Learning Tracks

Advanced manufacturing technologies (AMTs) may offer benefits to the pharmaceutical industry, but have all long-term implications been explored? Will these advanced manufacturing technologies result as intended in the lower cost of manufacturing, higher quality output, increased reliability of supply, lower prices, and bringing pharmaceutical manufacturing back to the U.S.? This session will explore how AMTs could change the pharmaceutical process and quality considerations for drug substances and drug products. Industry representatives will offer perspectives on potential, unintended implications of the adoption of AMTs, while FDA will share updates on their learnings with AMTs and expectations going forward not only from a manufacturing perspective but also from a quality perspective (e.g., management of life cycle activities (e.g., facility changes), investigation of adverse events; and audits). This session also will touch on the International Council for Harmonisation’s guideline on continuous manufacturing (ICH Q13).

Moderator: David Gaugh, RPh
Executive Vice President for Sciences and Regulatory Affairs, AAM

Speaker:
Sau “Larry” Lee, PhD
Deputy Director Science, OPQ, CDER, FDA

Panelists:
Atul Dubey
Senior Principal Scientist- General Chapters, USP

Navin Vaya, PhD
Senior Director, Formulation Development Solid Dose, Apotex Inc.