Drug Development for Gene Therapy 1st Edition

Drug Development for Gene Therapy, 1st Edition by Yanmei Lu is an authoritative, practical guide for scientists, clinicians, and biopharma professionals navigating the complex path from concept to clinic. Clear, concise, and expertly organized, this book blends cutting‑edge science with real‑world drug development strategy to equip readers with the tools needed for successful gene therapy programs.

Inside, readers will find in‑depth coverage of vector design and delivery systems, preclinical evaluation, safety and biodistribution, CMC and GMP manufacturing considerations, regulatory strategies across major regions (US, EU, Asia), and clinical trial design. Case studies and translational insights illuminate common pitfalls and best practices, making this an essential reference for anyone involved in gene therapy research, translational science, or regulatory affairs.

Whether you’re leading a start‑up program, contributing to an academic lab, or managing clinical development at a pharmaceutical company, Yanmei Lu’s practical explanations and strategic frameworks help accelerate decision‑making and reduce development risk. The writing balances technical rigor with clear guidance, making complex topics accessible without sacrificing depth.

Perfect for professionals and advanced students seeking a single, reliable resource on gene therapy drug development, this 1st edition offers a global perspective tailored to today’s regulatory and manufacturing realities. Add Drug Development for Gene Therapy by Yanmei Lu to your professional library to sharpen your development strategy and advance promising therapies from bench to bedside. Order now to stay ahead in the rapidly evolving field of gene therapy.

Note: eBooks do not include supplementary materials such as CDs, access codes, etc.