ARW ON RNA
A "Flight Plan" For Achieving These 3 mRNA Development Milestones
Here, in the final installment of this three-part series, I’ll share the panelists’ greatest learning experiences and regulatory advice (so far) on what we should be looking out for as we strive to achieve three big milestones: Entering the clinic; implementing advanced manufacturing technologies into our processes; and standardizing our manufacturing platforms.
OUR EXPERT NETWORK
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![Decisions ahead road sign-GettyImages-1131216270]( "Tune Therapeutics On Clinical Readiness, Technology Adoption")
Tune Therapeutics On Clinical Readiness, Technology AdoptionHeidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.
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![GettyImages-1480892977-doctor-gene-dna-brain-lungs-heart]( "How Platform Technologies Are Shaping The Gene Therapy Landscape")
How Platform Technologies Are Shaping The Gene Therapy LandscapeLeading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.
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![image001-(5)]( "A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies")
A Phase-Appropriate Approach For Assay Validation In Cell & Gene TherapiesThis article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities.
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![DNA Code-GettyImages-165657815]( "EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides")
EMA Issues Draft Guideline On The Development And Manufacture Of OligonucleotidesThe EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.
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![bottle and syringe serum drug-GettyImages-1337025915]( "This Digital Twin Approach Aims To Optimize ATMP Production")
This Digital Twin Approach Aims To Optimize ATMP ProductionManufacturing therapeutic cells includes labor-intensive processes. These researchers are developing a way to increase yields through cost-effective expansion protocols.
WEBINARS
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!
ARW ON BUSINESS OF BIOTECH
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![24_01_BoB_1280x720_Ep217]( "Pivoting To RNA With Circio's Dr. Erik Digman Wiklund")
This week, it’s another “Business of Biotech-meets-Business-of-RNA” takeover with Circio CEO Erik Digman Wiklund, Ph.D. and guest co-host Anna Rose Welch of Advancing RNA. While Circio’s legacy is in cancer immunology (it still boasts a cancer vaccine candidate targeting KRAS driver mutations), the company made a bold pivot, of sorts, when it committed headlong to the circular RNA future. Now, it’s in the throes of fine-tuning a platform for the development of novel circRNA medicines for rare disease, vaccines, and cancer.
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![24_01_BoB_1280x720_Ep216]( "mRNA Upstarts With Radar Therapeutics' Sophia Lugo and Eerik Kaseniit, Ph.D.")
Guest co-host Anna Rose Welch of Advancing RNA fame joins us on this week’s Business of Biotech podcast for a conversation with the leaders of RNA upstart Radar Therapeutics. The company’s co-founders, Eerik Kaseniit, Ph.D. (CSO & President) and Sophia Lugo (CEO), are making waves in the mRNA therapeutics space on the heels of the invention of a precision-expressed mRNA technology that laid bare the path to Radar’s inception.
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![24_01_BoB_1280x720_Ep199]( "Circular RNA with Orna Therapeutics' Tom Barnes, Ph.D. and Advancing RNA's Anna Rose Welch")
As if Orna Therapeutics' CEO, Thomas Barnes, isn't enough to draw you in to the Business of Biotech, we teamed up with Advancing RNA Editorial & Community Director Anna Rose Welch to co-host this week's episode. Together, Anna Rose and I press Dr. Barnes on his transition from academia to biotech, the therapeutic proposition of circular, or "O", RNA and why it holds great potential to best linear RNA constructs, the novel, platform- and partnership-based approaches Orna is taking to address B-cell lymphomas and Duchenne Muscular Dystrophy, viral vector and lipid nanoparticle complexity, and a whole lot more.
VIRTUAL EVENTS
- From Bottleneck To Breakthrough: Reimagining The mRNA Therapeutics Supply Chain
- 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
NEWSLETTER ARCHIVE
- 10.17.24 -- Resources For Trouble-Free Validation
- 10.16.24 -- Shifting Scales: Considerations For Small-Scale mRNA Production
- 10.09.24 -- Tips For Addressing Vaccine Demand – No Matter Your Therapeutic Background
- 10.09.24 -- One Unspoken Issue With FDA's Platform Designation
- 10.02.24 -- FDA's Platform Guidance Raises Questions For mRNA Makers
- 09.26.24 -- Industrializing mRNA Therapeutics