NOVEMBER - 20208In My OpinionJ. Fred Pritchard, Ph.D., Vice-President, Strategic Development, Celerion Inc.ByIMPACT OF NEW TECHNOLOGIES IN EARLY CLINICAL DEVELOPMENTAs a clinical pharmacologist working in early clinical research for over 35 years, I understand the need to continually evaluate and embrace new technologies that help deliver better data, faster in order to facilitate go, no-go decisions about new drug products. Such technology must be introduced carefully to meet the demands of a highly regulated research environment. This is of strategic importance for organizations whose focus is on early clinical research through purpose-built clinics and specialized bioanalytical laboratories. Early clinical studies involve assessment of a drug's action on the human body (both beneficial and potentially adverse) as well as how fast or slow the body absorbs, distributes and eliminates the drug (pharmacokinetics). Often, modifications to the drug's dosage is required during dose escalation studies. Compounding of sterile and non-sterile formulations for immediate use in the clinic is one capability that Celerion's research pharmacy offers. Web-based applications such as Pestle® and Simplifi-797 help ensure that the investigational product is compliant with demanding USP requirements. Advances in technology have been applied to the space in the research pharmacy where a product is handled. For example, hands-free technology for opening/closing doors and hand washing/drying stations, automated pressure differential adjustments/monitoring systems, video preparation verification systems which allow for pharmacist remote verification are all designed to decrease contamination risk. Recently introduced are J. Fred Pritchard
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