開催日: 2025年7月24日 (木曜日)
開催時間: 11am ET
関連ソリューション：Preclinical, Early Clinical, Late Clinical, Regulatory
関連ソフトウェア： Phoenixᵐᶜ
概要
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は、サターラのSVP, Translational Scienceです。医薬品開発科学者および規制戦略のグローバルチームを率いて、ライフサイクル全体を通じて顧客に価値を提供し、最終的には患者の医薬品へのアクセスを支援しています。Patrickは20年を超える医薬品開発の経験を持ち、医薬品開発の全段階にわたり取り組んできました。特に感染症、腫瘍学、炎症の他、新規の早期開発プログラムの設計、またモデリングとシミュレーションを応用して重要な開発プロブラムを解決するための専門知識を有しています。Patrickは元々、複雑な開発プログラムに対する戦略的サポートの提供に特化したヘルスケア企業づくりに尽力するd3 Medicine (サターラが2016年に買収) の共同創業者でした。d3 Medicine以前には、RocheでU.S. Clinical Pharmacology Leadを5年以上務め、臨床薬理とトランスレーショナル・メディシンの分野でさまざまな役割を担い、より大きな責務を果たすようになりました。また、ニューヨーク州バッファローにあるUniversity at Buffalo School of PharmacyとRoswell Park Cancer Instituteでは、准教授も務めました。Patrickは、New England Journal of MedicineやLancetなどの学術誌に、125件を超える査読付き論文を発表しています。He holds a PharmD from the University of California, San Francisco and completed his clinical residency at Duke University Medical Center.
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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