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Session 7: Interactive Discussion of Clinical, Nonclinical and CMC Issues and Learnings
Session Chair(s)
Kim Tyndall
President
CMC Tyndall Consultant LLC, United States
During this session the audience will interact with a panelists to discuss current and future concerns in the development of Oligonucleotide programs. The open discussion will focus on a set of questions and topics that have been predetermined by attendees prior to the conference and will include examples from case studies as well as complications faced by regulators.
Speaker(s)
Panelists
Scott Henry, PhD
Ionis Pharmaceuticals, Inc., United States
Vice President, Nonclinical Development
Michael Hodges, MD
Arcturus Therapeutics, United States
Independent Consultant
Arthur A. Levin, PhD
Levin BioScience, United States
Senior Consultant
Ramesh Raghavachari, PhD
FDA, United States
Chief, Branch I, DPMA1, OLDP, OPQ, CDER
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Paul Agris, PhD
The RNA Institute - University of Albany - SUNY, United States
Professor of Biological Sciences and Chemistry, Director
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