RNA Clinical Trials

CLINICAL TRIALS ARTICLES

Developing Exosome-Based RNA Therapeutics For CNS Regeneration
Inside the effort to use exosomes as natural nanocarriers that deliver RNA therapeutics safely across the blood–brain barrier to heal damaged neural tissue.
Bridging RNA Innovation: A CEO's Guide To European Expansion
For RNA biotechs, Europe isn't just the next market — it's the ultimate test of strategy. Here's what CEOs need to know.
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy
In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
Reclaiming mRNA's Story: How U.S. Policy Upheavals Are Pushing Us To Adapt
I’d like to believe everyone reading Advancing RNA already knows that mRNA is the greatest. So, this article isn’t going to outline why the U.S. government’s current efforts to disparage mRNA are harmful. Rather, I’d like to focus on how these policies are impacting our industry in both positive and negative ways — starting with a few takeaways I gleaned from a discussion at RNA Leaders.
Translating An Early-Stage mRNA Therapeutic Into The Clinic
In the following Q&A, Ethris CMO Thomas Langenickel shares some of his biggest questions and observations about the evolving mRNA therapeutics space that are the most impactful in translating early-stage RNA candidates into the clinic — particularly when that drug product boasts a novel formulation.
5 Takeaways From The MHRA mRNA Guidance
Having read and reread the MHRA's guidance on personalized mRNA cancer immunotherapies, the following five takeaways will function somewhat as a mind-meld, combining a few of my own thoughts/takeaways with those of the MHRA.

CLINICAL TRIALS VIDEOS

From Crisis To Confidence: Ensuring Smooth Regulatory Submissions

Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.

PepGen's SVP Head Of Clinical Development On Delivery Of Oligonucleotide Therapies

PepGen, a Cambridge, MA-based biotech, is advancing oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases. SVP Head of Clinical Development Dr. Michelle Mellion explains PepGen's trial of PGN-EDO51, the company’s lead product candidate for the treatment of DMD patients whose mutations are amenable to an exon 51 skipping approach. She also explains how the delivery of oligonucleotide therapies differ from other techniques in genetic medicine, and much more.

Fly Fishing Meets mRNA | ARW On RNA Ep05

Hosted by Cell & Gene Collaborative Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 5, Welch dives into the separate — but strikingly similar — worlds of fly fishing and mRNA R&D. In particular, she explains how a fly fisherman’s strategies to catch a fish relate to the work of mRNA scientists as they strive to identify the most appropriate immunogenicity profiles for their mRNA vaccines or therapeutics.

RNA-Based Therapeutics With Nutcracker Therapeutics' Dr. Geoff Nosrati

Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker — the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

The Evolving RNA Landscape: Navigating Science, Strategy, And Global Markets

Learn how partnering with an experienced CRO can streamline development, reduce costs, and accelerate the delivery of RNA therapies to patients worldwide.
Five Questions Biotechs Should Ask Before Selecting A Bioanalytical CRO

In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional; it is essential to survival and success.
Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows

Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.
Why Bioanalysis Needs To Break Free From Manual Bottlenecks

Bioanalysis remains one of the most persistent bottlenecks in drug development, with CROs displaying inefficiencies that are no longer operational nuisances but strategic liabilities.
Navigating The Complexities Of Planning And Executing Multiregional Clinical Trials

Plan your first overseas study or expand an established pipeline; with the help of strategic insights to navigate complexities, maximize investment, and position new therapies for international success.
Why New Zealand Is Emerging As A Clinical Trial Hub

New Zealand is rapidly emerging as a premier destination for clinical research, offering a unique combination of regulatory agility, scientific expertise, and cost efficiency.
LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations

Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.

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