Marius Setzer’s Post

Do you represent a UK Biotechnology Company working on Market Access in Europe? Are you aware of the new EU HTA Regulation coming into force in 2025 for oncology and ATMP (cell & gene) products, and the need to submit a Joint Clinical Assessment (JCA) dossier?   If you are not yet up to speed or wondering if you are fully aware of the new requirements and how they will affect your business, please drop me a note. Our Subject Matter experts would be delighted to talk you through the implications, ensuring that you can collect and deliver appropriate evidence for a successful launch. #marketaccess #weareiqvia #jca

Do you represent a UK Biotechnology Company working on Market Access in Europe? Are you aware of the new EU HTA Regulation coming into force in 2025 for oncology and ATMP (cell & gene) products, and the need to submit a Joint Clinical Assessment (JCA) dossier?   If you are not yet up to speed or wondering if you are fully aware of the new requirements and how they will affect your business, please drop me a note. Our Subject Matter experts would be delighted to talk you through the implications, ensuring that you can collect and deliver appropriate evidence for a successful launch. #marketaccess #hta #jca #biotechnology

I look forward to a productive, insightful discussion with Dr. Peter Marks

📢 Download the NEW European CDMO Landscape Infographic This new infographic summarises the main players with facilities in Europe who develop and manufacture Small Molecules, Biologics and Cell & Gene therapies. The global market for BioPharma Contract Development & Manufacturing (CDMO) is forecast to keep expanding, with the European CDMO market is projected to grow at a CAGR of 5% to 7.4% according to various reports. Download the hi-res infographic here: https://lnkd.in/eZszdPfn Note on the methodology: Due to the high number of Small Molecule manufacturers in Europe, we have only included CDMOs with in this category with more than one facility. Is your company missing? Let us know: https://lnkd.in/eERjzNBf #CDMO

👀 Look at this post! 53Biologics has been ranked as one of the top CDMOs in Europe for biologics production. 🚀 If you’re interested in learning how 53Biologics can support you, feel free to reach out to me. #53Biologics #GMP #biologics #CDMO

📢 Download the NEW European CDMO Landscape Infographic This new infographic summarises the main players with facilities in Europe who develop and manufacture Small Molecules, Biologics and Cell & Gene therapies.

Excellent graphic from PharmaSource showing how many CDMOs are out there. If you need help figuring out which one is the best partner for your organization, ISR's CDMO Quality Benchmarking reports can help.

Great to see the latest European CDMO Landscape Infographic from PharmaSource! The latest update, released earlier this week, includes CDMO providers across small molecule, biologics and C&G therapy categories. Download below for your overview of this rapidly growing and pivotal segment of the Biopharma market..

Cell therapy manufacturers need to understand the potential impact of cell clumps that may be present prior to administration of their final drug product. In the absence of significant regulatory guidance in this newly emerging form of therapeutic, the manufacturer needs to establish a #riskmanagement strategy for control of particulates, write Drew Kelner and Andreas M. Beckhaus of ProDeMaCon LLC Consulting in this new Cell & Gene article (which is part 2 of their 2-part article series on particles in #celltherapy products). https://lnkd.in/eMKrQGF5 #celltherapymanufacturing

Don't miss part 2 of Raman Sehgal's conversation with Thomas Eldered, Executive Chairman at Flerie 🎙️ In this episode, Thomas and Raman discuss: 👉The story behind Recipharm's decision to divest Cobra Biologics that led Thomas to become owner 👉 Flerie's mission and its patient-centric investment strategy in life sciences. 👉 How 'big faith' and the gene therapy revolution changed the fortunes of the loss-making biologics CDMO If you missed Part 1 of the conversation, you can find that here: https://lnkd.in/eYWFMUqn Listen below! You don't want to miss it ⬇️ #PharmaPodcast #CDMO #LifeSciences