QSP modeling solutions for cost-effective clinical development

Discover how an IO-focused company developing immunotherapies applied QSP modeling solutions for cost-effective clinical development.

CDR-Life is a biotechnology company developing T-cell engagers (TCE) across a broad range of targets and solid cancers. The company is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC).

解决方案

Early Clinical, Discovery

Therapeutic specialty

肿瘤学

Products

定量系统药理学软件

"A crucial factor for us in choosing Applied BioMath as our partner was their expertise, flexibility, and clear communication of how our preclinical data can support the QSP approach. That was a key part of our decision. We appreciate their dedication in helping meet our timelines.”

Melissa Vrohlings, Translational Science Leader at CDR-Life

Overcoming Challenges Using Expert Solutions

CDR-Life sought to establish the initial dosage for human trials and identify the therapeutic dose range using data from their preclinical studies.

Challenge

A key objective for CDR-Life was to select an appropriate first-in-human starting dose that would be high enough to potentially demonstrate efficacy, minimizing the need for extensive dose escalation cohorts before reaching the efficacious dose range.

解决方案

Applied BioMath* developed a QSP model based on preclinical data and knowledge of human disease. This model was used to support the starting dose selection which led to a higher starting dose than determined using a traditional MABEL approach and was approved by regulatory agencies.

“你们用来支持我们项目的 QSP 建模和临床药理软件包对我们研究的成功起到了至关重要的作用。您为项目注入的深厚专业经验与耐心具有变革性意义，助力我们打造出针对 T 细胞衔接器的尖端开发项目。基于 QSP 推导的起始剂量使临床试验得以采用更高剂量水平，且我们欣然宣布该剂量已获候选药物 CDR404（领先的 T 细胞衔接器）的新药研究申请（IND）及初步临床试验申请（CTA）批准。我们期待着利用真实患者数据更新 QSP 模型，并保持与 Applied BioMath 公司的持续合作。

Swethajit Biswas, Chief Medical Officer at CDR-Life

Impact

Thought-Leadership

Applied BioMath provided subject matter expertise and provided the rationale for the QSP approach, supporting the client’s overall development and dose justification for their IND submission.

Responsiveness to Client’s Needs

Applied BioMath’s team exhibited the flexibility to accommodate the client’s requests and meet CDR-Life’s tight timelines. This allowed the client to explore their questions throughout the project

Cost and Time Savings in the Clinic

Our innovative approach using QSP modeling allowed CDR-Life to start trials with a higher starting dose, which resulted in the need for fewer patients in trials, shortened the trial duration, and provided cost savings in their clinical development stages.

Development Driven by Forward Thinking

On a strategic level, the incorporation of QSP approaches to CDR-Life’s development program underscored its innovation and cutting-edge technologies to help accelerate the drug development process.

Fei Hua, VP, Modeling and Simulation Services

Explore more QSP chronicles

*Applied BioMath was acquired by Certara in Dec 2023

系统建模在临床开发中显著提升效率并降低成本

Overcoming Challenges Using Expert Solutions

Challenge

解决方案