning the product for full launch, partnering and potentially supporting reimbursement with payers.

Interpaces Biopharma Business is a market leader in providing pharmacogenomics testing, genotyping, and biorepository services to the pharmaceutical and biotech industries. The Biopharma Business also advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.

For more information, please visit Interpaces website at http://www.interpacediagnostics.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Additionally, all forward-looking statements are subject to the Risk Factors detailed from time to time in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10Q. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACTS:Investor Relations - Edison GroupJoseph Green(646) 653-7030jgreen@edisongroup.com

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Interpace to Host Conference Call and Webcast to Discuss Third Quarter 2019 Financial Results on Wednesday, November 13, 2019 - GlobeNewswire

A novel method to improve outcomes of surgery to treat epilepsy has now received approval for clinical testing in 13 French hospitals. The approach could provide a better therapeutic perspective against the drug-resistant form of the disease, which constitutes one-third of all cases, and is a development by Human Brain Project scientist Viktor Jirsa and an interdisciplinary team of collaborators.

To help clinicians plan surgery strategies, the scientists created personalized brain models of patients and simulate the spread of abnormal activity during epileptic seizures. The method represents the first example of a personalized brain modeling approach entering the clinic and will now be assessed over four years in a cohort of 356 patients under strict requirements.

How do we currently treat epilepsy?

Epilepsy is a wide-spread neurological disorder that affects around 50 million people worldwide. In many cases, the seizures that mark the disease can be controlled by drugs, but close to a third of all patients are drug-resistant. For them, the only remaining option is surgical removal of the epileptogenic zone, the area from which the seizure activity first emerges and then spreads. During surgery preparation it is critical to localize this area as precisely as possible in the brain, but very challenging with current methods. As a result, surgery outcomes are difficult to predict, with success rates of only around 60%.

This low success rate has largely stayed the same for the last 30 years. We hope our approach can finally improve the odds for patients, says Jirsa. In the Human Brain Project, Jirsa is the Deputy Leader of the research area of Theoretical Neuroscience.

The Human Brain Project and The Virtual Brain

Over the last five years and in large part within the framework of the Human Brain Project, Jirsa and his team worked on an approach that could bring a change. The team has adapted the open network simulator The Virtual Brain towards applications in epilepsy. This work has laid foundations for the project EPINOV, short for Improving EPilepsy surgery management and progNOsis using Virtual brain technology, a consortium coordinated by Fabrice Bartolomei (Hpital de la Timone) that brings together theorists like Jirsa, clinical neuroscientists, in particular from Marseille and Lyon, and the industry partner Dassault Systmes.

After two pilot studies showed promising results for the approach, the EPINOV-consortium has received approval from the French regulatory authority to put their approach to the test in a full-scale multi-centric trial with almost 400 prospective patients.

It represents the worlds first clinical trial ongoing using full brain network modeling, says Jirsa. When the authorization came in, it was like a huge pressure was relieved from me after all this hard work. Then followed last preparations to assure that all steps in the workflow of virtualization and evaluation of the patient brains are in order during the four-year period of the trial.

Bartolomei explains "This type of epilepsy affects millions of patients worldwide. The personalized modeling of epilepsy networks in drug-resistant patients is an innovative and scientifically validated approach, which proposes to enrich the interpretation of neurophysiological and neuroimaging tests, and thus to improve the surgical prognosis of epilepsy in an individualized way".

Jirsa and his close collaborators, Randy McIntosh at Baycrest Center Toronto and Petra Ritter at Charit Berlin, started building The Virtual Brain as an open-source brain network simulation engine from 2010 on, using neuronal population models and structural information from neuroimaging.

In the Human Brain Project environment, the conditions were perfect to go the decisive steps further towards applying it in a clinical context. The science underlying this trial is almost entirely a result of our work in the HBP, Jirsa says.

Simulating epilepsy

First, a personalized brain model is created from data on the individually measured anatomy, structural connectivity and brain dynamics for each patient. Through a series of steps, it is turned into a dynamic model, on which the seizure propagation can be simulated. High-Performance Computing enables the personalization of the brain network models through the application of machine learning.

The resulting brain avatar is customized to the individual patient and allows testing and estimating during surgery preparation. In a small cohort of retrospective surgery patients we were able to demonstrate that the predictions of the patients brain model correlate well with positive surgery outcome, Jirsa explains, and other labs have confirmed our results independently.

In half of the cases, the surgeons will have information from the epilepsy-model in their staff meetings, where therapeutic interventions are planned. It's a blind random design, half of these patients will be operated taking our model predictions into account, the other half will not. After four years, the statistics will show us hopefully to what degree the model predictions changed the surgery practice, results, and outcome, Jirsa says.

Within the EPINOV consortium, the industrial partner Dassault Systmes will develop a virtual brain-based simulation software prototype that could subsequently be provided to clinics worldwide. Headquartered in France, Dassault Systmes is a multinational software company focused on 11 industries including life sciences and the development of patient-centric modeling and simulation experiences.

There is a very big responsibility, Jirsa emphasizes and at the same time its very exciting that we have this chance to improve clinical practice and ultimately patients lives. And if the approach succeeds, it would also be the first modelling-based example of personalized medicine that makes the jump from research to clinical practice so the outcome will certainly be a signal to the field.

Katrin Amunts, Scientific Research Director of the Human Brain Project, highlights the significance of the move into the clinic: This breakthrough by Viktor Jirsa and his colleagues is a fantastic example of a new type of technology-enabled computational neuro-medicine. It is one of our central aims to catalyze developments like this that make concrete contributions in the fight against brain diseases to benefit patients.

Philippe Ryvlin, who leads the Medical Informatics Platform in HBP and the epilepsy surgery section of the European Reference Network EpiCARE emphasizes that this clinical trial, which will be the largest randomized study ever performed in epilepsy surgery, demonstrates that simulation of the human brain, as developed in HBP, has now reached a stage where it can be readily applied to address unmet medical needs.

Virtual Brain Researchers are also continuing their activities on clinical modeling for stroke and Alzheimers in collaboration with experts that the HBP brings together. For Jirsa seeing his work as a theoretical scientist gain this potential impact has been the result of a unique convergence: That we have come to this point was made possible by clinical expertise and our activities on The Virtual Brain and the Human Brain Project all coming together right place, right time, right people."

Reference

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

Originally posted here:
Simulation-based Method To Target Epilepsy Goes to Clinical Trials - Technology Networks

In the fall of 2017, Brandi Bryant had a nagging cough. It seemed mild enough that it would go away on its own, but she began to worry when she also started experiencing shortness of breath.

It was a tiny bit annoying, Bryant, 41, of Atlanta, told TODAY. Nothing that really bothered me or a cough so bad like bronchitis.

Bryant suspected she had developed asthma. But, the doctors thought it might be pulmonary fibrosis, a lung disease that causes scarring, which makes it difficult to breath. She tried to research it, but her symptoms didnt seem to fit.

Dr. Google said it was cancer," she said. "But, it didnt make any sense for me."

I was exercising OK, I was able to do everything, like running after my children, Bryant added. Even the pulmonologist said in the first appointment, This isnt cancer ... Its got to be something else.

Her doctors kept searching. They ordered a CT scan and followed up with a bronchoscopy to look directly into her airways. By this point, Bryant wondered if she had a disease like tuberculosis or even worse.

When she returned to look at the results, she sensed the doctor seemed sober. That's when she was told she had stage 3B lung cancer.

Bryant was stunned by the news, in part because she never smoked. She calls herself the judgiest of judges when it comes to smokers.

Trending stories,celebrity news and all the best of TODAY.

I run away when I see people smoking ... I didnt understand why you cant stop smoking, she said. "To have a cancer that we have been told that its only cause is smoking, I was blown away. I was completely devastated.

She started chemotherapy and radiation, but after her fourth round of chemotherapy she developed fluid around her heart and lungs. When doctors drained the fluid, they found it had cancer in it, too, and Bryant now had stage 4 cancer. Genomic testing revealed that it was anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer. People under 55 who never smoked are most likely to have this form of cancer, according to the Lung Cancer Foundation of America.

Going from stage 3, hoping for a cure, to stage 4 and you are incurable until you die ... It was overwhelming, she said. It was really, really tough.

Looking back, Bryant had thought her symptoms seemed mild, but her ex-husband mentioned months before her diagnosis that she coughed throughout the night. It hadnt been disrupting her sleep or how she felt, so she thought it was something small and never sought help for it.

I was so busy and taking care of the family. It didnt bother me, Bryant explained. It was not a priority. It is what we as women do.

Breaking the news about the cancer to her four children Amelie, 17, Karsyn, 11, Gabrielle, 9, and Ken, 5 was tough.

The hardest things, of course, was telling them, she said. The first thing my second daughter asked me was, Are you going to die? The hardest thing was me saying that I cant promise her. I dont know.

For a year and a half, Bryant has been on a therapy that targets the ALK mutation and has shrunk her tumors, meaning that, for now, there's no detectable cancer in her body.

The focus of lung cancer treatments is to stop it from spreading, according to Dr. D. Ross Camidge, director of thoracic oncology and the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, who did not treat Bryant.

"If the cancer has spread to other organs ... control, not cure, is the goal, he told TODAY via email. For some subtypes of lung cancer, like ALK, that control can be measured in years.

Expanded treatment options like genomic testing and targeted therapy are giving lung cancer patients better chances, Camidge added.

"Lung cancer is not one disease anymore, he said. Dividing it into different [types], based on the cancers genes, has been the key to the success of personalized medicine. Long-term control is much easier when you are individualizing treatment approaches to each patient.

For Bryant, she knows that the effects of her therapy are likely to last about three years and that treatment options are limited beyond this step. She hopes that sharing her story will help increase resources to investigate all lung cancers.

I am hoping we can do some more research and have more than one option available, she said.

Throughout her treatment, Bryant has continued to work and enjoy time with her family. She adopted a dog and took her children to Paris.

Im definitely more of a live-in-the-moment person, I realize that life is fragile for all of us," she said. "We just dont realize until it touches you in some way, where there is some kind of tragedy or you have a diagnosis that is life limiting."

Even though her future remains unclear, she stays positive and is making memories: The biggest thing I have done is I am present with my children."

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Nonsmoking mom thought she had asthma, it was lung cancer - TODAY

The biggest difficulty when treating cancer in the brain is the blood-brain barrier, a group of blood vessels that filter what enters and leaves the brain.

When cancer cells enter the brain, the blood-brain barrier becomes a blood-tumor barrier, which creates another obstacle for effectively getting cancer drugs to the brain.

A team at Purdue has developed an extensive identification of the blood-brain and blood-tumor barriers that interfere in brain metastases of lung cancer, which will provide a guide for developing treatments. The research was published in Oncotarget, a bio-medical journal that primarily publishes research on oncology.

Tiffany Lyle, an assistant professor in the College of Veterinary Science, led the team of scientists. Her work is centered on the pathology of the blood-brain barrier.

Brain metastases occur most frequently in patients diagnosed with breast and lung cancer and melanoma, Lyle said in a Purdue press release. She went on to explain that the metastases have a high survival rate, mainly because the blood-barrier makes it extremely difficult to get medication into the brain tissue.

Brain metastases, also known as secondary brain tumors, develop when cancer cells spread from their point of origin and into the brain. This is occurs in between 10% and 30% of adult cancer cases, according to the Mayo Clinic.

The researchers analyzed blood-brain and blood-tumor barriers in animal models using non-small-cell cancer cells, which make up the majority of lung cancers, and immunofluorescent imaging. They confirmed their results by studying blood-tumor barriers of brain metastases in brain tissue from cadavers.

We wanted to see what changes in the blood-brain barrier were occurring rapidly and which ones were sustained over time, Lyle said. Identifying those changes and pinpointing when they occur during the transition will be critical to developing treatment plant and being able to identify where, and when, cancer cells need to be targeted.

Lyle added that until the teams discovery, the blood-tumor barrier had not been properly identified in lung cancer.

During their analysis, the team observed that one of the changes in the blood-brain barrier to the blood-tumor barrier occurred in the astrocytes, one of the largest cells in the brain that serve a variety of functions. Lyle commented that this discovery alone will serve a key role in the development of future cancer treatment in the brain, as it shows the scientists where and when the brain prevents drugs from entering.

A goal of our research is to meaningfully contribute to the evolving field of personalized medicine and provide patients who have received a devastating diagnosis a sense of home for treatment possibilities, Lyle said.

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Purdue researchers develop map to make getting cancer drugs to the brain easier - Purdue Exponent

NEW YORK, Nov. 11, 2019 /PRNewswire/ --Cohen Veterans Bioscience (CVB), a nonprofit research organization dedicated to fast-tracking personalized diagnostics and therapeutics for brain health, today announced its strategic collaboration with Parexel Biotech, a new division of Parexel, for CVB's adaptive platform trial evaluating pharmacotherapeutics to treat posttraumatic stress disorder (PTSD).

Parexel Biotech will provide clinical trial implementation services over a multi-year period beginning in October 2019. "We are delighted to be part of this important adaptive platform trial exploring a precision medicine approach for the treatment of PTSD," says Parexel CEO Jamie Macdonald. "We look forward to partnering with CVB on this innovative trial design in the brain disorders arena and to contributing to this important new therapy, which has significant potential to benefit patients."

In September 2018, CVB was granted a research award by Advanced Technology International (MTEC Consortium Manager) on behalf of the U.S. Army Medical Research Development Command (MRDC). The award is for a 3.5-year clinical trial to test the efficacy and safety of pharmaco-therapeutics for PTSD via a well-powered adaptive platform trial (APT). CVB will lead this program and serve as the Clinical Coordinating Center (CCC), establishing a clinical trial infrastructure operating within the trial's governance structure. A government Joint Steering Committee (JSC) is a part of the governance structure and includes representatives from the Veterans Health Administration (VA), the National Institute of Mental Health, National Institute of Alcohol Abuse and Alcoholism, the Food and Drug Administration (FDA), and the Defense Health Agency's Psychological Health Center of Excellence. For more information read the press release here.

This Phase 2 adaptive clinical trial is scheduled to start in the Fall of 2020 and during the period of performance, at least two active drugs (pending selection) will be evaluated. Biological measurements will be incorporated to support a precision medicine approach to PTSD treatment. A goal of this trial is to identify a drug to advance to Phase 3 testing starting in 2022, and ultimately lead to an additional FDA-approved drug for the treatment of PTSD.

Parexel Biotech is Parexel's dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively, building on the Company's heritage of clinical, regulatory, commercial and technology expertise with enhanced strategic consulting and asset development capabilities.

"In our selection of Parexel Biotech to conduct this program, which has far-reaching implications for the field, we focused on their world-class reputation, proven track record of delivery and highly-flexible partnership approach," says Magali Haas, CEO & President of Cohen Veterans Bioscience.

About Posttraumatic Stress Disorder (PTSD) PTSD is a mental health condition that some people develop after experiencing or witnessing a violent or life-threatening event, such as combat, natural disaster, terrorist attack, or sexual assault. Symptoms of PTSD can include reliving the event or having flashbacks; avoiding situations that trigger the memories; losing interest in activities or feelings of fear, guilt, or shame; feeling anxious or always on alert for danger. PTSD affects about 8.6 million American adults each year and is the fifth most prevalent mental disorder in the United States. Overall prevalence rates among veterans of different conflicts range from 10-30% (OEF/OIF/OND/Gulf War/Vietnam).

The only approved medications for the treatment of PTSD are the selective serotonin reuptake inhibitors (SSRIs) sertraline (Zoloft) and paroxetine (Paxil) approved nearly 20 years ago.

The Department of Veteran Affairs (VA) 2017 Consensus Statement of the PTSD Psychopharmacology Working Group concluded that there is a deficient pipeline of new PTSD medications and an assessment of recent trial failures has generated concerns about how to best identify new targets for medication development and optimally design clinical studies. In a highly heterogeneous patient population such as PTSD, the availability of validated biomarkers or companion diagnostics would allow clinicians to predict the likelihood that a given patient would respond to a given therapeutic, enabling individualized medicine for these conditions. No biomarkers have been qualified nor cleared as companion diagnostics for PTSD by the FDA.

CVB will be spearheading the design and application of "Smart-" or "Adaptive-" clinical trials for PTSD. These studies include a prospectively planned opportunity for modification of one or more specified aspects of the study design based on data (usually interim data) collected from subjects in the study. To execute such a program, a centrally-managed platform clinical trial infrastructure will be established, potentially including academic, private, VA, and military research centers.

About Cohen Veterans BioscienceCohen Veterans Bioscience is a nonprofit 501(c)(3) research organization dedicated to fasttracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders. We are creating a paradigm shift in how we approach and treat brain health by utilizing cutting-edge technologies to establish enabling platforms and implementing our end-to-end catalytic operating model in translational science, clinical programs, data science, and digital health to advance personalized and precision medicine. To support & learn more about our research efforts, visit http://www.cohenveteransbioscience.org.

About Parexel Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science, biopharmaceutical and biotech customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.

Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.

Media Inquiries: Cohen Veterans Bioscience Nicole Harmon media@cohenbio.org

Parexel Wendy Ryan Tel.: +1 781-434-5104 Email: Wendy.Ryan@parexel.com

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Cohen Veterans Bioscience and Parexel Biotech Collaborate on Landmark Adaptive Platform Trial Studying Posttraumatic Stress Disorder (PTSD)...

Google is involved with one of the U.S.s major healthcare systems on a venture to collect and crunch the comprehensive personal-health information of millions of people within 21 states. The project between Google and Ascension (the countrys second-largest hospital system) announced the data collection is for the improvement of medical services. The collaboration, code-named Project Nightingale, began in secret last year, according to the reports.

The Catholic, non-profit has more than 34,000 providers and operates in 20 states and District of Columbia with 150 hospitals running all over these states. Under the agreement, Ascension patients data is eventually uploaded to Googles cloud computing platform. The publication adds that as many as 150 Google staff may have had access to the data and that some could have downloaded it.

The collaboration will give Google access to datasets that could help it tune its potentially beneficial artificial intelligence (AI) tools. Ascension said in a statement the agreement would also explore artificial intelligence and machine learning applications to help improve clinical effectiveness, along with patient safety. Many called for an instant change to privacy laws after Google Ascension partnership, the healthcare business it has combined with, boasted that the venture is completely legal.

Dr. Robert Epstein, an author, medical researcher and former editor-in-chief at Psychology Today, summed up the mood when he tweeted: You cant make this s*** up. #BeAfraid. At the time of the acquisition, many of the companys 28million users announced they were throwing their devices away for fear of Google getting its hands on potentially sensitive medical information. The company formerly had hyped smaller healthcare clients, such as the Colorado Center for Personalized Medicine.

The Google Cloud CEO, Thomas Kurian, has made it a main concern in his first year on the job to relentlessly chase business from leaders in six industries, including healthcare. Google recently announced plans to buy Fitbit Inc. for $2.1bn, aiming to enter the wearables market and invest in digital health.

Link:
Google and Ascension Partners on 'Project Nightingale' to Collect Healthcare Data in US - News Obtain