Outsourced Pharma Editorial

31. Why Your MES RFP Is Failing Before It Starts 5/6/2026

    Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

32. Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24 5/5/2026

    FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

33. Gaining An Edge In GLP-1 Production 5/5/2026

    The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

34. Kodak Flips The Script To Biopharma Manufacturing In Rochester 5/4/2026

    Well, that didn’t work out as planned, writes Chief Editor Louis Garguilo, referring to Kodak's plan in 2018 to revitalize the Eastman Business Park in Rochester, NY. The incoming chairman and now CEO, Jim Continenza, didn’t like that movie, and flipped the script. Instead, Kodak has, so to speak, returned to itself – back to a domestic specialty materials and chemicals supplier, intent on serving biopharma in that capacity.

35. How Generic Pharma Manufacturers Can Rebuild Margins Inside The Four Walls 5/4/2026

    The pricing dynamics for generic drugs turns formerly attractive products into high-volume, low-margin commodities. Lean and Six Sigma in four key areas can unlock efficiencies.

36. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

    This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

37. Making Mental Health Drugs: Promising Therapies And Manufacturing Challenges 4/30/2026

    Psychedelic therapies have shown promise in treating mental health disorders, but it will take close collaboration and cooperation of all related agencies and manufacturers to make this promise a reality.

38. Cell And Gene Therapy CDMOs: On The Path To $75 Billion in Services? 4/30/2026

    Cell and gene therapy (CGT) developers – and thus their service providers – have had their share of ups and downs. But what do the promise and uneven realities of these therapies add up to in the development and manufacturing outsourcing sector? According to a Towards Healthcare report, despite the bumps in the road, in 2025 the global CGT CDMO market grew to $8.2 billion. What of future predictions? Here's a detailed analysis.

39. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

    Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

40. Minimizing Regulatory Risk For Biologics Manufacturing Changes 4/29/2026

    Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.