Date: Thursday, July 24, 2025
Time: 11am ET
Solutions: Preclinical, Early Clinical, Late Clinical, Regulatory
Services: Modeling and Simulation, Drug Development
Products: Phoenix™
Overview
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 is SVP, Translational Science, Certara, where he leads a global team of drug development scientists and regulatory strategy that creates value for clients across the entire life cycle and ultimately accelerates patient access to medicines. With more than 20 years of drug development experience, Patrick has worked across all phases of drug development with deep expertise in infectious diseases, oncology, and inflammation as well as novel early development program design and applying modeling and simulation to solve critical development problems. Previously, Patrick was co-founder of d3 Medicine (acquired by Certara in 2016), helping to build a healthcare company that specialized in providing strategic support for complex development programs. Prior to d3 Medicine, Patrick was U.S. Clinical Pharmacology Lead at Roche for more than 5 years, where he worked in various roles of increasing responsibility in clinical pharmacology and translational medicine. He has served as an Associate Professor at the University at Buffalo School of Pharmacy and Roswell Park Cancer Institute in Buffalo, NY. Patrick has published more than 125 peer-reviewed articles in journals, including the New England Journal of Medicine and Lancet. 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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