Contributing Editors
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Using Automation For Antimicrobial Screening
10/5/2023
A major challenge with antimicrobial drug development is the necessity to test millions of drug compounds in the hope of finding one that will kill a given microbial pathogen. Laboratories are using robotic machines and automated solutions to try growing previously unculturable organisms that might be sources of antimicrobial compounds — and these efforts are finding success.
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FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don’t Mistake It For An Enforcement Delay
10/4/2023
On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.
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FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology
10/3/2023
The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products. This guidance describes recommendations related to hepatic impairment, drug–drug interactions, assessing QTc prolongation risk, and more. The public comment period ends December 11, 2023.
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7 Improvements in Clinical Supply Chain Management Your CFO Will Love
10/2/2023
There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.
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FDA Gives More Time To Comply With Certain DSCSA Requirements
9/27/2023
To the relief of pharmaceutical companies and their trading partners, the FDA has paused enforcement of some Drug Supply Chain Security Act requirements. The agency warns that it's not an excuse to delay compliance.
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FDA Introduces Quality Management Maturity Program
9/26/2023
The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.
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How To Lose A Batch In 10 Days
9/25/2023
Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will not only save your batches but also improve the quality, efficiency, and reliability of your operations.
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Understanding The FDA’s Current Focus On Risk Evaluation And Mitigation Strategies
9/21/2023
The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.
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Risk Tool Selection With ICH Q9(R1) In Mind
9/19/2023
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
9/18/2023
If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.