Cell and Gene Regulatory
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Understanding Potency In Gene Therapy Development
2/28/2024
Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.
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Video Clips From Cell & Gene Live: 2024 Regulatory Outlook With FDA's Dr. Peter Marks And Dr. Nicole Verdun
2/27/2024
Our recent Cell & Gene Live, 2024 Regulatory Outlook With FDA's Drs. Peter Marks and Nicole Verdun, was a chock full of data and valuable information. I've broken down the full-length presentation into bite sized video clips that you can view at your convenience.
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FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions
2/27/2024
On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.
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Digital Solution For Unified QA And QC Processes
2/27/2024
Explore the features and benefits of a digital solution that enables the optimization of batch release testing, stability study execution, and environmental monitoring.
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Streamlining Change Control To Increase Efficiency And Compliance
2/27/2024
Here, we outline a holistic approach to streamline the change control process, aiming to increase efficiency and compliance, improve quality, and shorten time-to-market.
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5 Considerations When Licensing Cell Or Gene Therapy Products
2/27/2024
This article discusses some of the key issues that licensors and licensees should consider when negotiating and drafting cell or gene therapy license agreements.
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Developing A Comprehensive Regulatory Approach For LNP Drugs
2/26/2024
The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
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Mass General Cancer Center’s Dr. Genevieve Boland on Amtagvi Approval
2/26/2024
The FDA’s approval of Amtagvi addresses an unmet need in melanoma patient care. Here, Genevieve Boland, M.D., Ph.D., from Mass General Cancer Center shares her insight on the approval.
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Precision Radiopharmaceuticals with Ratio's Jack Hoppin, Ph.D.
2/21/2024
Multimodal approaches to the delivery of radiologically active compounds have created a fertile environment for players in the space to put on a precision medicine clinic, so to speak. What’s more, Radiopharmaceuticals create a unique business opportunity given the closely related and necessary companion diagnostic arena.
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Understanding And Navigating Diverse Regulatory Environments
2/21/2024
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.