Serac Healthcare’s Post

  atai Life Sciences (NASDAQ:ATAI, ETR:9VC) co-founder and co-CEO Dr Srinivas Rao takes Proactive's Stephen Gunnion through the positive results from the Phase 1b trial for VLS-01, emphasizing its excellent tolerability and potential as a best-in-class treatment option. The trial revealed that the formulation exceeded expectations, particularly in terms of pharmacokinetics, with results comparable to intravenous administration. VLS-01 is being developed for treatment-resistant depression, a condition that impacts the lives of an estimated 100 million people globally. Srinivas emphasizes the potential of VLS-01 as a best-in-class treatment option, with excellent tolerability, patient-friendly administration and a short 2-hour in-clinic treatment time. The trial revealed that the formulation exceeded expectations, particularly in terms of pharmacokinetics, with results comparable to intravenous administration. Rao... Watch at #Proactive #ProactiveInvestors http://ow.ly/3fqe105Fnmb

Important milestone for our company as we announced early completion of enrollment in LunAIRo, Apnimed’s Phase 3 #OSA #clinicaltrial examining the efficacy and safety of AD109 compared to placebo at six-months and one-year. We believe AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with obstructive #sleepapnea who are either intolerant of, or refuse to use, positive airway pressure therapy. We want to thank the patients who volunteered to participate in this study, extend our gratitude to the investigators for their support and give a shout out to our amazing clinical and medical colleagues who made this important step possible. Topline data expected mid-2025. Learn more about the study design and its presentation at #ATS2024: https://bit.ly/4draxhP #biotech #innovation

FDA PAPER: Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together. Introduction. Artificial intelligence (AI)1 has the potential to revolutionize health care by advancing medical product2 development, improving patient care, and augmenting the capabilities of health care practitioners. Aligned with its mission of protecting, promoting, and advancing public health, and building on the Agency’s longstanding commitment to support innovative work in the development and regulation of medical products, the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) are jointly publishing this paper to provide greater transparency regarding how FDA’s medical product Centers are collaborating to safeguard public health while fostering responsible and ethical innovation. 

One Week Left! Join us LIVE on February 26th for the unveiling of Patholytix 4.0 - the future of drug safety assessment! Our Chief Scientific Officer, Pierre Moulin, alongside CEO, Donal O'Shea, and VP of Business Development, Research Pathology, Colin Doolan, will dive deep into the features of Patholytix 4.0. Here's what's in store: - Complete System of Record: Simplify inputs to regulatory submissions with automatic report generation. - AI-Powered Decision Assistance: Spot early failures of non-performant compounds during primary review with Foresight. - Enhanced Collaboration: Collaborate with partners securely from anywhere, anytime via our new web-based workflow. - Future-Proof Study Archiving: Confidently archive and reconstruct studies in compliance with GLP guidelines via adoption of DICOM Open Standards. Don't miss out - register now: https://lnkd.in/edjUZ4bB #Patholytix4Launch | #DrugSafetyRevolution | #FutureOfPharma

The identification and management of patients at high bleeding risk (HBR) undergoing TAVI are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI. Philippe GAROT https://ow.ly/mYNi50S3PKh

Looking forward to the insightful talks from my colleagues of CMC statistics experts, Bruno Boulanger and Pierre Lebrun in the upcoming IFPAC 2024 conference! #pharmaindustry #manufacturing #CMC #statistics

Ben Casavant, CEO of Tasso, Inc., recently sat down with Karen Jagoda on the Empowered Patient Podcast to discuss how Tasso's patient-centric approach to blood collection is increasing access to decentralized clinical trials. He shares, "When we think about the customer bases we're serving, we're working with many different pharmaceutical companies conducting critical and life-changing research. We just announced a partnership with the Parkinson's Foundation so they can help find ways to gather information and data about patients living with Parkinson's Disease. But they need that access and data from patients. By working with Tasso, we enable them to have that reach and accessibility." Listen here: https://bit.ly/4eex7dT #DecentralizedClinicalTrials #HealthcareInnovation #HealthTech

This. Right here. "the authors identify and characterize a small molecule, BCH-HSP-C01, that restores aberrant protein trafficking in neuronal models of adapter protein complex 4 deficiency." When we started what was then Cure SPG47, and is now Cure AP-4, we were really motivated by a wish, a prayer and our love for our children. It has been 7 years now, and we are on the the cusp of human clinical trials for AP4B1 #GeneTherapy, potentially have a couple of FDA approved #Drugs identified to consider off-label usage (still in early stages of discovery on this), and this amazing research right here. Wow. https://lnkd.in/eqrhdh9x

Thanks for having us LSX World Congress! Our CEO & Co-founder, Neel Patel, joined a panel to discuss the future of precision medicine. The conversation highlighted the growing recognition among stakeholders of the benefits that precision medicine offers. Although transitioning from traditional methods to precision medicine involves challenges—particularly with regulatory agencies and payers—the gap is closing, suggesting that these obstacles are diminishing. To overcome these challenges, fostering strong partnerships, engaging with regulatory bodies early, and demonstrating value and cost-effectiveness throughout clinical studies are key steps toward commercialising innovative precision medicine technologies. At ZiO Health, we're leading the way with real-time therapeutic drug monitoring to support precision dosing. #LSX2024 #precisionmedicine #therapeuticdrugmonitoring #medtech