Having a clear understanding of the relationship between exposure and both on- and off target effects is increasingly becoming an accepted prerequisite to Phase III clinical development for both small molecule and biologic therapeutics. Obtaining this understanding requires:
PKPD Strategies was formed to offer my extensive pharmaceutical and biotech development experience to companies wanting to adopt this proven approach to increasing the success of Phase III development by fully understanding nonclinical and early clinical results across all therapeutic indications.
Who We Are – Dr. Toothaker holds a Doctoral degree in Pharmaceutics from UW-Madison and has been directly involved in drug development for over 40 years. His career has focused primarily on relationships between pharmacokinetics and drug effect in both nonclinical and clinical settings. Roger left his position as VP of PKPD M&S at ICON to pursue independent consulting. Prior to joining ICON, he worked for Parke-Davis, P&G Pharmaceuticals, and TAP Pharmaceuticals. Roger served as Senior Director of Clinical Pharmacology at Akros Pharma, and was promoted to Vice President of Clinical Development at Akros, where he championed the use of Critical Path principles such as modeling/simulation, safety/efficacy biomarkers, and adaptive trials under a unique business model emphasizing the value of translational clinical research. This effort encompassed indications of cardiovascular, osteoporosis, immunology, diabetes, obesity, HIV, and HCV.
Marshall S, Madabushi R, Manolis E, et al. Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives. CPT Pharmacometrics Syst Pharmacol. 2019;8(2):87–96. doi:10.1002/psp4.12372
Model-based, or model-informed drug development is truly the smart way to develop drugs. Please feel free to contact us anytime to learn more about how this approach can improve the likelihood of success for your small molecule therapeutic.