Featured Editorial

31. 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.

32. 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.

33. 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.

34. 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

35. Engineering The Next Generation Of Lipid Nanoparticles For Advanced Therapeutics 6/10/2025

    Lipid nanoparticles (LNPs) face significant hurdles in clinical use due to challenges with their stability, manufacturing, and understanding how their complex characteristics impact therapeutic efficacy and safety.

36. A Guide To Designing mRNA Medicines 6/10/2025

    A poorly designed mRNA sequence can create ongoing difficulties during downstream clinical development and manufacture. Let's take a closer look at strategies and design software that you can employ.

37. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

    The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

38. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

39. Designing Our Way Toward Circular RNA Medicines With AI 5/21/2025

    The closed-loop structure of circular RNA can offer sustained, durable expression. We caught up with Sail Biomedicines' Kerry Benenato and Rajesh Ramaswamy to chat about ways to leverage AI for design/engineering.

40. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

    Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.