Preclinical Development – Biomolecular
Prathap Nagaraja Shastri, PhD
Scientific Director
Johnson and Johnson
Spring House, Pennsylvania
This prologue session serves as an introductory talk to the upcoming symposium on “Breaking Through Barriers in Preclinical Development To Improve Clinical Translation”
One of the challenges in translational medicine is to select first-in- human doses of investigational drugs based on findings in preclinical studies. Novel biologic modalities have complex mechanism of action with several interdependent factors that will impact pharmacokinetics, pharmacology, efficacy, and safety of the therapeutics. Therefore, traditional approaches may not be applicable. This symposium covers translation challenges, opportunities in understanding PK/PD and determining FIH doses for novel biologics modalities.
Learning objectives for the symposium –
Appreciate the key challenges, mitigation strategies, and translational considerations for prediction of FIH doses for CAR-Ts, AAV based gene therapies, and T-cell redirectors.
Get introduced to novel concepts, strategies, PK/PD approaches and retrospective learnings on translational considerations for these novel biologic modalities.