What You Should Know: 

– 23andMe, a genetic health and biopharmaceutical company launched Health Action Plan, a new digital tool for 23andMe+ members that draws on results from genetic reports, health history survey data, as well as blood and biomarker data to provide a uniquely tailored set of health recommendations out of hundreds of options.

– Health Action Plan is a helpful first step when it comes to prevention and early risk detection. It offers customers specific actions and next steps on their health journey. 

– 23andMe reminds customers that they should not use Health Action Plan to replace a visit to their primary healthcare provider.

Tailored Recommendations

Each recommendation is evidence-based, and written and reviewed by a team of scientists, genetic counselors, and medical experts at 23andMe. The new digital tool draws on a customer’s genetic health reports and their self-reported health history. Together, this data helps inform tailored recommendations, prioritizing the most critical steps for an individual to take. The more information a customer provides, the more personalized their recommendations will become.

In addition to suggestions on altering activities like sleep, diet, and exercise, other recommendations include learning about potential new treatments or activities for conditions, as well as entering additional health data, like diagnoses or family history, to further personalize recommendations. Eligible customers may also receive recommendations for further clinical action, like getting a blood test, which can now be coordinated directly through 23andMe. 

Testing managed through the 23andMe platform provides a fast and convenient way to order, pay, and schedule an appointment at a local lab, and receive results and a personalized clinical analysis in 3-5 business days.* The biomarker data, in addition to genetic data, can help identify possible health risks for individuals to take any necessary actions. Customers can also connect with a clinician to discuss their results.
**Blood testing through 23andMe is not available in NY, NJ, RI, OK, HI, PR

We are living in a mental health epidemic. An estimated 26 percent of Americans ages 18 and older – about one in four adults – suffer from a diagnosable mental disorder in a given year. Among mental disorders, cases of PTSD are on the rise. Roughly five percent of American adults suffer from PTSD in any given year and more than 13 million Americans reported PTSD in 2020 – most of whom are women. Standard PTSD treatments most often come in the form of pharmacotherapy or psychotherapy and include a cocktail of anti-depressant drugs, prolonged exposure therapy, eye movement desensitization and reprocessing and cognitive behavioral therapy. These treatment modalities have proven effective for many patients, and yet, PTSD is a unique journey for every patient, each of whom needs specialized treatment plans to meet their needs. 

A 2022 academic review showed that the effect sizes during clinical trials of both new psychotherapies and pharmacotherapies in mental disorders were small in comparison to the previously adopted ‘treatment as usual’ or a placebo. This study demonstrated that while current therapies work for many patients, they are not favored by all patients. Pharmacotherapy options often result in adverse side effects which can impact treatment retention, while psychotherapy can prove challenging for patients when they relive their experiences. We must embrace the latest medical innovations that have proven themselves in other areas of care to provide a third option for patients in need of a solution. 

Unlocking Biomarker-Based Mental Disorder Treatment 

As an objective and measurable biological signal of bodily processes, biomarkers are indications of conditions and diseases and have been used successfully throughout fields of medicine. From indicating of the presence of disease, to clinical trial matching, to measuring the efficacy of new and novel treatments, and enabling personalized treatment. Today, researchers utilize as many as seven distinct categories of biomarkers, including diagnostic, predictive and monitoring. 

While biomarkers have been used to advance many areas of care, the creation and adoption of brain biomarkers to identify, treat and manage neurological disorders has remained comparatively low due to several biological barriers. Biomarkers rely on blood, tissue, or urine samples, while neurological biomarkers are present in cerebral spinal fluid (CSF) but are often at undetectable levels in blood. While biomarkers can be developed and measured using various biological samples, this requires invasive procedures and consequently is not a viable treatment for many patients. The brain is also protected by the blood–brain barrier, shielding this crucial organ from harmful substances circulating in the bloodstream, making brain activity inaccessible to a blood test. 

Recognizing the potential value of biomarker-based neurological treatment and management, clinicians and product innovators have utilized existing technologies used to monitor brain activity, which include electroencephalogram (EEG) and functional magnetic resonance imaging (fMRI). EEG is a low-cost modality that measures brain electrical activity on the scalp through a patient-worn cap with electrodes, however, EEG is not able to measure electrical activity in deep brain regions. On the other hand, fMRI scanners are used to measure blood oxygenation (known as BOLD signal) in deep-lying specific brain regions but are expensive and complex to operate. 

While progress has been made in developing EEG-only solutions for brain biomarkers, this has been stalled by the inability to measure deep brain activity. As a result, the field of neurology was left for decades without a scalable and effective solution for monitoring deep brain activity, limiting our ability to diagnose and treat mental disorders. But recently, researchers made breakthrough discoveries to combine EEG and fMRI into scalable, affordable and portable solutions. This innovative, scientific mechanism will soon become a leading modality used to treat mental disorder treatment.  

In 2014, a study in NeuroImage introduced a novel imaging approach using fMRI-inspired EEG analysis. The results introduced a neurological biomarker that is calculated by identifying EEG features that correlate to activation levels of specific brain region processes associated with mental disorders as seen in fMRI. The biomarker was developed by performing a series of simultaneous acquisitions of datasets of EEG and fMRI under specific psychological paradigms. The EEG and fMRI voxel data of brain regions associated with mental disorders of interest were then fused using advanced statistical models to produce the biomarker. 

This development may mark a significant breakthrough for mental disorder care, transforming neuro-biomarkers from inaccessible bio-based signals to technology-powered brain activity indicators. For the first time, monitoring of biomarkers of activity associated with deep brain regions in a non-invasive, scalable and affordable model has become a reality and the field of mental disorder care is set for transformation. 

Mirror, Mirror on the Wall: Using Biomarkers to Follow Brain Activity 

Similar to biomarkers in other medical applications, neuro-biomarkers can shed light on the inner workings of brain activity without directly altering the neural state. In doing so, we can better understand the underlying mechanisms of mental disorders in response to triggers and design better treatments. An amygdala-based biomarker is just the first example of many that demonstrate the power of biomarker-based treatment for specific brain regions. 

There are thousands of published studies indicating the amygdala’s role in mental disorders. The amygdala is the control center of the fight-flight-freeze response – a response to stressful, frightening or dangerous events that dictates how the body responds to danger. The hyper-reactive amygdala has been clinically shown to play a significant role in PTSD, General Anxiety Disorder, Bipolar Disorder, Schizophrenia, and Borderline Personality Disorder. 

By utilizing tech-powered biomarker-based treatments that are based on specific brain regions – such as the amygdala – clinicians can provide a real-time data-based approach to treatment with greater clarity into a patient’s underlying mechanisms. With access to measurable insights, clinicians can provide customized treatment and with accurate and measurable insights, can power our approach to mental disorder care. In the long term, this can be utilized across a variety of mental disorders and better determine the best course of treatment, whether psychotherapy or pharmacotherapy and monitor their progress to enhance overall outcomes. 

We are beginning to see a monumental shift in mental disorder treatment. Embracing brain region or mechanism-specific neurological biomarkers to treat dysregulated underlying brain mechanisms, provides a third option of care that can augment existing pharmacotherapy and psychotherapy modalities. As a tech-based solution, neurological biomarkers can be used as a core asset along with the advances in automation and machine learning and create modalities that will continue to evolve with time and address other neurological conditions beyond mental disorders. In doing so we can continue to support mental healthcare professionals in providing patients the most effective and impactful treatment.  

About Oded Kraft 

Oded Kraft is the Co-Founder and CEO of GrayMatters Health and has over 25 years of international experience in global high-tech innovation and business development of both startups and large corporates that focus on medical device innovation. Before establishing GrayMatters Health, Mr. Kraft worked in executive business development roles within Roche and GE Healthcare and has also served on the board of several medical device companies in the EU, Israel and the US. Mr. Kraft holds an MBA and a BSc in Electrical Engineering from Technion Institute of Technology in Haifa, Israel.

What You Should Know:

• A team of leading clinicians, engineers, and neuroscientists has made a groundbreaking discovery in the field of treatment-resistant depression. By analyzing the brain activity of patients undergoing deep brain stimulation (DBS), a promising therapy involving implanted electrodes that stimulate the brain, the researchers identified a unique pattern in brain activity that reflects the recovery process in patients with treatment-resistant depression.
• This pattern, known as a biomarker, serves as a measurable indicator of disease recovery and represents a significant advance in treatment for the most severe and untreatable forms of depression. The team’s findings, published online in the journal Nature on September 20, offer the first window into the intricate workings and mechanistic effects of DBS on the brain during treatment for severe depression.

Modifying Brain Stimulation Techniques to Combat Depression

Deep Brain Stimulation (DBS) entails the placement of slender electrodes in a specific region of the brain to administer gentle electrical impulses, akin to a pacemaker. Although DBS has obtained approval and has been utilized for movement disorders like Parkinson’s disease for an extended period, its application in treating depression remains experimental. This research represents a critical advancement towards harnessing objective data acquired directly from the brain through the DBS device to inform healthcare professionals about a patient’s response to treatment. This valuable information can facilitate the adjustment of DBS therapy, customizing it to match each patient’s individual response and enhancing the efficacy of their treatment.

The researchers have now demonstrated the feasibility of monitoring the antidepressant effect continuously throughout the treatment process, offering healthcare providers a tool somewhat analogous to blood glucose testing for diabetes or blood pressure monitoring for heart disease. It provides real-time insight into the patient’s condition, distinguishing between normal day-to-day mood fluctuations and the potential onset of a depressive episode relapse. The research team, comprising experts from the Georgia Institute of Technology, the Icahn School of Medicine at Mount Sinai, and Emory University School of Medicine, employed artificial intelligence (AI) to detect changes in brain activity that coincided with patients’ recovery.

This study, funded by the National Institutes of Health through the Brain Research Advancing Innovative Neurotechnologies (BRAIN) Initiative, involved ten patients grappling with severe treatment-resistant depression, all of whom underwent the DBS procedure at Emory University. A novel DBS device was employed to record brain activity. Analysis of these brain recordings over a span of six months led to the identification of a shared biomarker that exhibited changes as each patient recovered from depression. Following six months of DBS therapy, 90 percent of the subjects experienced a substantial improvement in their depression symptoms, with 70 percent no longer meeting the criteria for depression.

“The use of explainable AI allowed us to identify complex and usable patterns of brain activity that correspond to a depression recovery despite the complex differences in a patient’s recovery,” explained Sankar Alagapan PhD, a Georgia Tech research scientist and lead author of the study. ”This approach enabled us to track the brain’s recovery in a way that was interpretable by the clinical team, making a major advance in the potential for these methods to pioneer new therapies in psychiatry.”

What You Should Know: 

– ALZpath, a developer of blood-based diagnostic biomarker testing for Alzheimer’s disease detection receives funding from the Alzheimer’s Drug Discovery Foundation (ADDF)’s Diagnostics Accelerator to accelerate the clinical availability  of ALZpathDx as a laboratory developed test (LDT). 

– ALZpathDx is a novel, proprietary assay for blood-based measurement of phosphorylated tau at threonine 217 (pTau217), a highly accurate, diagnostic biomarker for Alzheimer’s disease. The assay is performed on the Quanterix Simoa HD-X immunoassay analyzer.

Accelerate Analytical and Clinical Validation of ALZpathDx

ALZpathDx has been launched for clinical use as laboratory-developed test (LDT). Evaluation in independent clinical cohorts with multiple co-morbidities is currently being established to advance to an in-vitro diagnostic (IVD). The investment comes at a pivotal time in the advancement of Alzheimer’s disease treatments, with Biogen and Eisai’s Lecanemab (LEQEMBI®) recently receiving traditional FDA approval, ushering in a new era for the next generation of Alzheimer’s treatments. A critical barrier to widespread availability and use of these and other treatments to follow is the difficulty in diagnosing Alzheimer’s patients, particularly in the early stages of disease onset, when such treatments may have the most profound impact.

Biomarkers Enable the Next Phase of Clinical Care

Cognitive testing has traditionally been the primary method to diagnose Alzheimer’s disease, however, relying solely on cognition has limitations because patients only show symptoms after significant changes have occurred in the brain. Historically, the only definitive way to confirm an Alzheimer’s disease diagnosis was through autopsy.

As a more accessible and simple approach to understanding brain health, many are turning to biomarkers in peripheral fluids. In the last decade, cerebrospinal fluid (CSF) biomarker assessments have become an important diagnostic tool alongside bioimaging. However, obtaining CSF has its own challenges. Today blood-based biomarkers is considered the future of diagnosing Alzheimer’s disease. pTau217 outperforms other Alzheimer’s diagnostic biomarkers, including CSF and PET scans, to predict the likelihood of Alzheimer’s disease prior to the onset of symptoms.

What You Should Know:

• The Department of Defense and Philips announced a $10M ​award​ to ​expand the readiness of our service members with the Rapid Assessment of Threat Exposure (RATE) AI wellness tool.
• The first group in this new cohort are the​Air Force First Sergeants, who are responsible for overall squadron health and wellness.
• RATE is an AI algorithm, trained on clinical data from hospital-acquired infections to work with any off-the-shelf wearable to detect possible infection, acting like a “check engine light” for your body. By measuring 164 different biomarkers in the body, research shows the RATE algorithm can effectively detect infection as early as six days prior to diagnostic testing, with an average of 2.3 days.   
• The plan is for RATE to be device agnostic, but the current deployment of wearables will include Garmin watches and Oura rings. As the Philips-DIU team continues to prove out the new dataflow, the effort aims to add three additional popular wearable devices. The 11,000 former RATE users will also be able to re-affiliate with the projects if they still have the hardware.

What You Should Know:

– PsychoGenics Inc., a provider of AI-enabled phenotypic drug discovery and preclinical CRO services launches eCube®, a novel pharmaco-electroencephalography (“pharmacoEEG”) platform.

The platform supports phenotypic drug discovery, which unlike traditional target-based drug discovery, can identify novel treatments with multiple targets.

How eCube Works

eCube measures drug-induced changes to EEG spectra data and utilizes machine learning classifiers trained on reference drugs to predict the efficacy of novel compounds at the drug class (primary therapeutic indication) and subclass (primary mechanism of action) levels. In addition to predicting therapeutic applications for novel compounds, eCube can deliver translational biomarkers, providing an objective way to assess CNS activity, which is particularly important for compounds with unknown or complex mechanisms of action.

Similar to the Company’s AI-enabled, behavior-based platform, SmartCube®, eCube harnesses machine learning to identify CNS penetrant compounds and predict their therapeutic applications for neuropsychiatric disorders by comparing their EEG profiles to an extensive pharmacoEEG database comprised of hundreds of doses of CNS-active reference drugs. 

What You Should Know:

• Genialis, a computational precision medicine company unraveling complex biology to find new ways to address disease, today announced it raised more than $13 million in Series A financing to transform the way diseases are diagnosed and treatment decisions are made.
• Taiwania Capital and Debiopharm Innovation Fund co-led the round, with participation from previous investors First Star Ventures, Redalpine Venture Partners, and Pikas. Other new investors include P5 Health Ventures and several Angels. Ita Lu of Taiwania and Hamzeh Abdul-Hadi of Debiopharm will join Genialis’ Board of Directors. 

AI/ML-enabled Platform With a Biology-First Approach

Genialis is developing next-generation patient classifiers using machine learning and high-throughput omics data to capture underlying disease biology and predict how patients will likely respond to targeted therapies. The company will use the funds from the Series A to expand its proprietary ResponderID(™) platform and build out its comprehensive collection of clinically validated biomarker models to provide pinpoint diagnoses for virtually every cancer patient. To date, Genialis has used ResponderID in collaboration with biopharma to analyze clinical trial data and inform future trial designs for numerous investigational drugs. Genialis also supports the commercialization of next-gen biomarker assays with several leading diagnostic firms.

“With ResponderID, we sought to disrupt the historical linear progression of drug discovery and development, rather aiming to close the loop between drug development, patient care and new drug discovery,” says Rafael Rosengarten, Ph.D., co-founder and CEO of Genialis. “We chose to focus initially on biomarkers that improve the efficiency of drug development, that ensure the right patient gets the right medicine, and make an impact on real people’s lives in a shorter period of time.”

ResponderID is a machine learning platform for clinical and translational research, built from years of experience working with partners across the industry and advanced internal R&D. ResponderID yields new biomarkers for drug development and discovery programs, as well as diagnostic tests. ResponderID can read the status of virtually any NGS-based biomarker, including bespoke and proprietary signatures, from a single assay. The resulting output provides clinical and translational researchers with a comprehensive molecular portrait of patient disease phenotype enabling the most informed decision-making possible.

“ResponderID, Genialis’ predictive biomarker platform, enables precision medicine by identifying patients that are most likely to respond to treatments. Its use in drug development will optimize study designs and improve chances of clinical trials success, driving much-needed productivity gains for pharma R&D and accelerating the time to market for promising new drugs,” said Hamzeh Abdul-Hadi, Investment Director at Debiopharm Innovation Fund. 

Last year, ten publications and poster presentations at major scientific conferences featured results generated with ResponderID, including AACR, ESMO, and SITC. Genialis also co-authored a paper in the Journal of Clinical Oncologydescribing OncXerna’s navicixizumab ph1b trial, including retrospective analysis with the Xerna TME Panel. 

“Genialis is leading the collision of biology and AI. Our approach is biology first, but with a deep commitment to getting the data science right. Thus, we only succeed as a team that understands both worlds,” said Miha Stajdohar, Ph.D., co-founder and CTO of Genialis. “This capital brings together a global syndicate of clinical oncology and deep tech experts and will allow us to grow our in-house capabilities in multiple disciplines.”Genialis is growing its teams in both the U.S. and Slovenia across business, operations, life science, and data science functions and expanding its advisory boards. The company is also investing in R&D collaborations with several leading cancer centers, hospital groups, and clinical academic labs. 

What You Should Know:

– Accenture published Fast-Forwarding Healthcare through Data Collaboratives Report to discover how best health ecosystem players access data to fast-forward healthcare.

– Data generated by technical and scientific advances, like connected health devices, consumer health and medical-grade digital apps, individual multi-omics profiling data and the move to cloud storage, holds great promise for accelerated healthcare progress and precision medicine, and data collaboratives (DCs) might be the path forward. This report takes a closer look into DCs with a specific focus on oncology, as one of the largest therapeutic areas in terms of industry spending and new medications’ launch pipelines.

Understanding the Potential Data Collaboratives Hold to Generate Value in Healthcare

Life sciences companies increasingly use DCs to access high-quality data from ecosystem partners. The aim is to accelerate research and early development (R&D), clinical development, and post-launch insight generation. To better understand the extent, implications, and potential benefits of DCs, a survey was conducted  among 59 people who are heads of oncology and institutional review board (IRB) members. Of those surveyed, two-thirds already participate in DCs, and the remainder does not. This quantitative research was supported with qualitative research among 18 cross-industry experts (pharma & MedTech, technology service providers, cancer registries, research institutions, patient communities). The research was conducted across the US and the top five EU countries.

Oncology was deliberately selected for a close look into the therapeutic implications of DCs as it is one of the largest therapeutic areas (TAs)3 in terms of industry spending and new medications’ launch pipelines. The outcomes of the findings could apply across TAs. First, the researchers wanted to understand oncologists’ key DC participation drivers—including their preferred ecosystem setups. Then we profiled the key challenges involved in establishing DCs. Challenges to success were assessed and accelerator were looked at, along with, success factors, and strategies vital to effective DC establishment.

Oncologists believe that data collaboratives generate value\

The overall trend was clear: respondents were unanimous in their view that DCs generate significant value for patient outcomes. Nearly two-thirds (64%) agree strongly and 36% agree somewhat. They also generally believe that DCs generate significant value for research outcomes, though the agreement is more muted on this point (38% strongly agree and 54% somewhat agree). The survey indicates that DCs are more significant for patient outcomes than for research outcomes. Although Pharma and MedTech companies were not surveyed, it would be expected  to see significant DC value in the R&D space. While DC participants currently tend to share data more readily with regulatory authorities and clinical stakeholders, they are open to sharing more data with pharma companies in the future.

Technical and human obstacles to data collaboratives: As far as obstacles go, technology and sponsorship seem to be common threads among all respondents. The top five challenges, in order, are:

– Technical integration.

– Lack of sponsor commitment.

– Compliance with federal data protection regulations.

– Lack of trust among participants.

– Data harmonization

Life sciences companies can’t wait to have an extensive data ecosystem at their fingertips. The implications for product development are immense, and DCs represent a particularly attractive opportunity to stimulate innovation and access large datasets from multiple parties. However, establishing a DC is not to be underestimated as a venture. Many of them fail for lack of a solid business case or because the needs and interests of participating parties are not well understood, preventing the realization of cross- organizational benefits. Some fail at the point of conception, while others are unsustainable in the longer term. Yet, the faster and more effectively companies can implement DCs, the greater the competitive advantage they derive. Ultimately, the pioneering insights they obtain could drive improved healthcare—and make it more sustainable.

The report also highlighted pertinent challenges associated with DC’s which are as follows:

Business Challenges: Business challenges associated with DCs apply to both oncologists participating in DCs and those not doing so. High participation costs are flagged by 40% of those surveyed. Another key issue is that for 25% of the sample group, the benefit of participation is unclear – and the absence of a business model to generate a return on investment makes sponsors reluctant to commit. Single-sponsor dependence is also very risky for a DC project. A sustainable business model will generate value and improve revenues, winning over more than one sponsor. The study reveals that prospective DC partners want to use RWD from the collaborative to identify new treatment targets and biomarkers. Oncologists already using data collaboratives find the greatest value in clinical care improvement and decision-making. This dichotomy of interests suggests that a clear understanding of prospective partner needs is essential to attracting the right DC partners.

Data Challenges: Among oncologists spoken to, a hefty 64% of those who participate in data collaboratives have faced obstacles with the data (insufficient variety). Nearly half (44%) of the academic medical centers said that key required data sets weren’t available from the partners in the collaborative (too much data heterogeneity). Nearly a third (31%) said the DC provided poor- quality data. Other challenges included data heterogeneity (more than half (56%) of respondents said data harmonization is one of the biggest challenges). As a consequence, 21% of respondents highlighted the onerous process of agreeing on a common data model and terminology to reduce heterogeneity. Every potential DC partner follows its own standard or has simply adapted standards to some degree—a finding confirmed by our expert interviews. Disparate standards make it difficult to share data usefully between institutions—which applies mostly to unstructured data but not exclusively so. Overcoming these challenges is vital.

Technical Challenges: Almost all (92%) of academic medical centers in data collaboratives have faced technical issues. The main technology challenges involve the technical integration of hospital systems with the collaborative. A third have faced technical difficulties with the DC platform itself or its associated services. The  survey indicates that more than 90% of academic medical centers still use a purely centralized approach for data exchange with the DC. The centralized approach creates lengthy legal discussions on data transfer. When DCs generate copies of data, adherence to data privacy regulations becomes more complex. The approach inherently prevents expansion into certain countries due to local data privacy and security laws that prohibit data copying or transfer. Further drawbacks of the centralized approach include consent management difficulties, double- data entry, and large data transfer costs.

Data Privacy Challenges: Compliance with data sharing or data protection regulations is important. Data privacy issues are more common in Europe than in the U.S—on average, almost seven in 10 of those we surveyed have faced data privacy/legal obstacles. That number rises to nearly eight in Europe. The experience of setting up data collaboratives and enabling data-sharing initiatives across regions has shown that transferring health data across country borders is also an obstacle. For oncologists not currently participating in a DC, data security and privacy constraints represent the top barrier to participation in a DC. In fact, data privacy and security constraints are a hurdle for 60% of potential partners. addressing and implementing technical data security and privacy requirements was a challenge for 21% of our sample group.The challenge is underlined by the fact that 31% of medical centers want better data privacy and security approach.

Partner Ecosystem Challenges: Appropriate partners are, per definition, indispensable to the success of a DC. Potential partners must be identified, approached, and evaluated against a set of criteria. Among our respondents, almost nine out of ten have faced obstacles with the partner ecosystem. In terms of ecosystem partner challenges, a lack of trust among participants was the fourth most mentioned challenge overall among participating medical centers. It was also one of the challenges most often raised by industry experts. Political conflicts and partners’ personal interests could be related to a lack of trust, and respondents mentioned them as important challenges.

Legal Challenges: Research found that 64% of academic medical centers have faced governance and legal challenges. Challenges include the creation of data transfer, usage, and governance agreements and agreeing on intellectual property (IP) and other contractual terms. Industry experts we spoke to confirmed that contractual and governance agreements and signings are particularly onerous hurdles. Yet it is crucial to create an overarching (and binding) legal structure to achieve mutual trust and transparency.

What You Should Know:

– Protai, a proteomics and AI-powered drug discovery startup revolutionizing the way new drugs are discovered, today announced a $12 million extension of its seed round, bringing the total amount to $20M.

– The round includes existing investors Grove Ventures and Pitango Healthcare and was joined by Copenhagen-based Maj Invest Equity Fund. The additional funding will be used to build Protai’s oncology drug discovery pipeline, expand data acquisition as well as increase its discovery activities via pharma partnerships.

Portai Launches Collaborations With Leading Hospitals and Expands Advisory Board

Genomic biomarkers are only relevant for approximately 15% of tumors, thus limited in use. Protein-level biomarkers can predict patient populations not seen by genomic means, by directly measuring proteins, their interactions, and their functions. To tap into the potential of protein-level data, Protai has built a proteomics AI-based platform that comprehensively maps the course of a disease on the protein level. Its technology allows it to better predict which patients will respond to a given drug, as well as discover novel drug targets that were missed by genomic approaches. These discoveries may be the key to significantly accelerating drug discovery and clinical development, lowering the time and costs of R&D.

Since its initial funding last year, Protai has opened laboratories at its Israel R&D center for data acquisition, biological validation and drug discovery activities and recruited an experienced drug discovery team with significant experience in successfully bringing drugs to the clinic. Additionally, Protai established collaborations with several leading hospitals, and now has access to over 100k well-defined banked samples for its comprehensive tumor mapping process, focused on gyno-oncology and lung cancer indications.

With the additional funding, Protai will expand its activities to include an oncology drug discovery pipeline, initially focusing on targets with a clearly-defined novel patient population biomarker, derived from its AI proteomics platform. To help navigate these efforts, the company has added Dr. Sharon Shacham, a serial biotech entrepreneur and Founder of Karyopharm Therapeutics, to Protai’s Board of Directors. In addition, Protai is supported by leading oncology experts, including Prof. Giulio Draetta, Chief Scientific Officer at MD Anderson and former Pharma executive; Prof. Bradley J. Monk, Director of Gynecologic Oncology at the St. Joseph’s Hospital and Director of GOG Partners; Prof. Funda Meric-Bernstam, Chair of the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center, and Dr. Jurgen Moll, former Head Molecular Oncology, Sanofi Vitry.

“We are excited to announce this funding that supports our mission to enhance the drug development pathway from discovery through to commercialization,” said Eran Seger, CEO and co-founder of Protai. “I am extremely proud of our talented team and the achievements we have made to date. We look forward to scaling our organization and its important work towards revolutionizing the drug development landscape.”

What You Should Know:

– Vysioneer, a provider of applied AI for Oncology, today announced a data-sharing agreement with Pfizer, a global leader in pharmaceuticals. The agreement aims to lay the foundation for the application of AI in oncology clinical trials.

As part of the agreement, Vysioneer gains access to one of Pfizer’s oncology clinical trial datasets to apply Vysioneer’s advanced machine-learning techniques to facilitate the drug efficacy assessment process, thereby allowing Pfizer to assess drug efficacy with greater granularity and explore advanced biomarkers and novel endpoints.

– Vysioneer’s AI technology provides objective tumor response assessments and unlocks novel biomarkers that cannot be derived by human readers due to time and resource constraints, to predict patient outcomes at the earliest time points.

What You Should Know:

– Joi Women’s Wellness (Joi), a modern, femtech proactive approach to women’s health care, today announced the company’s official nationwide launch and availability of its hormone optimization and peptide therapy treatments, as well as the introduction of a new telehealth platform that provides a goals-based, customizable experience to help women own their health journey and manage the hormone and age–related changes to their bodies.

– Joi offers health coaching and tailored treatments to help women feel their best from the inside out.

Customized Wellness Treatments and Telehealth Coaching

Nearly half of women aged 30 to 60 have experienced symptoms of hormonal imbalance and say that hormones have negatively affected their overall well-being. Yet, they are likely to be dismissed when raising these concerns to doctors. Recent studies have found 66% of women feel their health concerns are misunderstood and 84% feel their concerns are dismissed by clinicians.

Founded by husband and wife Josh and Katy Whalen, who have experienced the power of hormone optimization and peptide therapies themselves and have since become experts on these treatments, Joi was developed alongside top medical experts specializing in anti-aging and regenerative medicine to help women take back control of their health.

“After struggling with infertility and then finally having my two children, I found myself frequently feeling fatigued, hormonal, and struggling with brain fog. It wasn’t until I began optimizing my hormones and using peptide therapy, that I started feeling like myself again,” said Katy Whalen, co-founder and CEO of Joi. “It was unbelievable to me that these therapies weren’t a regular part of women’s healthcare, especially as they go through the major hormonal and age-related changes postpartum and during perimenopause or menopause. Our mission at Joi is to make these science-backed and effective therapies accessible to women across the U.S. through an experience that is entirely virtual and highly tailored to their needs. It can be overwhelming to know where to start, especially if you’re new or unfamiliar, but Joi is designed to be with you every step of the way.”

Joi’s approach is focused on holistic preventative care, understanding the root cause of a patient’s symptoms to then create custom treatment plans to help them reach their goals. Everyone’s health journey is different, and Joi offers personalized one-on-one solutions based on needs, not one-size fits all.

How It Works

The Joi experience is simple and straightforward. Patients begin the process by scheduling a $25 online healthcare visit with one of Joi’s medical providers to discuss health concerns and goals. If needed, patients will then complete comprehensive labs to check key biomarkers. From there, Joi’s medical team provides patients with a personalized health report based on lab results and health goals that outlines a customized treatment plan. Once the patient determines which treatments they’d like to move forward with, they are shipped straight to their door.

Goals-Based Approach

Joi offers 1:1 coaching to help keep patients on track to reach their health goals, including monthly virtual check-ins and unlimited messaging. Patients also get access to private group coaching workshops as well as a 20% discount on supplements. As part of the Joi family, patients will also get unlimited follow-ups to fine-tune treatment plans. Additionally, the company offers multiple lab options, including the ability to send a nurse or licensed phlebotomist to a patient’s home or office.

Some people think of retail pharmacists as standing behind the counter bottling pills, answering insurance questions, or discussing side effects with a customer.  

But the COVID pandemic fundamentally changed the role of the neighborhood pharmacist, from primarily dispensing medication to increasingly being the source of urgent and primary care for patients.  With the successful administration of more than 300 million COVID vaccinations, an ongoing doctor shortage, and healthcare deserts in large parts of the country, the need for this transformation has never been more evident.  

Pharmacies are increasingly well-positioned to serve at the start of the healthcare continuum by providing easy access to clinical services, medication therapy management, immunizations, and walk-in patient consultations.  With 95 percent of Americans living within five miles of a pharmacy and healthcare provider shortages impacting communities across the country, it only makes sense that pharmacists become first-choice providers for a growing number of clinical services.  Pharmacies are now the “front door” to health care.  

Driven by the Biden Administration’s Test-to-Treat program, pharmacies are now in the process of going beyond immunizations into areas such as infectious disease, prescribing hormonal contraceptives, tobacco cessation, medical nutrition therapy and preventive counseling.  

Pharmacists’ role as health care providers will reach an unprecedented scale, making it easier than ever for patients to access basic care, creating business opportunities for pharmacies to provide more health care services to the communities they serve.    

Recognizing the role pharmacists are ready and able to play as accessible, convenient health care providers, Kentucky became the first state in the nation to enable pharmacists to offer potentially life-saving colon cancer screenings in 2022.  Making it easier for patients to access colon cancer screenings is just the latest example of the expanding, patient-centric, clinical role pharmacists play and is a trend to watch in the delivery of health care.

Filling the Void

The United States has been facing a primary care physician shortage that is only projected to get worse.  According to the American Association of Medical Colleges (AAMC), “a shortage of up to 122,000 physicians is projected by 2032, including up to 55,000 in primary care and 66,000 in other specialties.”

Supporting retail pharmacies as they fill the care gap left by physician shortages and transition to an effective, patient-centric clinical services business model requires real-time communication and seamless data sharing among pharmacists, diagnostic providers, physicians, and patients.  Linking the care team together in a way that provides for not only the efficient delivery of care but efficient provider billing with full interoperability will be essential to the long-term success of pharmacies as providers of clinical services. 

The need for simplicity and interoperability of pharmacy data management systems and patient communications solutions has never been greater.  Today’s community pharmacy can only optimize patient care and profitability with technology solutions that empower pharmacists with improved efficiencies in billing and workflow, and that provides easy access to patient records to bring actionable data and functionality to the point of care, when and where it’s needed. 

Interoperability makes it possible for quick configuration and synchronization of ever-evolving data-sharing formats and protocols, enabling quick response to new requirements and opportunities as they arise over time.   

Among the top 10 benefits of choosing the right HIPAA-compliant, SaaS-based platform that promotes vendor-neutral and device-agnostic interoperability that enables sharing and reuse of curated patient health data sets are:

– Delivering more patient-centric healthcare services that cater to the patient community

– Executing and documenting flawless clinical encounters from start to finish

– Using a billing-enabled EHR that guides documentation for effective patient encounters, follow up and billing.  Establishing timely billing practices to ensure optimal reimbursement and pharmacy revenue growth

– Surging adoption of electronic medical records now means there are many new formats that have generated additional demands for better integration.  Bridging data and imaging silos across and between institutions using semantic ontological frameworks

– Protecting privacy and compliance through multiple security layers, including: 

   – User access authentication

   – Access and permissions defined by an administrator

    – Full audit traceability with role-based access control

    – Data encryption in transit and at rest

– Ensuring always-updated software helps avoid situations like the recent Southwest Airlines technology debacle that led to the cancellation of thousands of flights.  By using cloud-based solutions, pharmacy users can always have automatic access to the latest software versions, without ever having to deal with maintenance or costly, time-consuming software updates. The platform itself and the data pool would both be scalable

– Analyzing data,  including documenting and reporting quality of care metrics and transforming information into actionable insights, can lead to searching individual patient records to visualize longitudinal patient encounters.  However, search “like” functionality at the patient population level can help pharmacies visualize distinct disease characteristics, distinct patient biomarkers and other characteristics such as outcomes

– Elevating pharmacists to the role of a care provider will require efficient credentialing but will also empower freedom of movement to other states.   Credentialing and payor enrollment tools will help pharmacists get enrolled, contracted, and credentialed so they can deliver more clinical services more efficiently and get reimbursed for them

– Implementing crucial provider collaboration that runs across all verticals

– Collaborating with data-sharing APIs that ingest data and deliver it across disparate platforms

Will pharmacists seize the empowerment opportunity? 

Only with true interoperability will pharmacists be able to increase revenues, collaborate effectively, enhance operating efficiencies, improve health outcomes, and lower the costs of healthcare management.  

Working with clinical and financial data in today’s extremely complex healthcare environment is extraordinarily challenging. Even with the best platform, experience and expertise are essential to properly combine and utilize technology elements so that analytics can make sense of and convey accurate and meaningful information and manage it all intelligently, and to be more informed it is necessary to take healthcare training in a continuous manner

Simplified interoperability in the pharmacy greatly improves efficient access to information and makes pharmacies less reliant on any one system or technology.  With the right system, pharmacists can have at their fingertips electronic access to patient’s lab and immunization history, companion vaccine opportunity identification, immunization registry and public health reporting, prescriber communication and targeted outbound patient communications – all to keep the pharmacist and their patients in sync at the center of care.  

Time is of the essence to make data system improvements and stay ahead of the rapid transformation of the pharmacy industry as it evolves from a medication dispensing model to a clinical care service model.  

There has never been a greater call for technology-empowered pharmacists to step in to fill healthcare provider voids and to deliver the kind of accessible, convenient patient-centric care expected today.  The technology is ready.  Are America’s pharmacists?

About David Pope, PharmD, Chief Pharmacy Officer

In his role as Chief Pharmacy Officer at XiFin, David drives the company’s innovation and product portfolio strategy for pharmacy. He is a nationally-recognized expert in medical informatics and clinical services in the pharmacy space, and has served as an advisor for the Center for Disease Control (CDC) as well as multiple Fortune 500 healthcare-related organizations.

What You Should Know:

– During a press preview event at CES last night, Withings unveiled, U-Scan, a miniaturized urine health lab that will change the way people and health professionals will monitor vitals from the comfort and privacy of their own bathroom. 

– U-Scan consists of a technologically advanced pebble-shaped urine analysis reader that sits within the toilet bowl.  Its changeable cartridges are designed to assess specific biomarkers without the need for external sample capture or strips.  It is simultaneously being developed for the consumer health and professional medical markets.  

– The first health professionals are using it to develop noninvasive cancer screening and powering a clinical study to improve the follow-up of patients with cystine renal lithiasis and uric acid renal lithiasis. 

U-Scan For Professionals – How it Works

While easy to use, U-Scan overcomes multiple technical and chemical challenges. Developed with in-vitro diagnostic experts, it was four years in the making and resulted in 13 patent application families.  As a complete system, U-Scan performs three tasks:    

1) Automated Sample Capture – using a sophisticated reader within a toilet bowl

Just 90 mm in diameter, the rechargeable U-Scan reader is engineered to distinguish between external liquid and urine and automatically funnel samples for analysis. Urine flows efficiently to a collection inlet thanks to its pebble-shaped design.  A pump is activated when a thermal sensor detects the presence of urine, which starts a sample’s fluidic journey within a microfluidic circuit. 

After its collection, the urine sample is injected into a test pod where the chemical reaction is read by an optical module. At the end of each measurement, the circuit returns to the idle position and the remaining liquid is purged through a waste outlet. The system is subsequently cleaned with every flush. 

2) Biomarker Analyses – within a miniaturized urine lab tailored to specific use cases  

The rotating cylindrical U-Scan cartridge is a tiny chemical assessment chamber containing dozens of miniaturized test pods that can deliver reliable results. When the reader delivers the sample to the injection point U-Scan begins the chemical analysis within moments.  It automatically transmits results via Wi-Fi and then rotates the cartridge to expose the next test pod to the injection point.

The module system is purposely designed to allow for bespoke cartridges to be developed as required by use cases. 

3) Actionable  Data– unlocking new health data streams    

The data collected with U-Scan For Professionals can be analyzed and delivered to audiences in a variety of ways depending on the use case.

As the latest device within the Withings ecosystem, U-Scan For Professionals is compatible with Withings RPM, the highly advanced Remote Patient Monitoring solution that places the patient experience at the heart of the telehealth experience. The ability to carry out daily urine analysis greatly increases the health data Withings can offer partners, making it one of the most comprehensive platforms on the market.   

Leveraging its API, Withings partners can bring patients’ data to their own environment and offer results or actional advice in their own voice and brand. 

Debut in Europe

U-Scan will debut in Europe with two consumer health cartridges, including U-Scan Cycle Sync for women’s monthly cycle tracking and syncing and U-Scan Nutri Balance, a detailed metabolic guide to hydration and nutrition. Withings Health Solutions, the company’s business-to-business division, has launched U-Scan For Professionals to bring this technology to the medical and healthcare industries.

What You Should Know:

– Sonde Health, a Boston, MA-based health technology company committed to bringing accessible health monitoring to everyone raises $19.25 million in a Series B investment round led by Partners Investment, with participation from NEOM Company, KT Corporation, and existing investors, including co-founder PureTech Health and M Ventures.

– The AI vocal biomarker company will use the funding to accelerate its commercial growth, expand its platform into new health conditions, and enter new geographies.

Enterprise Vocal Biomarker Technology

Co-founded by PureTech Health, Sonde Health has the largest and most diverse health-labeled voice dataset with over 1.2 million voice samples from over 85,000 subjects on 4 continents. Sonde is the only vocal biomarker company to offer AI/machine learning-based monitoring products for multiple health conditions and to have developed the ability to embed its technology into device chipsets for passive and safe health monitoring through voice.

Today, Sonde provides its enterprise vocal biomarker technology to companies across several health verticals, including telehealth, pharmaceutical, remote patient monitoring, and consumer/medical devices. Sonde licenses its platform to customers globally in two ways:

Health Checks

Respiratory Fitness: Sonde’s platform can detect and monitor respiratory health conditions, like asthma, from 6 seconds of voice. Patients are engaging with Sonde’s respiratory fitness health checks 2+ times per week.

Mental Fitness: Sonde’s platform can detect and monitor evidence of depression and anxiety from 30 seconds of voice. Patients are engaging with Sonde’s mental fitness health checks 3+ times per week.

Vocal Biomarker Development

MCI, COPD, General Health: Sonde is developing novel vocal biomarkers using its proprietary “research-build-validation” methodology with clinical partners.

“Digital biomarkers are becoming a mainstay in healthcare. Today’s healthcare companies are realizing how vocal biomarkers can engage people earlier in their health. The data and insights found in voice can power health monitoring and patient stratification so issues can become apparent well before a costly medical event occurs,” said David Liu, CEO of Sonde Health. “With voice and any listening device, accessible and effective health monitoring can be made available to the majority of the world.”

Millions of Americans live with acute and chronic pain that affects every aspect of their lives. Pain by itself is an important marker of how a patient is feeling and indicates what kind of medical intervention might be necessary. The healthcare industry needs a clinically acceptable way to objectively measure pain and since pain is a very complex mixture of biochemistry and genetics and it’s unlikely that a laboratory test that directly quantifies pain will be developed.  

Doctors have been using questionnaires and subjective responses including, the answer to the popular question, ‘What is your pain on a scale of 0 to 10?’ Unfortunately, each person’s pain tolerance and perception are different. Responses can be exaggerated or underplayed, pain can vary in how it is experienced or the conditions it is caused by…not to mention, adults and children can experience pain differently. It’s ultimately up to the clinician to determine the level of pain. To further complicate the pathology, clinicians may treat pain differently when it is a symptom versus when it becomes the primary pathology. One clinically actionable solution is to indirectly quantify the effects of pain using motion as a functional biomarker.

There is no question that a multi diagnostic strategy is always the best when applied to any disease. Healthcare professionals have now found that assessing a patient’s functional movements including balance, gait, and range of motion is more important than a subjective pain-based response alone. New tools have made it possible to use motion as a functional biomarker and endpoint for many treatments where the pain is involved. The ability to assess sudden or gradual changes in movement can be a vital factor in the early diagnosis, treatment, and management of a wide number of painful health issues. 

Can pain be quantified? A new clinical trial showcases landmark progress in objective pain measurement. 

Diagnostic and therapeutic challenges overly rely on self-reporting and the paucity of biologically-based objective methodologies. Non-addiction medicine rehabilitation specialists are likely to adjust medications based on patients’ complaints and justify increasing dosages, secondary to inadequate pain control, attributing such scenarios to the development of tolerance or progression of the disease.  Without objective signs of non-adherence, the clinician may increase dosage accordingly by the absence of aberrant behavior. This does not rule out the presence of tolerance, physical dependence, addiction or drug diversion.  Patient behavioral variability renders subjective analyses unreliable, and well-informed addicted patients can avoid these indirect indicators until the addiction severity overpowers self-control.

There are many treatments for pain and the ability to quantify the patient’s functional status can aid the clinician in the determination and management of their pain. A recent clinical study led by medical director Gladstone C. McDowell II, M.D., of Integrated Pain Solutions is being conducted to understand the link between functional motion and incapacitating back and leg pain in patients being treated with Nevro Corp. HFX Spinal Cord Stimulation. Dr. McDowell’s work was chosen as the Best Spinal Cord Stimulation Abstract winner at the 2022 American Society of Pain and Neuroscience (ASPN) annual Conference. 

The year-long study involved 25 adult patients who were implanted with the Nevro Senza^® Spinal Cord Stimulator (“SCS”). Patients’ functional status were assessed using the Oswestry Disability Index (“ODI”), a standard patient self-reporting instrument. A clinical sensor-based motion system was also employed to systematically measure functional motion and cognition in patients to warrant the use of a permanent stimulation device. Strategically placed sensors allow for the noninvasive capture of normal and pathological motion data to identify, assess, and adequately transform patient motion patterns including ambulation, balance, symmetry, range of motion, and cognition. 

Inside the Clinical Study: What doctors observed.

The study was able to demonstrate there was a significant disparity between the patient’s perception, their ODI score, and the objective measurement of their function, analyzed by the sensors. 

Overall, patients who received the SCS system had a significant and measurable improvement in functional motion (gait and overall balance). The few patients that were ultimately not ideal candidates for SCS implantation demonstrated significant dysfunction pre-implantation that may have indicated a lack of functional improvement post-implantation. In addition, the study confirmed that the testing and measurement of movement-based functional biomarkers provided objective and actionable analyses with greater accuracy, augmenting traditional subjective pre- and post-surgical pain assessment protocols.

AI, ML, and Sensor Technology for Pain Measurement and Management

Advancements in AI, ML, and sensor technology are finding their place in the healthcare industry. These technologies are being used to quantify unmeasurable parameters like pain; objectify physical, surgical, pharmacological, and cognitive therapies; and as a real-time biofeedback therapeutic tool that defocuses patients’ attention on the pain and discomfort and redirects their focus on their functional performance. 

The development of laboratory-grade, portable technologies that provide clinically relevant information regardless of the patient’s location are critical since pain is a ubiquitous problem and access to the appropriate specialist is not equivalent across the country.

The ability to quantify, measure and manage the effects of pain is a significant advancement in treating pain-related pathologies and can improve the lives of millions living with pain anytime, anywhere.  

Patients, practitioners and payers will all benefit.

About Frank Fornari, Ph.D.

Frank Fornari, Ph.D., is a life sciences consultant, educator and entrepreneur with extensive experience in pharmaceutical, basic scientific research, clinical medicine, toxicology, chemistry, and drug development. He is also chairman and founder of BioMech, a leading-edge biotechnology company that develops and distributes real-time motion analytics and artificial intelligence/machine learning solutions, including BioMech Lab™ and Coretex™ that quantify and improve outcomes in healthcare, sports/wellness and industrial sectors. For more information, visit www.biomech.us.