Passionate About Developing Talents and Commercial Organizations | Driving Biotech & Pharma Pipelines Success through Strategic Partnerships | Expert in CDMO & Biomanufacturing
🌟 𝐇𝐮𝐠𝐞 𝐭𝐡𝐚𝐧𝐤𝐬 𝐭𝐨 𝐨𝐮𝐫 𝐟𝐚𝐧𝐭𝐚𝐬𝐭𝐢𝐜 𝐩𝐚𝐧𝐞𝐥𝐢𝐬𝐭𝐬 𝐟𝐨𝐫 𝐬𝐩𝐨𝐭𝐥𝐢𝐠𝐡𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐜𝐫𝐮𝐜𝐢𝐚𝐥 𝐫𝐨𝐥𝐞 𝐨𝐟 𝐂𝐌𝐂 𝐢𝐧 𝐭𝐡𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐫𝐨𝐚𝐝𝐦𝐚𝐩! 🌟 Their insights made it clear that CMC decisions can significantly impact asset valuation and out-licensing potential. A standout moment? 🚨 Corinne Venot’s eye-opening statistic: 𝐨𝐯𝐞𝐫 𝟓𝟎% 𝐨𝐟 𝐝𝐮𝐞 𝐝𝐢𝐥𝐢𝐠𝐞𝐧𝐜𝐞𝐬 𝐟𝐚𝐢𝐥, 𝐨𝐫 𝐚𝐬𝐬𝐞𝐭𝐬 𝐚𝐫𝐞 𝐝𝐞𝐯𝐚𝐥𝐮𝐞𝐝, 𝐝𝐮𝐞 𝐭𝐨 𝐂𝐌𝐂 𝐢𝐬𝐬𝐮𝐞𝐬 in her Pharma licensing experience. And Johannes Roebers shared a compelling case about a topical product that reached Phase III, only to fail because formulation and delivery systems were overlooked early on—an end to what could’ve been a great biotech story. 💡 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬 𝐟𝐨𝐫 𝐁𝐢𝐨𝐭𝐞𝐜𝐡𝐬: 1.𝗜𝗻𝘃𝗲𝘀𝘁 𝗶𝗻 𝗖𝗠𝗖! Biotechs often underestimate CMC strategy and execution budgets. 2. 𝗗𝗲𝘀𝗶𝗴𝗻 𝘁𝗵𝗲 𝗖𝗠𝗖 𝗿𝗼𝗮𝗱𝗺𝗮𝗽 𝗲𝗮𝗿𝗹𝘆 to ensure your tox material matches the future GMP process/platform/CDMO. 3. 𝗟𝗲𝘃𝗲𝗿𝗮𝗴𝗲 𝗘𝘅𝗽𝗲𝗿𝘁𝘀 with deep experience in the field to avoid later pitfalls, in both Drug Substance and Formulation/Drug Product aspects. 4. 𝗨𝘀𝗲 𝗣𝗿𝗼𝘃𝗲𝗻 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺𝘀/𝗖𝗗𝗠𝗢𝘀. Stick to innovating the asset/not the process—ensure future CMC transferability to a commercial Pharma/CDMO site. 5. 𝗧𝗵𝗶𝗻𝗸 𝗕𝗲𝘆𝗼𝗻𝗱 𝗣𝗵𝗮𝘀𝗲 𝗜! Plan for scalability, transferability, and early de-risking of commercial COGS with market access in mind. Our discussion highlighted that 𝗖𝗠𝗖 𝗰𝗮𝗻 𝗲𝗶𝘁𝗵𝗲𝗿 𝗼𝗽𝗲𝗻 𝗱𝗼𝗼𝗿𝘀 𝗳𝗼𝗿 𝘀𝘂𝗰𝗰𝗲𝘀𝘀 𝗼𝗿 𝗰𝗿𝗲𝗮𝘁𝗲 𝗿𝗼𝗮𝗱𝗯𝗹𝗼𝗰𝗸𝘀 at the out-licensing stage. And while CMC might be seen as a “boring topic” by investors (thanks Matthieu Coutet for the candid statement!), it’s under more scrutiny than ever. 🚀 𝗠𝗲𝘀𝘀𝗮𝗴𝗲 𝘁𝗼 𝗲𝗮𝗿𝗹𝘆-𝘀𝘁𝗮𝗴𝗲 𝗯𝗶𝗼𝘁𝗲𝗰𝗵𝘀: 𝗺𝗮𝗸𝗲 𝗖𝗠𝗖 𝗮 𝗽𝗿𝗶𝗼𝗿𝗶𝘁𝘆—𝘁𝗵𝗶𝘀 𝗲𝗮𝗿𝗹𝘆 𝗶𝗻𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁 𝘄𝗶𝗹𝗹 𝘀𝗲𝘁 𝘆𝗼𝘂 𝘂𝗽 𝗳𝗼𝗿 𝗹𝗼𝗻𝗴-𝘁𝗲𝗿𝗺 𝘀𝘂𝗰𝗰𝗲𝘀𝘀! #BioEurope #ProductDevelopment #CMC #AssetValuation #BioPharma #ProductLifeGroup #Sofinnova #Beigene # AGCBiologics #NioSync
🌟 Another great panel addressing CMC development from investor, Biotech and CDMO perspectives 🌟 We were honored to host this conversation at EBD Group Bio-Europe Fall, on the topic of CMC development – an aspect that is often time overlooked but plays a crucial role in biotech asset valuation . A big thank you to our esteemed panelists: Johannes Roebers, PhD (ProductLife Group), Matthieu Coutet (Sofinnova Partners), Christoph Winterhalter (AGC Biologics), Corinne VENOT (BeiGene), Neil McLoughlin (NíoSync Limited) and our moderator Christelle Dagoneau (ProductLife Group) for their valuable contributions and insights on this topic. 🔗 Want to learn yourself from the experts? Access the full recording here: https://lnkd.in/eCTg7tRS Make the most out of your day 3 of Bio-Europe! Stop by Booth 45 to meet with: Geary H., Fernando Mayoral Alonso, Christelle Dagoneau, Johannes Roebers, PhD and Maria Cristina Cadena Laso and discuss how we can support your Product Development needs. #PLGEvent #Biotech #pharma #innovation #healthcare #productdevelopment #lifescience #CMC #Biopharma #BioEurope
Thank you Christelle Dagoneau, great topic, great panel and examples shared. Nothing new for me, being part of the CDMO industry for 20 years +. CMC, squeezed between long and expensive DS development and then clinical trials, is totally underestimated as part of the future success of drugs. How can CMC be made attractive and not "boring", as was quoted during the panel discussion? This should be the goal of all service providers, without whom none of pharma's successes would be possible...
Passionate About Developing Talents and Commercial Organizations | Driving Biotech & Pharma Pipelines Success through Strategic Partnerships | Expert in CDMO & Biomanufacturing
2moMatthieu Coutet, Corinne VENOT , Christoph Winterhalter, Neil McLoughlin, Johannes Roebers, PhD many thanks again for making this session entertaining and insightful 👍👍