CLINICAL TRIALS ARTICLES

  • 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.

  • Ancient Molecule, Modern Medicine: The Science, Strategy, & Stakeholders Behind tRNA Therapeutics

    As we all know well, “unearthing” our molecules’ potential poses numerous technical and business-related challenges for young biotech companies. Here, Werner and I continue our conversation, unpacking some of these internal and external challenges the company is navigating as it strives to bring tRNA to the commercial market.

  • Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward

    Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.

  • Pictures At An [mRNA]Exhibition: What We Can Learn From Picasso (Pt. 1)

    In my presentation, I argued that there are several lessons we can learn from Picasso that will also help our own industry mature. In the upcoming weeks, I plan to unpack these lessons, highlighting specific instances in which I see our industry taking these lessons to heart and making progress — starting here with lesson 1: Being Innovative Comes After We Master The Basics

  • "Raiders Of The Lost Codon:" Alltrna On Evolving "Ancient" tRNA Into Therapeutics

    Here, in part one of this two-part article, we identify how tRNA stands apart from other RNA modalities and gene therapies, as well as how this molecule’s unique “skill set” is guiding the company’s future clinical strategy.

CLINICAL TRIALS VIDEOS

It goes without saying that achieving cell-specific delivery is the most often discussed challenge facing the RNA-LNP field near- and long-term. However, as these three LNP experts share in this Advancing RNA Live clip, they have a whole list of additional R&D and CMC priorities we must address/accomplish to improve RNA-LNPs’ efficacy in personalized and gene therapy approaches.

In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, that could jeopardize the success of a clinical trial.

Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.

In this Advancing RNA Live clip, BioNTech’s Ben Muir and Hopewell Therapeutics’ Kate Zhang share their perspectives on the most exciting novel screening methods, innovative preclinical models, and next-gen technologies they hope can/will eventually help us bridge the translation gap between preclinical models and the clinic.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS