Welcome to Advancing RNA Live – An interactive forum to discuss the most important technologies and trends impacting the rapidly evolving field of RNA-based therapeutics.Throughout the year, our Chief Editor, Anna Rose Welch, will sit down with industry experts to discuss how biopharmaceutical companies address various challenges in RNA therapy development, including analytical, quality, manufacturing, and regulatory issues. These discussions often include Q&A sessions with attendees, and each Advancing RNA Live session will be archived and accessible at any time by registered site users.
OPENING THE “BLACK BOX” OF THE MRNA REGULATORY PARADIGM
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Opening The “Black Box” Of The mRNA Regulatory Paradigm
This Advancing RNA panel discussion covers the broad learnings therapeutics developers can (or can’t) adapt from the previously approved mRNA vaccine products, and what an “ideal” RNA therapeutics regulatory paradigm could look like
GOT RAW MATERIALS? THE STATE OF THE MRNA SUPPLY CHAIN
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Got Raw Materials? The State Of The mRNA Supply Chain
This discussion delves into how Advancing RNA can address concerns over the current “health” and availability of both small- and large-scale RNA therapeutics.
- The State of the Linear mRNA Supply Chain—In Brief
- Next-Generation RNA Modality Supply Considerations
- How Could saRNA & circRNA Simplify Manufacturing & Supply Chain Management?
- The 3 C’s Of mRNA-LNP Material Sourcing
- What’s In The Vial?! A [Brief] Meditation On Control Strategy
- Defining Phase-Appropriate GMP Principles: Where Do We Start?
- Crafting A “Durable” Partnership: A Two-Pronged Approach
- Why Our Conversations About Supply Chain Should NOT Overlook This Key Aspect
REVOLUTIONARY INCREMENTALISM FUTURE-PROOFING MRNA DRUG MANUFACTURING
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Revolutionary Incrementalism: Future-Proofing mRNA Drug Manufacturing
Industry experts share go-to best practices, suggestions, and experiences for prioritizing and streamlining technical operations endeavors to prepare mRNA therapeutics companies for the clinic and, eventually, the commercial market.
- Assessing The Manufacturability Of Prospective Lead mRNA Candidates
- How To Foster Greater R&D And CMC Integration In Your Organization
- The Current State Of The mRNA Supply-Chain — In Brief
- Is The IVT Reaction A Coy Mistress? The Knowns & Unknowns
- Considerations To Better Understand/Mitigate Raw Material Variability
- “Continuous Improvement:” Defining Your Purification Process & Product Specifications
- Thinking Differently About The Future Of mRNA Manufacturing
RISK REDUCTION IN MRNA THERAPEUTIC DEVELOPMENT
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Risk Reduction In mRNA Therapeutic Development
mRNA is at an inflection point. To reach its therapeutic potential in chronic, and even rare, disease applications, some biopharmaceutical manufacturing fundamentals must be addressed.
- Risk Reduction In mRNA Therapeutic Development: Meet The Panel
- Chromatography And Column-Free Processes
- Therapeutic Market Opportunities For mRNA
- Addressing Safety Risks In mRNA Therapeutics
- LNP Stability In mRNA Therapeutics
- mRNA Supply Chain And Critical Component Risks
- Novel Excipients Versus Active Substances And Inflammatory Response
- mRNA, TFF, And Next Steps To Tackle mRNA Therapeutic Challenges
MRNA UPDATE: BEYOND PROPHYLACTIC VACCINES
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mRNA Update: Beyond Prophylactic Vaccines
mRNA-based therapeutics are widely regarded as a “next big thing” in biopharma, but manufacturing them is fraught with complex challenges. Check out this digital event from Bioprocess Online Live featuring a discussion with mRNA process development experts on the front lines of the mRNA therapeutics revolution.
- mRNA Therapeutics: To The Liver, And Beyond!
- Maintaining Stability: How We’re Getting RNA Where It Needs To Go
- The Launch Pad: Why Platforms Matter For mRNA Therapeutic Development
- Paths To mRNA Degradation, And How To Mitigate Them
- Analytics & Assays: Defining mRNA Therapeutic Impurities Early & Often
- Optimizing mRNA Formulations In A Bottlenecked & Bifurcated Supply Chain
- Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want?
- What Indications Can, And Will, mRNA Therapeutics Address?
MAJOR TRENDS IN NEXT-GEN RNA ENGINEERING
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Major Trends In Next-Gen RNA Engineering
From tissue specificity to potency and durability, major trends in RNA are developing as the space continues to evolve at record-breaking speed. In June 2023, Cell & Gene Live welcomed Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics for a deep dive into how RNA can accelerate drug development and how the evolution in the scale-up production of novel engineering technologies impacts near- and long-term deployment of new therapies.
ADVANCEMENTS IN TARGETED MRNA DELIVERY
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Advancements In Targeted mRNA Delivery
mRNA has broad potential as a therapeutic. The clinical translation of mRNA therapeutics has been made possible through advances in the design of mRNA manufacturing and intracellular delivery methods. However, broad application of mRNA is still limited by the need for improved delivery systems.
LNPS & BEYOND: OPPORTUNITIES IN RNA DELIVERY
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LNPs & Beyond: Opportunities In RNA Delivery
The rapid development, scale-up, and successful commercialization of mRNA vaccines served as a great case study on the importance of mRNA/RNA therapeutics. For those striving to develop next-gen RNA therapeutics, achieving more specifically targeted non-viral delivery is a large hurdle to broadening their applicability, durability, and effectiveness.
About Anna Rose Welch
Anna Rose Welch is the editorial and community director of Advancing RNA. In this role, she is forging close relationships with the leading voices and organizations in the RNA industry. In addition to penning thought leadership articles and developing other creative forms of content on the evolving RNA industry, she hosts panel discussions and is an active participant in the RNA/ATMP conferences circuit.
Prior to entering the advanced therapies space, Anna Rose built a global editorial following as the Chief Editor of Biosimilar Development.
Over the past decade, her work in the biologics and advanced therapies spaces has taken her across the world to chair conferences, give presentations, moderate panel discussions, and serve on conference advisory boards. Most notably, she has been involved with the BioPhorum ATMP Conference, Phacilitate’s RNA Connect, the AGC CDMO Summit, the World Vaccine Congress, DIA Biosimilars Conference, and the U.S. Chamber of Commerce Annual Healthcare Summit. In 2018, the trade association Grupo FarmaBrasil invited her to Brazil where she addressed members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilar manufacturers on establishing national biologics and biosimilar policies.
In 2018, her first book of poetry, We, The Almighty Fires, was published by Alice James Books. She lives in Erie, PA, where she is a violinist in the Presque Isle Pro Musica chamber orchestra and an aspiring ballet dancer.
Connect with Anna Rose on LinkedIn:
https://www.linkedin.com/in/annarosewelch/