Learning Tracks

Recent advances in biopharmaceutics risk assessment are reshaping how industry and regulators evaluate oral solid dosage forms and their clinical performance. This session will explore the FDA’s evolving biopharmaceutics risk assessment framework and its implications for generic drug development and regulatory decision-making. Discussion topics will include the transition of dissolution testing from a traditional quality control measure to a more clinically predictive tool, as well as approaches for assessing the impact of material attributes, formulation and manufacturing variables, and gastrointestinal physiological conditions on in vivo dissolution and systemic absorption. Speakers will examine how products are categorized across varying levels of biopharmaceutics risk and how those risk classifications may inform dissolution testing strategies, bioequivalence considerations, and associated regulatory expectations. This session will provide attendees with insight into emerging scientific and regulatory thinking, opportunities for industry alignment, and practical considerations for implementing risk-based biopharmaceutics approaches in oral solid dosage form development.

Moderator: Emilija Fredro-Kumbaradzi, PhD
Director, Biopharmaceutics & Statistics, Apotex Inc.

Biljana Jankovic, PhD
Head of Pharmaceutical Research, Sandoz

Bhagwant Rege, PhD
Division Director, OPQA I, OPQ, CDER, FDA

Fang Wu, PhD
Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Hailing Zhang, PhD
Division Director, OPQA II, OPQ, CDER, FDA