This presentation will focus on increasing speed to clinic, including historical trends over the last 30 years in the time required to go from DNA sequence to Phase 1 human clinical trials. Data for monoclonal antibodies will be presented, with some discussion on how the lessons learned apply to other products. The impact of new technologies, as well as changing regulatory requirements and industry learnings, will be covered. The scientific topics will include the requirements and need for cell cloning, the use of cell pools and transient gene expression, and the use of site-directed integration and clone pools. The business topics will include the use of process, analytical, and manufacturing platforms, as well as strategies to overlap activities and compress Gannt charts. Just recently, a combination of technologies and strategies have been employed to reduce the timeline down to 3-6 months. Although these breakthroughs were employed in an emergency COVID-19 scenario, they serve as a model and benchmark for all future projects.
Describe the historical trends over the last 30 years in the time required to go from DNA sequence to Phase 1 human clinical trials for monoclonal antibodies
Understand and potentially apply new technologies, as well as changing regulatory requirements and industry learnings, to reduce this timeline.
Benchmark themselves against those who recently achieved timelines of 3-6 months, in terms of technologies, strategies, and outcomes.