Guest Columns
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What Time Is Best To Bring My CDMO On Board?
4/17/2024
The answer might be sooner than you think and entail more transparency than you're used to.
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Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
4/17/2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
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Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
4/16/2024
Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.
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Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
4/12/2024
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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AI Is Unearthing New Drug Candidates, But It Still Needs Human Oversight
4/11/2024
AI can accelerate timetables and minimize wasted resources by analyzing vast amounts of data, but human oversight is necessary to address the limitations and biases of AI systems.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
4/10/2024
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
4/9/2024
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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Digitizing CMC Knowledge Management
4/8/2024
Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.
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Managing Supply Chain Risks Using Relational Risk Analysis
4/5/2024
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
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When Does GMP Matter In Non-GMP Settings?
4/5/2024
Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.