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October 10, 2019
Accelerated Drug Development in the Era of Breakthrough Therapies
Join representatives from SCiAN and Biocatalyst 4 Development as they explore the drug development process; from selecting the lead indication to designing/executing a trial under accelerated timelines.
Drugs designated as "breakthrough therapies" benefit from expedited drug development and regulatory reviews. A study may start off as a first-in-human (FiH) trial and evolve to include expansion cohorts that address phase 2 and/or phase 3 objectives, all within a single integrated protocol. Expanded cohorts lead to rapid patient enrolment and increases the risk of patients exposed to a drug of unknown efficacy or minimally characterized toxicity profiles. To mitigate these risks, drug development processes must address challenges in trial logistics, data collection and analysis/reporting of data. This talk walks the audience through the drug development process for a breakthrough therapy—from selecting the lead indication to designing/executing a trial under accelerated timelines.
Considerations in selecting a lead indication for oncology
Overview of clinical development programs in oncology
Challenges associated with accelerated programs