Many stakeholders discussed yesterday in #Brussels the importance of the EU’s global competitiveness for Europeans living with rare diseases. Caroline Ven , CEO of #pharmabe, stressed that competitiveness is key. pharma.be’s memorandum for the 2024 national elections is entitled “For a healthy Belgium”. Healthy in terms of both its citizens and the economy of the country. Caroline Ven: “To secure future #competitiveness of the #EU, three cornerstones need to be in place: increased fundamental R&D the right conditions for entrepreneurship and performant national #healthcare systems, including sufficient budgets for innovative treatments including for rare diseases.”. “For example, only 53% of the 19 orphan dossiers, including advanced therapy medicinal products ( #ATMPs), analysed in 2023 by the Belgian Commission of Reimbursement led to reimbursement.”. In addition, she focussed on the many Unmet Medical Needs still existing. Industry has the addressing of #UMNs at its very core. But sometimes it takes huge efforts, e.g., $ 42 billion has already been spent on clinical trials for Alzheimer’s diseases, without a cure being available yet. At the same time, it is not just about breakthrough #innovation, room for incremental innovation is absolutely crucial: this is true across industries. The return on investments, also in R&D for rare diseases, is essential to ensure the virtuous cycle of biopharmaceutical R&D: current earnings are invested in the treatments of the future. #GlobalCounsel EURORDIS-Rare Diseases Europe @Radiorg Eva Schoeters EFPIA - European Federation of Pharmaceutical Industries and Associations EUCOPE - European Confederation of Pharmaceutical Entrepreneurs EuropaBio - the European Association for Bioindustries UCB Novo Nordisk Sanofi Belgique Takeda in Belgium #rarediseases #orphandrugs #Belgium Emma Eatwell Stefan Joris Alexander Natz Daria Julkowska
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Yesterday, I attended this insightful event to discuss the burden of rare diseases. It's clear that their impact is profound, often overshadowing more common illnesses due to their complexity and the unique challenges they present to people. One of the most significant takeaways for me is the need for unity in creating an EU regulatory environment that not only encourages research but also accelerates approvals. Countries must collaborate to harmonize Health Technology Assessments (HTA) across Europe, ensuring fair access to treatment and cure. There is definitely a lot of work ahead of us, but this kind of conversation is exactly what we need to make change happen. #rarediseases #lifescience
Many stakeholders discussed yesterday in #Brussels the importance of the EU’s global competitiveness for Europeans living with rare diseases. Caroline Ven , CEO of #pharmabe, stressed that competitiveness is key. pharma.be’s memorandum for the 2024 national elections is entitled “For a healthy Belgium”. Healthy in terms of both its citizens and the economy of the country. Caroline Ven: “To secure future #competitiveness of the #EU, three cornerstones need to be in place: increased fundamental R&D the right conditions for entrepreneurship and performant national #healthcare systems, including sufficient budgets for innovative treatments including for rare diseases.”. “For example, only 53% of the 19 orphan dossiers, including advanced therapy medicinal products ( #ATMPs), analysed in 2023 by the Belgian Commission of Reimbursement led to reimbursement.”. In addition, she focussed on the many Unmet Medical Needs still existing. Industry has the addressing of #UMNs at its very core. But sometimes it takes huge efforts, e.g., $ 42 billion has already been spent on clinical trials for Alzheimer’s diseases, without a cure being available yet. At the same time, it is not just about breakthrough #innovation, room for incremental innovation is absolutely crucial: this is true across industries. The return on investments, also in R&D for rare diseases, is essential to ensure the virtuous cycle of biopharmaceutical R&D: current earnings are invested in the treatments of the future. #GlobalCounsel EURORDIS-Rare Diseases Europe @Radiorg Eva Schoeters EFPIA - European Federation of Pharmaceutical Industries and Associations EUCOPE - European Confederation of Pharmaceutical Entrepreneurs EuropaBio - the European Association for Bioindustries UCB Novo Nordisk Sanofi Belgique Takeda in Belgium #rarediseases #orphandrugs #Belgium Emma Eatwell Stefan Joris Alexander Natz Daria Julkowska
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Diseases know no borders. And neither does our commitment to fight them together. Had a very useful day of meetings yesterday in Brussels, organized by EFPIA. With colleagues from various European countries, we talked about important topics. Such as: ✅ the clinical research ecosystem in Europe; ✅ revision of the European pharmaceutical legislation; ✅ a competitive strategy for Life Sciences & Health. Europe risks 'missing the boat' in drug development, compared to the United States and China. Less clinical research on our continent, for example, does not only affect European patients, who therefore have later access to innovative drugs. It is also bad for the level of knowledge of our doctors. Mario Draghi recently wrote a penetrating report on Europe's strategic position: 'The future of European competitiveness'. We also talked about ways to responsibly and effectively face the challenges in European healthcare together with other stakeholders - such as politicians, scientists, patient organizations, doctors and journalists. Let no one be under the illusion that we can solve major challenges like #Alzheimer's, #cancer and #obesity from a silo. Together we are so much stronger! #wewontrest #clinicaltrials #eupharmalegislation EFPIA - European Federation of Pharmaceutical Industries and Associations Andy Powrie-Smith Lavinia Meloni Maryna Bokorna Jack Neill-Hall Espen Snipstad Veronika Bendere Stephanie Prate
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Great article on this #RareDiseaseDay. RLM Consulting
Invented in Europe does not guarantee early access to medicines. Belgian PM Alexander De Croo and European Commissioner Margrethe Vestager want to work on this and make sure patients have swift access to innovation born in Europe. Read the full article here 👇 Eva Schoeters Jonas Geerinck Anant Murthy, PhD argenx
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🌟 RWE4Decisions is taking part in #HTAi2024Seville - one panel today and another panel tomorrow. Today, RWE4Decisions Steering Group member Francois Meyer moderated a very successful session on “Can We Agree When an RCT Is Not Possible and the Implications for Comparative Effectiveness?”. Many thanks to our brilliant speakers and to the very interactive audience! Antoine Vanier presented the findings on non-randomised studies in Haute Autorité de Santé's paper on 'Rapid access to innovative medicinal products while ensuring relevant HTA': https://lnkd.in/dSdp4rfs. Anne-Pierre Pickaert from France Lymphome Espoir provided the patient perspective on participation in clinical or single arm trials and the balance between ethics and the need for evaluating comparative effectiveness. James Ryan from AstraZeneca delved into the European Medicines Agency's conditional approval system and the cases when single arm trials might provide the most reliable information. 💡 Let us know in the comments if you participated in today's session and any reflections on the topic. 👇 🔜 We look forward to welcoming you tomorrow at 17:15, in room Andalucia 1&2, for our second panel: “Post-Launch Evidence Generation: Can We Anticipate When and What We Need?”. #RealWorldEvidence #RCT #HTA Health Technology Assessment international (HTAi)
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The Fourth Annual Nordic Innovation Day (NID) returns to Valby, Denmark on 26 September 2024. Will you join us? Hosted by @Lundbeck and @Medidata Solutions, NID brings together thought leaders and innovators from the region, so that they can gain inspiration from each other, and examine the opportunities, latest advancements and challenges in clinical trials. The aim of the NID is to spur innovation and knowledge-sharing. The event provides a forum where attendees exchange ideas and ask questions. Above all, NID offers a great opportunity to network with peers from across the Nordics, who are working on similar challenges and explore solutions. There is very limited availability at the event. For the agenda and more details, visit the NID website https://lnkd.in/etJx92am #NIDDenmark #Medidata #Lundbeck #WeAre3DS #FerringPharmaceuticals #AscendisPharma #DiamydMedical #NovoNordisk #LifeSciences #Nordic #LifeSciences #digitaltransformation #ClinicalTrials #Medidata #artificialintelligence #AIinHealthcare #ClinicalDevelopment #Pharma #DigitalHealth #AI #productivity #PatientCentricity #datamanager #VirtualTwin #clinicalinnovation #regulatory #regulatorylandscape #regulatorychange #clinicaldatamanagement #modellingandsimulation #digitalhealth #digitalhealthtechnologies #generativeai #largelanguagemodels #medicalimaging
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Partnering with pharma & biotech companies, delivering bespoke global pricing & market access launch strategies, specialising in EU & UK
Our in-depth full report from #EPAConf is here! Our report consolidates key plenaries and tracks, and includes main takeaway points from Graham Foxon's talk on #EUHTA. 📌 If our summary is helpful, take a moment to repost it to your network ♻ #healthcare #marketaccess #pharma #rarediseases #realworldevidence #digitalhealth #digitaltransformation
📢 𝐖𝐨𝐫𝐥𝐝 𝐄𝐏𝐀 𝐂𝐨𝐧𝐠𝐫𝐞𝐬𝐬 𝟐𝟎𝟐𝟒 𝐑𝐞𝐩𝐨𝐫𝐭 𝐢𝐬 𝐡𝐞𝐫𝐞! 👇 Remap Consulting joined over 1,500 other delegates from pharma, biotech and Payers/HTA's, in attending Europe's World Evidence, Pricing and Access Congress in Amsterdam, Netherlands from 12th - 13th March 2024. Our report summarises the key plenary sessions and parallel tracks that took place during the conference, and key takeaways from Dr. Graham Foxon's talk on the #EUHTA. Click to read the PDF report ➡ https://lnkd.in/ejKYkCT7 We'd love to hear your thoughts about #EPAconf , please share them below! 💬 #healthcare #marketaccess #pharma #hta #rarediseases #realworldevidence #digitaltransformation
World EPA Congress 2024
https://remapconsulting.com
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⚠️ EVENTO DA NON PERDERE ⚠️ 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐧𝐠 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐢𝐧𝐭𝐨 𝐚𝐜𝐜𝐞𝐬𝐬 𝐟𝐨𝐫 𝐀𝐓𝐌𝐏𝐬 𝟑𝐫𝐝 𝐄𝐔-𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐍𝐞𝐭𝐰𝐨𝐫𝐤 𝐦𝐮𝐥𝐭𝐢-𝐬𝐭𝐚𝐤𝐞𝐡𝐨𝐥𝐝𝐞𝐫 𝐦𝐞𝐞𝐭𝐢𝐧𝐠 📅 15 Novembre 2024 📍 Piazza della Pilotta, 4 - 00187 Roma AIFA Agenzia Italiana del farmaco and the EU-Innovation Network (EU-IN) are organising a multi-stakeholder meeting in Rome to be held on 15 November 2024. The meeting focuses on how innovation in the development of Advanced Therapy Medicinal Products #ATMPs can be translated into effective and safe therapies at the point of care in Europe. The objectives are to: ▪️ seek feedback from developers on the main challenges and barriers currently encountered from early development to access, ▪️ provide insights on scientific and regulatory advice tools available to innovative developers at European and national level, ▪️ discuss opportunities for promoting mutual exchange and interactions between stakeholders with the aim of strengthening the European innovation ecosystem. The meeting will provide an open forum for discussion with a view to raising awareness of existing initiatives, as well as identifying further actions that could help to foster collaboration between stakeholders and ultimately facilitate patient access to safe and effective ATMPs. Virtual participation to the event is open to all stakeholders. Registration 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐨𝐩𝐞𝐧 𝐮𝐧𝐭𝐢𝐥 𝟓 𝐍𝐨𝐯𝐞𝐦𝐛𝐞𝐫 𝟐𝟎𝟐𝟒. ⬇️ Learn more and go to registration form ⬇️
Translating innovation into access for ATMPs: 3rd EU-Innovation network multi-stakeholder meeting | European Medicines Agency (EMA)
ema.europa.eu
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Clinical Trial Diversification: What do Hong Kong & the Greater Bay Area Have to Offer? Hong Kong has grand plans to become one of Asia’s leading clinical trial hubs. Important regulatory upgrades and increased integration with mainland China via the Greater Bay Area initiative – including a new dedicated GBA Clinical Trial Institute at the Hong Kong/mainland border – mean that this is not just a pipe dream. However, as an illuminating panel discussion hosted by PharmaBoardroom at last month’s BIOHK 2024 conference showed, several challenges still need to be ironed out to fully realise Hong Kong’s clinical trial hub potential. Featuring: Henry Yau of Clinical Trials Centre, The University of Hong Kong, Charlie Chen of Nuance Pharma, and Xia Jin of Immuno Cure Read more at: https://lnkd.in/dfYcR--R
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The recent overhaul of the EU's General Pharmaceutical Legislation (GPL) marks a pivotal moment in our quest to modernize healthcare. Why am I excited about it? 🔍 Innovation at its core The proposed amendments to streamline processes at the European Medicines Agency are a step in the right direction, promising a predictable and efficient regulatory environment. 📉 Addressing a concerning trend A study by Dolon warns of a significant decrease in incentives for companies to invest in breakthrough medicines in Europe. Addressing it, would power Europe's global R&D investment share. This is not just about numbers; it's about the millions of lives at stake and the years of life lost due to delayed or inaccessible treatments. 🚀 The way forward As we engage with the European Union Institutions on these proposals, let's champion policies that are pro-patient and pro-innovation. This will foster an environment conducive to investment, particularly for small and medium biotech enterprises. #pharmainnovation #EUpharma #LegislativeChange #PatientCare
A recent study from Dolon, commissioned by EFPIA, shows that proposals to reduce regulatory data protection reduces the incentive for companies to invest in breakthrough medicines by 55% in Europe over the next 15 years. Moreover, it could further accelerate Europe’s decline in innovation compared to the USA, China and Japan. This could result in: - A one-third reduction in Europe’s share of global R&D investment by 2040. - Loss of 1 in 5 medicines in development which would no longer be economically viable in Europe. - A loss of 16 million years of life lost due to increased mortality and premature death across the EU. Unless changes are made, Europe will become reliant on other regions' medical innovation and supplies and patients will wait longer for the latest advances in treatments. Investing in health leads to people living healthier, longer lives and promotes overall economic prosperity. Read more in this blog by Gilles Marrache: https://lnkd.in/dgQ-FuMJ #WeWontRest
An Investment We Can't Ignore: Reflections on the Changing EU Pharmaceutical Landscape (Guest blog)
efpia.eu
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🚀 Access to orphan drugs in emerging markets At the World Orphan Drug Congress USA 2024 that took place 2 weeks ago, challenges related to accessing orphan drugs in low- and middle-income countries (LMICs) were discussed, including: 📢 Awareness: A lack of disease awareness, unclear treatment protocols, and limited knowledge of the benefits of new therapies. 🌐 Accessibility: Disorganized healthcare systems and inadequate transportation networks leading to delayed diagnoses and insufficient care. 💊 Availability: A stringent Pricing & Market Access (P&MA) environment often resulting in orphan drugs being excluded from public reimbursement. 💰 Affordability: High drug costs, and constrained healthcare budgets At Inbeeo, we provide strategic insights to accelerate patient access to orphan drugs in emerging markets, supporting them in: · Product and market prioritization · Access pathway prioritization · Commercialization strategy · Developing pricing strategies 💬 Let’s Chat! 💬 Reach out for an informal chat, and let’s explore how we can be your partner in devising access strategies for orphan drugs in emerging markets #MarketAccess #PatientAccess #OrphanDrugs #EmergingMarkets
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European Policy and Market Access Advisor
6moExcellent and interesting contributions by all participants in a constructive and open dialogue: strong call for rare disease action plan!