ANSEA’s Post

Innovation opens opportunities for patients and caregivers, especially with cell and gene therapies offering the chance to tackle intractable diseases…but what happens if we cannot match innovation in science with innovation in our healthcare systems? Let’s discuss at the Pharma MARCON.

Last week, Andrew Cummins and Mathieu Loiseau attended the World Orphan Drug Congress Europe in Barcelona, connecting with biotech leaders and sharing insights and best practices to expand access to their innovative, life-changing medicines across Europe. Here are some of their key takeaways: • From January 2025, all new ATMPs and oncology medicines will require a joint clinical assessment (JCA) at the European level, with further details still emerging. • Payors, regulators, and pharma/biotech companies need to continue to harmonise patient engagement activities to ensure the development of new treatments, devices, and health systems. • To increase participation and retention, and to reduce the burden on families, CROs should consider decentralised clinical trials more often. If you want to reach out to the team to discuss further, visit: https://lnkd.in/e7XfVg4M #WODC #OrphanDrugs #WODCBarcelona #RareDisease

🌐 Join us for Avance Clinical's upcoming webinar to uncover the strategic advantages of early-phase #oncology clinical development across Australia and the USA! 🇦🇺🇺🇸 Our expert speakers, Gabriel Kremmidiotis, Alex Kavros, PhD, and John Zalcberg, will explore how Australia's streamlined regulatory pathways, leading research centers, and significant R&D tax incentives make it an ideal starting point for oncology trials. They will also discuss how transitioning to the USA for later-stage trials aligns with FDA requirements and offers access to a diverse patient population, which is essential for successful oncology research. Discover how an integrated approach can ensure a seamless transition, maintain trial consistency, and maximize R&D tax benefits. 🔗 REGISTER NOW: https://lnkd.in/g-6WaG93 #ClinicalTrials #OncologyResearch #DrugDevelopment #Pharma #CRO #Biotech #Australia #USA #R&D #FDA #ClinicalResearch #Biotechnology #HealthcareInnovation #CancerResearch #ClinicalDevelopment #Webinar #PharmaInnovation #LifeSciences #ResearchAndDevelopment #Healthcare

Massive Bio is introducing our latest innovation, the Drug Utilization Optimizer (#DUO), at the ASCO Annual Meeting 2024 in Chicago! Building on the success of our SYNERGY-AI platform, DUO is set to transform how pharmaceutical commercial teams target and engage physicians. This innovative analytics and real-time notification platform provides unparalleled insights and efficiencies, allowing commercial teams to analyze the competitive landscape with up-to-date and accurate data. DUO connects with the right physicians, identifies relevant patients quickly and efficiently, increases brand revenues, and reduces the cost of sales. Unlike traditional real-world data companies, we improve operational efficiency and facilitate patient access to medicines by providing real-time and detailed insights. We recognize the challenges in cancer clinical trials and continue to work rapidly to bring more hope. Visit our booth at #ASCO24 to learn more about DUO and see a demo and click on the link below. 👉🏻 https://bit.ly/3yL8eGo Booth: #29137 Selin Kurnaz, PhD, Arturo LoAIza-Bonilla MD, Çağatay M. Çulcuoğlu, Toygun Onaran, Oz Huner, Aslan Aslanağı, Eren Caskurlu, Hakki Isik, PMP, Mert Sarı, Ertuğrul T., Toykan Dogan, MCogSc, #MassiveBio #ClinicalTrials #Innovation #Oncology #AIinHealthcare

On today’s #BiotechHangout, hosts Chris Garabedian, Brad Loncar, Tim Opler, Dawn Bell, PharmD, John Maraganore and Eric Schmidt dig into the obesity market with a look at Stifel Institutional's report & key findings, $PFE’s once daily oral GLP-1, report on patients discontinuing GLP-1 drugs in 2 yrs & GLP-1s for obesity-related cancers, plus deals of the week: $LLY to acquire $MORF for $3.2B & Flagship’s $3.6B fund, clinical readouts: $RHHBY’s TIGIT study, $QURE’s Huntington’s data, $IDYA’s MAT2A data, and Evaluate Pharma's World Preview report & pharma forecast, and more: https://lnkd.in/ehnrvAUc

😀 Finally we see #treatment success reflected through both #pain and #inflammation reduction in #osteoarthritis patients (quantified with #DCEMRI, IAG, IMAGE ANALYSIS GROUP). ♥ It was such a pleasure and privilege to present the #imaging efficacy data for these two studies, designed and run by Paradigm Biopharmaceuticals and Eupraxia Pharmaceuticals Inc. 💊 This year's Clinical Trial Symposium at #OARSI brought focus on the new technologies for #OA #imaging and #biomarker science. I believe that by #innovating, we will reach the target of disease modifying #osteoarthritis drugs and impactful evidence of univocal #patient response in our #trials. With Morten Asser Karsdal, Ali Mobasheri, Mikael Boesen, Ali Guermazi, MD, PhD, Philip Conaghan, Felix Eckstein, John Carrino, Dr. Alex Iakimov, M.D., Alan Brett PhD, Loeser Richard, Anne C. Bay-Jensen, Christoph Ladel, Virginia Kraus, Jérémie SELLAM, Mona Dvir-Ginzberg, Mohit Kapoor who contributed their time and knowledge to make #OARSI24 the worldwide success. Look forward to the next meeting in 2025! Presented by James Helliwell & Amanda Malone for Eupraxia and Paul Rennie and Mukesh Ahuja for Paradigm)  

#Orthopedics #Orthopedic Surgery #Sports Medicine #Musculoskeletal #Arthritis #Orthopedic Surgeons #Orthopedic Physicians #Clinical Trials # Clinical Research #Rheumatologists #DMOAD

Exciting News! Our CEO, Janet Qi, was recently featured in a Clinical Leader article discussing the FDA advisory committee's critique of Lykos Therapeutics' MDMA studies. Despite the 9-2 vote against the validity of MDMA-assisted therapy trials, this highlights the crucial need for rigorous and well-designed clinical trials in the psychedelic field. At PurMinds, we remain committed to advancing the scientific and clinical understanding of psychedelic compounds. Our focus on meticulous research and innovative formulations, such as our proprietary psilocybin and non-hallucinogenic novel chemical entities, drives us forward. We believe in the potential of psychedelics to revolutionize neurological care and are steadfast in our pursuit of evidence-based therapies. Read the full article to learn more about our perspectives and the future of psychedelic clinical research: link in comments! #PurMinds #Psychedelics #MentalHealth #ClinicalResearch #Innovation #FDA #MDMA #PTSD

⌛ January 2025 is fast approaching! Our latest article, written by Market Access Analyst Tia Kwong, dives into how manufacturers of oncology and advanced therapy medicinal products (ATMPs) can prepare for the upcoming EU HTA regulation. Learn about the importance of early organisational prep, seeking Joint Scientific Consultation (JSC) advice, and aligning resources for simultaneous EMA and JCA submissions. Plus, get insights on optimising local HTA submissions. 𝐑𝐞𝐚𝐝 𝐧𝐨𝐰👉 https://lnkd.in/eUYn3JgV #euhta #jca #europeanhta #jointclinicalassessment #marketaccess #pharma #healthcare #Oncology #ATMP

Biotech and pharma companies - How do we determine the most efficient regulatory path for codeveloped companion diagnostic tests (CDx)? A CDx can significantly maximize return on investment in clinical trials, but transitioning from a research-grade to a clinical-grade assay can present resource management challenges, especially for emerging companies. Regulatory experts Mwango Kashoki and Sinan Sarac share how to minimize time and resources in our New Medicines, Novel Insights Oncology report: https://lnkd.in/eNiy26EP #PrecisionOncology #Regulatory #NovelInsights