EuroIntervention’s Post

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. https://lnkd.in/e6Ri8Wez

  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

UPDATE: Sequence2Script now includes activity scores for CYP2C9, CYP2D6, and DPYD. Activity scores are calculated according to guidelines published by the Clinical Pharmacogenetics Implementation Consortium.

First Patient In (FPI). Not all visits are equal. 🍾🥂It can be a time to break out the champagne or... ...an unmitigated disaster. FPI is a pivotal moment and a huge milestone. Its often the culmination of years of work to commence the next phase of a drug. While it's often a cause for celebration, it also brings to light the immense challenges and responsibilities that come with conducting clinical trials. Take, for example, a recent situation handled by TruLab during a Phase 1 oncology study. A simple error in shipping labels could have sent critical ambient blood samples to the wrong laboratory—across the country. Thanks to TruLab's vigilant monitoring and quick communication, the samples were redirected to the correct location, preventing potentially significant delays and additional patient burden. This incident underscores the importance of precision and attention to detail in every aspect of a trial, from FPI to the final patient out. It also highlights how technology, like TruLab's innovative technology, plays a crucial role in ensuring sample integrity and protocol compliance. As we mark these significant milestones, let us also remember the lessons learned from each challenge—transforming potential disasters into triumphs of innovation and dedication. #ClinicalTrials #HealthcareInnovation #PatientSafety #FPI #TruLab"

Radiation proctopathy can have a large impact on the every day life of a patient, with unexpected and large quantities of bleeding occurring spontaneously. Published literature has shown the application of PuraStat to have a positive impact on these patients. Take a look for yourself: https://bit.ly/4ctYlMD #purastat #3dmatrix #peptidetechnology #peptides #bleedmanagement #GI #RP #patientoutcomes

Don't miss the insightful conversation led by @Mark with @Fernanda at the 25th Annual Clinical Trial Supply Europe 2024 Conference, discussing the advantages of global supply chain orchestration for efficient and strong clinical supply processes. Watch the session recap here: https://okt.to/BpZGrm #OCTMedDevice #CTSEurope #ClinicalTrials #ClinicalLogistics #Healthcare #Pharma #biotechnology

[PANEL DISCUSSION ALERT!] On 25 September, join a panel of experts to discuss the key factors for successfully supporting a clinical trial from a bioanalytical perspective. You do not want to miss this >>> https://hubs.ly/Q02KcT860

From the rise of specialized clinical logistics environments to the need for increased collaboration across ecosystem partners, Mark Patterson and Fernanda Teles recap some of the key highlights of a very engaging panel discussion at the 25th Annual Clinical Trial Supply Europe 2024 Conference. Explore these highlights here: https://okt.to/NqHKRo #OCTMedDevice #CTSEurope #ClinicalTrials #ClinicalLogistics #Healthcare #Pharma #biotechnology

This is a very encouraging trend for companies like Wellumio. It means that long-standing challenges like poor MRI access can be solved. #imagingtechnology #innovation #medtechinnovation

From the rise of specialized clinical logistics environments to the need for increased collaboration across ecosystem partners, Mark Patterson and Fernanda Teles recap some of the key highlights of a very engaging panel discussion at the 25th Annual Clinical Trial Supply Europe 2024 Conference. Explore these highlights here: https://okt.to/0CwtgO #OCTMedDevice #CTSEurope #ClinicalTrials #ClinicalLogistics #Healthcare #Pharma #biotechnology