How modeling and simulation (M&S) supported the development of the immuno-oncology drug pembrolizumab
During his time at Merck (MSD) our consultant Andreas Lindauer participated in the modeling and simulation team that worked on numerous model-informed approaches to support the development of pembrolizumab (KEYTRUDA), a new monoclonal antibody approved for the treatment of melanoma and other cancer types. Check out a series of recently published articles by this M&S team.
- Translational PK-PD model to support the dose selection in early human studies (http://onlinelibrary.wiley.com/doi/10.1002/psp4.12130/full)
- Use of M&S to optimize the design of a clinical study (http://onlinelibrary.wiley.com/doi/10.1002/psp4.12132/full)
- Population pharmacokinetics of pembrolizumab (http://onlinelibrary.wiley.com/doi/10.1002/psp4.12139/full)
- Application of a tumor-growth modelling to pin-point the exposure-response relationship (http://onlinelibrary.wiley.com/doi/10.1002/psp4.12140/full)
How the different bits and pieces of this large M&S project fit together and eventually helped to bring pembrolizumab to patients at light-speed is concisely described here: http://onlinelibrary.wiley.com/doi/10.1002/psp4.12131/full
If you want to dig further into the matter and want to see how the M&S was eventually part of the regulatory review you may want to check out the Clinical Pharmacology review summary on the FDA web site: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000ClinPharmR.pdf. Andreas is especially proud to see one of the key figures from the translational model ended up in this document (page 12).