Whitepapers The Basics of the Individual Expanded Access Request Process: A Resource for Physicians Read More about The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
Blog Posts Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial” Read More about Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”
News & Events [Video] Institutional Biosafety Committee Review: Strategies to Secure Rapid IBC Approval for Human Gene Transfer Trials Read More about [Video] Institutional Biosafety Committee Review: Strategies to Secure Rapid IBC Approval for Human Gene Transfer Trials
Blog Posts Four Key Elements You Need to Know About the Role of IBCs in Gene Therapy Trials Read More about Four Key Elements You Need to Know About the Role of IBCs in Gene Therapy Trials
News & Events [Webinar] IRB and IBC Required Approvals in Gene Therapy: Addressing Challenges in a Growing Market Read More about [Webinar] IRB and IBC Required Approvals in Gene Therapy: Addressing Challenges in a Growing Market
Ask the Experts As a sponsor, does my HGT clinical trial require IBC approval at all sites? Read More about As a sponsor, does my HGT clinical trial require IBC approval at all sites?
Ask the Experts Does Human Gene Transfer research at my site require IBC approval? Read More about Does Human Gene Transfer research at my site require IBC approval?
Ask the Experts How should we handle financial conflicts of interest in FDA-regulated clinical trials? Read More about How should we handle financial conflicts of interest in FDA-regulated clinical trials?
Whitepapers Ethical and Biosafety Oversight of Gene Transfer Clinical Research: What Sponsors and CROs Need to Know Read More about Ethical and Biosafety Oversight of Gene Transfer Clinical Research: What Sponsors and CROs Need to Know