16 November | 18:30-21:00

Evaluating Immuno-Oncology Treatment with PK/PD Modelling

Instructor:

Tao You, Ph.D., PK/PD Modelling Lab Head, Boehringer Ingelheim

Discovery and development of cancer treatments (e.g. radiotherapy, chemotherapy, cell-directed targeted therapy, immune therapy) require PK/PD modelling for robust experimental design and unambiguous data interpretation. This short course will introduce how translational PK/PD modeling for chemotherapy and cell-directed targeted therapy can be used to relate preclinical data with clinical response. We will also discuss the basics of PK/PD modelling that are relevant to evaluating novel immuno-oncology treatments. It will help attendees to learn about dose selection, estimation of therapeutic window, and translational sciences based on PK/PD modeling.

18:30 Introductions to the group

18:40 Translational modelling for cell-directed cancer therapies: the successful case studies

The lecture will provide a historical perspective for translational modelling that has been developed for chemotherapies and cancer cell-directed targeted therapies. It will discuss the following topics:

• How do we define the quantitative relationship between preclinical efficacy and clinical activity for these treatments?
• What does compelling preclinical evidence entail?
• Is it possible to set minimum preclinical efficacy criteria to qualify a novel treatment for clinical success?

Discussions:

Limitations of the approach/conclusions

• How shall this translational modelling framework be used in practice to best support drug projects? Where does it add value?
• Which ideas can be borrowed to support immuno-oncology projects?

19:40 Break

20:00 The basics of immuno-oncology modelling

This lecture will focus on the basics of immuno-oncology modelling, including:

• Common models for antibody PK
• Target engagement modelling including MABEL approach

Discussions:

• What are the main gaps from target engagement to disease modulation to (preclinical and clinical) outcome?
• How to fill in these gaps in practice to enable robust clinical translation of preclinical results?

21:00 End of Course

Speaker Biography:

Tao You, Ph.D., PK/PD Modelling Lab Head, Boehringer Ingelheim

Tao You heads oncology preclinical PK-PD modelling at Boehringer Ingelheim in Vienna, where he creates, grows and leads mathematical and statistical modelling capability to support the discovery and development of novel cancer treatments. Tao's modelling work enables robust clinical translation and generates compelling preclinical evidence. Prior to BI, Tao served as a physiological/PK-PD modeller at AstraZeneca (Discovery Sciences/Oncology Bioscience DMPK), where he developed novel QSP models for cancer treatments including Osimertinib and ATM inhibitors. Those models recognised and reconciled differences between in vitro and in vivo data, guided preclinical and clinical experimental design, and supported selections of dose and dosing schedule. Tao earned his PhD in Systems Biology at the University of Aberdeen after completing his MSc in Molecular Engineering at Singapore-MIT Alliance