Alexander Weir’s Post

📚 Thrilled to Share an Academic Milestone! 🎓   Leading up to my graduation, I’ve been reflecting on my postgraduate journey. Last month, I officially completed my MSc in International Health Policy at The London School of Economics and Political Science (LSE) I’m thrilled to share that I achieved a distinction for my dissertation, which I wrote alongside my placement at Dolon Ltd.   My research explored a significant milestone in European health policy—the Joint Clinical Assessment. This initiative aims to harmonise clinical effectiveness frameworks across the through a standardised health technology assessment , addressing fragmentation in pharmaceutical decision-making. While national agencies will retain control over pricing, the JCA marks a pivotal step toward a unified European pharmaceutical market.   For the rare disease community, however, the JCA raises critical concerns. Through interviews with stakeholders in pharmaceutical manufacturing, patient advocacy, and health technology assessment, my findings highlight challenges such as the PICO framework, evidence generation, and barriers to market entry for orphan drugs. These issues underscore the delicate balance between innovation and harmonisation, with significant implications for patients relying on rare disease therapies.   This journey has been deeply rewarding, particularly as the JCA prepares for implementation in January 2025. I’m excited to continue engaging with the pharmaceutical space and witnessing the intersection of policy and industry in real time.   I'd like to extend a thank you to my LSE and Dolon supervisors, Ranjeeta Thomas and Isabelle Laurence, for their invaluable guidance in this dissertation process. If this topic resonates with you, I’d love to connect and share my findings in more detail. #EUHTA #JCA #marketaccess

Regulatory #pharmanews roundup – if you didn’t get a chance to learn about two important developments in UK #lifesciences last week, read on here… 📖 £16 million to fund UK-Switzerland life sciences research: https://lnkd.in/e3ny2jYx 📖 Legislative milestone for UK clinical trials: https://lnkd.in/eDWA39QM

Want to gain a better understanding of the underlying science, applications and processes involved in the manufacture of biotherapeutics and advanced therapies? Join us - https://ow.ly/Jse150TqXrP Training course: An Introduction to Biomanufacturing and Advanced Therapies When: 19th December Location: CGT Catapult's Skills Training Laboratories "Coming from a non-gmp, non-commercial background, I found the health economics, market access and biomanufacturing aspects of the course useful in helping me build a holistic overview of the ATMP sector." #AdvancedTherapies #Biomanufacturing

New research on public-private collaborations has lessons for partnerships intending to solve society’s biggest problems. In sum, private companies and public institutions struggle to get as much done together as private companies working together in groups. “When public and private entities work on the same projects, they should import some governance and conflict-resolution ideas that are more common in private-private contracts, including joint steering committees, development milestones, and joint patent provisions.” Read more in research from Birgul Arslan of Rotterdam School of Management, Erasmus University, Gurneeta Vasudeva of University of Minnesota - Carlson School of Management, and Betsy Hirsch, PharmD, FCCP, FIDP, FIDSA of University of Minnesota College of Pharmacy.

Round 2 of the #FAILSAFE funding is now open for applications! The FAILSAFE project, led by the University of Exeter’s MRC Centre for Medical Mycology (#MRC CMM) and funded by the UK Department of Health and Social Care’s Global AMR Innovation Fund (#GAMRIF), is dedicated to tackling the urgent global challenge of #Fungal Antimicrobial Resistance (fAMR). These grants are to support cutting-edge research to develop diagnostics, therapies, and preventative strategies to combat fAMR. The project emphasises collaboration, particularly with partners in low- and middle-income countries (#LMICs), to ensure the research addresses real-world challenges and delivers tangible benefits where the need is greatest. Proposals should align with at least one of the following themes: Microbial Pathogenesis Biomarkers and Diagnostics Innovative platforms One Health Typically, projects will be expected to last up to 12 months in duration. Funding awarded will be as follows: Seedcorn projects – up to £75,000 Mid to large projects – from £75,000 to £250,000 For more information contact: [email protected]. or visit: https://lnkd.in/dRSHfTtN

 Revolutionizing Clinical Trial Design: A Data-Driven Approach Are you looking to optimize your clinical trials and accelerate drug development?  James M. McGree et.al.(2023)team has developed a novel approach to designing adaptive clinical trials that requires minimal assumptions about the underlying data. By leveraging Bayesian methods, we can: Increase efficiency: Reduce trial duration and sample size. Enhance ethical considerations: Prioritize patient safety and well-being. Improve decision-making: Adapt trial designs based on emerging data. Want to learn more? Let's connect and discuss how we can help you design and analyze your next clinical trial! https://lnkd.in/g2aaaA2i #clinicaltrials #drugdevelopment #bayesianstatistics #adaptivetrials #biostatistics

Unlocking the Potential of Treatments: How Clinical Trials Can Be More Precise Clinical trials often paint a broad picture, but what about patients who don't fit the mold? New treatments might hold promise for specific subgroups, even if the overall results seem underwhelming. Alihan Hüyük et al. (2024) propose Syntax, an innovative trial design that identifies these responsive subpopulations efficiently. Imagine: Finding the right patients for the right treatment: No more one-size-fits-all approaches! Faster development of effective therapies: Targeting the right group streamlines the process. More efficient use of resources: Stop wasting resources on patients who won't benefit. Challenges? Let's discuss how Syntax can address challenges in designing effective clinical trials. Want to learn more? https://lnkd.in/g2aaaA2i

The 🇪🇺-funded #ECRAIDPrime adaptive platform trial has received full regulatory approvals to initiate the study in Belgium and Germany. At the project's General Assembly last month, Principal Investigator Chris Butler shared, "The excitement was palpable, bringing us together as a group. We’re now looking forward to receiving approvals in more countries, allowing us to begin our trial across all seven countries, with hopefully more to come." Read more 👉🏾 https://lnkd.in/ek3Kuk-A #europeancommission #primarycare #COVID19 #pandemicpreparedness University of Oxford Nuffield Department of Primary Care Health Sciences - University of Oxford UMC Utrecht Norwegian Institute of Public Health ECRIN (European Clinical Research Infrastructure Network) University of Antwerp Laboratory of Medical Microbiology Alike W. van der Velden Frank Leus Aida Salcic Claire-Marie Martis Ilse Rietveld Victoria C. Simensen Jacques Demotes Mainard #clinicaltrials #clinicalresearch Chris Butler

West Virginia University and GATC Health Partner to Launch Strategic Program to Accelerate Academic Research into Market-Ready Therapies https://lnkd.in/gfvCgEw3 The innovative program harnesses GATC’s AI-powered platform to rapidly de-risk and optimize drug discovery and development, accelerating the transition to clinical trials. MORGANTOWN, W.Va., Jan. 28, 2025 /PRNewswire/ — West Virginia University (WVU), one of [...]

If you’re planning to apply to the IDeA Clinical & Translational Research Network (CTR-N) or the IDeA Clinical & Translational Research Development (CTR-D) programs, don’t miss our upcoming webinars. The next application due date for both programs is October 9, 2024. The CTR-N Award program (P50) webinar will take place on August 21, 2:00-4:00 p.m. ET, and the CTR-D Award program (P20) webinar is scheduled for August 23, 2-4 p.m. ET. During the webinars, we’ll provide an overview of the notices of funding opportunities and answer any questions you may have. For more details on the upcoming webinars, check out our #NIGMSFeedbackLoop blog—link in the comments. #FundingOpportunity