Industry Insights

  1. AI-Enhanced Clinical Project Management For Cell And Gene Therapy Clinical Trials 8/12/2025

    Consultant Jessica Cordes explores two of the most critical uses of AI for cell and gene therapy clinical trials: real-time patient journey coordination and predictive enrollment. 

  2. July 2025 — CDMO Opportunities And Threats Report 8/11/2025

    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.

  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. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  5. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  6. Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities 8/4/2025

    The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

  7. The Building Blocks Of A Robust Analytical Assay 8/1/2025

    Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

  8. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

  9. Accelerating NAMs For A Human-Based Future In CGT Development 8/1/2025

    The Complement-ARIE Consortium, led by FNIH’s Stacey Adam, Ph.D., is advancing the development, validation, and regulatory adoption of human-based new approach methodologies (NAMs) to transform preclinical testing and accelerate cell and gene therapy development.

  10. The Rise Of NAMs 7/31/2025

    New Approach Methods (NAMs) are rapidly being accepted as replacements for preclinical animal tests long considered to be the gold standard. NAMs include systems of organoids, organs-on-chips, AI-based prediction models, and non-mammalian species.