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

25+ years biopharmaceutical executive leader and industry innovator

Starting his career as a pharmaceutical process R&D laboratory scientist, Michael K. O’Brien worked his way up to leadership roles in pharmaceutical operations and new technology research, development and commercialization at companies including Wyeth and Pfizer before founding NGT BioPharma Consultants in 2017. His expertise extends to all stages and dimensions of drug development, including API and drug product R&D, technology transfer, regulatory CMC, digital/data technology development, and manufacturing technology innovation.

Michael frequently serves as an invited speaker at international conferences and symposiums. In 2019, he was named an Industry Influencer on The Medicine Maker 2019 Power List.

HIGHLIGHTS

• Championed and led a program to design, fabricate and implement a modular, continuous oral solid dose manufacturing facility that was built off-site, assembled in a warehouse, is transportable and currently produces drug product supplies for an FDA approved oncology drug. The miniature factory, referred to as PCMM, won the 2016 ISPE Facility of The Year Award.
• As the acting head of a 200+-person, large biopharma Chemical Development organization, Michael was responsible for the cGMP Kg-laboratories, Pilot Plant, API external supply group, EH&S team, and Synthesis R&D groups.
• An agent for strategic change who utilized well thought out business cases and stakeholder alignment processes to secure senior management support for status quo transformation.
• Enabled the development of critical digital, analytical, drug substance and drug product platform technologies through internal/external collaborative business models, leading to their implementation into CMC operations.
• More than 55 publications, presentations and patents.

EXPERTISE

• API and drug product research, development and commercialization
• Organizational and operational excellence
• Innovative technology platform design and implementation
• Collaborative, expert-network building

EXPERIENCE

• President & CEO, NGT BioPharma Consultants
• Vice President Pharmaceutical Sciences Technology & Innovation,
  Pfizer Pharmaceutical
• Assistant Vice President, Wyeth Chemical Development
• U.S. Head Chemical Process Research, Rhone-Poulenc Rorer/Aventis
  (now Sanofi Pharmaceuticals)
• Research Scientist, Hercules Inc.

EDUCATION

• PhD, Organic Chemistry Case Western Reserve University
• BA, Ohio Wesleyan University

ACCOMPLISHMENTS

• Industry Influencer, Medicine Maker 2019 Power List
• Outstanding Alumnus of Chemistry, Case Western Reserve University,2017
• Chair, ISPE API CoP (Science Based Regulatory Subcommittee, 2012 – 2014
• Member, PhRMA API Technical Group, 2006 – 2011
• Chair, Philadelphia Organic Chemistry Club, 1997 – 1999