Executive Insight, Healthcare Consultants’ Post

📣The Inbeeo view from Swiss Biotech Day!📣 Christel Jansen and Vincenzo Straccia were representing the Inbeeo team at the Swiss Biotech Association Swiss Biotech Day congress recently as well as visiting nearby clients. We were  both amazed to see first-hand such a breadth of innovation coming from this global Life Sciences hub in the heart of Europe – both very exciting and humbling at the same time. Christel and I had the privilege of meeting with organisations at the beginning of their journeys as well as with leaders from global institutions that are improving lives for people around the world at scale. It was a truly inspirational few days! A further highlight was visiting the Roche Building 1 in Basel (thank you again for the snap Christel!😎).  Your team may be at the point of looking for further investor support, or beginning to consider reimbursement strategy or indeed life cycle optimization. Just as with the vision communicated at Swiss Biotech Day and the views from Building 1, Inbeeo can help you see the bigger picture and what is possible. Want to discuss further? Please don't hesitate to reach out! #marketaccess #drugpricing #pharmaceuticals

Collaboration: The powerful leverage in Drug Development BioArctic's post highlighting CEO Gunilla Osswald's revised perspective on AstraZeneca's 5R Framework for successful drug development is spot on. As a scientist with 12 years of experience leading Offspring Biosciences, a Tissue Analytics CRO, as well as previously working on the big pharma side overseeing outsourcing of research, I offer my take on this. Synergy through Collaboration: The Power of the 6th R Gunilla's insightful addition of a 6th "R" – Right Collaboration – to the existing 5R framework is a powerful recognition of the critical value CRO partnerships brings to drug development. Indeed, the CRO industry's tremendous expansion during the past 15 years is a direct reflection of the growing need for specialized expertise in today's complex drug development landscape. Beyond Execution: The Embedded Scientific Partner However, maximizing the value of these collaborations hinges on how they are structured and executed. This is where Gunilla Osswald's concept of "Right Collaboration" comes into play. My experience is that the ideal scenario involves the CRO functioning as a truly embedded scientific partner, actively involved in designing, executing, and evaluating studies that drives the projects forward to the next critical decision point. This collaborative approach stands in contrast to operative models for outsourcing where the CROs serve primarily as an extension of the pharma company's lab, executing tasks with limited input. BioArctic’s 6R framework, with its emphasis on Right Collaborations, paves the way for a more symbiotic relationship which leverages the strengths of both pharma and CRO for an accelerated and successful drug development progress. A Shared Journey As scientists and industry professionals, both within pharma and CROs, we share a common goal: advancing the development of safe and effective drugs that brings true value to our common client – the patients. Let's unlock the power of true collaborations, as outlined in the 6R framework, to turn this vision into reality. What do you think? Share your experiences from collaborative CRO partnerships in the comments! #Collaboration #DrugDevelopment https://lnkd.in/dfPpTRgc https://lnkd.in/dgPX22aV

Insightful discussion on the value of partnerships at Executive Insights 2024 Emphasizing that partnerships are critical for successful drug development, especially for small companies like BioArctic that rely on collaborations, Gunilla Osswald, BioArctic CEO, was one of the speakers at the Executive Insights 2024 conference hosted by Cytel, DNB, and Flerie. Osswald values partners who are truly interested in working together cooperatively to achieve strong relationships and added a sixth "R" to the classic 5R concept in pharma negotiations - focusing on the significance of relationships and their ability to advance innovation. The six Rs: - Right target - Right patient population - Right dose and exposure - Right study design - Right safety - Right collaborations

Welcome to the NLSDays 2024 in Malmö! This significant event, the Nordic Life Science Days 2024, will return to Malmö, Sweden, on 18-19 September. We will be exhibiting at this great event! Nubilaria, stand number C04. We are also a presenter at conference. Date: 18 September 2024 Time: 14:15 Location: Main Hall Our colleagues Franco Schiannini and Erich Cavicchiolo are excited to have you at this prestigious event and are looking forward to your presence! https://lnkd.in/d4VHZKyZ #clinicalresearch #healthcaredata #healthcareit #healthcaresoftware #data #healthcare #pharmaceuticals #digitalhealthcare #pharmaceuticaltechnology #clinicalresearch #clinicaltrials #digitalhealth #healthtechnology #healthtech #clinicalresearch #clinical #cro #clinicaldata #clinicaltrialmanagement #clinicalstudies #clinicaldataplatforms #remotehealthcare #remotehealth #clinicaloperations #clinicaldevelopment #clinicaloperations #clinicaldata #remotemonitoring #datamanagementplatform #datamanagement #pharma #lifescience #rwe #rwd #epro #sops #etmf #edc #sdv #edc #cra #rtsm #sae #uat #gcp #qa #ecoa #iwrs #esource #econsent #decentralizedtrials #decentralizedstudies

🌟 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

Experts gather at LSX - partnering for Life Science eXecutives Congress to discuss the impact of the new EU HTA regulation on biotech and pharma in Europe. From their perspective, trying to streamline 27 member states into one initiative is a mighty endeavour, which will include trial and error, but one that will hopefully result in a more unified system for all member states.

Join us for at our joint Breakfast Seminar with World Courier "From Molecule to Market: Navigating the Complexities of Drug Development”. 📅 April 25, 2024 | 8:30am CET 📍 BioM Biotech Cluster Development GmbH, Martinsried In this informative morning discussion as we delve into the journey from scientific breakthroughs to market success. Our expert speakers will explore the complex process of transforming groundbreaking molecules into marketable products, offering valuable insights and strategies for success. Learn more and register here: 🔗 https://lnkd.in/djr56EGe Key Takeaways: ✅ Understand global regulatory landscapes in Europe and the US ✅ Learn successful market access strategies, focusing on the German and European markets ✅ Explore logistics management from early development to commercialization ✅ Engage in an interactive Q&A session with industry experts Can't join in person? Register for online attendance to access valuable insights from anywhere: 🔗 https://shorturl.at/bv036 Don't miss out on this opportunity to enhance your drug development strategies. #CencoraPharmalex #DrugDevelopment #RegulatoryAffairs

We’re pleased to announce that Caitlyn Krebs, our Co-Founder and CEO, will be presenting at the BIO Investor Forum by the Biotechnology Innovation Organization in San Francisco this week. She’ll be discussing how Nalu Bio has identified a unique opportunity at the intersection of two emerging fields: The Endocannabinoid System (ECS)—the body’s natural balancing mechanism—and its application to essential health needs such as pain management. By combining our expertise in cannabinoid science with a pharmaceutical approach, we’re developing non-intoxicating molecules precisely tailored to unlock the untapped potential of the ECS and deliver scalable solutions that set a new standard for health and wellness. 🗓 When: October 16 at 1:30 p.m. 📍 Where: California Room, Fairmont Hotel, San Francisco Join us to learn more about our progress in tackling one of the most vital health challenges of our time—non-addictive pain therapeutics that provide sustained relief with the ambition to displace opioids. For more information about the event: https://lnkd.in/dZf3Myxg #BIOInvestorForum #DrugDiscovery #PainManagement #OpioidAlternatives #ChronicPain #PharmaAI

🌟 **Celebrating Groundbreaking Analysis in Biopharma IPOs** 🌟 Kudos to Stephen Hansen and BioCentury Inc. for their insightful analysis (https://lnkd.in/eeECPHf5) on preclinical IPOs in the biopharma landscape from 2020-2024. This study challenges the preconceived notion that preclinical IPOs are inherently riskier and less rewarding. Contrary to popular belief, preclinical IPOs have demonstrated share price performances on par with their clinical counterparts, while also raising substantial capital. In our recent analysis, 'Meeting the Moment: Alignment Between Company Formation & Stakeholder Demand Across Biopharma’s Innovation Ecosystem,' we at Ipsos North America explored similar themes leveraging BioCentury's powerful BCIQ database (https://lnkd.in/ejzWXatG). For those navigating the biopharma investment landscape, these insights highlight the critical importance of data analysis and industry expertise in uncovering actionable insights and strategic opportunities for key stakeholders across biopharma's innovation ecosystem, upon which large Pharma and the future of medicine depends. #Biopharma #Innovation #IPOs #Healthcare #Investment #BioCentury #PreclinicalResearch

Join Claire Sadler and Pauline Garner at the Small Molecules Bites & Insights event, Unlocking Solutions to Early Phase Drug Development Challenges. "An engaging session hosted by Lonza and Bionow, where you'll discover strategies to overcome complex drug development challenges in early phase. Lonza's first Small Molecules Bites & Insights event in the UK offers a unique opportunity to learn from industry experts on how to accelerate the development of your drug substance and drug product, addressing critical first-in-human challenges. - Gain valuable knowledge from experts in the field - Learn actionable methods to streamline your development process - Connect with peers over a complimentary lunch, expanding your professional network Register https://lnkd.in/eMBdgMZR to secure your spot and take the first step towards overcoming your development hurdles." Register to receive the presentations after the event if you can't attend in person. #drugsafety #drugdiscovery