Subject Matter Expert: First-in-Human
Jakob Bonde serves a Head of Regulatory Affairs, Small Molecules, at Lonza’s site in Visp, Switzerland, advising internal and external global customers on regulatory compliance and writing and reviewing Chemistry, Manufacturing and Controls (CMC) documentation for drug substances and drug products. Before joining Lonza in 2018, Jakob held Regulatory Affairs and Quality CMC positions in Pfizer, J&J/McNeil, Grünenthal, Mondobiotech, Medpace, and Clinipace. His areas of expertise include CMC writing and change control; clinical development consulting in typical and accelerated procedures; and global clinical trial start-up for chemical entities, biologics, and advanced therapy medicinal products (ATMPs). Jakob earned his Master of Science degree in Pharmaceutical Sciences at the University of Copenhagen. He then trained in the Novartis Nervous System Research Division, working with metabotropic glutamate receptors (mGluRs), and the Aarhus University Hospital Pharmacy, working on qualification of analytical equipment and development of analytical methods.