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More Case Studies: Managing Change In Vaccine Production https://lnkd.in/ekgzfaY4 - By Eric Doerr, MESc., P.Eng., Manufacturing Sciences and Analytical Technology, Sanofi, Toronto Effective management of process and equipment changes for vaccine production hinges on transparent and meaningful communication among all stakeholders.

"Being part of an industry that's really positively affecting billions of people's lives across the globe—I mean, how can you not like that?" - Scott Goodberlet In the world of biomanufacturing—where the goal is to create medicines that will help cure people of their ailments—quality is one of the most important everyday driving factors of excellence. As advancements in biotechnology continue to redefine the possibilities within the industry, the assurance of product quality remains non-negotiable. To dive further into quality in biomanufacturing, we spoke to Scott Goodberlet, VP and Head, Quality Americas Region and Device Quality, at AstraZeneca.  Read below to uncover how Scott views quality in the biotech industry, his advice on the most important aspects of organizational quality, and how he successfully incorporates quality in AstraZeneca’s daily operations. https://lnkd.in/eZw6sAMR --- #Biomanufacturing #Quality #BioTurns10 #GenerisBIO #Blog

📢 Major Restructuring at BIO 📢 The Biotechnology Innovation Organization (BIO) is undergoing significant changes under the leadership of new CEO John F. Crowley. As part of an internal restructuring effort, BIO has laid off around 30 employees, including key executives. 🔍 Key Details: 🔹 Leadership Changes: Departures include Chief Policy Officer John Murphy, Chief Science Officer Cartier Esham, and Chief Public Affairs and Marketing Officer Rich Masters. 🔹 Strategic Realignment: CEO John Crowley, an industry veteran from Bristol Myers Squibb, Novazyme, and Amicus Therapeutics, aims to better align operations with BIO's mission and strategic priorities. 🔹 Industry Challenges: The restructuring follows a series of major company defections from BIO due to the impact of the Inflation Reduction Act, which introduced significant changes to drug pricing regulations. 🔹 Defections: Notable companies that have left BIO include Pfizer, UCB, Takeda Pharmaceuticals, and AbbVie. 💬 Crowley emphasized the need for these changes to ensure BIO remains effective in representing the biotech industry's interests amid evolving challenges. 🔜 Upcoming Event: BIO’s annual International Convention will take place in San Diego from June 3 to June 6, featuring sponsors like Merck, Amgen, Genentech, Avantor, and Eli Lilly. #Biotechnology #BIO #IndustryNews #Leadership #Restructuring #Pharma #Healthcare #Biotech #InflationReductionAct #TradeGroup #StrategicAlignment #BIO2024 #Innovation

🌐 How do you transition from local R&D to global commercial success in BioPharma?   📘 Find out in our newly released whitepaper, packed with expert insights and actionable strategies – a must-read for #biotech firms looking to scale globally.   🔬 The whitepaper includes topics such as: - Integrating commercial thinking into R&D from the start - Pitfalls of emerging innovator companies - Launching a first product while building the organization - Setting realistic expectations for biotech fundraising and launch - 7 “make or break” factors for emerging biopharma companies   💡 Whether you are preparing for your first product launch or looking to refine your approach to global markets, this guide helps you navigate the complexities of the #biopharma industry.   👇 Swipe through the whitepaper below or download the full version here: https://lnkd.in/d7KB9K73.   🔍 If you want to find out more about the vibrant biotech ecosystem in the Greater Zurich Area, please click here: https://lnkd.in/dA6YX8yD.   Nicola Heffron, Alexion Pharmaceuticals, Inc.; Joe Magliocco, Blue Matter; Paul Pospisil, Korn Ferry; Thomas W. Fuchs, MSc, MBA, Economic Promotion Canton of Zug #innovation #pharma #research #development #commercialization

The journey of a drug delivery concept to a marketable serial product is long and full of pitfalls. Efficient structures and processes are essential to successfully navigate this path, and they must interlock to ensure success. The article of my colleague Michael Wiglenda describes the approach taken by Gerresheimer in the industrialization of such products, using the example of various successfully completed development projects.   Read the article published in the OnDrugDelivery to discover more: https://lnkd.in/eTmtHaFf #innovatingforabetterlife #drugdelivery #industrialization #pharma #biotech

💊 The Rise of New Pharma! 🌟 A shift is happening in the pharmaceutical industry: "New Pharma" companies are emerging and making waves, potentially crowding out established giants. According to a recent Reuters Breakingviews analysis, this transformation is driven by innovation, agility, and novel business models. Key insights: -Innovation Leadership: Smaller, agile companies are leading with cutting-edge research and innovative treatments. -Market Dynamics: The traditional dominance of Big Pharma is being challenged by these nimble competitors. -Investment Trends: Venture capital and strategic investments are increasingly favoring New Pharma, recognizing their potential to disrupt the industry. As the landscape evolves, both challenges and opportunities arise for all stakeholders in the healthcare ecosystem. #Pharma #NewPharma #BigPharma #Innovation #Healthcare #Biotech #MarketTrends #Investment #IndustryShift #PharmaceuticalIndustry #HealthcareInnovation

📢 Sartorius and Sanofi Revolutionize Drug Manufacturing 🔬 Sartorius is collaborating with Sanofi to develop an end-to-end platform for integrated and continuous downstream bioprocessing ICB. 👥 Sartorius will contribute its engineering and manufacturing expertise to commercialize ICB platforms based on prototypes developed by Sanofi. 📜 In return, Sanofi will grant Sartorius exclusive access to its know-how and patents related to the ICB platform. 🌍 The collaboration aims to reduce the cost of drug manufacturing and improve the environmental footprint of operations. 🚀 The platform will combine flexibility with the advantages of intensified bioprocessing to get life-saving drugs to patients faster. 💼 Integrated continuous biomanufacturing maximizes efficiency by enabling uninterrupted and steady materials flow. 🏭 ICB reduces the overall process footprint, leading to lower raw material and energy consumption, higher productivity, and less waste. #BioprocessUpdates #bioprocessing #collaboration #drugmanufacturing #processintensification #Sartorius #Sanofi #endtoendplatform #continuousbioprocessing #efficiency #environmentalfootprint #knowhow #patents #flexibility #life-savingdrugs #waste reduction ▷ Read the full article here: 📎 https://lnkd.in/dH8KkdRZ

I’m pleased to see recent studies show that #biotech innovation, particularly in smaller markets, will likely remain unaffected by #Medicare price negotiations. The research indicates that R&D in smaller biotech firms, which rely more on equity investments than revenue, will continue to thrive. Additionally, larger companies, accustomed to agile management and strategic resource allocation, may only need to make minor adjustments. Overall, the #InflationReductionAct is unlikely to have a detrimental impact on the innovation landscape in the #LifeSciences sector.

Good R&D investments shouldn't require your own R&D. Or at the very least, you shouldn't be starting from scratch. Exciting startups are improving the ways pharma, material science, and other R&D-heavy industries are creating new knowledge. VCs need to get better at telling signals from noise. Using epistemology to identify the core levers where value can be created will help VCs invest better. Let's talk R&D. Be agentic. #venturecapital #research #researchanddevelopment #industryinsights #pharmaceutical #pharma

🚀 Catalysts for Accelerated Innovation: Strategic Partnerships in Biotech 🚀 In the dynamic world of biotechnology, strategic partnerships are not just beneficial; they’re essential. From licensing agreements to equity investments, these collaborations enable biotech start-ups to overcome resource constraints and the complex, costly nature of drug development. With major pharma companies like Novartis AG expecting up to 40% of their pipeline from biotech, the reliance on these partnerships has never been more critical. Biotech start-ups, driven by the quest to revolutionize healthcare, often face significant hurdles. Strategic partnerships with larger pharma companies, academic institutions, or research organizations can offer more than financial support—they bring shared vision, expertise, and resources to the table. This article by Joab Williamson and Alexander Spicer delves into the transformative potential of these partnerships. Learn how they serve as a driving force for innovation, helping biotech companies navigate the high-stakes landscape of drug development. 🔗Read the full article here: https://lnkd.in/gHyxnt-3 #Biotech #Pharma #Innovation #StrategicPartnerships #Healthcare #DrugDevelopment #R&D #Novartis #Biotechnology #Startups #MedicalScience #Collaboration #LifeSciences #ClinicalOperations #CorporateDevelopment