Milana Dreo’s Post

Combinations for customers in context ▶️Knowing your customers, including their needs and wants ▶️Quality target product profile ▶️Brilliant products in a real-world context ▶️Innovation: What's out there and how you can engage with it Join Paul Johnson, Paul Johnson Consulting Limited and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/3WjjFx0 The summit aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

We are thrilled to announce that Kevin Brunet, Head of Devices Development and Primary Packaging Quality at UCB, will be speaking at the 6th Drug-Device Combination Products conference on October 15-16, 2024, in Berlin, Germany. With over 12 years of experience in the development and manufacturing of medical devices and drug-device combination products, Kevin has built a robust expertise across various functions, including R&D, supply chain, operations, and quality. His key strengths lie in design and development, risk management, and supplier audits and management, with a proven track record of bringing innovative products to approval and launch, including navigating N.B. audits and H.A. inspections. #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/3WjjFx0 #combinationproducts #design #engineering #drugdelivery #digital #connecteddevices #medicaldevices #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #DDSs #conference #summit #ssr #hfe #pharmaceuticalmanufacturing #regulatory #injectabledrugs #injectables #injectiondevices #digital #drugdevicecombination #humanfactor #humanfactorengineering

▶️ Recent successful submissions of drug-device combination products: Lessons learnt and new horizons Join Kevin B., UCB and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/3WjjFx0 The summit aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #hfe #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience #drugdevicecombination #humanfactor #humanfactorengineering

Notified body opinions for single integral products: 3 years in, where do we stand? ▶️ Notified body capacity for Article 117 reviews ▶️ Experience on submissions to multiple notified bodies: classification, process, requirements ▶️ Practical advise for Article 117 submissions Join Juan Martín Carriquiry, Beyond Conception GmbH and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/3WjjFx0 The summit aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

Excited to introduce Juan Martín Carriquiry, Partner at Beyond Conception GmbH, as a speaker at the 🔸6th Drug-Device Combination Products🔸 summit, taking place on October 15-16, 2024, in Berlin, Germany. Juan is a recognized thought leader in the field of Medical Devices and Combination Products across the EU and beyond. With extensive experience in guiding Global Pharma clients through complex compliance challenges, he has been instrumental in helping companies navigate the latest regulatory requirements. As Managing Director at Beyond Conception, Juan has been at the forefront of pioneering efforts in Europe’s Combination Products sector. He has successfully led clients to secure Notified Body Opinions and achieve compliance with key regulations, including the EU MDR, EU IVDR, and other global frameworks. His deep understanding of the EU regulatory landscape and expertise in Notified Body interactions have made him a sought-after speaker at industry-leading conferences. Juan’s approach goes beyond mere compliance; he is dedicated to creating value for his clients by aligning regulatory strategies with business goals. His insights will be invaluable to those attending #VLDDCP 2024. Join us in Berlin to gain from Juan’s wealth of knowledge and experience in the ever-evolving world of Drug-Device Combination Products. 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/4cH86Xd #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

▶️ Applying human factors regulatory knowledge to optimize the submission process Join Dr. Horacio M. P., Novo Nordisk A/S and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👉 https://buff.ly/3WjjFx0 The summit aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscience

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The promise of #cellandgenetherapies as a revolutionary treatment modality is at risk if we don’t address the critical #bottleneck of creating #scalablemanufacturing processes. The traditional drug development model that prioritizes early clinical data to secure partnerships with big pharma doesn’t translate for #CGTs. Without investing in scalable, cost effective manufacturing processes early in development, they may never be fully accessible to patients. High therapy costs and #supplychain limitations already hamper access, the key to unlocking widespread adoption is in implementing advanced #manufacturingtechnologies and #digitalinfrastructure to reduce development risk, streamline production, and ensure #commercialviability. The future of CGTs relies on a framework that integrates process design, automation, and data-driven insights from the start, rather than waiting until after clinical trials. Planning for scale at the earliest stages ensures that products meet demand, achieve cost targets, and secure market access, providing life-saving therapies to patients, most critically at an affordable cost. 

It is good to see that there is a growing recognition to focus on commercial viability of assets early in the development phase. In the article, we have identified common impediments that tend to defer difficult conversations and have proposed ideas on that can facilitate implementation of the practices that would increase the likelihood of the asset to be commercially successful. By delivering potential cures, #CGTs have shifted the paradigm on the value therapeutic interventions bring to the patients. We need to, therefore, rethink our current development and commercialization playbook and introduce a paradigm shift in our playbook and elevate the business model viability of the entire class of #CGTs. Jason C. Foster Gaurav Shah Barry Heavey #celltherapies, #genetherapies, #biotech, #biopharma, #cellandgenetherapies, #venturecaptial, #privateequity, #hedgefund,

Navigating the complex world of life sciences, especially in combination products, is a journey filled with challenges and opportunities. These products, blending drugs, devices, and biological products, are more than just scientific marvels; they are the future of medical innovation. But the real question is, how do we efficiently and safely bring these products to market while adhering to FDA regulations? It's about understanding the intricate landscape of life sciences and finding solutions that work. From addressing regulatory complexities to integrating drug and device designs, each step is crucial. Join me in exploring ways to navigate these challenges, improve efficiency, and prioritize safety. Interested in a deeper dive? Check out my blog post for more insights: https://lnkd.in/gMWwCezt #lifesciences #medicaldevices #FDAregulation