argenx’s Post

The #WODC conference is coming up next week. Join our CCO Dennis Akkaya as he moderates a panel discussion on Oct 31 at 16:10 with recognized experts Ramona Reichenbach (Novartis), Pedro Franco (Merck Serono), and François Houÿez (EURORDIS) as they delve into ‘Compassionate Use in the EU: Challenges and the Path to Harmonization’, discussing the current landscape and a path forward.      Under the moderation of Dennis, the dialogue will provide an insightful overview on:    📚 A Comprehensive Overview: Journey through the historical to current regulations of compassionate use in the EU.  🏔 Challenges Unveiled: Active discussion about the hurdles and bottlenecks in the EU Compassionate use process.  🎯 Actionable Insights: Learn about real-world pathways and solutions to harmonize compassionate use practices.    Also attending are our mighty team of Jasmin Schelhaas Eline Heidenrijk and Angela Sarmiento Betancourt. Are you attending? Come visit us at our booth 8️⃣ 6️⃣ and speak with our team about our expertise in #CompassionateUse, #ExpandedAccess programs, and #RWD collection, as well as our #CTRecruitment offering and learn more about latest developments within pre-approval access for BioPharma.    Follow myTomorrows and World Orphan Drug Congress Europe for more. #raredisease #orphandrug --> see the agenda -->  https://lnkd.in/dkxcGrX 

On Tuesday, December 12, #Caribou announced (press release: https://bit.ly/3RH9y3T) positive FDA feedback for the initiation of a Ph3 trial evaluating CB-010 (allogeneic #CD19 CAR-T; PD-1 KO + TCR KO) in patients with ≥2L #LBCL, set to start by YE 2024. Celltelligence provides insights on the significance of the FDA’s decision, discussing the possible outcomes of CB-010 in ≥2L LBCL and the hurdles that Caribou could encounter along the clinical development of its lead asset: https://bit.ly/CT-839114

The global community of #MarketAccess professionals met in France on 2 October 2023 at the Market Access Day Paris 2023 – the first post-pandemic event of the Market Access Society (#MAS). Dr. Meriem Bouslouk-Marx, #AMNOG Expert and Founder of #MBMFutureHealth, presented a paper with the title ‘Case Study – Zolgensma® in Germany’. Onasemnogene abeparvovec (Zolgensma®), a #GeneTherapy to treat the #RareDisease spinal muscular atrophy (SMA), served in her presentation as an example for market access and reimbursement decisions made in #Germany under AMNOG. The resolutions published by the G-BA – the decision-making Health Technology Assessment (HTA) body in Germany – on the advanced therapy medicinal product (ATMP) and orphan drug Zolgensma® illustrate the increasing complexity of the procedures for #ATMPs and #OrphanDrugs at the G-BA. The upcoming EU Joint Clinical Assessment will certainly not reduce this complexity.

With 3 weeks to go, the team here is ready for #WODC on Oct 31 – Nov 2. We have the Mighty team of Dennis Akkaya, Jasmin Schelhaas, Eline Heidenrijk and Angela Sarmiento Betancourt all attending in Barcelona 🇪🇸   We look forward to our CCO Dennis hosting a panel discussion on Oct 31 at 16:10 with recognized experts Ramona Reichenbach (Novartis), Pedro Franco (Merck Serono), and François Houÿez (Eurodis) as they delve into ‘Compassionate Use in the EU: Challenges and the Path to Harmonization’, discussing the current landscape and a path forward.      Under the moderation of Dennis, the dialogue will provide an insightful overview on:    🛤 A Comprehensive Overview: Journey through the historical to current regulations of compassionate use in the EU.  🏔 Challenges Unveiled: Active discussion about the hurdles and bottlenecks in the EU Compassionate use process.  💡 Actionable Insights: Learn about real-world pathways and solutions to harmonize compassionate use practices. Are you attending? 😃 Visit us at our booth 86 and speak with our team about our expertise in #CompassionateUse, #ExpandedAccess programs, and #RWD collection as well as our, #CTRecruitment offering and to learn more about the latest developments within pre-approval access for BioPharma.    Follow myTomorrows and World Orphan Drug Congress Europe for more. #raredisease #orphandrug 🗒 https://lnkd.in/esU7EFd  

Navigating different regulatory ecosystems, understanding the concerns/approaches of regulators in different countries and providing data that is specific to the ecosystem requirements of that country is one of the most nuanced and under-appreciated activities in taking a therapy to human trials. With each persistent step, we come that much closer to the clinic ! Taslimarif Saiyed, PhD Anand Anandkumar

Throwing it back to November's COG West Coast meeting where Oranee Daniels MD shared her experiences outsourcing an early-phase clinical trial to Australia. Check out the key takeaways from her talk on the blog post linked below! #australia #clinicaltrials

It’s been a busy Monday. The day started with a call with Jouni Kock and colleagues in Finland and the Baltics looking at Digital therapeutics and the landscape in each market. Followed by a call with Solene BIMBENET, our European Digital therapeutics lead. Later in the afternoon a call with Alberto Navia-Osorio Pascual and colleagues from Portugal. Walking through a specific DTx and looking at market fit. In between UK team calls and planning for the The Pharmacy Show and the The Labour Party political conferences next week. This is Viatris, building healthcare not as it is, but as it should be. #digitalTherapeutics #Patientempowerment #PatientAccess

We are thrilled to announce EUROPACCESS - Your Pharma Partner as a Silver Sponsor at the 4th Orphan Drugs and Rare Diseases Conference on October 9-10, 2023. Stay tuned for their insights on improving access to innovative treatments in Europe. #pharmapartner #silversponsor #orphandrugs #rarediseases #londonconference #conference2023 #marketsandmarkets

And Yvanne Enever and PHARMExcel we are getting very excited too! - Both for the event as a whole, and for this particular panel session which has an amazing line up of panellists. I know that all the #nhs and commercial sites that are attending are particularly looking forward to hearing the thoughts and insights from the sponsors and CROs taking part in this panel. #ILTT23 #clinicaltrials #clinicalresearch

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