First-of-its-kind Human Trial to be revealed at ASCO 2024. First-in-human trials act as the bridge for advancing new, promising drug candidates and are primarily conducted to establish the safe dosage range for subsequent clinical development. Numerous stakeholders are actively engaged in discussing their first-in-human trial data findings. This data appears highly compelling, particularly in the context of the innovative class of therapies currently in development within the pipeline. For more captivating insights, visit: https://lnkd.in/dj6Za_QE #FirstInHuman #ClinicalTrials #DrugDevelopment #SafeDose #MedicalResearch #TherapeuticInnovation #PipelineProgress #ClinicalData #HealthcareAdvancement
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💡 Join Joseph Zabinski, Ph.D., M.E.M. and DIA for an upcoming webinar focused on addressing one of the biggest challenges in #pharma: clinical trial recruitment Our AI-powered platform, OM1 Polaris, uses #realworlddata to identify hard-to-reach patient populations, reduce recruitment timelines, and save costs—transforming outcomes for complex conditions like cutaneous #lupus. 📅 Don’t miss it!: https://okt.to/lmIkLy
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If you are developing a medicine for a rare disease and have more questions about Orphan Drug Designation, watch our webinar “Orphan Drug Designation - Do You Have the Global Strategy?” now on YouTube! Access the online recording of the webinar using the link below: https://lnkd.in/dWyuaS2e The webinar will help you understand the benefits of Orphan Drug Designation, providing insights on how to use OD as a tool for significant financial discounts or additional scientific support. You will also gain a deeper understanding of the advantages of applying simultaneously to ODs globally and the specific benefits provided by each region. For any further questions, please contact our expert, Liam Spencer. #LumisInternational #OrphanDrugDesignation #OrphanMedicine #OrphanDesignation
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If you are developing a medicine for a rare disease and have more questions about Orphan Drug Designation, watch our webinar “Orphan Drug Designation - Do You Have the Global Strategy?” now on YouTube! Access the online recording of the webinar using the link below: https://lnkd.in/dWyuaS2e The webinar will help you understand the benefits of Orphan Drug Designation, providing insights on how to use OD as a tool for significant financial discounts or additional scientific support. You will also gain a deeper understanding of the advantages of applying simultaneously to ODs globally and the specific benefits provided by each region. For any further questions, please contact our expert, Liam Spencer. #LumisInternational #OrphanDrugDesignation #OrphanMedicine #OrphanDesignation
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What is #PTRS, how is it used, & what’s at stake? 🤔 PTRS is an estimate of a drug development program’s probability of success based on a technical (PTS) and regulatory (PRS) analysis. How is it used?👇 PTRS is integral to the #drugdevelopment process, used by companies to make informed decisions about which drug candidates to advance, to allocate resources effectively, and to navigate the increasingly complex regulatory requirements. What’s at stake?👇 With drug development costs ranging from “$314 million to $2.8 billion” according to JAMA, the importance of PTRS accuracy is critical for drug development forecasting. Looking for more insights about PTRS? Subscribe to our newsletter: https://lnkd.in/gc5MBZBy
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Register below to learn more about the emerging important role of methylation-based ctDNA testing applications in MRD and response monitoring!
Join us for an upcoming online panel discussion focused on the transformative role of methylation-based ctDNA testing for minimal residual disease and response monitoring in clinical trials. Industry leaders Minakshi Guha, Jonathan Beer, Diana Merino Vega, and our VP of global scientific affairs Kimberly Banks will explore how liquid biopsy testing can accelerate drug development by enhancing patient enrollment, providing early therapy response monitoring, and expediting study evaluation. Register today: https://bit.ly/3YIeU2H 📅 Date: November 19 🕦 Time: 12:00pm ET
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Will you be at #ARVO2024? Let’s connect! Join me for one of the many poster presentations featuring new and updated data demonstrating the potential efficacy of our lead drug candidate for Meibomian Gland Dysfunction (MGD). Session details are in the link below.
✈️ Seattle-bound for #ARVO2024? Learn about the efficacy and safety data from the Phase 2 studies of our lead drug candidate for Meibomian Gland Dysfunction during our 8 poster presentations featuring expert physicians and investigators: https://lnkd.in/g8U_innn #Ophthalmology
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We have analyzed the innovative molecules reached Phase 3 clinical trial stage as per class and therapeutic targets. Enjoy the analysis and outcomes 🚀
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A potential treatment for motor neurone disease could be around the corner, after a new drug developed by The University of Queensland produced successful results in a human clinical trial. 👨🔬 The UQ spin-out company NuNerve announced its lead drug candidate NUN-004 was safe and effective in the Phase 1 study. Read: https://bit.ly/4ivpUIe #UQ #QBI #news #research #mnd
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As the landscape of rare disease treatment continues to evolve, gaining access to the European market represents a pivotal opportunity for U.S. biotech firms. The European Union’s Orphan Drug Regulation offers robust incentives for drug developers, but navigating its regulatory framework requires specialized knowledge and experience. Written in collaboration with Fierce Biotech, our latest whitepaper explores the critical components of early access programs, comparing them with open-label extensions and offering a roadmap for U.S. biotech companies aiming to extend their innovative therapies to European patients. It aims to illuminate the pathway from clinical trial to market, demonstrating how expanded access programs can significantly accelerate patient access and enhance trial robustness. Download our whitepaper at: https://lnkd.in/eSpH5gN4 #Biotech #RareDisease #OrphanDrugs #EAP #OLE #OpenLabelExtensions #FierceBiotech
Unlocking European market access for rare disease therapies: Navigating the transition from open label extensions to early access programs
fb-resources.fiercebiotech.com
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When a cytokine storm arrives, it hits hard and quickly – even within 12-36 hours. That usually isn’t enough time to get the cytokine lab results back from external specialty send-outs. And that in turn makes developing new interventions that much harder At Kypha we know that timely cytokine analysis can deliver more accurate results and give healthcare providers and drug developers the information they need to make better decision faster. Kypha’s rapid test platform is designed specifically to address these challenges, and deliver better clinical trial data. Find out more at https://lnkd.in/eMnzviYj #diagnostics #immunediagnostics #complement #cytokinestorm #immunemonitoring
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