CLINICAL TRIALS ARTICLES
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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.
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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.
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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.
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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
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"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.
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Learning From Oligos: Delivery & Clinical Strategies For mRNA Therapeutics
Those of us who attended the Alliance for mRNA Medicines’ inaugural Ascent conference last fall had the opportunity to hear from Zdravka Medarova of TransCode Therapeutics on her experiences working in the oligo sector. Here, I summarize some of her learnings and/or suggestions for the encoding RNA field as we set out to develop mRNA therapeutics for oncology.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.
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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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Delve into the evolving in-vivo CAR therapy landscape, examining key technological innovations, major industry players, recent clinical progress, and regulatory developments.
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In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.
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Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.
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Many clinical trial oversight problems can be avoided or mitigated by sponsor understanding root causes and being a proactive collaborator with its partners.
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Enabling sites to focus solely on critical data facilitates faster data entry, reduces queries, and fosters better relationships between sponsors, CROs, and sites.