Brian Trautman

Developed and implemented development and commercialization strategies for oral oncology drug products including support of marketing authorization applications and clinical regulatory documentation. Directed and coordinated GMP drug product manufacturing, method development and validation, release/stability testing, primary/secondary packaging, and clinical trial material kitting and labelling. Managed development and manufacturing activities conducted in-house and at external CMOs.

Directed start-to-finish clinical supply activities across multiple Phase 1 through Phase 3 small molecule, biologic, and cell therapy clinical studies, including forecasting drug product demand, planning and coordinating packaging and labeling, and supervising distribution of kitted clinical trial materials to global clinical sites.

Managed and led R&D activities for pulmonary delivery of mRNA formulations, including designing and conducting formulation-device compatibility studies, developing aerosol characterization methods, and designing in vitro and in vivo aerosol delivery systems. Utilized QbD principles to explore relationships between formulation variables and aerosol performance, post-aerosolization biophysical properties, and post-aerosolization expression.

Led aerosol analytical activities in support of early-stage pulmonary drug development, including method development, tech transfer, IVIVC, and drug product characterization and stability internally and at external CMOs. Held Analytical CMC Lead position on multiple drug products and worked closely with Formulation/Process Development, Quality, and Regulatory/Clinical teams.

Planned, designed, and led Phase 1 and Phase 2 aerosol development activities covering methods, drug-device interactions, product robustness, and IVIVC. Held Aerosol Development CMC lead role and had responsibilities managing method transfer, method qualification, and release/stability testing conducted with global CMOs.

Developed phase-appropriate test methods for characterizing the aerosol properties of inhaled dry powder formulations. Evaluated physical formulation properties and performed bench-scale spray-drying experiments to assess excipient effects on chemical and aerosol performance.

Conducted aerosol performance characterization on novel inhaled dry powder and liquid formulations across different delivery devices. Developed and characterized systems for in vivo delivery of aerosols.