As the #BIO2024 Conference approaches, iNGENū CRO is here to support companies navigating the complex landscape of biotech innovation and regulatory compliance. 🔬 Why partner with iNGENū? Cost Efficiency: Our unique business model reduces clinical trial costs by up to 70%, democratizing access to high-quality research. Regulatory Expertise: We offer comprehensive support for FDA, EMA, TGA, and MHRA regulatory requirements, ensuring your projects advance smoothly and swiftly. The Australian Advantage: Leveraging fast track regulatory processes and significant R&D tax incentives in Australia, we provide a strategic advantage in bringing products to trial faster and more cost-effectively. Even if you're not at BIO2024 and looking to explore new strategic partnerships or need advice on navigating FDA-centric clinical trials, we're here to help you achieve your research goals with our full suite of services from Phase 1 to Phase 3 trials. Reach out to learn more about how our innovative approaches can tailor support for your needs during and beyond BIO2024. #Biotechnology #ClinicalTrials
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As the #BIO2024 Conference kicks off this week, iNGENū CRO is here to support companies navigating the complex landscape of biotech innovation and regulatory compliance. 🔬 Why partner with iNGENū? Cost Efficiency: Our unique business model reduces clinical trial costs by up to 70%, democratizing access to high-quality research. Regulatory Expertise: We offer comprehensive support for FDA, EMA, TGA, and MHRA regulatory requirements, ensuring your projects advance smoothly and swiftly. The Australian Advantage: Leveraging fast track regulatory processes and significant R&D tax incentives in Australia, we provide a strategic advantage in bringing products to trial faster and more cost-effectively. Even if you're not at BIO2024 and looking to explore new strategic partnerships or need advice on navigating FDA-centric clinical trials, we're here to help you achieve your research goals with our full suite of services from Phase 1 to Phase 3 trials. Reach out to learn more about how our innovative approaches can tailor support for your needs during and beyond BIO2024. Anthony.Legere@iNGENuCRO.com #Biotechnology #ClinicalTrials #clinicalresearch
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𝐓𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦 𝐘𝐨𝐮𝐫 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 𝐰𝐢𝐭𝐡 𝐏𝐫𝐚𝐧𝐜𝐞𝐫 𝐑𝐓𝐒𝐌® Are you navigating the complexities of clinical trial designs? Whether you're working on highly intricate studies or early phase trials, Prancer RTSM® is here to support you. Our cutting-edge Interactive Response Technology (IRT) solution offers unparalleled flexibility, enabling you to scale your global supply strategy seamlessly when the time is right. Discover how Prancer RTSM® can revolutionize your next study with its robust features and adaptable design. Let us help you achieve new heights in clinical research efficiency and precision. 👉 https://bit.ly/3SwTFNR #experience #clinicaltrials #RTSM #innovation #biotech #pharma #4gclinical
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Balancing value creation and risk is critical in any #biotech endeavor, explains IQVIA. In this whitepaper, experts dig into how #ClinicalTrial teams can navigate optimal development paths and strike this critical equilibrium. https://bit.ly/3KHN3rv
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📢 We are less than two weeks away from the opening of the second cycle of this year’s funding round! New information is now available on the CARB-X website, including additional Target Product Profiles for the therapeutics and preventative themes as well as clarifications to minimal entry criteria. Do you have questions about the scope of the funding round or the application process? Take a look at our Frequently Asked Questions. 🔗 View here: bit.ly/3W3TKcs 📥 Sign up for the CARB-X newsletter to be notified when the Portal opens: carb-x.org/sign-up/ #AMR #StopSuperBugs #SuperBugs #AntibioticResistance #Medicine #GlobalHealth #ProductDevelopment #Innovation #Biotechnology #antibiotics
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The Pharma R&D Annual Review 2024 is out now! For over 30 years, we've tracked how the climate is shifting, revealing the currents and tides that shape the drug development landscape. Join us as we take the industry's temperature - download the full report today. https://ow.ly/8VYf50R8Px0 #PharmaRnD #AnnualReview #PharmaTrends
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The Pharma R&D Annual Review 2024 is out now! For over 30 years, we've tracked how the climate is shifting, revealing the currents and tides that shape the drug development landscape. Join us as we take the industry's temperature - download the full report today. https://ow.ly/XTkU50R8P2n #PharmaRnD #AnnualReview #PharmaTrends
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With capital preservation top-of-mind, and clinical success more challenging than ever, we’ve seen a significant uptick in demand for our services which focus on optimizing the relationship between Sponsor and CRO. As we go about supporting our current clients, we thought we’d share with our network how we support sponsors to get the most from their clinical outsourcing activities 👇 #drugdevelopment #biotech #innovation #clinicalresearch #lifesciences
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Join KCAS Bio's webinar on June 6 and gain insights into evolving best practices for conventional and spectral flow, optimizing protocols and instrumentation for reliable data, and non-clinical and clinical applications in drug development. Register now! >>> https://hubs.ly/Q02wxNgN0
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As a biotech, it can be difficult to raise the capital needed to perform your first clinical trial. But without a trial, you don’t have the data to submit to the FDA. Running a trial requires you to cashflow your firm for 12-24 months - and that’s just to see the study through. On top of all that, you’re also accountable to your shareholders.. Oh, and you’re competing with large biotech firms who have (seemingly) unlimited funding. So, what options do you have? In this longform article we deep dive into the challenges US biotechs are facing and some potential solutions we suggest. Link below! #clinicalresearch #preclinical #clinicaltrials #biotechnology
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🌟 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
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