Michael K. O’Brien, PhD – President & CEO

Mike K. O'Brien NGT BioPharma ConsultantsPresident & CEO of NGT BioPharma Consultants, Dr. O’Brien is recognized as a forward-thinking, innovative biopharmaceutical industry executive.

Dr. O’Brien previously served as the acting head of a large biopharmaceutical Chemical Development organization, where he oversaw the cGMP Kg-laboratories and pilot plant as well as the Synthesis R&D, API External Supply and Environmental, Health and Safety (EHS) groups. As VP Pharmaceutical Sciences Technology & Innovation at Pfizer he championed the design, fabrication and implementation of a portable, continuous, miniature and modular (PCMM) oral solid dose manufacturing facility that was fabricated off-site, assembled in a Pfizer warehouse and ultimately commissioned to provide launch and commercial supplies of the 2019 FDA approved oncology drug Daurismo.

An agent for transformative change who strategically aligns stakeholders to ensure cross-functional support for status quo makeover, Dr. O’Brien’s expertise extends to the development of digital, analytical, drug substance and drug product platform technologies, which when implemented, improve the efficiency of critical CMC processes. He was named an Industry Influencer on The Medicine Maker 2019 Power List and has more than 55 publications, presentations and patents. 

Expertise 

  • CMC drug development from late discovery through commercial tech transfer
  • Ground-breaking technology conceptualization, development and commercialization
  • Organizational architecture and corporate stakeholder alignment