ARW ON RNA

Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.
OUR EXPERT NETWORK
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
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Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And Manufacture
No matter how you approach it, mRNA manufacturing is expensive. The raw materials, technologies, and educated labor force require immense investment. To avoid incurring extra costs and to ensure your strategy is precise and risk averse, identify an experienced partner that prioritizes communication and first-time-right manufacturing.
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How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do
Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.
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What Happens If The National Cancer Institute Loses Funding?
The National Cancer Institute is operating under a continuing resolution that maintains funding at the FY 2024 level of $7.22 billion. But when adjusted for inflation, it effectively reduces the real value of research dollars. So what are the consequences?
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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In close partnership with Johns Hopkins and TriLink BioTechnologies, Jeff Coller, Ph.D. and Michelle Kim, Ph.D. have built a sandbox for RNA developers and aspirational RNA business builders to play in. On this week's episode of the Business of Biotech, we team up once again with Advancing RNA's Anna Rose Welch to learn about the venture, dubbed the Johns Hopkins University RNA Innovation Center.
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Dr. Tal Zaks joins the Business of Biotech for the second part of "Story Time With Tal," discussing his transition from Moderna's CMO during the COVID-19 pandemic to co-founding Exsilio Therapeutics, an mRNA startup. The episode explores Exsilio's foundation, scientific focus, team recruitment, and its $82 million Series A funding led by Novartis Venture Fund and Delos Capital, with support from prominent investors like OrbiMed, CRISPR Therapeutics, and J.P. Morgan Life Sciences Private Capital.
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Tal Zaks, M.D. was Chief Medical Officer at Moderna before, during, and immediately following the company's headline role during the COVID pandemic. If that doesn't pique your interest about the stories he can tell, this episode of the Business of Biotech surely will. Tune in to the first installment of this two-part episode for insight from the early days of mRNA that you probably haven't heard before.
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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
- The "Tides" Have Changed: Outsourcing Oligos And Peptides
- Accelerating mRNA-LNP Development: A Deep Dive Into Analytical & Manufacturing Technology Innovation
- A Deep(er) Dive Into The mRNA/RNA-LNP Outsourcing Paradigm
- Navigating The Outsourcing Paradigm For RNA Modalities
- Achieving Next-Generation mRNA-LNP Therapeutics Delivery
- From Bottleneck To Breakthrough: Reimagining The mRNA Therapeutics Supply Chain
NEWSLETTER ARCHIVE
- 04.23.25 -- Establishing Analytical Methods For mRNA-Based Therapies
- 04.21.25 -- Bringing Your mRNA-Based Drug From Pre-Clinical To Commercial
- 04.16.25 -- Britney Spears/ Take On mRNA Platform Analytics
- 04.10.25 -- Navigating Clinical Trial Trends In 2025
- 04.09.25 -- Is The mRNA Payload The Real MVP Of Targeted Delivery?
- 04.02.25 -- Understanding The New MHRA Guidance For mRNA Immunotherapies