Speed Session
Chairs: Kevin Bailey (Regeneron) and Rohini Desphande (Amgen)
This session seeks to explore efforts, tools, technologies, business practices that can accelerate the pace of biopharmaceutical development. Presentations are sought involving bioprocess, analytical, formulation and delivery (as well as bringing various technical disciplines together in new ways) that have a focus on increasing speed. Potential topics may include, but are not limited to: speed to clinic; accelerating or minimizing critical path activities affecting integrated speed of end-to-end development; reliance on platforms, minimization of time-consuming rework; approaches to speed process characterization, validation and specification-setting for products progressing very rapidly toward approval; improved paradigms to improve cycle times for clinical and commercial production.
Speakers
- Integrated Strategy to Enable Rapid Delivery of Material for IND Enabling Toxicology Studies- Scott Estes, Biogen Idec
- Accelerated Drug Development Enabled By Velocimab® Technologies- Darya Burakov, Regeneron
- Towards making biologic drugs on demand- Chris Love, MIT
- Amgen's Next Generation Biomanufacturing Facility- Kimball Hall, Amgen
- Development of a Device Platform to Speed Products to Clinic and Market- Ron Peeples, Pfizer