Formulation and Delivery
Steve Byrn, PhD
Professor
Purdue University
West Lafayette, Indiana
Vadim Gurvich, PhD
Executive Director
University of Minnesota
Minneapolis, Minnesota
Accelerated Development: Past, present, and Future. Stephen Byrn, Ph. D., Purdue University and Improved Pharma, LLC, Pamela Smith, Improved Pharma, LLC
Accelerated Development has been a goal of pharmaceutical scientists for over 50 years. In the 1950’s pharmaceutical scientists were discussing ways to accelerate drug discovery and development of anticancer drugs. In that timeframe, there was also great interest in accelerated stability. Interest in accelerated development has continued. In the 2000s Stephen Byrn and the Aptuit team developed an accelerated development strategy named INDiGO (to my IND I go). This strategy remains today as an offering of Evotec in Verona, Italy. On the technical side, accelerated development depends on hard technology capabilities in: (1) Advanced analytical chemistry; (2) Accelerated stability analysis; (3) Solid-state chemistry; and (4) process control. Another exciting capability that can accelerate development is the construction of digital twins to allow process simulations at the earliest points of development.