Sylvie Berrebi

With new EU HTA regulations coming online next year, the continent's leading national-level HTA bodies have a crucial role to play in ensuring a comprehensive and holistic approach to healthcare evaluation and regulation. This is just one of the topics discussed in a frank and wide-ranging interview with Lionel Collet, president of France's Haute Autorité de Santé who describes how HAS has evaluated 200 products during the past two years under its unique early access procedures and outlines why HAS is addressing the complexities of mental health in its 2030 strategic plan. Get the full picture at: https://lnkd.in/ehS-cs8Y

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#PancreaticCancer poses a significant challenge to public health in 🇪🇺! Our Position Paper, co-developed with Pancreatic Cancer Europe, Cancer Patients Europe - CPE, epc european pancreatic club, and UEG - United European Gastroenterology, delves into the facts surrounding pancreatic cancer, outlining the current challenges and proposing actionable solutions in the next five years. Read the full paper ➡ https://lnkd.in/enhN8cSk #PancreaticCancer #EUElections #EUElection2024 #EU4Health #HealthUnion #EUCancerPlan #DigestiveCancers EU Health and Food Safety EU Science, Research and Innovation European Health and Digital Executive Agency (HaDEA) European Parliament European Commission EU Health Coalition WHO Regional Office for Europe IARC - International Agency for Research on Cancer / World Health Organization

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Registrations for the DIA Health Technology Assessment (HTA) Forum are NOW OPEN! 🚀 With the implementation of the EU HTA Regulation (HTAR) just around the corner, this year’s forum is shifting gears to focus on the practical aspects of its implementation. Join HTA body representatives, industry, patients, and clinicians to discuss and shape the future of HTA in Europe. Featured topics include: ◾ Implications of the EU HTAR implementation ◾ Evidence generation for decision-making ◾ Insights into JCA and JSA ◾ Building a new EU-level system ◾ Case study featuring a PICO simulation Don’t miss out on this chance to create a successful European system that contributes to faster patient access! Register now: https://bit.ly/457c9tj. #HTAForum #HTA #HTAR #Patients

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#BSR Analysis of 1,362 pts starting 1st JAKi before EMA warnings on JAKi (1/23) showed 28% prev failed ≥3 bDMARDs & 80% met ≥1 EMA JAKi risk criteria -that included 1) age ≥65 2) incr CV risk; 3) current/past smoker; 4) prior cancer

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Find out Elena Nicod's takeaways from the Health Technology Assessment international (HTAi) 2024 Annual Meeting panel session "Characteristics or rare diseases that make health technology assessment difficult". #HTAi2024Seville #HTA #RareDiseases

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What are the implications of US and EU healthcare policy changes for stakeholders, including biopharma companies, healthcare providers, payers, and patients? How can these stakeholders forge ahead and navigate this evolving landscape? Read what the experts think at this Deep Dive from The Evidence Base® of the ISPOR—The Professional Society for Health Economics and Outcomes Research 2024 session, "Staying Ahead of the Curve: Navigating Policy Changes and Ensuring Patient Access in the Era of IRA and EU HTA." Speakers: Corey Ford (Cencora), Michael Drummond (University of York), Casper Paardekooper (Vintura, part of Cencora) and Kimberly Westrich (National Pharmaceutical Council). #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy #inflationreductionact #jointclinicalassessment

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EIPG is among the 250 members joining CMA (Critical Medicines Alliance) and was present at the inaugural meeting today in Brussels. After the opening speech by Ursula von der Leyen, the Director of HERA (L. Muschel) and the President of the Alliance (O. Girard) presented the objectives and the methodologies to be adopted. The results of a first pilot investigation on 11 critical medicines were presented and discussed. Two working groups, one on strengthening manufacturing capacity in the EU and another on reinforcing the global supply chain, were introduced. Discussions were promoted through Q&A sessions. #eipgeu #criticalmedicines #alliance #EU #BE #presidency #shortages

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❗ Are pharmaceutical and medical device manufacturers ready for the new EU HTA process? 𝐇𝐀𝐕𝐄 𝐘𝐎𝐔𝐑 𝐒𝐀𝐘! 🗣 In October 2022, we launched a survey to gather crucial insights from industry executives about their readiness for the emerging #EUHTA process, alongside capturing their prevailing sentiments and expectations. We revisited these respondents in September 2023, and now we are conducting a new survey to uncover if and how perspectives have changed since then! If you currently work in #pharma or #biotech, we'd like to hear your thoughts on this rapidly changing landscape. Our survey will take no more than 5 minutes to complete, and you'll receive a full report once the survey concludes, allowing you to benchmark against other respondents. 🖱 Click here to complete ➡ https://lnkd.in/e3h4bwaR #jca #marketaccess #healthcareindustry #hta #healthtechologyassessment #jointclinicalassessment #survey

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The European Commission launched the Critical Medicines Alliance to address medicines shortages in the E.U. The alliance brings together policy makers, industry and patients to evaluate supply chain vulnerabilities and develop recommendations on mechanisms to prevent shortages. Read more: https://bit.ly/4be0jiA #AgencyIQ #Politico #LifeSciences #Regulatory #Regulation #EuropeanCommission

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Oncodesign Precision Medicine - OPM has secured €5.6 million in funding for its DEMOCRITE project, aimed at demonstrating the effectiveness of OPM-101 in treating Inflammatory Bowel Disease (IBD). OPM-101, derived from OPM's Nanocyclix® platform, inhibits RIPK2, a key regulator of cell death and inflammation. The project focuses on Immune-Induced Ulcerative Colitis (IIUC), a severe form of IBD. The funding will support the completion of Phase 1 and Phase 2a clinical trials to establish proof of concept for OPM-101's efficacy in IIUC patients. The project also aims to secure a commercial partnership for the continued development of OPM-101 in IBD treatment. OPM-101 is one of many kinase inhibitor molecules derived from the Nanocyclix® platform, which target enzymes that regulate essential cellular functions, making them promising targets for precision medicine. The success of the DEMOCRITE project will advance OPM's mission to establish a precision medicine sector in France and solidify its leadership position in kinase inhibitor development. By targeting RIPK2, OPM-101 has the potential to provide a novel and effective treatment option for patients with IBD. Philippe Genne

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Dive into the world of regulatory strategy with our experts, Romain Kherrat, Sofia Ataide, and Yanbing Bertho. Join us on May 14 at 4 pm CEST for a new webinar, 'Shaping Regulatory Strategy: Unleashing Competitive Insights with Contextual Regulatory Intelligence.' Discover the latest global drug approval trends, explore recent pharmaceutical regulation developments, and get an insider's view into the life of a regulatory strategist. Unlock valuable competitive insights using our cutting-edge regulatory intelligence powered by GenAI. Register now: https://lnkd.in/dDRUARAZ #regulatoryaffairs #regulatory #GenAI

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We're looking forward to participating in the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe 60th anniversary conference "Today, Tomorrow, Together for Public Health" where Baron-Papillon Florence will discuss the value of vaccination and how we can unlock the potential of novel therapies #EDQM60

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🌐 Expanding Access Using Early Access Pathways 🚀 Did you know there is a world of funding opportunities that support early access for innovations? 💡 🌍 In Europe, France leads the way with its Early Access Authorisation (AAP), Compassionate Access, and the recent Direct Access program, offering crucial pathways for innovative treatments. 🌍 Exploring further, Poland's Medical Fund Bill was implemented to accelerate access to orphan drugs that demonstrate a high level of innovation (TLI). 🌍 Another example is Ireland’s Exempt Medicinal Product scheme which under special circumstances offers early access to unlicenced treatment options. 🌍 Looking across the Mediterranean Sea, Turkey's named patient program enables the import of critical medicines yet to receive local authorization, demonstrating a commitment to accessible healthcare in the MENA region. It's important to note that these critical drugs will be added to the overseas drug list, with manufacturers required to apply for Marketing Authorization (MA) within three years of inclusion. 🌍 Moreover, Saudi Arabia allows the importation of unregistered products exclusively for hospital-use products that have obtained MA outside of the country. It's noteworthy that the manufacturer must seek Saudi Food and Drug Authority regulatory authorization within six months following the importation date. 🌎 Heading to South America, Colombia's Unavailable Vital Medicines (MVND) program facilitates patient access to essential medicines during times of shortage, absence, or emergency situations, showcasing Latin America's dedication to health equity. 🌎 Additionally, in Argentina, the Regime for Exceptional Access to Medicines allows for the importation of unregistered medicines for individual patients, further expanding pathways for accessing essential treatments in the region. Notably, if the treatment is covered by this regime for more than a year, the National Administration of Drugs, Food and Medical Devices (ANMAT) may actively promote its registration considering its special health interest. However, the registration also depends on the frequency of its use and the technical-scientific evaluation carried out by the National Institute of Medicines (INAME). At Inbeeo, we carefully monitor these funded as well as unfunded early access and alternative pathways across Europe, MENA, North America, LATAM, and APAC 🌐. 💬 Ready to navigate these an >100 other early access opportunities? Reach out for an informal chat, and let's collaborate on unlocking the potential of your product for patients worldwide together!✨ #pharmaceuticals #marketaccess #patientaccess #earlyaccess #Earlyaccessprograms #alternativeaccessprograms

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🧬 3 challenges and opportunities in rare disease drug development 🇪🇺 In Europe alone, approximately 36 million people are suffering from rare diseases, which is approximately equivalent to half the population of France. 🚨 There is no cure for most rare diseases, and the field suffers from gaps in medical and scientific understanding. Nevertheless, impressive progress has already been made in recent years and appropriate treatments and medical care have proven to enhance the quality of life and extend the lifespan of those affected. Our team explored three challenges and three opportunities for the current R&D of rare diseases: 🔴 Challenge 1: small patient populations exacerbate clinical trials 🔴 Challenge 2: limited knowledge of rare diseases impacts research strategies  🔴 Challenge 3: development of therapies for rare diseases isn’t financially feasible Despite these challenges, there are promising opportunities that could pave the way for the development of new therapies for rare diseases: 🟢 Opportunity 1: innovative technologies and designs in clinical trials 🟢 Opportunity 2: potential of multinational research collaborations  🟢 Opportunity 3: chances of personalized treatment approaches 💡 Want to learn more about the challenges and opportunities that could transform the landscape of rare disease research? Read our latest article here: https://lnkd.in/eNDuMZWU #healthcare #pharmaceuticals #pharmaceuticalindustry #raredisease #drugdevelopment

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To ensure CGTs are commercially viable, payment models need a fundamental rethink... Elisabetta Zanon, Director for the Alliance for Regenerative Medicine shares her insights on Europe's financial landscape for CGT with RegMedNet. As healthcare systems work to adapt to accommodate these novel therapies, the need for innovative payment strategies – such as spreading payments over time or linking them to patient outcomes – becomes increasingly more important. With seven therapies having been withdrawn from the European market in recent years due to commercial reasons, there's a collective need for the industry to evolve – ensuring these therapies are not just approved but also accessible and affordable. Read more ⬇️ https://lnkd.in/gjvtK5z3 #ManufacturingBrighterFuture #CellTherapy #GeneTherapy #PatientAccess

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The recognition of vaccine specificities in the EU #HTA Regulation is a good first step towards streamlining the way vaccines are assessed in the EU. We now need to ensure that these specificities are implemented appropriately in the HTA framework https://bit.ly/45078Tg #WeWontRest

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🌟 Calling all healthcare professionals and community members! 🌟 The ONCODIR project and the Greek’s Ministry of Health are currently conducting a comprehensive #survey aimed at identifying key behavioral barriers impacting health-related quality of life. Through this survey we're also assessing preferences related to healthcare services and support, understanding social and cultural factors affecting health behaviors, and exploring the impact of economic factors on healthcare decisions. Your experiences and perspectives are invaluable in shaping effective healthcare strategies tailored to address the unique challenges faced by communities. By sharing your insights, you're contributing to the creation of targeted solutions that have the potential to positively impact health outcomes. 💪💼 Your participation can help pave the way for transformative changes in healthcare delivery and support systems. Take the survey in English here: https://lnkd.in/dKtmanuv and in Greek here: https://lnkd.in/dWQkzDNq I-SENSEGroup/ICCS contributes to ONCODIR as the Technical Manager! #ONCODIR #HealthcareSurvey #CommunityImpact #colorectalcancer #cancer #health

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