Rob Ju

Background

About Rob Ju

Dr. Ju is recognized for his in-depth knowledge and experiences in both formulation and dissolution method development, as his teams were directly responsible for the formulation development of 7 NDAs and dissolution method development of 6 NDAs. He is a Director at Abbvie where he established and leads the Drug Release and Product Performance group with focuses on in silico modelling, biopharmaceutics tools, and cross-functional alignment. Extensive interactions with global regulators on the evolving and somewhat divergent reequipments of dissolution related to discrimination, biowaiver, safe space, IVIVC (two approved IVIVCs) and PBPK/PBBM modelling (two approved PBPK models). Recognized expertise in biopharmaceutics, in silico modelling, various modified release formulations, pediatric formulations, amorphous solid dispersion, and FDC technologies for challenging molecules. Patents filings and litigation. Experiences with eye care products (implants and eye drops) and high-concentration biologics. Broad-based understanding of drug product development including knowledge management, clinical supplies, risk assessment, compliance, and regulatory functions. Dr. Ju founded the Pediatric Working Group and chaired the Drug Product Leadership Group of IQ Consortium. He was inducted to the prestigious Vowiler Society within AbbVie, sat in the Scientific and Education Board of NIPTE, and an Adjunct Professor of Roosevelt University. In leisure, Rob enjoys coaching sport teams, working out in the gym, and reading.