概述
The FDA’s plan to phase out animal testing is a transformative step that paves the way for innovative, human-relevant preclinical approaches that are more predictive, efficient, and ethical. There is a long history at the FDA of using validated new approach methodologies (NAMs), including in silico tools and computational modeling as a framework for regulatory decision-making to support this transition effectively.
As a global leader in Model-Informed Drug Development (MIDD) strategies, Certara is ready to support the industry with a comprehensive offering of advanced modeling tools and development expertise that directly align with the FDA’s vision for the future of drug development.
Register for this webinar to learn how:
- Use of NAMs can be integrated into your development programs. Learn the opportunities and considerations for the reduction in animal testing in pre-clinical safety studies made possible by the FDA’s roadmap.
- PBPK and QSP models simulate monoclonal antibody behavior across diverse populations and disease states without relying on preclinical animal models.
- Pharmacometric and PK/PD analyses inform dose selection, optimize trial design, and reduce uncertainty in first-in-human studies thru late-stage development.
- Real-world evidence strategies complement modeling and simulation by providing context-rich insights into patient safety and efficacy, disease progression, and treatment outcomes.
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Senior Vice President, Certara Drug Development Solutions
从药物早期发现到报批和上市后，Fran 在全球战略性和运营性药物开发方面拥有超过 25 年的经验。她在战略性药物发现和开发方面拥有广泛的知识，尤其侧重于发展策略和模型引导的药物开发 (MIDD) 的应用。
Vice President, Regulatory Strategy, Certara
Geoff 拥有 20 多年的专业经验，在美国、欧洲、亚太地区（在日本、中国和韩国有深入的经验）和中东地区的监管和业务成就有目共睹。
SVP, Head of Simcyp PBPK Modeling Services
Hannah 在跨国药企深耕逾 20 年，尤其在 PBPK 和 PKPD 建模方面拥有深厚的背景。她在 PBPK/PKPD 建模和其他 DMPK 相关主题方面发表了 70 多篇论文，并通过建模与模拟技术深刻影响药物研发项目，积累了丰富的实践经验。
SVP, Translational Science, Certara
Dr. Patrick F. Smith 现任 Certara 转化科学高级副总裁，领导由药物开发科学家和监管策略专家组成的全球团队，致力于为客户创造全生命周期价值并加速患者获取药物。凭借逾 20 年的药物开发经验，Patrick 拥有药物开发各个阶段的工作经验，在传染病、肿瘤学和炎症，以及新颖的早期开发方案设计，乃至应用建模和模拟来解决关键开发问题方面都具有深厚的专业知识。
Senior Vice President and Head of Quantitative Systems Pharmacology
Piet van der Graaf 现任 Certara 高级副总裁兼 QSP 负责人，同时也是莱顿大学系统药理学教授。Piet 是 2013 - 2016 年莱顿药物研究学术中心的研究主任。1999 - 2013 年，Piet 在辉瑞公司的研发生物学、药代动力学和药物代谢、以及临床药理学等部门担任过多种领导职务。Piet 于2012 - 2018 年担任 CPT: Pharmacometrics & Systems Pharmacology 的创始主编，随后成为 Clinical Pharmacology & Therapeutics 的主编。Piet 曾在伦敦国王学院师从诺贝尔奖获得者 Sir James Black，接受了临床医学的博士培训。他曾获得 2024 年美国临床药理学与治疗学会（ASCPT）颁发的 Gary Neil 药物开发创新奖，同时也是国际定量药理学会（ISoP）2021 年领袖奖的获得者。Piet 是英国药理学会的当选委员，在定量药理学和药物开发领域发表了超过 200 篇同行评议的论文。
Marc has 25+ years of experience in Safety Pharmacology, Pharmacology, Pulmonary, Cardiovascular (hypertension, thrombosis, heart failure), inflammation, early and late nonclinical program design and execution. He is also a thought leader in cardiovascular risk assessment.
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