Industry Insights

1. Amgen Bets On Agility In The Age Of AI 6/13/2025

   The company is speeding up process optimization with tools like predictive analytics, digital twins, and generative AI copilots.

2. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

   The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

3. Navigating Data Management Requirements For Sterile Manufacturing 6/11/2025

   Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.

4. The Promise Of Focused Ultrasound For AAV Gene Therapy Delivery 6/11/2025

   Dr. Bernie Owusu-Yaw, a research fellow at Brigham and Women’s Hospital and Harvard Medical School, is pioneering a promising gene therapy approach that combines focused ultrasound with novel AAV capsids to safely and effectively deliver therapeutics across the blood-brain barrier, offering new hope for treating challenging neurodegenerative diseases.

5. 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.

6. 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.

7. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

8. Demystifying The Common Technical Document For Global Submissions 6/5/2025

   The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.

9. The Hidden Risk In Cell & Gene Therapy Commercialization 6/5/2025

   Of the root causes of new product launch failure, insufficient relative advantage is by far the most important. Let's take a closer look at lessons we can learn from two key (approved) cell therapies.

10. May 2025 — CDMO Opportunities And Threats Report 6/4/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.