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Advancing RNAAdvancing RNA is a Life Science Connect community focused on the rapidly evolving field of RNA-based therapeutics. It aims to provide valuable insights, discussions, and resources for professionals developing RNA-based drugs. Primary members of the community consist of individuals from biopharma organizations engaged in pre-BLA development, often in the pre-IND discovery stage. The community addresses various challenges in RNA therapy development, including analytical, quality, manufacturing, and regulatory issues. Additionally, Advancing RNA is positioned within the broader Life Science Connect network, allowing members to access additional resources as needed for their RNA therapy development journey.Advancing RNA Get more Advancing RNA insight with our FREE newsletter sign me up Log In or Subscribe Analytical/Quality Manufacturing Formulation Outsourcing Clinical Trials Supply Chain Listen & Watch Advancing RNA Live ARW ON RNA FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers As I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development. Two "Spicy" Takeaways On The FDA's Platform Designation Guidance Is This The Hardest Question Facing mRNA Therapeutics Makers? Translatability: The Challenge Keeping mRNA Therapeutics Execs Up At Night More From ARW on RNA OUR EXPERT NETWORK FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers As I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development. Great siRNA Science Or Savvy Business Acumen? You Need Both Silence Therapeutics has two wholly owned siRNA therapies now in clinical trials and one partnered program with AstraZeneca. Silence's CEO discusses the need for good science, making smart business decisions, and cultivating partnerships. Developing & Manufacturing Oligonucleotides: An Overview An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides. A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development.  Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream. More From Our Expert Network WEBINARS Maximize Quality Assurance Through Rapid Sterility Testing Managing Freeze And Thaw Applications: Single-Use Containers Vs. Bottles Evolving Into Biopharma 4.0: A Stepwise Journey Of Digital Transformation Building An Effective Contamination Control Strategy For Final Sterile Filtration Train Biomanufacturing Operators More Efficiently With Blended Learning Accelerate Process Development With HTS Chromatography Tools Deciphering mRNA Immunogenicity: Early Assessment Of Human Immune Response How To Value Automation With The Return On Invested Capital Model More From Webinars Get the latest articles from Advancing RNA delivered to your inbox. I agree to the Terms. I agree to the Privacy Statement. SIGN ME UP MEET ARW I’ve spent the past 10 years building relationships across the biologics and advanced therapies industry. In addition to hosting conversations and writing thought leadership articles, my goal as the editorial and community director for Advancing RNA is to find creative ways for the RNA (and broader ATMP) space to discuss, debate, and ultimately define a mature RNA therapeutics industry.     Start the conversation by following me on LinkedIn! FREE EBOOK: MODERNA'S REGULATORY JOURNEY This collection of articles tells the story of how Moderna brought one of the first mRNA vaccines to the market and has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. VIRTUAL EVENTS Can We Do Better? Current & Future Realities of mRNA Process Development Opening The “Black Box” Of The mRNA Regulatory Paradigm Got Raw Materials? The State Of The mRNA Supply Chain mRNA For Cancer Immunotherapy: 2024 Outlook mRNA Update: Beyond Prophylactic Vaccines Risk Reduction In mRNA Therapeutic Development More Virtual Events NEWSLETTER ARCHIVE 09.11.24 -- Is This The Hardest Question Facing mRNA Therapeutics Makers? 09.04.24 -- Why Bridge RNA Is Taking The RNA Space By Storm 08.28.24 -- The RNA Challenge Keeping RNA Execs Up At Night 08.26.24 -- Solutions For mRNA And Nanoparticle Manufacturing 08.21.24 -- Innovation Advances In mRNA Medicine 08.21.24 -- Simplifying Preclinical Development And Scale Up Of Lipid Nanoparticles More Newsletters This website uses cookies to ensure you get the best experience on our website. Learn more Got it! 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