Preclinical, Clinical, and Translational Sciences

Keynote: Current Status and Future Perspective of Pre-Clinical in vivo Studies vs in vitro/in silico Predictive Biopharmaceutics Tools

Moderator(s)

• YT

  Yasuhiro Tsume, PhD (he/him/his)

  Prin Scietist
  Merck & Co., New Jersey

Keynote Speaker(s)

• 

  David Sperry, PhD

  Executive Director
  Eli Lilly and Company
  Indianapolis, Indiana

The use of animal studies to design formulations has a long history in the pharmaceutical field. More recently, some researchers are moving away from preclinical animal studies for formulation design. In this presentation we will cover the considerations when deciding if an animal study is useful for formulation development. We will also cover the challenges associated with animal studies, including pros and cons as well as translatability. Finally, we will discuss the tools and techniques that can be used in place of animal studies as well as case studies illustrating the challenges.