日期： 2025 年 7 月 24 日, 星期四
时间： 11am ET
Services: Modeling and Simulation, Drug Development
产品： Phoenix™
概述
A smarter, data-driven approach to QTc analysis can streamline your development timeline while minimizing costs and regulatory risk. Traditional strategies often rely on a one-size-fits-all solution—an approach that can either miss opportunities for simplified C-QTc analysis or underestimate the need for more robust analysis.
On the contrary, a stepwise strategy that begins with an exploratory concentration-QTc analysis can help chart a more efficient and cost-effective course. By pairing early insights into your data with program goals, you can determine whether to pursue a waiver, run a focused TQT analysis, or build a complex model only when truly necessary.
In this webinar, Certara experts will break down this approach and provide insight into how evolving regulatory expectations are shaping QTc evaluation
- Patrick F. Smith, PharmD – SVP, Translational Science
- Adekemi Taylor, PhD – VP, Regional Lead USA, Division 1, Quantitative Science Services
- Kara Schmelzer, PhD – Sr. Director, Consulting
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SVP, Translational Science
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。Patrick 此前曾联合创办了 d3 Medicine（被 Certara 于 2016 年收购），旨在帮助打造一家专门为复杂的开发计划提供战略支持的医疗公司。在创办 d3 Medicine 之前，Patrick 在 Roche 的美国临床药理学主管职位上任职超过 5 年。他在该公司的临床药理学和转化医学部门担任了多个职务，承担日益重要的职责。他一直是布法罗大学药学院兼罗斯威尔帕克癌症研究所的副教授。Patrick 已在各期刊上发表超过 125 篇同行评审的文章，其中包括曾在《新英格兰医学期刊》和《柳叶刀》上发表文章。他拥有加州大学旧金山分校的药学博士学位，并在杜克大学医学中心完成了临床住院医师培训。
VP, Regional Lead USA, Division 1, Quantitative Science Services
Dr. Taylor joined Certara in March 2011. She holds a PhD in Chemical Engineering from the Pennsylvania State University. Prior to joining Certara, she worked for four years as a Senior Research Pharmacokineticist at Merck Research Laboratories, West Point, PA where, she provided biopharmaceutic and Drug Metabolism and Pharmacokinetics department representation for several clinical development programs. At CSC, Dr. Taylor has led and been involved in multiple consultancy projects, performing population PK, PK/PD, efficacy and safety exposure-response, and concentration-QTc modeling to support regulatory filings, study design and general drug development. She has provided pharmacometric support across a variety of therapeutic areas, including oncology, HIV, diabetes, cardiovascular, neurology and immunology.
Sr. Director, Consulting
Dr Schmelzer is a Senior Director in Certara with over 20 years of experience in modeling and drug development. A PhD-qualified pharmacologist and toxicologist by training, she has worked as a clinical pharmacologist in biotech companies and has provided drug development consultancy to many large and small organizations. During her career she has developed, executed and managed clinical pharmacology plans, quantitative modelling and regulatory strategies in specific populations for both small molecules and biologics. Her projects reach across the drug development cycle (nonclinical, first in human through to approval). She has also led multi-functional project teams, and provided translational science leadership for projects in the early stages of clinical development involving novel mechanisms of action. She has extensive experience in translational PKPD, PBPK, C-QTc analysis, and Met ID across multiple therapeutic areas including cardiology, pulmonary, neuroscience, neuromuscular, and oncology.
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