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Collaborating On the Drug Development Process Eisai and Janssen Pharmaceutica formed a strategic partnership to seek Food and Drug Administration (FDA) approval to market rabeprazole, a new "proton pump inhibitor," that reduces gastric acid secretion. Knowledge about the pathophysiology of the diseases being treated, as well as the clinical pharmacology of rabeprazole, had increased substantially since the beginning of the clinical development program. Thus, new analyses and interpretations of the clinical trial results were needed before submitting a New Drug Application (NDA) to FDA. Working in collaboration with the Eisai and Janssen team, we produced an NDA within six months that was subsequently approved by FDA. Science for Organizations carried out analyses that demonstrated: which dose of rabeprazole should be approved results that initially raised safety concerns actually reflected the drug's long term effectiveness rabeprazole had a faster first-day effect than competing products Garvey Associates provided: important overall regulatory and scientific perspective evaluations of various clinical results regarding the drug's safety Arishel analyzed results from the drug's pharmacokinetic studies, showing that: the formulation used for clinical trials was bioequivalent to the final marketed product potential drug interactions related to metabolism of rabeprazole through the cytochrome P450 system lacked important clinical significance Our affiliates each do what they do best, in much the same way that a seasoned team of movie makers: director, actors, camera operators, sound crews, and so forth--come together to make a movie. We have collaborated on all kinds of projects, in many different organizations, sometimes over many years together. As a result, we are efficient, focused and effective, with a solid record of accomplishments. We can quickly assemble a team that can step right into a clinical development program and usher it through FDA approval.