This roundtable discussion covers practical and technical considerations to assess before starting a First-in-Human (FIH) clinical trial. To kickstart the discussion, a short presentation on some of the different model-independent and model-based approaches to determining FIH dose is presented.
The panel discussion covers costs, timelines, and data needs surrounding different types of approaches for selecting FIH doses and will provide some context on different ways to identify the appropriate method as it relates to larger drug development milestones.
At the end of this roundtable discussion attendees should have a better understanding of:
- Costs and timelines associated with determining FIH doses
- Model independent and model-based approaches to FIH doses
- Dose selection for initial toxicology studies
- Considerations for FIH doses depending on different routes of administration, molecule type, or indication
Meet the Panelists & Moderator
Mark A. Bush, Ph.D.
Vice President, Clinical Pharmacology & Pharmacokinetics
Dr. Bush has over 20 years of experience in clinical pharmacology and pharmacokinetics with a particular focus in clinical pharmacology study design and interpretation. His therapeutic concentrations include endocrinology and metabolism in early phases of development. Dr. Bush has worked on hundreds of PK and popPK analyses throughout his career.
Teodora (Dora) Pene Dumitrescu, Ph.D.
Senior Consultant, Pharmacometrics
Dr. Dumitrescu has over 8 years of experience as a clinical pharmacology and pharmacometrics lead on cross-functional clinical development teams resulting in successful regulatory approvals. She has extensive experience in popPK/PD modeling, clinical trial simulation and design, probabilistic risk assessment, pediatric extrapolation, and applying quantitative pharmacology principles for decision making across multiple therapeutic areas.
Mark Sale, M.D.
Executive Vice President, Pharmacometrics
Dr. Sale has over 20 years of extensive experience conducting complex popPK analyses across diverse therapeutic areas and is one of the pharmaceutical industry’s thought leaders in modeling and simulation. Before joining Nuventra, Dr. Sale was the Global Director of Research Modeling and Simulation for GlaxoSmithKline prior to starting an independent consultancy in 2006 in popPK, modeling, and simulation.
Salil N. Pendse, M.S.
Quantitative Systems Pharmacologist II
Salil has more than 7 years of experience building mathematical models of cellular modes of action, physiologically-based pharmacokinetic (PBPK) modeling, bioinformatics, and building visualization tools for effective communication of complex scientific results. He has authored or co-authored more than 20 peer-reviewed publications in toxicology ranging from novel algorithms for interpreting transcriptomics data, to using PBPK modeling for informing chemical safety in juvenile populations.
Celeste Vallejo, Ph.D.
Quantitative Systems Pharmacologist I
Dr. Vallejo is experienced in model development in many different fields including those with differing data availability. She has designed various types of models used in understanding infectious disease transmission in which data can be scarce to neural networks in which data availability is much less restrained. Dr. Vallejo has applied numerous data analysis techniques in her work and developed an algorithm for sampling input parameters for a large-scale model in order to quantify model uncertainty.