Formulation and Delivery
Bart Hens, PharmD, PhD (he/him/his)
Biopharmaceutics Scientist/ Drug Product Design Biomodeler
Pfizer
Filippos Kesisoglou, Ph.D. (he/him/his)
Distinguished Scientist
Merck & Co., Inc.
Rahway, New Jersey
Stephen Stamatis, PhD
Director
Eli Lilly and Company
Indianapolis, Indiana
Siddhi Hate, PhD
Senior Advisor
Eli Lilly and Company
Carmel, Indiana
.jpg "Nikoletta Fotaki, PhD photo")
Nikoletta Fotaki, PhD
Professor of Biopharmaceutics
University of Bath
Bath, England, United Kingdom
Animal studies are crucial component of oral drug development, aiding in the assessment of efficacy, safety, and pharmacokinetic properties before human trials. They provide critical information to support advancement of the right candidate to the clinic for oral delivery. While animal studies provide invaluable insights into the biopharmaceutics of an oral drug, the successful translation of preclinical information to humans remains a formidable challenge. This could be due to various factors including inappropriate selection of animal species for specific formulations to inherent variations in efflux mechanisms, active transport, and gastrointestinal physiology between preclinical models and humans. To bridge this gap, it is imperative to delve into these nuances and address key topics. Ultimately, we aim to advance our understanding of the current role of animal studies and outline strategies to improve best practices in animal studies for optimizing formulation strategies, improving translational research, and enhancing the success of oral drug development pipelines. This discussion is essential, particularly as the interest in physiologically based biopharmaceutics models are gaining momentum among both industry and regulators. These models provide a promising opportunity to potentially mitigate reliance on animal studies in drug discovery and development. Thus, by fostering dialogue and collaboration in this domain, we can collectively pave the way for more ethically sound and scientifically robust approaches to drug development.
AAPS Oral Biopharmaceutics and Absorption Modelling (OBAM) community proposes a hot topic session to delve into the current trends and best practices for application of animal studies in early and late phase of drug development to support oral drug development. In 2023, OBAM community created a survey to learn about trends in utility of animal studies from industry and academia. A live discussion focusing on following sub-topics aims to further foster a dialogue and comprehensive understanding of best practices and future of animal models for formulation development and translational research.