Accelerating Gene Therapy Success: From Vector Development to Scalable Manufacturing and Clinical Execution
Webinar - 2026년 7월 7일(화) 오후 2시
Accelerating Gene Therapy Success: From Vector Development to Scalable Manufacturing and Clinical Execution
- 2:00 – 2:30 From Design to Delivery: Scalable RUO Viral Vectors for Non-clinical Success
- 2:30 – 3:10 Transforming rAAV Manufacturing Economics: Cost-Reduction Considerations Through Scalable High-Throughput Development and Manufacturing
- 3:10 – 3:40 One Shot, Many Challenges: Clinical Operations in AAV Gene Therapy
유전자치료제 개발은 혁신적인 벡터 설계에서 시작하여, 효율적인 제조 공정 구축과 성공적인 임상 운영으로 이어지는 복잡한 여정을 포함합니다. 특히 바이럴 벡터 기반 유전자치료제는 연구 단계의 벡터 개발부터 상업화를 고려한 제조 전략, 그리고 환자에게 실제 치료를 전달하기 위한 임상 실행 역량까지 전 과정에 걸친 통합적인 접근이 요구됩니다.
이번 웨비나에서는 Thermo Fisher Scientific의 전문가들이 연구용(RUO) 바이럴 벡터 개발 및 생산, 비용 효율적인 AAV 제조 전략, 그리고 AAV 유전자치료제의 임상 운영 과정에서 직면하는 주요 과제와 해결 방안을 공유합니다. 벡터 개발, 제조 공정 최적화, 임상 운영에 이르는 유전자치료제 개발의 핵심 단계별 인사이트를 통해 성공적인 개발 및 상업화를 위한 실질적인 전략을 확인할 수 있습니다.
연구 단계에서 임상 단계까지, 유전자치료제 개발 전 주기를 아우르는 최신 트렌드와 실질적인 실행 전략을 만나보시기 바랍니다.
Session 1: From Design to Delivery: Scalable RUO Viral Vectors for Non-clinical Success
- Speaker: Julia Braun, Viral Vector Production Service Lead, Thermo Fisher Scientific
- Comprehensive support spanning initial plasmid design, construct optimization, and final high-quality viral vector production.
- Versatile manufacturing volumes tailored for Research Use Only (RUO) applications through rigorous non-clinical studies.
- Custom viral vectors built utilizing optimized Gibco™ LV-MAX™ Lentiviral production system and AAV-MAX Helper-Free AAV production system to deliver high transduction efficiency across hard-to-transfect cells and robust in vivo animal models
Session 2: Transforming rAAV Manufacturing Economics: Cost-Reduction Considerations Through Scalable High-Throughput Development and Manufacturing
- Speaker: Ian Goodwin, Director, Technical program design, Pharma Services, Thermo Fisher Scientific
- Why current viral vector manufacturing costs remain a barrier to broader patient access
- How high-throughput development can improve yields and lower COGs
- Key considerations for developing commercially sustainable AAV manufacturing processes
Session 3: One Shot, Many Challenges: Clinical Operations in AAV Gene Therapy
- Speaker : Kim Watanabe, Global Head, Cell and Gene Therapy, Thermo Fisher Scientific
- Critical operational challenges in AAV gene therapy trials from patient enrollment through post-treatment monitoring.
- Best practices for managing site activation, product logistics, and cross-functional stakeholder coordination in global studies.
- Lessons learned and future approaches to enhance efficiency, compliance, and patient experience in gene therapy clinical programs.
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