- Examine approaches to accelerate the pace of biopharmaceutical development across multiple platforms and modalities
- Clinical development velocity can affect CMC approaches, and what we’ve learned through this experience
- How does acceleration impact our quality, regulatory, and development functions?
- Understanding acceleration effects on process monitoring and analytics throughout the product lifecycle
- Discuss what steps we, as an industry, will need to take together to make this the new normal
EVP Translational Sciences,
Chief Quality Operations Officer
John Pinion has over 26 years of global experience leading biologic, small molecule pharmaceutical, gene therapy and device operations across Asia, Europe and the Americas. His expertise and leadership spans engineering, quality, manufacturing and translational sciences. He joined Ultragenyx in July 2015 and currently holds the role of EVP, Translational Sciences and Chief Quality Operations Officer. Mr. Pinion provides leadership for Ultragenyx’s translational sciences functions to include Pharmacology and Toxicology, Research and Bioanalytical Development, as well as GxP Quality and Compliance and CMC Analytical Development and QC.
As a key member of Ultragenyx’s executive leadership team reporting directly to the organization’s CEO, he also contributes to ongoing business development, clinical development, commercial and strategic planning activities.
In the ten years prior to joining Ultragenyx, Mr. Pinion held roles of increasing responsibility at Genentech (subsequently Roche post Genentech acquisition), departing the organization as Senior Vice President and Global Head of Quality and Compliance for Pharma Technical Operations based in Basel, Switzerland.
Previous to Genentech, Mr. Pinion spent 17 years in operational and senior leadership roles in Baxter International’s Renal, Bioscience, Parenterals and Device divisions.
John currently sits on the Board of Directors and has served as the Chair of the Audit and Risk Committee of Aroa Biosurgery Ltd, a soft tissue repair company commercializing regenerative tissue substitutes based in Auckland, New Zealand. He holds a B.S. in Mechanical Engineering from West Virginia University and lives in Northern California with his wife and two sons.