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Session 9 Track 3: Innovative Manufacturing Approaches and Regulatory Implications
Session Chair(s)
Ramin Darvari, PhD, MS
Research Fellow
Pfizer Inc., United States
Rohit Tiwari, PhD
Director, Global Regulatory Affairs-CMC
Eli Lilly & Company, United States
Continuous improvement in manufacturing of nucleic acid-based modalities requires innovative approaches, with the potential for introduction of new challenges, including the regulatory implications. This session will feature some of the recent innovative manufacturing approaches, along with a panel discussion to highlight the current regulatory landscape and identify prospects in closing potential gaps in understanding.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the critical risk factors associated with innovative manufacturing approaches
- Recognize and identify the relevant CMC challenges during the development stages
- Learn about developmental and regulatory considerations in mitigating the CMC risks
Speaker(s)
Solvent and Reagent Reuse in Solid Phase Oligonucleotide Synthesis
Martin "Marty" Johnson, PhD
Eli Lilly, United States
Vice President, Engineering
A Ligation Platform Approach to Enzymatic Oligonucleotide Assembly
Doug Fuerst, PhD
GSK, United States
Senior Director Drug Substance Development
Revolutionizing Nucleic Acid Manufacturing: Showcasing a Cutting-Edge Platform for Fully synthetic Cell-free Production of Nucleic Acids
Joe Russo
Pfizer, Inc. , United States
Senior Principal Scientist/Group leader
Speaker
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Quality Assessor
Speaker
Paresma (Pinky) Patel, PhD
FDA, United States
Division Director, Office of Product Quality Assessment III