Business Development Consultant

Fred Burkhardt has more than 28 years of experience in the pharmaceutical industry with two global pharmaceutical companies, holding a variety of key roles across the spectrum of clinical planning, implementation, data, and trial management for phase 1 through 4 in a variety of therapeutic areas. Fred held bench scientist positions in drug discovery and development as well as administrative roles in clinical research, gaining deep experience in the clinical trial development process. He has a deep understanding of clinical trial FDA regulations for drug development, external sourcing and vendor oversight, statistical analysis centers, external committees, DSMB services, AROs, bioanalytical PK analysis services, and oversight and quality assessments of global vendor contracts for small molecule drug intermediate manufacturing.