Innovative Study Design

At ICPD, we pride ourselves on our innovative study designs. From glassware to mice to man, our novel study designs have provided the opportunity to gain new insights into the pharmacokinetics-pharmacodynamics (PK-PD) of drugs. PK-PD-based studies allow for better discrimination of drug effect and hold the promise to change how drugs are developed today and in the future.

ICPD insights have been recognized by the Food and Drug Administration (FDA) and by sponsors looking to improve the efficacy of new drugs. ICPD scientists helped pioneer a new method for the clinical study of bacterial sinusitis. This novel method has been cited in the revised FDA Guidance for Industry, entitled, “Acute Bacterial Sinusitis: Developing Drugs for Treatment.” This technique allowed for serial sampling of sinus aspirate for microbiologic and PK information. Data derived using this study design has allowed, for the first time, the characterization of the time-course of drug exposure, inflammatory markers in this closed space of infection, and drug effect, as well as provided the opportunity to optimize dose and identify the optimal length of therapy for acute maxillary sinusitis.

Moreover, ICPD scientists conducted a series of analyses in an effort to identify alternative treatment regimens that would be expected to be at least as efficacious as standard therapy. Most recently, analyses involving oritavancin, which were based upon drug exposure data in humans derived from previous clinical studies and animal infection models in which oritavancin was dosed in a manner that resulted in exposures which mimicked those achieved in humans, demonstrated the potential benefit of front-loaded dosing strategies. Based upon these analyses, Targanta Therapeutics Corporation launched a Phase 2 clinical trial comparing two short and intensive oritavancin dosing regimens with the
previously-studied oritavancin regimen for the treatment of patients with complicated skin and skin-structure infections. Oritavancin, administered in a single or in an infrequent dosing regimen, demonstrated comparable efficacy and safety to a three-to-seven day course of oritavancin therapy, as administered in two previously conducted Phase 3 clinical trials.