Koneksa

Our CMO John Wagner, MD, PhD was on a panel on Streamlining Clinical Trials for Patients and Clinicians through Digital at LSX World Congress in Boston. Thanks and great meeting everyone at the event!

Parkinson's News Today covers our recent news with Regeneron: Regeneron has joined the data syndication program for Koneksa‘s LEARNS study that’s assessing the potential of digital biomarkers for measuring the progression of #Parkinson’s disease. The program enables Regeneron to gain immediate and continuous access to data and results as the trial progresses, which may accelerate the adoption of digital measures into the company’s own clinical efforts. Regeneron is the second participant in the data syndication program, following Merck (known as MSD outside the U.S. and Canada), which joined in March. Read the article: ???? https://lnkd.in/eHe59dvt

??How can we make clinical trials more inclusive, efficient, and patient-centered? Sarah Valentine, our Partnerships Lead at Digital Medicine Society (DiMe), will explore this and more during LSX USA Congress on September 11. The panel discussion will cover: ?? Co-creating a solution with patients and medical professionals ?? Scaling digital clinical trials solutions ?? Achieving diversity, equity, and inclusion in decentralized trials ?? Partnering for success- Is a unified digital clinical trial solution the answer? ?? Investing in clinical trial tech – investor perspectives ?? Register today with code DiMe15 for 15% off and be part of the conversation! https://lnkd.in/e5ktRfqn Koneksa Hawthorne Health, Inc. Tasso, Inc. FINN Partners

FirstWord HealthTech covers our recent news with Regeneron: Health tech company Koneksa announced on Tuesday that Regeneron has joined its data syndication partnership programme focused on the remote study of Parkinson's disease progression. As part of the partnership, Regeneron will gain real-time access to de-identified data, study monitoring and analysis results. Regeneron is the second participant to sign on following Merck & Co., which joined the programme in March. Koneska CEO Chris Benko noted that detecting early signs of Parkinson's disease and validating potential biomarkers is critical. "We are gaining momentum with the addition of Regeneron to our syndication," he said. "Our goal is to bring together biotech and pharma companies with real-time data sharing and analysis to expedite the validation and adoption of digital measures to unlock more data insights in clinical trials." Read the article: https://lnkd.in/e__shbVv

This week, healthcare technology company Koneksa announced that Regeneron has joined the company's Data Syndication Program for the LEARNS study, which is examining the viability and potential use(s) of biomarker data gathered from patients via wearable biotechnology devices. Read the full press release: https://lnkd.in/eixZMarp #MedTech #Health #Parkinsons #Technology #Medical

Thanks pharmaphorum for covering our recent news with Regeneron. Regeneron is the second pharma group to sign up for access to data from a remote study run by health technology firm Koneksa that is exploring the use of digital biomarkers to track patients with Parkinson's disease. Read the article: https://lnkd.in/eY7aYatv

We’re excited to announce Regeneron has become a member of our Data Syndication Program for the LEARNS observational study. This study aims to remotely measure disease progression using digital biomarkers in neurodegenerative disorders. As a member, Regeneron will have real-time access to the deidentified study data, study monitoring, and analysis results. “At Regeneron, we believe that digital #biomarkers have the potential to improve the development of novel therapeutics, and collaboration helps make this a reality. Koneksa’s data syndication community allows us to leverage collective expertise and gain insights that will inform future investigational therapies for #Parkinson’s disease,” said Gary Herman, M.D., Senior Vice President, Clinical Development Unit Head, Genetic Medicines. “As leaders in innovative drug development, we encourage this community-based approach and believe the appropriate use of evidence-based digital measures in clinical trials can help ensure robust and reliable data collection.” Read the release: ???? https://lnkd.in/eixZMarp

Thank you to Koneksa for sponsoring this year’s Parkinson’s Disease Therapeutics conference. Koneska stands at the forefront of digital biomarker evolution to develop robust, validated and patented algorithms designed to support early detection and specific therapeutics considerations for Parkinson’s disease research. The PD Therapeutics Conference is The Michael J. Fox Foundation's annual scientific conference and the only one in the world focused exclusively on Parkinson's disease drug development. Our 16th annual conference will be happening on October 17th in New York City. Visit our website to learn more. https://bit.ly/3XaQq1c

Despite widespread interest and substantial investment in the adoption of sensor-based digital health technologies (sDHTs) for remote data capture in drug development trials, no drug has been approved based on an sDHT-derived primary endpoint in the United States (US). The review below describes two choices currently available to pharmaceutical study Sponsors as they consider the adoption of digital endpoints in their trials: 1. they may navigate the traditional route of compiling the evidence to support the sDHT-derived endpoint in their investigational new drug (IND) application, requiring specific expertise and substantial resources; or 2. they may navigate the drug development tool (DDT) pathway with the goal of qualifying their sDHT-derived endpoint as a biomarker or clinical outcome assessment applicable to a broader context of use (COU), either alone or as part of a partnership or consortium. The review describes the nuances of each regulatory pathway; the evidentiary requirements for supporting an sDHT-derived endpoint and the technology used to capture it; and the impact that an sDHT's regulatory status may have on a Sponsor's decision to use it for data capture in a clinical investigation. By systematically comparing the IND and DDT pathways, the overarching goals of the review are to support the increasing deployment of sDHTs within the clinical research setting and help advance regulatory science in the field of digital medicine. Read the "Regulatory Pathways for Qualification and Acceptance of Digital Health Technology-Derived Clinical Trial Endpoints: Considerations for Sponsors” review here: https://lnkd.in/eFHq7b6t By authors: Jessie Bakker, MS PhD? Elena Izmailova Aude Clement? Steve Hoffmann? Chris Leptak? Joseph Menetski? John Wagner, MD, PhD

The article “Assessing the Net Financial Benefits of Employing Digital Endpoints in Clinical Trials”?conducted “a comprehensive assessment of the financial net benefits of digital endpoints in clinical trials” and?demonstrated that “the use of digital endpoints in clinical trials can provide substantial extra value to sponsors developing new drugs, with high ROIs”, with phase III trials demonstrating substantial increases in expected net present value (eNPV) and return on investment (ROI). Koneksa, supports and collaborates with the community to advance these technologies and further leverage their benefits in clinical research. Read the full article here:https://lnkd.in/eSEe8p_Y #DigitalEndpoints #ClinicalTrials #DigitalBiomarkers