Featured Editorial

41. All Of Us Need To Be Rooting For The FDA 7/23/2025

    In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

42. Ancient Molecule, Modern Medicine: The Science, Strategy, & Stakeholders Behind tRNA Therapeutics 7/22/2025

    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.

43. Tales From The Trenches: Developing Potency Assays Outside Big Pharma 7/18/2025

    Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.

44. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

    Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

45. Enzymatic Ligation: The Next Chapter In siRNA Manufacturing 7/11/2025

    During my three days at TIDES, I sat through several talks about the industry’s progress toward enzymatic ligation approaches for siRNA manufacturing. In the following article, I’ll share a few of the biggest takeaways I garnered from these different presentations, with a particular focus on the efficiencies the industry hopes such efforts unlock in the long-term. 

46. RNAi vs. mRNA: Two Therapies, Two CDMO Strategies 7/8/2025

    The biotech industry is often described in grand dichotomies such as innovator vs. generic, small vs. large molecule, or clinical vs. commercial. These differentiators influence development and manufacturing, CDMO selection and outsourcing strategies. There are also nuanced pairings, such as mRNA vs. RNAi.

47. 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies 7/3/2025

    The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

48. Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward 6/27/2025

    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.

49. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

    Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

50. Pictures At An [mRNA]Exhibition: What We Can Learn From Picasso (Pt. 1) 6/20/2025

    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