What every developer should know to maximize BTD value by Dr. Jason Mercer, Ph.D., RAC and Strategic Program Innovator The Food and Drug Administration’s (FDA’s) Breakthrough Therapy Designation (BTD) program offers spons...
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...
Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products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...
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