NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Royal Hathaway

Practice Area Focus

  • Vaccines
  • Drugs
  • CMC
  • CMC Compliance
  • Quality Assurance

Biography

Mr. Hathaway joined NDA Partners as an Expert consultant in 2015. He has extensive experience in the pharmaceutical industry including pre-clinical and clinical drug development and manufacturing, and in the development of commercial manufacturing processes.

His professional experiences include positions at Otsuka America Pharmaceutical, Inc. as the Senior Manager of Technical Services and Process Development, Director of Manufacturing at Miza Pharmaceuticals Inc., and Manager of Technical Operations at Cardinal Health. While at the Glaxo Research Institute, as a Research Investigator and Senior Research Scientist, he developed solid, sterile, liquid and inhalation dosage products.

In his early career at The UpJohn Company, he developed and operated the company’s first preformulation laboratory - establishing systems and procedures to perform preformulation studies to support formulation development and studying the effects of formulations on the stability of drugs.

Mr. Hathaway recently provided technical expertise on the advanced aseptic processing technology for the application and manufacturing of vaccines with the Bill and Melinda Gates Foundation. He holds three patents for fluid application devices and the development of a process system Method and Apparatus for Preparing a Solution of Shear Sensitive Material.