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Cell and Gene Therapy

Leveraging Breakthrough Therapy Designation (BTD) for Gene Therapy Development: Key Lessons from a Case Study

by Dr. Jason Mercer, Ph.D., RAC and Strategic Program Innovator FDA’s Breakthrough Therapy Designation (BTD) program offers sponsors a powerful opportunity to expedite development of promising therapies for serious or life-thr...

July 7, 2025 | Blog, Cell and Gene Therapy

Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products

By Dr. Jason Mercer, Ph. D., RAC, Strategic Regulatory Innovator The world of cellular and gene therapy (CGT) is advancing rapidly, with new technologies offering transformative potential for patients facing serious and rare co...

February 21, 2025 | Cell and Gene Therapy

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Cell and Gene Therapy

Leveraging Breakthrough Therapy Designation (BTD) for Gene Therapy Development: Key Lessons from a Case Study

Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products

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