Cell and Gene Therapy Archives

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

Certara2025 年 11 月 10 日

新闻报导

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

Explore the top challenges in cell & gene therapy commercialization, featuring expert insights from Fran…

Certara2025 年 9 月 12 日

Blog

Dose Optimization using the Gene Therapy Virtual Twin® Platform

This blog explains how using the Gene Therapy Virtual Twin® Platform can help optimize dosing…

Certara2025 年 9 月 9 日

Video

Gene Therapy: A Transformative Shift in Rare Disease Treatment

After decades of promise, gene therapy is finally starting to deliver on its potential—especially for…

Certara2025 年 2 月 26 日

Press Coverage

2025 cell and gene challenges: Scalability, supply chain and manufacturing

Explore insights on 2025 challenges in cell and gene therapy, including commercial viability, with expert…

Certara2025 年 2 月 3 日

Blog

CMS 细胞与基因治疗（CGT）准入模式详解：你从未听说过的最重要的药品定价立法

2024 年 12 月 13 日 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…

Certara2024 年 12 月 13 日

Publication

Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper

The promise of viral vector-based gene therapy (GT) as a transformative paradigm for treating severely…

Certara2023 年 6 月 14 日

On-Demand Webinar

基因疗法治疗罕见病的希望与陷阱

The state of gene therapy faces much uncertainty as recent regulatory and clinical setbacks have…

Certara2021 年 4 月 29 日

Case Study

基因治疗临床试验设计中的早期价值评估

A global biotechnology company engineering precision genetic medicine for rare diseases was in need of…

Certara2021 年 2 月 12 日

细胞和基因治疗

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

Dose Optimization using the Gene Therapy Virtual Twin® Platform

Gene Therapy: A Transformative Shift in Rare Disease Treatment

2025 cell and gene challenges: Scalability, supply chain and manufacturing

CMS 细胞与基因治疗（CGT）准入模式详解：你从未听说过的最重要的药品定价立法

Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper

基因疗法治疗罕见病的希望与陷阱

基因治疗临床试验设计中的早期价值评估

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