PKPD Strategies, LLC Information

PKPD Strategies was formed to offer my three decades of pharmaceutical and biotech development experience to companies wanting to better understand the relationship between exposure and both on- and off target effects of their potential new therapeutic using information from nonclinical and early clinical development in order to increase the success of Phase III development. The primary focus of PKPD Strategies is assisting pharmaceutical and biotechnology companies with: • PKPD aspects of clinical development plan preparation and study design • clinical synopsis and protocol preparation or review • review of bioanalytical method validations and result summaries • evaluation of the clinical implications of nonclinical PKPD results • assessing the impact of clinical results on subsequent • clinical study designs and sequencing • nonclinical or clinical PKPD gap analysis and regulatory summarization