Antibody development - A medium-sized pharma company asked Dr. Fisher to simulate a clinical trial involving an antibody. Simulations revealed that the proposed clinical trial was likely to fail. The company ignored these recommendations and the trial failed as predicted. The company asked Dr. Fisher to propose a new dosing regimen, simulate this regimen, and use this information to convince regulatory authorities to permit trials to resume.
Real-time analyses - A startup pharma company contacted Dr. Fisher, asking for some rapid analyses of Cp data from one clinical trial to permit selection of a dosing regimen for subsequent trials. Final decision on this dosing regimen had to be made within 5 days. Within 3 days, Dr. Fisher provided preliminary NONMEM analyses, simulated dosing regimens for the second trial, advised on improved sampling regimens to better define pharmacokinetic parameters.
Diligence - A medium pharma company was planning to develop a dosing regimen for a novel delivery system. Preliminary data obtained from an academic investigator suggested that the desired delivery profile would be easy to achieve. However, the company had reviewed only summary data that appeared to show an excellent release profile. Further review by Dr. Fisher revealed that none of the subjects studied has an acceptable release profile (during a period that slowly ascending concentrations were desired, some subjects showed a rapid increase and others a decrease such that the mean profile appeared desirable despite no subject demonstrating favorable data). The company realized that additional phase I data was needed before the product could continue.