NOVEMBER 2017CIOAPPLICATIONS.COM 19esearch and development costs to market authorization are formidable. Given the pattern of product attrition occurring throughout the development lifecycle, outsourcing decisions accentuate the importance of earlier phase clinical research from the time of IND enabling studies for first in human studies, through demonstration of target engagement and dose ranging. Across phases, clinical protocols increasingly address multiple hypotheses. The structure and level of assessments are increasingly complex whether based upon number or type of procedures, work burden, or cost. As many products achieving approval are derived from smaller pharmaceutical and biopharmaceutical organizations with constrained staffing, an ability to amplify the effectiveness of development teams by strategic outsourcing is mandatory. This is particularly important for clinical trial services given a tendency to repetitively engage the same centers with exceptional research capabilities and the need for informed site engagement. Given product sophistication, and the refined patient phenotypes now targeted, a disciplined therapeutic focus has best prospects for success. Doing More with Less The decade that normally occurs from product conceptualization to marketing approval leaves proprietary patent life to approximately 10 years. This R&D landscape results in more complex and aggressively implemented programs, with a greater emphasis upon technology for acquisition of research data, as well as tracking to project milestones. In aggregate, accelerated programs protect intellectual property, access government incentives facilitating development, and exploit regulatory flexibility in standards for product approval. Minimizing patient sample ­ particularly for rare diseases ­ while maximizing experimental treatment for all patients is dominant.Innovation in trial design occurs in tandem with enhanced execution which exploits technological innovation for data acquisition and decision-making. A mandate exists to quickly move through the development cycle informing a complex set of outcomes demanded by multiple stakeholders. An "inflection point" research and development strategy therefore develops in which key business decisions require predictable study metrics, and real-time data tracking. Given this dynamic, product "value" in early phase research is defined across variables including safety, predictable exposure, target engagement and proof of concept studies using populations optimized for signal detection. Additionally, although pursuing well-established and predictable development pathways has merit, innovative strategies exploit "nearest neighbor" indications by creating programs simultaneously evaluating molecular targets common to many indications (e.g., a basket strategy).MICHAEL F MURPHY, MD, PHD, CHIEF MEDICAL AND SCIENTIFIC OFFICER, WORLDWIDE CLINICAL TRIALSRMAXIMUM VALUE, LIMITED DATA, AND DEVELOPMENT TO INFLECTION POINTSMichael F MurphycXoinsights
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