Margot Khouri, PhD’s Post

Do you represent a Germany or Austria based 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. #IQVIA #JCA #DrivingHealthcareForwardTogether #MarketAccess #WeAreIQVIA

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

ProShare Advisors Buys 530 Shares of CRISPR Therapeutics https://lnkd.in/gDgF-wQa On the recent trading day, ProShare Advisors made a significant investment by purchasing 530 additional shares of CRISPR Therapeutics. This move demonstrates ProShare Advisors' increased confidence in the company's potential for growth and success in the field of gene editing and therapeutics. #investment #therapeutics #stocks THE Women CEO Magazine

Gene Therapy Market Growth Trends and Latest Insights 2024 For More Insights: https://lnkd.in/dHFR_CvU Novartis | Gilead Sciences | Jazz Pharmaceuticals | Orchard Therapeutics - U.S. | Bristol Myers Squibb | Amgen | Adverum Biotechnologies #genetherapy #genetherapymarket #growthtrends #latestinsights #marketreport2024 #gene #celltherapy

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

🧬What are the 5 key differences between developing Cell & Gene Therapies in the United States vs European Union? While 'traditional' drug categories like small molecules have long-standing similarities, for cell and gene therapies (CGTs) and other complex biologics, the regulatory processes in the United States and European Union vary considerably. This ebook from Thermo Fisher Scientific (summarised in the video below by PharmaSource) explains the 5 key differences to be aware of: 1️⃣ Terminology: Biologics in the US vs Advanced Therapy Medicinal Products (ATMPs) in the EU 2️⃣ Guidance documents and governing regulations 3️⃣ Regulatory interaction and approval Pathways 4️⃣ Manufacturing expectations, inspection processes + documentation 5️⃣ Commercialisation requirements with shorter approval timelines Over time, we hope regulators may converge on harmonised expectations. But for now, download this ebook! https://lnkd.in/eNGRNfPQ #cellandgenetherapy #atmp

Navigating the complexities of developing and manufacturing #cellandgenetherapies, as well as #advancedtherapymedicinalproducts (ATMPs), demands unparalleled expertise and significant resources. To mitigate risks, #biotech and #pharma sponsors often collaborate with contract development and manufacturing organizations for their industry-leading capabilities. Partnering with a #CDMO offers a strategic advantage in terms of state-of-the-art facilities and a robust regulatory understanding, but how can sponsors be sure they’re picking the right one? Our new infographic breaks down the top 10 traits to look for in a #CDMO partner for cell and gene therapies and #ATMPs, exploring three essential categories to keep in mind: 1. The quality of the relationship 2. Credentials and capabilities 3. Foresight and flexibility Download the infographic to learn more: http://spr.ly/6043ZYX5h

🚀 Exciting Announcement!🚀   We've just launched the 𝗖𝗲𝗹𝗹 & 𝗚𝗲𝗻𝗲 𝗧𝗵𝗲𝗿𝗮𝗽𝘆 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗦𝘂𝗺𝗺𝗶𝘁 (October 28-30, 2024 | Washington, D.C.)!   📄 𝗚𝗿𝗮𝗯 𝘆𝗼𝘂𝗿 𝗰𝗼𝗽𝘆 𝗼𝗳 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗮𝗴𝗲𝗻𝗱𝗮 - https://ter.li/jmcq67   In the fast-evolving world of cell and gene therapy, staying ahead of regulatory changes is critical. The stakes are high, and your IND and BLA applications need to be flawless to speed up approval and bring life-saving therapies to patients faster.   𝗧𝗵𝗶𝘀 𝗽𝗶𝘃𝗼𝘁𝗮𝗹 𝘀𝘂𝗺𝗺𝗶𝘁 𝘄𝗶𝗹𝗹 𝗼𝗳𝗳𝗲𝗿 𝘆𝗼𝘂 𝘁𝗵𝗲 𝗰𝗵𝗮𝗻𝗰𝗲 𝘁𝗼: 📈 Stay updated on evolving regulatory guidance 📚 Learn from real-world case studies 🔍 Explore new CMC guidance   The knowledge and connections shared this October will make the difference between success and delay. You'll hear from top biopharma leaders like David Uguen (Orchard Therapeutics - U.S.), Shirley Bartido (TAKEDA PHARMACEUTICALS AMERICA, INC.), Yao-Yao Zhu (AstraZeneca), and many more.   📖 𝗩𝗶𝗲𝘄 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗯𝗿𝗼𝗰𝗵𝘂𝗿𝗲 𝗻𝗼𝘄 - https://ter.li/jmcq67   Now's the time to navigate the complex regulatory landscape and accelerate your therapeutic pipelines! #CellandGeneTherapyRegulatoryAffairsSummit

📢 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