The Certara Blog

Author: C. Kirkpatrick, C. Rayner

Carl Kirkpatrick is the Director of the Centre for Medicines Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University. Since receiving his Doctor of Philosophy (Medicine) from the University of Otago (NZ) in 2002, Carl has worked at the University of Queensland and more recently Monash University. Carl has extensive knowledge in the area of PK/PD modeling and the factors that alter these processes, pre-clinical and clinical drug development, and clinical applications to optimization of therapy. He has worked on projects and produced publications across a number of therapeutic areas including diabetes, cardiovascular disease, cancer, aged/frailty, and infectious diseases (bacteria, viruses, and fungi). — Craig Rayner has more than 15 years of drug development experience. His past appointments include leadership roles in Clinical Pharmacology and Early development (Roche), Clinical development (CSL-Behring), in Business Development/Licensing as Global Due Diligence Director (Roche) and as an academic researcher in clinical pharmacology and infectious disease research (Monash University). Dr. Rayner has extensive experience in early and late development of therapeutics, regulatory interaction experience with all major global health authorities, multiple filings and accountability for numerous due diligences, active support of negotiations, deal making and integration activities. He holds an Adjunct Associate Professorship in Pharmaceutical Science (Monash University), and is broadly published in clinical pharmacology and also infectious diseases.

Recent Posts

Using a Pharmacology to Payer Framework to Support Product Development

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]

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How to Plan and Implement a Pharmacology to Payer Framework

Pharmacology to the payer (P2P) is an innovative approach to create a framework for dialogue between drug sponsors, regulators, and payers. The core structure is the sequential linking of quantitative mathematical models—pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), disease progression, epidemiology, health utilization, and health economics. In this blog post, we discuss how working with an amazing team of […]

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