Cell and Gene Regulatory
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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.
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Alofisel P3 Cell Therapy Facility
2/21/2024
Despite various issues with a client's CQV project, CAI delivered the project on time and significantly contributed to the delivery of the first ATMP facility in Ireland.
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Proven Vial Containment That Scales From R&D To Commercial
2/20/2024
Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
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Optimizing Process Loads For VHP Decontamination
2/20/2024
Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.
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Implementing A Risk-Based Approach To Calibration
2/20/2024
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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Remote Regulatory Assessments Q&A
2/20/2024
Explore what Remote Regulatory Assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of non-compliance.