Koneksa

Thanks Contract Pharma for covering our recent CBO appointment of Eric Luthi. https://lnkd.in/eXSRT53U

eCOA Consortium Announces a New Article: Implementing Sensor-based Digital Health Technologies in Clinical Trials: Key Considerations from the eCOA Consortium C-Path’s eCOA Consortium is pleased to announce that Implementing Sensor-based Digital Health Technologies in Clinical Trials: Key Considerations from the eCOA Consortium has been published in the American Society for Clinical Pharmacology & Therapeutics (ASCPT) Journal Clinical and Translational Science. The article provides an in-depth assessment of the scientific considerations around the use of sensor-based digital health technologies in clinical trials, all set in the context of supporting trial participant compliance with these technologies. Detailing key topics from clinical considerations to data sharing, the paper represents the collection of eCOA Consortium member experience coupled with peer-reviewed literature and relevant regulatory recommendations. Access here:?https://lnkd.in/eZyDKYTW #eCOA #CPath #DHT #DrugDevelopment

We’re thrilled to welcome Eric Luthi as Chief Business Officer. In this newly created role, Mr. Luthi brings over 25 years of experience in life sciences and will lead corporate and business development initiatives at Koneksa. “We’re thrilled to welcome Eric to lead our business development team,” said Chris Benko, CEO and Co-Founder of Koneksa. “With his extensive industry expertise and proven success in driving growth and strategy, Eric will play a pivotal role in advancing our strategic initiatives and forming essential partnerships with leading healthcare organizations. His leadership will be invaluable as we empower biopharma companies to utilize digital biomarkers to accelerate clinical trials and unlock critical data insights.” Read the release: https://lnkd.in/eiTKrj2z

For the last four years, Koneksa has proudly committed to promoting civic engagement by observing Election Day as a company holiday. Whether they’re casting a vote or volunteering at the polls, Koneksans are assured the time needed to participate fully in the democratic process. https://lnkd.in/dyCm9XHz #ElectionDay #CivicEngagement #Inclusion #Vote

Last Tuesday our CMO John Wagner, MD, PhD joined jp clancy, Andrew E. M., Robert Schuck and Nancy M. Allen LaPointe in a lively discussion around Integrating Sensitive Endpoints in Early-Phase Trials at Duke-Margolis Institute for Health Policy’s workshop around Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development. The discussion included best practices and considerations when selecting appropriate clinical outcome assessments that are also meaningful to patients, with a focus on strategies for integrating sensitive endpoints in early phase trials, including digital measurements. #drugdevelopment #digitalbiomarkers #biomarkers

?? Register for the upcoming DiMe webinar on October 30, 11am EDT: Regulatory Pathways for Qualification and Acceptance of Digital Health Technology-Derived Clinical Trial Endpoints: Considerations for Sponsors and join?Jessie Bakker, MS PhD and Elena Izmailova as they discuss the available regulatory approaches to support the increasing deployment of DHTs within the clinical research setting and to help advance regulatory science in the field of digital medicine, based on the recent publication in American Society for Clinical Pharmacology & Therapeutics' Journal. Read the article here:? https://lnkd.in/eDGy_QBs REGISTER HERE for the webinar?? https://lnkd.in/eZEPAebt #DiMe #journalclub #DHT #drugdevelopment #Regulatory

???? Congratulations to our Chief Medical Officer John Wagner, MD, PhD, for being the recipient of the Gary Neil Prize for Innovation in Drug Development, presented by the American Society for Clinical Pharmacology & Therapeutics which aims to stimulate the application of innovative science to #clinical drug development. ???? John is the latest recipient of this recognition, which was first established in 2004. He joins the ranks of other notable leaders in the industry. Congratulations, John! More info: https://www.ascpt.org/ #ASCPT #innovation #drugdevelopment

?? Counting down to our next Journal Club on October 30 at 11 a.m. ET! Join us for an engaging discussion featuring the following industry experts: ??? Elena Izmailova (Koneksa) ??? Jessie Bakker (Koneksa) ??? Benjamin Vandendriessche Digital Medicine Society (DiMe) The session will explore the complexity of obtaining regulatory endorsement for sensor-based digital health technology (sDHT) endpoints in the US. With the lack of approved drugs based on sDHT-derived endpoints, our speakers will review two key regulatory pathways available to pharmaceutical study Sponsors: the traditional IND pathway and the drug development tool (DDT) pathway. We’ll cover the benefits, challenges, and regulatory considerations of each route. ?? Take a look at the paper we’ll be discussing: https://bit.ly/3NCNLaS ?? Register now to secure your spot: https://bit.ly/4e0d6X5

The work, "Regulatory Pathways for Qualification and Acceptance of Digital Health Technology‐Derived Clinical Trial Endpoints: Considerations for Sponsors", by Jessie Bakker, MS PhD,?Elena Izmailova, Aude Clement, Steve Hoffmann, Chris Leptak, Joseph Menetski, and John Wagner, MD, PhD has received over ?500 views??in the Journal of Clinical Pharmacology and Therapeutics since it was published online on August 15, 2024! We are happy to contribute to the advancement of regulatory science and clarify questions around DHT use in drug development. Read our paper here ?? https://lnkd.in/e6tDKCTt #digitalbiomarkers #DHT #drugdevelopment #clinicaltrials #regulatory #ViewsMilestone ASCPT Journal Family

We are proud to share that our Chief Medical Officer John Wagner, MD, PhD is the American Society for Clinical Pharmacology & Therapeutics 2025 recipient of the prestigious Gary Neil Prize for Innovation in Drug Development, which aims “to stimulate the application of innovative science to clinical drug development.” John is the latest recipient of this recognition, which was first established in 2004. He joins the ranks of other notable leaders in the industry. Congratulations, John! More info: https://www.ascpt.org/ #ASCPT #innovation #drugdevelopment?