ARW ON RNA
Fortunately, as multiple presenters during the AGC CDMO Summit explained, there have been a few historical case studies of how the industries preceding us did (or didn’t quite) do the due-diligence they should have to trigger meaningful societal change. Not only do these case studies provide a few tactical pointers for those of us in the mRNA/RNA therapeutics space, I also think they can be particularly instructive in helping us craft/finetune mRNA’s value proposition.
OUR EXPERT NETWORK
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Emerging Partnership Trends In Oligo-Based Medicines
The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.
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Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.
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Tune Therapeutics On Clinical Readiness, Technology Adoption
Heidi 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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How Platform Technologies Are Shaping The Gene Therapy Landscape
Leading 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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A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies
This 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.
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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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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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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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
- 11.06.24 -- Mastering mRNA Manufacturing: A Focus On Raw Materials & Supply Assurance
- 10.31.24 -- Navigate Regulatory Landscapes In Your mRNA Drug Development
- 10.31.24 -- Key Considerations For Aseptic Filling
- 10.30.24 -- A "Flight Plan" For Achieving These 3 mRNA Development Milestones
- 10.28.24 -- Nanoparticle Enabled Formulation And Drug Delivery Solutions
- 10.24.24 -- Are We Really Living In An mRNA Regulatory "Desert"?