GHP Executive Awards 2017

8 | ghp Executive Awards 2017 Best Translational Science Company - New York Established in 2004, ICPD comprises of a group of pharmacists, physicians, and Ph.D. scientists each commonly bound by a personal devotion to making a difference within the pharmaceutical market. Paul explains this aim and how the firm works to achieve it through its dedication to excellence. “At ICPD, our mission is to shape the way antibiotics are developed and used to care for patients through an area of pharmacology called pharmacokinetics-pharmacodynamics. Everything we do at ICPD supports this singular mission. Whether it is discovering the right dose, interval and duration of therapy for a new antimicrobial, antiviral or biologic agent; discovering ways to overcome antimicrobial resistance; educating drug developers and regulators on how to better meet the needs of patients; or creating new tools to be used by clinicians at the patient’s bedside, we are always looking for ways to improve the lives of patients around the world. Everything we do at ICPD supports this singular mission: to shape antibiotic usage worldwide.” ICPD offers clients three broad categories of support, each building upon the other. It all begins in the laboratory, and the firm has created a fully-equipped antimicrobial translational medicine facility. This has been staffed with first-class scientists to deliver results quickly and reliably; in so doing, the firm generates knowledge about a potential new drug and minimizes risk to the Sponsor and future patients. ICPD performs analytical drug assays (including biological, chemical, and protein binding assays), in vitro screening of candidate drugs for microbiologic activity and static time-kill studies (including cell culture, drug susceptibility, mutation frequency, and plaque assays), in vitro infection models (including one-compartment chemostat and hollow fiber), and in vivo infection models (including the most common translational models). Second, ICPD’s mathematical analyses of pre-clinical and human data are regularly used to support go-no-go decisions, dose regimen selection, and regulatory body decision-making. Sponsors call upon ICPD to shed light on program failures and provide an understanding of the efficacy and safety of new agents. Analyses that the firm routinely perform include population pharmacokinetic and pharmacokinetic-pharmacodynamic model development, optimization of pharmacokinetic study design, dosing guideline development, sparse pharmacokinetic sampling, optimized pharmacokinetic-pharmacodynamic study design, pre-clinical and clinical pharmacokinetic-pharmacodynamic model development, joint pre-clinical and clinical Bayesian pharmacokinetic-pharmacodynamic model development, and Monte Carlo simulation supporting dose-selection and susceptibility test interpretive criteria. Third and critically, ICPD communicates the implications of pre-clinical and clinical analyses. This includes presentations at national and international meetings, publishing scientific manuscripts and interactions with drug regulators in the United States, Europe and Asia. Paul is keen to emphasise the importance of the firm’s work and states: “Fundamentally, the problems we face are complex. On one hand, identifying the right dose, dosing interval and therapy duration is complex. This requires not only integration of microbiological, pharmacokinetic, pre-clinical and clinical data through mathematical models but also an understanding of antimicrobial The Institute for Clinical Pharmacodynamics (ICPD) serves as a centre for translational science collaboration to the world, supporting pharmaceutical and biotechnology companies to provide safer and more effective drugs to patients through advanced methods of pharmacokinetic and pharmacodynamic systems analysis. We invited the firm’s President, Paul G. Ambrose, to describe the firm and the range of services it offers. GEX17011