Physiology-based pharmacokinetic (PBPK) models are broadly applied in late phase drug discovery/ development. Traditionally, compounds are prioritized based on hierarchical filtering with predefined cut-offs for desirable range of various parameters. PBPK models, when combined with related pharmacodynamic assumptions, offer a valuable platform to integrate multiple parameters driving the in vivo PK profile required for target engagement. They also provide mechanistic interpretation of key drivers for the predicted profile to further help with compound design strategies. As such, these results enable compound prioritization in a holistic manner, focusing on multi-property optimization (MPO). This presentation will provide a brief overview of the structure and application of an internal PBPK model. Examples of successful application of this tool on a small molecule drug discovery program will be shared to illustrate its role in driving decisions to guide compound progression.

The purpose of this webinar is to: 1. Provide valuable knowledge exchange between ADC developers andthe Regulatory Agency (FDA) 2. Hear from leading experts in PK/PD, pharmacometrics, & clinical pharmacology, plus clinicians and regulatory minds, fostering collaborations and partnerships that can propel ADC projects seamlessly. 2. Demonstrate the successful integration of pharmacokinetics and pharmacometrics in ADC clinical development, enhancing your ability to apply these principles to your own work

This webinar is intended to provide education and updates of this evolving area to scientists and graduate students.

This webinar is intended to educate on emerging knowledge on transporter activity modulation in disease state like liver Cirrhosis/hepatic impairment, and its implications on PK in specific populations.

Attendees will be educated on utility of mathematical models to characterize ADME of TPs. Emerging modeling approaches will be introduced and recent case examples will be discussed.

By understanding the relationship between biomarkers (e.g., antibody titers) and efficacy in preclinical species, how this translates to the clinic, to inform humoral and cell responses needed for protection will allow for adequate understanding of clinical effects in special populations, posology for new variants, and the potential for drug interactions. Together, these data-driven approaches should be embraced to accelerate the delivery of safe and efficacious vaccines to patients globally.

This course was developed by the ISSX Modeling and Simulation Focus Group and will be moderated by Maria Posada, Ph.D., Eli Lilly and Company, USA, Oliver Hatley, Ph.D., Certara UK, United Kingdom, and Jaydeep Yadav, Ph.D. Merck, USA. This short course will focus on the fundamentals of modeling and simulation, spanning several modeling disciplines, including PBPK, QSP, PopPK and Biopharmaceutics, (small molecules, peptides, proteins, or new modalities). The course will include the fundamentals for beginners, advancement, and application, as well as case examples.

This virtual workshop will focus on the advancements in the application of PBPK as a mechanistic tool in the discovery and development setting. The workshop has been structured into three sessions with emphasis on emerging trends such as special population, biomarker-informed DDI modeling, and diverse drug development applications. Each session will include lectures and short presentations, the latter will be selected from the pool of abstracts from the students and industry attendees. The workshop includes access to all presentation slides and recordings.