New Biological Markers Found That May Predict Which Patients Won’t Respond to Chemotherapy

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The investigators identified new biological markers that may predict which ovarian cancer patients won’t respond to chemotherapy. Chowdhury et al, Cell.

Using a novel proteogenomic strategy and a variety of machine learning tools, investigators from the Icahn School of Medicine at Mount Sinai and colleagues have identified a 64-protein signature that may predict a subset of ovarian cancer patients who are unlikely to respond to chemotherapy.

The multicenter study, published online August 3 in Cell [DOI#: 10.1016/j.cell.2023.07.004], reports on a pioneering analysis of chemo-refractoriness in high-grade serous ovarian cancer (HGSOC). The work also implicates possible therapeutic targets for these patients.

Epithelial ovarian cancer causes 185,000+ global deaths annually. HGSOC accounts for 60 percent of these deaths. Despite advances in treatment, mortality has remained the same for these patients in the past 40 years. Currently, there’s no way to distinguish refractory cases (who never respond to chemotherapy), leading some patients to unnecessarily experience the adverse effects of platinum-based chemotherapy without the benefits.

“To address this critical unmet need, we performed a proteogenomic analysis to identify molecular signatures of refractory HGSOC and potential treatment targets. Predictors of chemo-refractoriness could enable precision oncology, sparing patients the toxicity and helping to identify the most effective therapy through targeted clinical trials,” says Pei Wang, PhD, Professor of Genetics and Genomic Sciences at Icahn Mount Sinai and co-corresponding author on the paper.

The investigators studied 242 tumors samples collected from HGSOC patients comprising both chemo-refractory and chemo-responsive individuals before they received chemotherapy. Using advanced computer models to analyze protein and gene expression profiles of the tumors, they found a specific group of 64 proteins that can predict which tumors won’t respond well to the first-line platinum-based therapy. This prediction was confirmed in two independent cohorts of patients.

In addition, based on pathway activity measurements derived from the proteomics data, the team also identified five new HGSOC subtypes, validated in two independent patient groups and in lab-grown tumor mouse models, suggesting that different treatment strategies may be needed.

Next, the researchers plan to confirm their findings in additional retrospective and prospective studies.

Once validated, these tools, say the investigators, can be used by clinicians to design customized alternative treatments other than the current standard chemotherapy to help patients with refractory tumors.

As a part of the research, the lab of Amanda Paulovich, MD, PhD, a lead author of the study, is working on a new test that uses a multiplex assay panel to measure the proteins in the prediction model faster and more efficiently. Dr. Paulovich is a professor at Fred Hutchinson Cancer Center in Seattle, where she holds the Aven Foundation Endowed Chair.

The test will combine information from multiple proteins to create a single score that indicates the likelihood of chemo-refractory disease. If successful, say the investigators, it could be a significant development for about 35 percent of patients with ovarian cancer who could avoid treatments that won’t work for their specific type of cancer.

The paper is titled “Proteogenomic analysis of chemo-refractory high-grade serous ovarian cancer.”

Authors on the Cell paper include: Shrabanti Chowdhury, PhD, (Icahn Mount Sinai); Jacob J. Kennedy (Fred Hutchinson Cancer Center); Richard G. Ivey (Fred Hutchinson Cancer Center); Oscar D. Murillo (Fred Hutchinson Cancer Center); Noshad Hosseini, PhD candidate (University of Michigan School of Medicine); Xiaoyu Song, DrPH (Icahn Mount Sinai); Francesca Petralia, PhD (Icahn Mount Sinai); Anna Calinawan (Icahn Mount Sinai); Sara R. Savage, PhD (Baylor College of Medicine); Anna B. Berry, MD (Syapse, Inc.); Boris Reva, PhD (Icahn Mount Sinai); Umut Ozbek, PhD (Icahn Mount Sinai); Azra Krek, PhD (Icahn Mount Sinai); Weiping Ma, PhD (Icahn Mount Sinai); Felipe da Veiga Leprevost, PhD (University of Michigan School of Medicine); Jiayi Ji (Icahn Mount Sinai); Seungyeul Yoo, PhD (Sema4); Chenwei Lin, PhD (Fred Hutchinson Cancer Center); Uliana J. Voytovich (Fred Hutchinson Cancer Center); Yajue Huang, MD (Mayo Clinic); Sun-Hee Lee, PhD (Mayo Clinic); Lindsay Bergan (Fred Hutchinson Cancer Center); Travis D. Lorentzen (Fred Hutchinson Cancer Center); Mehdi Mesri, M.Med.Sci.PhD (National Cancer Institute); Henry Rodriguez, PhD, MS, MBA (National Cancer Institute); Andrew N. Hoofnagle, MD, PhD (University of Washington); Zachary T. Herbert, MS (Dana-Farber Cancer Institute); Alexey I. Nesvizhskii, PhD (University of Michigan School of Medicine); Bing Zhang, PhD (Baylor College of Medicine); Jeffrey R. Whiteaker, PhD (Fred Hutchinson Cancer Center); Samuel C. Mok, PhD (The University of Texas MD Anderson Cancer Center); Scott H. Kaufmann, MD, PhD (Mayo Clinic); Charles Drescher, MD (Fred Hutchinson Cancer Center); Marcin Cieslik, PhD (University of Michigan School of Medicine); Pei Wang, PhD (Icahn Mount Sinai); Michael J. Birrer, MD, PhD (University of Arkansas for Medical Sciences); Amanda G. Paulovich, Md, PhD (Fred Hutchinson Cancer Center); and Clinical Proteomic Tumor Analysis Consortium (CPTAC) Collaborators (NYU School of Medicine, University of Miami, University of California San Francisco, and University of Minnesota).

This work was done in collaboration with the U.S. National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) and supported by grants U01CA214114, R50CA211499, U24CA210993, U24CA271114, U24CA210954, U24CA210967, U24CA210972, P30CA240139, P50CA136393, S10OD028685, and P30CA015704, as well as from a generous donation from the Aven Foundation.

To view competing interests, please see the paper at Cell.

About the Icahn School of Medicine at Mount Sinai

The Icahn School of Medicine at Mount Sinai is internationally renowned for its outstanding research, educational, and clinical care programs. It is the sole academic partner for the eight- member hospitals* of the Mount Sinai Health System, one of the largest academic health systems in the United States, providing care to a large and diverse patient population.

Ranked 14th nationwide in National Institutes of Health (NIH) funding and among the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges, Icahn Mount Sinai has a talented, productive, and successful faculty. More than 3,000 full-time scientists, educators, and clinicians work within and across 44 academic departments and 36 multidisciplinary institutes, a structure that facilitates tremendous collaboration and synergy. Our emphasis on translational research and therapeutics is evident in such diverse areas as genomics/big data, virology, neuroscience, cardiology, geriatrics, as well as gastrointestinal and liver diseases.

Icahn Mount Sinai offers highly competitive MD, PhD, and Master’s degree programs, with current enrollment of approximately 1,300 students. It has the largest graduate medical education program in the country, with more than 2,000 clinical residents and fellows training throughout the Health System. In addition, more than 550 postdoctoral research fellows are in training within the Health System.

A culture of innovation and discovery permeates every Icahn Mount Sinai program. Mount Sinai’s technology transfer office, one of the largest in the country, partners with faculty and trainees to pursue optimal commercialization of intellectual property to ensure that Mount Sinai discoveries and innovations translate into healthcare products and services that benefit the public.

Icahn Mount Sinai’s commitment to breakthrough science and clinical care is enhanced by academic affiliations that supplement and complement the School’s programs.

Through the Mount Sinai Innovation Partners (MSIP), the Health System facilitates the real-world application and commercialization of medical breakthroughs made at Mount Sinai. Additionally, MSIP develops research partnerships with industry leaders such as Merck & Co., AstraZeneca, Novo Nordisk, and others.

The Icahn School of Medicine at Mount Sinai is located in New York City on the border between the Upper East Side and East Harlem, and classroom teaching takes place on a campus facing Central Park. Icahn Mount Sinai’s location offers many opportunities to interact with and care for diverse communities. Learning extends well beyond the borders of our physical campus, to the eight hospitals of the Mount Sinai Health System, our academic affiliates, and globally.

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  • Mount Sinai Health System member hospitals: The Mount Sinai Hospital; Mount Sinai Beth Israel; Mount Sinai Brooklyn; Mount Sinai Morningside; Mount Sinai Queens; Mount Sinai South Nassau; Mount Sinai West; and New York Eye and Ear Infirmary of Mount Sinai.

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Hilary Framke to Build Relationships in the EHS Community and Beyond

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“…this position affords me the opportunity to shape the SafetyStratus system and services into the most effective EHS software on the market—serving the industry’s ultimate goal of reducing risk to prevent injuries and environmental harm.”-Hilary Framke, VP of EHS Solutions

SafetyStratus, an enterprise EHS software platform company that works with partners across a variety of industries to optimize Environmental, Health, and Safety (EHS) programs, announced that Hilary Framke, a progressive leader for EHS in industrial and commercial markets, has joined the company as the first Vice President of EHS solutions. In this role, she will guide SafetyStratus’ strategic plan for building a space for the EHS community to contribute their voice in the shaping of products that meet the needs and advance the work of the industry.

Before joining the SafetyStratus team, Framke served as the Head of EHS for a global business line within Siemens Healthineers. During her time in this position at the third largest medical device manufacturer in the world, Framke led the environmental, health, safety, sustainability, and functional strategy to achieve record-breaking results in environmental protection and total recordable incident rates (TRIR). In this last year, Framke spearheaded global projects for all 68,000 Siemens Healthineers employees in major risk categories including ergonomics, global standards in electrical safety and the control of hazardous energy, diversity and inclusion for gender equality in leadership roles, and more.

Commenting on her appointment to VP of EHS Solutions, Framke said, “I was first introduced to the SafetyStratus platform in 2012. At the time, my organization was investigating options in the EHS software space, and I agreed to a demo. I was blown away by how intuitive and user-friendly the system was. I’ve spent my entire career in the manufacturing industry as an EHS leader, directly facing the work-related risks that lead to employee injuries/illnesses, compliance exposure, and environmental impact. I know firsthand how frustrating it can be when a software solution doesn’t provide the efficiency that was promised. I’ve always been a leader committed to change and this position affords me the opportunity to shape the SafetyStratus system and services into the most effective EHS software on the market—serving the industry’s ultimate goal of reducing risk to prevent injuries and environmental harm.

My mind is buzzing with the potential to make a huge impact, not just with one organization, but with all those clients that SafetyStratus currently serves and those we will meet in the future. This new position enables me to walk behind the ‘technology curtain’ and have a seat at the table for product development, capability, functionality, and value. I want to secure this same privilege for as many EHS professionals as I can so that they too can contribute their past experiences and skills to the shaping of solutions for EHS issues in today’s workplace.”

Delving deeper into how this transition into a position within a software company appealed to her, Framke explained, “the modern workplace is facing new environmental, resource, and workforce challenges and opportunities. EHS practitioners are seeing the boundaries of their responsibilities being pushed to include sustainability, remote work risk control, and mental health. All the while, expectations to improve KPI performance and compliance assurance are becoming more aggressive. This push-and-pull between expectations, resources, and scope can only be resolved through technology-driven efficiency. Software that provides real-time insights using the power of EHS data is how EHS leaders can prioritize efforts that add immediate value and communicate the biggest risks to all levels of the organization, from executives to frontline leadership. I’m thrilled to contribute my professional EHS experiences to make a real difference in how software enables world-class EHS performance.”

Operating within an environment of continuous improvement, Framke will collaborate with the entire SafetyStratus team—from operations, sales, and marketing to product development. The scope of these interactions will include Framke contributing recommendations and oversight of changes that translate to improvements in productivity, business integration, remote work engagement, employee collaboration, and data visibility. SafetyStratus will be promoting opportunities to introduce Framke both internally and externally, leading to discussions on system performance, usage, satisfaction, and EHS thought leadership that are expected to positively impact current operations and the overall EHS industry.

About SafetyStratus

Empowering digital transformation in EHS programs with the power of leading-edge technology backed by a team of safety professionals, SafetyStratus has been trusted to advance critical safety priorities across organizations within Academia, Healthcare, Construction, Manufacturing, Research & Development, and more. We support innovation in saving lives and the environment by successfully integrating knowledgeable people and sustainable processes with our multi-level, cloud-based platform. Incorporating a driving focus on our clients, we build and teach configurable solutions to evolving problems—moving institutions into the future.

With headquarters located in Plano, Texas, our company has an employee base of industry experts and innovators, spanning the globe.

For more information visit http://www.safetystratus.com or LinkedIn, Twitter, and Facebook.

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The Lustgarten Foundation Announces Extraordinary Year of Research Grants Fueling Bold and Innovative Pancreatic Cancer Research

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To date, the Lustgarten Foundation has funded more than $250 million in research grants and has been a leading force in every major advancement in pancreatic cancer research.

“For 25 years, Lustgarten has been an industry trailblazer, driving progress and inspiring hope throughout the community. Our commitment remains resolute as we build on this momentum with a clear vision of a future with pancreatic cancer cures,” said Linda Tantawi, CEO of the Lustgarten Foundation.

The Lustgarten Foundation, the nation’s largest private funder of pancreatic cancer research, today announced a remarkable year of funding, awarding 17 new grants to researchers at 13 leading institutions. These grants, totaling $23 million, support Lustgarten’s collaborative, science-focused strategy, which drives outcomes across three research pillars—early detection, new drug development, and personalized medicine. With the addition of these new grants, the Lustgarten Foundation supports a total of 59 active grants across 30 institutions. The Foundation concentrates on translating its understanding of the underlying biology of pancreatic cancer into clinical applications for patients.

“The Lustgarten Foundation was founded on the principle that funding innovative, cutting-edge research is the only way to improve patient outcomes and ultimately transform pancreatic cancer into a curable disease,” said Linda Tantawi, CEO of the Lustgarten Foundation. “For 25 years, Lustgarten has been an industry trailblazer, driving progress and inspiring hope throughout the community. Our commitment remains resolute as we build on this momentum with a clear vision of a future with pancreatic cancer cures.”

Of the $23 million awarded:


  • 24% supports early detection and interception efforts, aiming to develop and deliver tools enabling early diagnosis of pancreatic cancer; develop and optimize biomarkers enabling early detection in the general population; develop approaches for risk assessment and management of high-risk groups.
  • 60% supports new drug development projects, aiming to accelerate the development of therapies; identify novel drug targets based on an understanding of the biology of pancreatic cancer initiation and progression; accelerate preclinical and clinical testing of novel drugs and combinations in pancreatic cancer.
  • 16% supports personalized medicine studies, aiming to implement a personalized medicine program; better characterize and understand the heterogeneity of pancreatic cancer; develop tools to guide treatment decisions matching the right treatment to the right patient at the right time.

This investment reflects Lustgarten’s dedication to advancing pancreatic cancer research faster than ever before, driving new breakthroughs, and giving patients the best chance for survival and quality of life.

This year’s grants included:

The LABS (Lustgarten Advancing Breakthrough Science) Program, a hallmark of the Foundation’s unique research strategy, had an especially momentous year, with three out of the six dedicated laboratories up for renewal. After rigorous review, Lustgarten continued funding for all three labs, located at Cold Spring Harbor Laboratory, led by David Tuveson, MD, PhD, Massachusetts Institute of Technology, led by Tyler Jacks, PhD, and Dana-Farber Cancer Institute, led by Brian Wolpin, MD, MPH. The LABS Program provides long-term funding to promote the development of innovative ideas and speed the pace of discovery by incentivizing interdisciplinary team science, including groups with complementary expertise across the pipeline from target discovery and validation to preclinical development and clinical testing. Additionally, funding was also renewed for Dr. Tuveson’s study “Organoid Personalized Therapeutics Phase 4 Project-OPT4.” OPT4 will build on previous phases, which leverage patient-derived organoid (PDO) models to study pancreatic cancer and drive forward the development of early detection tools and therapeutic options.

Lustgarten Foundation-AACR Career Development Awards Honoring Ruth Bader Ginsburg and John Robert Lewis awarded to Ashley Kiemen, PhD, Assistant Professor of Oncology and Pathology, Johns Hopkins University School of Medicine, for her study “3D Morphological Analysis of Human Pancreatic Cancer Liver Metastases,” and Christina Ferrer, PhD, Assistant Professor of Pharmacology, University of Maryland, Baltimore, for her study “Metastasis-Initiating Cells in Pancreatic Cancer.” These awards foster and grow the number of early-career women and underrepresented scientists working in pancreatic cancer research and honor the lives and legacies of two iconic Americans lost to pancreatic cancer. The awards support trailblazing investigators committed to increasing the understanding and treatment of pancreatic cancer.

LEAD (Lustgarten Equity, Accessibility, and Diversity) Project grants awarded to Karyn Goodman, MD, MS, Vice Chair of Radiation Oncology and Associate Director of Clinical Research at Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, for her study “Navigating Pancreatic Cancer Multidisciplinary Care to Address Cultural and Language Barriers to Clinical Trial Enrollment among Mandarin and Spanish Speaking Patients with Pancreatic Cancer,” and Rebecca Snyder, MD, MPH, Associate Professor in the Departments of Surgical Oncology and Health Services Research at The University of Texas MD Anderson Cancer Center, for her study entitled “IMPACT Diversity: An Integrated Multi-level Plan to Address Clinical Trial Diversity.” The LEAD Grants were created to increase the recruitment and retention of underrepresented groups in pancreatic cancer clinical trials.

Lustgarten Foundation-Swim Across America-AACR Early Detection Research Grant awarded to Ajay Goel, PhD, Professor and Chair, Department of Molecular Diagnostics and Experimental Therapeutics Beckman Research Institute of the City of Hope, for his study “A Circulating Epigenetic Signature for Early Detection of Pancreatic Cancer.” This new partnership with Swim Across America will stimulate innovative work in the early detection of pancreatic cancer and bring new talent to the field.

Advancing pancreatic cancer detection efforts grants awarded to Elliot Fishman, MD, Director, Diagnostic Imaging and Body CT, and Professor of Radiology and Radiological Science, Johns Hopkins University School of Medicine, for his study “Felix 2.0: The Integration of AI into the Early Detection and Management of Pancreatic Cancer with Novel AI Algorithms and Advanced Data Analysis,” and Alan Yuille, PhD, Bloomberg Distinguished Professor, Department of Computer Science, Johns Hopkins Whiting School of Engineering, for his study “Felix Civitas.” These projects build on the success of the FELIX Program, funded by Lustgarten since 2016. The FELIX Program uses data from thousands of CT scans to teach computers to detect tumors small enough to be missed by even the most experienced radiologists.

Innovation and Collaboration Program grants awarded to Kacper Rogala, DPhil, MRes, Assistant Professor of Structural Biology and of Chemical and Systems Biology, Stanford University School of Medicine, for his study “Establishing Choline Transport as Selective Vulnerability of Pancreatic Cancers,” and David Kashatus, PhD, Associate Professor, Microbiology, Immunology, and Cancer Biology, University of Virginia, for his study “The Role of Lipid Droplets in Pancreatic Cancer Metastasis.” This program provides seed funding for highly innovative research projects with significant potential to accelerate Lustgarten Foundation’s mission to transform pancreatic cancer into a curable disease.

Dr. Robert F. Vizza Lustgarten Clinical Accelerator Initiative (CAI) grants awarded to Dafna Bar-Sagi, PhD, Executive Vice President, Vice Dean for Science, and Chief Scientific Officer, NYU Langone Health, for her study “Evaluation of the Mechanism and Efficacy of IL-15 Superagonist-based Neoadjuvant Chemo-Immunotherapy for Pancreatic Cancer,” Andrew Lowy, MD, Director of Surgical Oncology and Associate Professor, Moores Cancer Center at UC San Diego Health, for his study “A Phase 2 Trial of FOLFIRINOX plus Eganelisib in Patients with Borderline Resectable Pancreatic Cancer,” Michael Pishvaian, PhD, MD, Director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs Associate Professor of Oncology, Johns Hopkins University School of Medicine, for his study “A Phase II Trial of Olaparib, Pembrolizumab, and Lenvatinib as Second-Line Therapy for BRCA1, BRCA2, or PALB2-Mutated Metastatic Pancreatic Adenocarcinoma,” and Peter Allen, MD, Chief, Division of Surgical Oncology, Duke University School of Medicine, for his study “A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer.” The CAI reduces the time from clinical trial concept to launch using a Lustgarten-developed process based on the best available science and employing innovative biomarkers. With four new trials added this year, there are now eight trials supported through this innovative program.

“We will continue to bring new and transformative research to light to help patients and families impacted by pancreatic cancer and to ensure that discoveries can move to the clinic as quickly as possible,” said Andrew Rakeman, Vice President of Research at the Lustgarten Foundation. “Now is our time to empower pancreatic cancer researchers and propel critical research forward.”

To date, the Lustgarten Foundation has funded more than $250 million in research grants and has been a leading force in every major advancement in pancreatic cancer research.

About Lustgarten Foundation

The Lustgarten Foundation funds the world’s preeminent pancreatic cancer researchers, driving the pursuit of bold and innovative science toward earlier detection, better treatments and transforming pancreatic cancer into a curable disease. Our mission is rooted in the belief that research is fundamental, in fact, it is the only way to produce real results. The Lustgarten Foundation is a catalyst in the field of pancreatic cancer research. Lustgarten-funded science has been a driving force in every major advancement in pancreatic cancer research since 1998. We believe time is everything for pancreatic cancer patients and their families. The Foundation funds research where creative risks yield high rewards to accelerate and expand life-saving treatment options. And we believe in the power of community. Lustgarten programs and events provide people affected by pancreatic cancer a voice and a place to create hope, together. The Lustgarten Foundation is the largest private funder of pancreatic cancer research and 100% of all donations fuel the research to advance understanding of this complex, devastating and historically underfunded cancer. For more information, visit  http://www.lustgarten.org.

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Validation Institute Announces Program Validation Achievement

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ValidationInstitute.com

Validation Institute confers Program-Level Validation only for vendors whose savings or outcomes are backed by actual double-blinded trials. Validation Institute backs the mathematical integrity of these validations with a unique $50,000 Credibility Guarantee.

Acacia Mental Health (“Acacia”), the leader in rapid, medication-free treatment of depression and anxiety, announced that it has achieved the prestigious Program Validation from Validation Institute for its BRAIN™ protocol. The Program Validation delivers unmatched cost reductions and better outcomes for treatment-resistant Obsessive Compulsive Disorder (OCD). Per the independent analysis, the BRAIN™ protocol is cost-effective in addressing treatment-resistant obsessive-compulsive disorder, with remission rates >30%. Further, 58% have a meaningful response.

This validation follows scientific publications co-authored by Acacia scientists. This research showed that remission was possible in many cases. Remarkably, the remission of symptoms was rapid – relief was experienced in days or weeks after treatment.

The approach is both safer, and less costly compared to the standard of care. “It’s been remarkable to see people regain hope,” says David Carreon, M.D., the Stanford-trained psychiatrist and co-founder of Acacia.

Acacia is the first mental health vendor and only the third solution provider to achieve a Program validation. They join two other companies, Kaia Health, and Virta Health, as program-level validated vendors.

“In a crowded marketplace, Acacia’s innovative OCD treatment with Behavioral Response Augmented Intelligent Neuromodulation™ (BRAIN) treatment stands out for proven impact on health outcomes and driving significant cost savings,” said Benny DiCecca, CEO of Validation Institute.

Robust solutions to the mental health crisis have never been more critical. Acacia treats a full range of patients, from depression and anxiety to severe OCD. “OCD has a 10x higher suicide rate compared to depression. Our rapid-acting, medication-free treatment available for OCD as part of a health benefit plan could be lifesaving,” said Owen Muir, M.D., SVP of Strategy for Acacia and a dual board-certified child and adult psychiatrist in Acacia’s New York Center of Excellence.

Meanwhile, payers struggle to manage skyrocketing employee medical costs. The Department of Labor issued recent guidance that could “crackdown” on mental health parity violations. Unlike mental health solutions that offer only medication or therapy, the Acacia approach goes further– even when other treatments have not helped.

Guarantees of Valid Outcomes Measurement

Validation Institute confers Program-Level Validation only for vendors whose savings or outcomes are backed by actual double-blinded trials rather than participants-vs-non-participants or other methodologies. Validation Institute backs the mathematical integrity of these validations with a unique $50,000 Credibility Guarantee.

Al Lewis, generally acknowledged as the country’s leading outcomes reviewer and author of the only textbook on vendor outcomes measurement, is adding his own $100,000 guarantee separately. He says, “No vendor in OCD even approaches this level of integrity in study design or outcomes. And certainly not both together. No need to take my word for this. I guarantee it.”

Read the Validation Report here.

About Validation Institute

Validation Institute is an independent, objective, third party organization on a mission to improve the quality and cost of healthcare. Based in Woburn, MA the organization is made up of a network of health benefits purchasers, health benefits advisors, and healthcare solution providers focused on delivering better health value and stronger outcomes than conventional healthcare. http://www.validationinstitute.com

To learn more, visit AcaciaClinics.com

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Genedata Selector 9.0 Automates Critical Quality Attribute Assessment of Cell and Gene Therapy Products

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Digitalizing Biopharma R&D

With Genedata Selector 9, we have made another major step forward in our goal to enable innovative biopharmaceutical R&D organizations to decrease the time-to-market of life-changing cell and gene therapy products. Othmar Pfannes, Ph.D., CEO at Genedata

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced a new release of Genedata Selector®, the collaborative end-to-end solution that provides quality control automation support to companies striving to make safe and efficacious cell and gene therapies more accessible to patients worldwide.

Genedata Selector is an enterprise platform that automates the identification and monitoring of critical quality attributes during cell and gene therapy development and manufacturing. Equipped with out-of-the-box workflows named Playbooks, the platform enables scientists to perform data analyses accurately and efficiently, independent of data analysts. Bioinformaticians can include proprietary workflows for NGS data processing and analysis and make them available across an organization facilitating automation and improved process standardization. As a modular platform with sample management capabilities, Genedata Selector facilitates sample tracking and provides user-friendly decision-making tools that support in-depth analysis of pass/fail samples.

Selector 9, the latest release, focuses on providing specialized analytical workflows for biotherapeutic characterization and adventitious agent detection to meet required regulatory standards. In particular, this release has eliminated data handling redundancies and further improved the interoperability of Genedata Selector, for example by enabling easy integration of proprietary Nextflow pipelines into the platform for NGS data processing. This enables users to benefit from best practices for developing innovative cell and gene therapy products. Finally, the tighter integration with high-performance computing environments enables Genedata Selector users to manage system resources while gaining scalability and power.

Genedata Selector is fully compliant with FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. During CGT product development, biopharmaceutical R&D organizations gather large volumes of highly diverse experimental data, for which Genedata Selector provides a centralized location that integrates those data and connects them to their respective sample metadata. Teams involved in product development can easily access these data, to for example monitor changes in critical quality attributes and make data-informed decisions about which products should proceed in the manufacturing process. Additionally, Genedata Selector is validation-ready for deployment in GxP environments, and if required, Genedata can also provide computer system validation support.

“With Genedata Selector 9, we have made another major step forward in our goal to enable innovative biopharmaceutical R&D organizations to decrease the time-to-market of life-changing cell and gene therapy products. With its best-in-class analytical capabilities, Genedata Selector enables the biopharma industry to apply NGS and efficiently monitor product quality during bioprocess development and product manufacturing”, said Othmar Pfannes, Ph.D., CEO of Genedata. “We will continue to invest in further accelerating experimental workflows and automating complex data analytical processes to help our customers efficiently develop biotherapeutics of the highest quality.”

About Genedata

Genedata transforms data into intelligence with innovative software solutions that incorporate extensive biopharma R&D domain knowledge. Multinational biopharmaceutical organizations and cutting-edge biotechs around the globe rely on Genedata to digitalize and automate data-rich and complex R&D processes. From early discovery all the way to the clinic, Genedata solutions help maximize the ROI in R&D expenditure. Founded in 1997, Genedata is headquartered in Basel, Switzerland with additional offices in Boston, London, Munich, San Francisco, Singapore, and Tokyo.

http://www.genedata.com

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Contact

Allison Kurz

Genedata

Public Relations

pr@genedata.com

Disclaimer

The statements in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to contract cancellations, developing risks, competitive factors, uncertainties pertaining to customer orders, demand for products and services, development of markets for the Company’s products and services. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

All product and service names mentioned are the trademarks of their respective companies.

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M&S Technologies Improves Active Eye Tracking with SMARTracker™ 2

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Smart System® VR Headset

“Patients need to stay focused on that central cross, or else the test data will be inaccurate. Knowing exactly when that happens, and getting the patient back to the fixation point, means a huge leap forward for visual field testing.”



Niles, IL: M&S Technologies, makers of a line of visual testing equipment and software, today announced the release of an improved software feature for their Smart System Virtual Reality (VR) headset that better helps maintain patient fixation during visual field testing.

The new SMARTracker™ 2 technology uses a new generation of sophisticated eye tracking capabilities to register when patients have lost fixation on a central point or cross. The system will then pause testing and gently remind the patient to fixate again, at which time the test will resume.

“One of the biggest challenges for visual field tests is ensuring that patients maintain fixation during the test,” says Mike Umali, National Sales Manager for M&S Technologies. “Patients need to stay focused on that central cross, or else the test data will be inaccurate. Knowing exactly when that happens, and getting the patient back to the fixation point, means a huge leap forward for visual field testing.”

SMARTracker™ 2 is M&S Technologies’ next generation of eye tracking technology. Improving on an already advanced software, it can detect finer eye movements to increase test validity even further, making it the most advanced eye tracking software in the market.

“We were one of the first companies to offer eye tracking technology to begin with,” says Umali. “But our goal is to reach 100% accurate test results—that is what is going to give doctors the best data possible. Our long history and experience with vision testing software has allowed us to develop an advancement that gets us closer to that goal.”

“M&S Technologies providing accurate, reliable data,” emphasizes Umali, “is what ultimately allows eye care professionals to provide the best possible treatment plans and patient care.”

Unlike most available headsets on the market, the eye tracking software in the Smart System VR Headset surpasses the competition by detecting even the most subtle eye movements. This heightened sensitivity ensures exceptional accuracy, providing a direct and precise measure of the patient’s gaze in real-time.

Visual field tests are a common form of testing for eye disease such as glaucoma, which is one of the leading causes of irreversible blindness worldwide. Many of the worst cases of glaucoma can be avoided with early detection and timely intervention.

The Smart System VR Headset from M&S Technologies is a proven way to obtain various kinds of visual field testing data. It offers practices increased flexibility, allowing them to test in any environment, including a well lit room with no internet connection needed. It is especially helpful for patients with mobility issues or who have difficulty maintaining position for an extended period in a traditional visual field testing device.

About M&S Technologies: Founded in 1990, M&S Technologies is a software development and device manufacturer, rooted in state-of-the art software development, local manufacturing, and superior customer service. M&S is known worldwide for leading technological advancements in visual testing systems. M&S is dedicated to bringing high quality, extremely accurate testing products to eye-care professionals, optometry schools, and universities.

For more information, please visit http://www.mstech-eyes.com/vr-headset.

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Oova, Inc.’s Study Harnesses Hormone Data and Age to Precisely Determine Cycle Day within the Menstrual Cycle

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Oova

Oova, Inc. is proud to announce the publication of its latest groundbreaking study in MDPI journal, Medicina, titled “Using Hormone Data and Age to Pinpoint Cycle Day within the Menstrual Cycle.” Conducted by esteemed scientists and co-authors, led by Dr. Amy Divaraniya, PhD founder of Oova, Inc., Dr. Mark B. Woodland, MD, Chair of Obstetrics and Gynecology at Tower Health, and Elinor Hills, content and brand lead at Oova, Inc, their discoveries bring a new understanding of the female reproductive cycle, particularly women with irregular periods, and confirms just how advanced and accurate remote hormone tracking has become.

Adding to Oova’s extensive collection of research and data on women’s hormone levels, the study challenges the standard norms used for comparison and disproves the assumption of a 28-day reproductive cycle. Shedding light on this inaccuracy and working towards a greater understanding of the female reproductive cycle. The study illustrates that the remote hormone monitoring platform can now analyze women’s cycles and pinpoint where an individual is in their cycle with minimal data points and the technology within Oova’s AI-powered app.

Oova, developed by Dr. Divaraniya, is a testing system that allows users to track their luteinizing hormone (LH) and pregnanediol-3-glucuronide (PdG) fluctuations throughout their cycles. The platform collects quantitative hormone measurements through urine to identify users’ unique fertile windows and predict ovulation. In this study, the Oova team evaluated hormone data from 4,123 cycles across 1,233 users, analyzing and tracking the LH and PdG via urine tests throughout menstrual cycles across different age groups.

Key Findings from the Study Include:

1. While 23.67% of women self-reported they had a 28-day cycle, only 5.23% actually did. Population-level data showed that women typically expected their cycle to be longer than it was.

2. Oova’s data challenged the assumption that a woman’s follicular and luteal phases are of equal lengths and that ovulation occurs exactly in the middle. Instead, the follicular phase was generally longer than the luteal phase. Furthermore, the data revealed that as women age, the length of the follicular phase decreases, while the luteal phase increases.

3. Using Oova’s hormone data to train their algorithm, Oova can now determine a woman’s cycle day based on her age and hormone levels with 95% confidence. This is groundbreaking, as it allows for a thorough understanding of a woman’s cycle, even if it’s irregular.

“Our mission at Oova is to empower women with an accurate understanding of their reproductive health, giving them control on their journey to pregnancy. Further, our mission is to challenge the status quo and debunk widely accepted inaccuracies to set new standards in women’s healthcare. This study is proof of our capabilities at Oova, and we can now say with confidence that at-home hormone monitoring offers more precise cycle tracking than textbook estimations, benefiting fertility planning, clinical management, and general health monitoring,” says Oova founder and study leader, Dr. Amy Divaraniya.

Dr. Divaraniya developed the OOVA technology after her own 18-month struggle to get pregnant. Over-the-counter hormone tests were not conducive to tracking her irregular menstrual and ovulation cycle. She has created advanced technology, that provides a hormone monitoring solution for women facing cycle irregularities, a symptom that studies have shown affects more than 87% of the female population [reference link . Oova’s data has been integral in discovering hormone patterns of Oova users in advanced maternal age. It has led to identifying hormone patterns that indicate patients’ presentation of signs of reproductive disorders such as PCOS. This latest study represents a groundbreaking advancement, as it reveals the possibility of precisely pinpointing where a person is in their cycle using only one measure of LH and PdG, a capability previously unattainable. These and future Oova findings have the potential to fill significant gaps within reproductive healthcare and beyond.

In addition to Oova’s consumer and clinician business, the company holds an ongoing study and research department. They are actively looking for partners to support their independent research. Past research collaborators include Massachusetts General Hospital, New Hope Fertility Center, and IRMS at St. Barnabas Hospital. If you’re interested in collaborating on additional research projects, please reach out to the Oova team at research@oova.life.

For all media inquires, please contact Sara Spiegel at sara@withsarapr.com

For general inquiries, please contact info@oova.life

About Oova, Inc.:

Oova is the fertility translator that fully illuminates a woman’s fertility, giving her and her care team the clearest steps to conception. Founded by doctors and backed by Mount Sinai Hospital, Oova has created a consumer-first, data-driven experience valuable to patients and healthcare providers. Oova’s at-home urine test measures luteinizing hormone and progesterone to immediately inform a woman of her most fertile days and confirm ovulation. By delivering advanced personalized analytics and real-time action plans with every hormone reading, Oova is transforming the fertility care experience. Oova has partnered with the leading fertility and women’s health practices in the United States. To learn more, visit Oova’s website.

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Creating Healthier Communities as Vice President, Development and Corporate Relations

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Josh Fertitta, CHC’s new VP of Development and Corporate Relations

“Josh will be an integral part of the team, helping to expand CHC’s mission and impact, increasing the number of people and communities served.” ~ Dr. Jean Accius

Today, CHC: Creating Healthier Communities announced the appointment of Josh Fertitta as the organization’s new vice president, development and corporate relations. Fertitta joins CHC’s executive leadership team and will lead a high-performing team in developing and executing a national fundraising and revenue generation strategy to accelerate CHC’s growth and collective impact.

“Our vision is a world where every person in every community can live their healthiest life,” said Dr. Jean Accius, CHC president and CEO. “This is a bold, ambitious goal, and requires new ideas and innovative approaches to close the opportunity gaps that impact health in this country. Josh will be an integral part of the team, helping to expand CHC’s mission and impact, increasing the number of people and communities served.”

Fertitta is an innovative leader with a proven track record in cultivating strategic partnerships across sectors and industries. Most recently, Fertitta worked as the Senior Director of Development for The Catholic University of America where his team exceeded the campaign fundraising goal of $35M for the School of Arts & Sciences. Prior to that, he was the Director of Workforce Development for the State of Louisiana and also served as Director of Development for Café Reconcile and for New Orleans Public Charter Schools.

“CHC’s powerful mission drew me to the organization,” said Fertitta. “I’m inspired by the impactful work and partnerships at the local, regional, and national levels. I’m looking forward to driving transformational giving and accelerating growth to ensure CHC can help even more people and communities.”

Fertitta earned a Bachelor of Science in Psychology from Tulane University. His past board service includes chair of the Marigny Opera House Foundation, president of the Association of Fundraising Professionals New Orleans Chapter, and member of the Tres Doux Foundation, which builds programs for children with autism spectrum disorder and the families who love them.

View CHC’s leadership team.

ABOUT CHC: CREATING HEALTHIER COMMUNITIES

CHC: Creating Healthier Communities exists so that every person in every community has an opportunity to live their healthiest life. We leverage partnerships to raise funds, deliver programs and elevate solutions in communities. We focus on awareness and access, education and advocacy, and philanthropy. Together with partners, we’ve been creating healthier communities for more than 65 years. Join us at chcimpact.org or @chcimpact.

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Twenty-Six Year, IBM Executive Sherri Thomas, Joins Camelot Secure As Chief Revenue Officer, To Propel Growth And Innovation

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Sherri Thomas, Joins Camelot Secure As Chief Revenue Officer,

“We proudly welcome Sherri Thomas into our Camelot family. Her remarkable journey with IBM speaks volumes about her expertise and passion for driving growth.” — Stanford Oliver, CEO, Camelot

“We proudly welcome Sherri Thomas into our Camelot family. Her remarkable journey with IBM speaks volumes about her expertise and passion for driving growth. I am confident that Sherri’s global perspective and unwavering commitment will play a pivotal role in propelling Camelot to new heights,” said Stanford Oliver, CEO, Camelot.

As Chief Revenue Officer, Thomas will drive all Camelot’s go-to-market and revenue-generating initiatives and sales. These revenue-impacting functions include field sales, business and product development, engineering, customer success, operations, and marketing. In addition, she will support the Board of Advisors and cross-functional leadership teams.

Thomas has had a diverse and extensive experience with IBM, holding various leadership positions across different regions and business units. She has held strategic roles, including Vice President of IBM Federal Ecosystems, Global Vice President for Strategy & Transformation in the financial services sector, and Head of the IBM Innovation Studio in Munich, Germany. The career journey with IBM showcases her in-depth experience in strategic, customer-focused engagements across hardware, software, and consulting services from the Partner Ecosystem and Federal System Integrators. In addition, Thomas’ contributions span multiple industries and locations throughout North America and Europe—demonstrating her global perspective and impact on IBM’s growth and success.

“As Chief Revenue Officer, I am eager to lead Camelot’s go-to-market and revenue-generating initiatives, leveraging my expertise in global sales and customer success. I look forward to working alongside the leading cybersecurity experts at Camelot to offer the highest quality of service and the most comprehensive protection for our customers’ data and systems,” said Thomas.

About Camelot Secure

Camelot is a leading cybersecurity company that takes a revolutionary approach to protecting digital assets. Unlike traditional cybersecurity solutions that rely on reactive measures, Camelot operates from a threat perspective, proactively identifying and mitigating threats before they can cause damage. In addition, the company leverages a world-class workforce of the military, intelligence community, and private sector experts to protect our customers’ data and systems, their components, and common cyber-attack surfaces. The company uses the most advanced solutions to address cybersecurity challenges, including proactive, automated Advanced Persistent Threat (APT) Hunt tools and offensive attack surface monitoring technologies. Through these services, Camelot enables its customers to be more proactive and predictive in their approach to cybersecurity, delivering exceptional value and empowering businesses to protect their digital assets like never before.

Learn more at camelotsecure.com.

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Sustainability Takes Center Stage at the 2023 PODD Drug Delivery Conference

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On the back of this momentum, I’m thrilled to host a panel of experts in a discussion of sustainability in manufacturing and development of delivery technologies and devices at the 2023 PODD. – Dr Monica Adams, GSK

The Conference Forum announced that the 13th annual PODD: Partnership Opportunities in Drug Delivery conference will feature sustainability as a main topic addressed throughout the agenda, October 16-17 at the Westin Copley Place, in Boston, MA.

“The biopharma and drug delivery industries are actively moving to embed sustainability into core principles, products, and processes,” said Dr Monica Adams, Head – Packaging, Device and Design Solutions, GSK. “On the back of this momentum, I’m thrilled to host a panel of experts in a discussion of sustainability in manufacturing and development of delivery technologies and devices at the 2023 PODD.”

“As many pharmaceutical companies commit to accelerate the delivery of net zero health systems and sustainable practices, it is imperative to feature perspectives on the implementation and implications for these initiatives,” said Andrew Goldstein, Producer of the PODD Conference.

The PODD 2023 conference featured sustainability sessions include:

Dr Marianne Ølholm, Senior Vice President, Devices and Delivery Solutions, Novo Nordisk, will join the PODD Conference as the Sustainability Keynote. Dr Ølholm will participate in a fireside discussion on Laying a Path for a More Sustainable Future in the Device R&D Space.

Rasmus Just, Vice President, Device Innovation, Novo Nordisk, will present a holistic approach to Integrating Sustainability in Device Development.

Dr Monica Adams, Head – Packaging, Device and Design Solutions, GSK, will moderate a panel discussion on Working Towards Sustainability in the Manufacturing and Development of Delivery Technology & Devices with perspectives from AstraZeneca, GSK, Novo Nordisk and Teva.

Nanoparticle engineering company, Nanoform will present a session called A Patient and Planet Centric Approach to Enabling Drug Delivery

Additional topic areas for PODD 2023 include: AI/ML and computational biology approaches to drug delivery, new approaches in CNS/PNS delivery, facilitating collaboration between formulation and device teams during combination product development, ophthalmic delivery, the future of digital technology in the connected device space, high-volume/high-concentration injectables and targeted delivery of gene editing technologies.

The PODD Conference fosters collaborations between pharmaceutical, biotech, and drug delivery companies to develop more effective therapies for patients, improve the patient experience of taking medicine and extend the life cycle of the medicine. With pharmaceutical companies committing to reduce emissions and decarbonize, the PODD conference will highlight cross-industry perspectives on integrating sustainability in the development of drug delivery technologies.

Pharmaceutical companies presenting include: Sanofi, Pfizer, AstraZeneca, Amgen, Eli Lilly & Company, Novo Nordisk, Chiesi USA, Genentech, Novartis, Takeda Pharmaceuticals, Roche, Gilead Sciences, GSK, Bristol Myers Squibb, Johnson & Johnson, AbbVie, Regeneron, Teva Pharmaceuticals, Ionis Pharmaceuticals, Voyager Therapeutics, Apellis Pharmaceuticals and Beam Therapeutics.

To learn more about the event, visit PODDConference.com

About the PODD: Partnership Opportunities in Drug Delivery Conference:

Pharma, biotech and the drug delivery industries gather annually at PODD to assess delivery needs, latest trends and information on deals and learn about a wide range of innovative drug delivery technologies that could improve the delivery of various types of drugs. This can include proteins, peptides, oligonucleotides, biologics, and small molecules and more. PODD provides business development opportunities through organized networking and a partnering tool for new, emerging and established collaborations.

About the Conference Forum:

The Conference Forum is a life science industry research firm that develops conferences, podcasts, newsletters and webinars primarily around how to get therapeutics to patients faster. They examine and challenge the complex ecosystem of drug development and delivery, bringing ideas together from a variety of sources to help advance clinical research with common goals that are patient-focused. They are committed to creating the best content, exchange of ideas and solutions among peers, as well as providing high-quality networking.

Learn more about the Conference Forum at theconferenceforum.org.

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