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日期: 2026 年 12 月 3 日, 星期四

时间: 11:00am - 12:00pm ET

概述

What can existing clinical trial evidence tell you about the potential of your next drug candidate, and how can you use that evidence to make better development decisions?

Join Certara experts Matt Zierhut and Roman Casciano to explore how publicly available clinical trial evidence, curated through CODEX Analytics and analyzed using model-based meta-analysis (MBMA), can provide quantitative insights to support drug development decisions.

See how CODEX helps teams identify relevant studies, explore treatment outcomes, compare therapies, and uncover evidence gaps. Learn how MBMA builds on that evidence to characterize treatment effects and dose-response relationships, benchmark treatment performance, and evaluate development scenarios.

Through real-world examples, Matt and Roman will show how these approaches can inform dose selection, clinical trial design, treatment differentiation, development strategy, and regulatory interactions. They will also discuss how CODEX, customized databases, and quantitative analyses can complement internal databases, AI-enabled curation, and data science capabilities.

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Key learning objectives:

  • How CODEX turns clinical trial evidence into curated, analysis-ready data.
  • How MBMA characterizes treatment effects, dose-response relationships, and development scenarios.
  • How these approaches can inform dose selection, trial design, and treatment benchmarking.
  • How MBMA can support regulatory interactions and evidence generation.
  • How external evidence can complement internal AI and data science capabilities.

Who should attend

This webinar is designed for professionals who use clinical trial evidence to guide development decisions, including:

  • Pharmacometrics and Quantitative Sciences: MBMA, PK/PD modeling, exposure-response analysis, and quantitative decision-making
  • Clinical Pharmacology and Clinical Development: Dose selection, trial design, treatment differentiation, and development strategy
  • Regulatory Affairs and Regulatory Science: Model-informed evidence generation, regulatory strategy, and quantitative justification
  • Biostatistics and Biometrics: Evidence synthesis, comparative effectiveness, and quantitative analysis
  • HEOR, Market Access, and Medical Affairs: Comparative evidence, treatment outcomes, and evidence generation planning
  • Data Science and AI: Clinical trial databases, AI-assisted curation, evidence integration, and advanced analytics
  • Therapeutic Area and R&D Leadership: Clinical development strategy, portfolio decisions, and evidence-based decision-making

演讲嘉宾:

Matthew Zierhut

Matt Zierhut, PhD MBA

Vice President, MBMA Capability Lead, Certara Drug Development Solutions

Matt 通过基于模型的荟萃分析(MBMA),推动已发表的临床结果数据融入开发决策及商业与监管策略。Matt 与临床开发团队密切合作,确保在做出最关键决策的时候,能利用 MBMA 发挥最佳影响力。

Roman Casciano

Roman Casciano, MEng

SVP, Evidence & Access

作为一名应用卫生经济学家和市场准入战略专家,Roman 亲自领导了数百项与产品价值展示相关的全球市场准入、HEOR 和真实世界证据方面的工作,并在与支付方和 HTA 机构的正式和非正式交流中积累了丰富的经验。

 

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