Our Expert Network

1. Can America's Retreat On mRNA Be Europe's Opportunity? 8/28/2025

   With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.

2. Oligos Step Into The Spotlight: A Growing Force In Genetic Medicine 8/18/2025

   Oligonucleotide therapeutics are experiencing a new wave of momentum. As the science evolves and the market opportunity expands, the landscape is poised for continued growth and diversification.

3. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

   Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.