Best Practices for Optimizing Dose Escalation in First in Human Studies

Best Practices for Optimizing Dose Escalation in First in Human Studies

Comprehensive clinical support in early phase studies to make better go/no-go decisions

With increasing R&D costs and declining industry success in getting products to market, pharmaceutical companies need to maximize the knowledge collected in early Phase I/IIa study data to make better go/no-go decisions and improve success in late stage development.

Steps to improve your dose selection and ultimately the value of your early clinical data

This webinar will provide best practice insights into dose selection for First in Human (FIH) dose escalation studies to mitigate risk and optimize the value of your early clinical data. Using illustrative scenarios, we will explore key protocol design considerations along with essential pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation techniques.

Identifying the best dose escalation scheme in FIH studies is a critical and often underestimated step in early development decision-making. Likewise, setting up ideal study collection procedures is key to getting the most out of the subject data to efficiently produce an accurate understanding of your compound’s strengths and susceptibilities.

This webinar will examine ways to:

• Optimize FIH study design from sampling plans to adjusting dose escalation based on tolerability and PK-PD during the course of the study for the most efficient and effective strategy
• Use PK-PD modeling and simulation to guide dosing for each cohort

By participating in this webinar, you will gain an understanding of ways to make the most of your early clinical development — from efficiently conducting studies to providing dependable model predictions to optimize the overall process. These key factors in early drug development significantly improve the knowledge of the molecule at Proof of Concept, overall success or failure of compounds, and ultimately your return on investment.

Speakers

N. Seth Berry, PharmD, Director, Clinical PK/PD Modeling & Simulation, & Center for Statistics in Drug Development, Quintiles

Dr. Berry is Director of Clinical Pharmacokinetic / Pharmacodynamic (PK/PD) Modeling and Simulation in the Quintiles Innovation Group. He has a PharmD from the University of Missouri-Kansas City, School of Pharmacy, a 2-year Post-Doctoral PK/PD Fellowship with the University of North Carolina, and a 2-year Pharmacometrics Fellowship with the Center for Drug Development Science, Georgetown University (now at the University of California – San Francisco). Since joining Quintiles in 2004, Dr. Berry has focused on Model-Based Drug Development, with an emphasis in population PK/PD modeling and simulation. Dr. Berry has performed population PK/PD meta-analyses for regulatory submission labeling requirements and conducted clinical trial simulations for optimizing study design. Dr. Berry has numerous publications and presentations in the pharmacometrics discipline, while also mentoring PK/PD Fellows, providing workshops, and training seminars. Dr. Berry is a high performance computing expert with strong backgrounds in NONMEM®, S-Plus®, and R.

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Professor Tim Mant, FRCP FFPM, Vice President, Medical Research and Principal Investigator, Quintiles

Having completed an Honours degree in Pharmacology and graduating in medicine from Guy’s Hospital in 1979, Tim Mant trained at various London hospitals in Internal Medicine, Clinical Pharmacology and Human Toxicology. He was one of the founders of GDRU (Guy’s Drug Research Unit). His major activity at Quintiles has been as Principal Investigator for the investigation of new chemical entities in man. In addition to research he maintains teaching and clinical activities. Professor Mant has published over 60 articles relating to Clinical Pharmacology and Human Toxicology cited on PubMed. He has co-authored the three most recent editions of: “A Textbook of Clinical Pharmacology and Therapeutics” (Ritter, Lewis, Mant & Ferro) and the accompanying “Questions for Self Assessment” (Mant, Lewis, Ritter & Ferro), Arnold Publications. He was appointed Visiting Professor at King’s College London School of Medicine at Guy’s, King’s and St Thomas’ Hospitals, London in January 2008. Professor Mant is Honorary Consultant Physician at Guy’s & St Thomas’ Hospital NHS Foundation Trust. He is an examiner for the Diploma in Pharmaceutical Medicine, was an MBBS examiner and lectures on BSc, MSc & MB courses at King’s College London. He is an Educational Supervisor for Postgraduate Training in Pharmaceutical Medicine in the U.K. and is the Organiser for the Advanced Human Pharmacology Course in Exploratory Development and Phase 1 Studies at KCL. He was the instigator of the first Intercalated BSc programme in Translational Medicine which started at KCL in 2009. Tim Mant is co-lead for the Experimental Medicine and Therapeutics Cluster at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London’s Comprehensive Biomedical Research Centre funded by the NIHR.

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