Workshop

Join us for a one-day workshop hosted by M&S Decisions, to focus on translational mechanistic modeling in support of First-in-Human (FiH) safe starting dose selection.

The topic addressed in the workshop is of utmost importance, given the intricacies in pharmacokinetics and pharmacodynamics, and the corresponding unique safety challenges inherent to this multi-component therapeutic modality. The mechanistic modeling approach presented, which we will examine in a practical, hands-on manner, represents a must-have element in CTA/IND submissions.

The case examples which we will be focusing on during the workshop are based on the actual modeling applications in the development of T cell engagers (TCE) and other types of bispecific antibodies, although the overall methodology becomes generally for other types of novel multi-component therapeutics, such as autologous and allogenic cell therapies, antibody-drug and -oligo conjugates, targeted lipid or polymer nanoparticles with encapsulated drug, PROTACs etc.

In fact, our session will take participants through various modeling approaches, from a more empirically driven workflow to estimate FiH starting dose using minimal anticipated biological effect level (MABEL) criteria, to a mechanistically oriented translational approach using a quantitative systems pharmacology (QSP) modeling workflow The latter will be based on an integrative cloud infrastructure, “Simurg”, and a set of packages from the R programming environment.