Expertise:   

Program management Research & Development – medical device concept design & development, registration, launch and global scale-up.  Small molecule and biologic development from pre-clinical to phase 4 studies.  

Program leadership to coordinate clinical, medical, CMC, regulatory and quality teams to execute global clinical trials, complete regulatory filings and commercialization. Sterile, single-use drug and solution container design and process technology (sterile fill, frozen, glass containers).

Experience:  

  Headed design, manufacturing, and international operations functions for Baxter International and Amgen.  Program Manager Baxter-Alliance Pharmaceuticals joint venture.

Other:  

Global regulatory insight (FDA, EMEA, CFDA, Health Canada, TGA, Japan MOH, ANVISA).  Global manufacturing (sterile fill/finish), API sourcing, international drug importation, controlled substance and cold-chain transport.