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Next Steps from Speed to Patients


‐ Jan 26, 2022 12:15pm

In today’s world being able to supply medicines to patients faster is not only a competitive advantage but of critical importance for saving lives. In response to increasing demands for a broad range of modalities, Global Regulatory Agencies are using new and existing programs to reduce development timelines towards faster product licensure or authorization with the goal of patient benefit. Such increasing demands and the requirements of regulatory programs puts manufacturing on the critical path and has disrupted the way that products are developed. No longer do manufacturers have years to perfect the manufacturing process or build new facilities. Manufacturers are creating modular/mobile facilities and applying advanced analytical technologies to meet the demand. In addition, process development can be a key factor in speed to patient. The US FDA has used Emergency Use Authorization to enable faster distribution of drugs. This session will explore how these experiences can be used by the regulators and manufacturers to expedite development without impacting product quality. Talks will focus on available regulatory programs for accelerated product development, lessons from EUA applications that potentially can be applied to standard applications, manufacturing advances and a development perspective on how CMC can help enable speed to patients.