Innovations and the Drug Development Cycle Process & Players

Gina Calarco Smith is a scientific director at the Critical Path Institute, a non-profit organization acting as a neutral entity to build private public partnerships with regulators to address unmet needs in drug development. Ms. Smith sits within the Pediatrics Program and contributes to the work of the International Neonatal Consortium (INC). Prior to joining C-Path Ms. Smith was at LabCorp Drug Development as a Senior Director of Strategy & Planning within the rare diseases, advanced therapies, and pediatrics team (RAPT). In this role she planned strategies and responded to risks or issues that arose within pediatric and complex rare disease clinical trial work. Gina received her nursing degree in 2001 and is a pediatric registered nurse, earning her master’s in public health in 2010 from the University of Kansas. Nearly her entire career has been focused within pediatrics beginning as a neonatal ICU nurse and moving into study coordination of infectious diseases and vaccine research at Children’s Mercy Hospital in Kansas City, project management of Phase I - IV pediatric clinical trials at a global clinical research organization (CRO), strategy and planning for complex and rare indication pediatric clinical trials, and now as a scientific director of pediatrics at C-Path