Red Nucleus的动态

?? Happy Thanksgiving Week ?? ?? COG: CRO Summit Content Preview ?? Section E: Site Relationships Catherine Gregor (Florence Healthcare) will explore site enablement technology and its impact on trial efficiency. Her session will demonstrate how innovative tools can streamline study start-up, improve data quality, and optimize resource allocation. She will provide practical insights for implementing these technologies to enhance site performance. Chris A. Learn, Ph.D, PMP (Parexel) will discuss site collaboration in cell and gene therapy trials. He will address site identification best practices across the US and Europe, focusing on staff upskilling strategies. The presentation will cover training approaches and site selection criteria specific to these specialized trials, aiming to optimize site engagement in advanced therapeutic studies. COG: CRO Summit brings together #contractresearchorganization leaders to discuss the latest innovations, challenges, and opportunities in the global #clinicaldevelopment landscape. Held on the 3rd & 4th December, at the Raleigh Marriott City Center. Free registration, and further information found here: https://lnkd.in/ew8U_6nq

?? Don't miss these 3 exciting new changes for #WODC 2025!?? Get ready for an exciting year at the #WorldOrphanDrugCongress with 3 newly-added tracks designed to push the boundaries of orphan drug innovation: 1?? Manufacturing: the future of manufacturing within Cell & Gene therapy and best practices to overcoming manufacturing and commercialisation obstacles 2?? Investment & Funding: Innovative funding strategies and what do investors look for before investing in rare disease. Learn about what investment models there are to overcome Orphan drug development bottlenecks 3?? BioPharma Showcases: Highlighting upcoming and existing orphan drug developers and what’s new on the horizon. Showcasing the latest pipeline, potential partnering opportunities and highlight the growing interest in a multiple disease areas It’s all happening in Amsterdam this October - don’t miss your chance to explore what’s new for 2025! ????Join these discussions and get your tickets now at super early bird rates from just €295 with group bookings or €495 for individual tickets. Act quick, these prices are only available for a limited time and will only increase! Secure your spot here: https://buff.ly/3VIDzSC ???? Patient group members, ERN affiliates, and healthcare professionals can apply for one of our limited free passes: https://buff.ly/3VLLUF4 Or for more information, check out our page: https://buff.ly/3POw8Gp #RareDiseases #PharmaNetworking #PatientAdvocacy

?? At the start of a new year, everyone thinks about what changes will come over the next 12 months and what that means for the future. The EU life sciences industry is no exception. ???? With EU HTA coming into force from 12 January for new cancer and cell & gene treatments, developers, patients, and governments alike will soon discover how the processes they have been preparing for work in practice. ?? Patients, clinicians, and medicine developers have all expressed interest in making sure that the right experts are in the room where these decisions are made. ?? Amid uncertainty about evidence requirements and tight timelines, APCO is here to support you through the entire market access journey - from EMA approval to launch strategy. ?? For more information, please contact our in-house experts Sture Alne and Hannah Bettsworth! #APCO #publichealth #EU #HTA #marketaccess #EUpublicaffairs

?? Reducing the high costs of manufacturing advanced therapies is crucial to ensuring widespread patient access. Academic institutions and nonprofits play a key role in the development of complex gene therapies, but doing so requires significant investment and commercial viability concerns, and often sees the development of promising treatments for rare diseases paused before they can reach patients who could benefit. By streamlining cell therapy manufacturing and automating labor-intensive steps, throughput can be increased, costs lowered, and reliability improved – addressing many of the barriers to viability. Our CEO Jason C. Foster talked to Pharmaceutical-Technology to outline how IRO?, our manufacturing platform, can support manufacturers to scale up production and reduce costs – making therapies more affordable for providers and patients. Find out how IRO? could scale your impact. Book a demo today ?? https://lnkd.in/eXEXEGZZ Thank you Pharmaceutical-Technology for the feature: https://lnkd.in/dewsVbcd #IRO #TheNewStandard #AutomateBetterBiology #AccelerateProductDevelopment #ScaleYourImpact

?? Game-Changing Clinical Trials of 2024: Hits, Misses, and Everything in Between! ?? 2024 has been a rollercoaster for the biopharma industry, with groundbreaking advancements and unexpected twists. Here are some highlights shaking up the landscape: ?? Novo Nordisk's CagriSema: Nearly 23% weight loss in the REDEFINE 1 study—setting the stage for a fierce obesity market showdown! ??? Vertex's Alyftrek: A once-daily cystic fibrosis therapy that’s already making waves after its December approval. Goodbye, Trikafta—hello, extended patent protection! ?? Ionis' Tryngzola: Ready to debut in a rare disease market, but can it outpace a potent competitor arriving mid-2025? ?? Roche’s Lunsumio & Columvi: Fixed-duration dosing in B-cell lymphomas could dethrone AbbVie/Genmab's Epkinly. The race is on! ?? Pfizer’s Hemophilia A Gene Therapy: Safer than BioMarin's Roctavian? Phase III data suggests a major edge with fewer ALT increases. These trials aren’t just shaping the market—they’re reshaping possibilities for patients around the globe. What are your predictions for 2025? ?? #ClinicalTrials #BiopharmaInnovation #CitelineInsights #Citeline #NovoNordisk #Vertex #Ionis #Roche #Pfizer #2024 #2025

?? The path to accessible, affordable cell and gene therapies isn’t only about clinical breakthroughs. Each step – from manufacturing to payer strategies – needs careful optimization. In the first of a five part series – co-authored by our CEO Jason C. Foster, @Molly Borchardt at Precision AQ, Philip Cyr at Precision AQ, and Erin Lopata at Precision AQ and published on CGTLive – examines manufacturing challenges and their impact on patient access. Key takeaways include: ?? Autologous cell and gene therapies hold great promise, but their high costs present a significant barrier to widespread access ?? Patients face not only financial hurdles but also nonmonetary challenges, such as delayed diagnoses, limited access to specialized care, and considerable travel and lodging expenses ?? Payers remain concerned about the long-term efficacy of these therapies, complicating decisions on coverage and affordability, especially in light of limited data on patient outcomes Read the first part In a five-part series in CGTLive examining the manufacturing and market access challenges that currently limit patient access to cell and gene therapies ?? https://lnkd.in/eUUaczH8 #ManufacturingBrighterFutures #CellTherapy #GeneTherapy #PatientAccess #Biotechnology

?? Advanced Therapies Week Exclusive: Leading the Way in Advanced Therapies - A Fireside Chat on ACT of Hope ?? Join Carol Houts, Chief Commercial Officer of Germfree, and Alexander Seyf, CEO of Autolomous, for a profound discussion on ACT of Hope, the newly established scientific advisory board pushing the boundaries of access to cell and gene therapies. Carol and Alexander, as pioneering members, will explore ACT of Hope’s mission to tackle barriers in patient access and enhance collaborations across industry leaders, clinical centers, and regulatory bodies. Delve into their innovative approaches to manufacturing, regulatory frameworks, and ensuring equitable patient access. Tune in to uncover the strategic goals, early successes, and future ambitions of ACT of Hope, and how it’s shaping the future of advanced therapies. #AdvancedTherapiesWeek #ATW25 #AdvancedTherapies?#CellTherapy #GeneTherapy

The gene therapy cost for Sickle Cell Disease (SCD) is around $2 million per patient. Given SCD is significantly more prevalent in African countries, particularly in sub-Saharan Africa, a cost-effective and affordable treatment is of urgent need.

?? Breakthrough Therapies or Regulatory Minefield? The Truth About ATMPs Revealed! Advanced Therapy Medicinal Products (ATMPs) are revolutionizing medicine, but navigating their development is like walking through a regulatory labyrinth. ???? Our article uncovers: ?Why ATMPs are the next frontier in treating cancer and rare disorders ?How global health authorities are fast-tracking these innovations ?The complex classification system of cell and gene products Don't miss out on understanding the future of medicine. Read our in-depth analysis now and stay ahead of the curve: https://shorturl.at/0BOc6 #ATMP #CGT #BiotechInnovation #RegulatoryAffairs