Abstract:

Biologics development represents a substantial advancement in the pharmaceutical industry because of their promise and huge success in the oncology, immunoscience, and cardiovascular disease areas. Prior to entering the marketed product development phase, each biopharmaceutical needs to go through series of stages that will allow or disallow the biologics asset to become a commercialized product. Each of those phases includes development planning and designing of studies to test relevant hypotheses to support the drug label if approved.

In this study, the findings from the survey that was conducted previously as planned. It is organized into various sections, which include a summary of the study approach, the original research questions and hypotheses, the actual number of interviewed participants and response rate, and the general quantitative results of the survey in terms of gender, age, department, and experience. The chapter then presents qualitative results from content analysis and then finally, an in-depth discussion of the implication of these findings.

Keywords: Fast to First in Human, Biologics, study approach, survey.

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