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, technology-savvy business executive with over 25 years of biopharmaceutical industry research and development experience.

From 2001 through 2010, Michael served as the AVP of Wyeth’s Synthesis Research & Development (SR&D) group and as the acting head of Chemical Development, overseeing the cGMP Kg-laboratories, Pilot Plant, SR&D, EH&S, and the API External Supply departments. After the 2010 acquisition of Wyeth, Michael transitioned to become Pfizer’s Pharmaceutical Sciences Vice President of Technology & Innovation, where his diverse group of scientific leaders and technology experts developed and managed the Pharmaceutical Sciences technology strategy. The teams’ activities included creating and leveraging innovative funding approaches to address Pfizer’s future-state API, drug product, analytical, and digital technology capabilities. The creation and management of multi-party external alliances directed towards the design, development, and implementation of high-value technology platforms reinforced the teams’ efforts, resulting in several very successful platform implementations. Notably, Michael championed the design, fabrication, and implementation of a portable, continuous, miniature, and modular (PCMM) solid oral dose manufacturing facility.  The first of its kind facility 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.

After leaving Pfizer in early 2018, Michael decided to leverage his decades of scientific expertise, leadership experience, and entrepreneurial endeavors to establish an innovative and transformative consulting firm, NGT BioPharma Consultants, founded in late 2018, was created to partner with life sciences companies of all sizes, offering strategic advice, ‘boots on the ground’ assistance, and outsourcing solutions. The company’s leaders, experts, and professionals are strategically focused on biopharmaceutical drug development and the advanced technologies foundational to the industry’s development & manufacturing of medicines.

Over the years, Dr. O’Brien has received many awards and recognitions, including Case Western Reserve University’s prestigious 2017 Department of Chemistry Outstanding Alumnus Award and being named an Industry Influencer on The Medicine Maker 2019 Power List. His contributions to the public domain include more than 60 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