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Session 3A: Starting Materials: Beyond Simple DNA and RNA Derived Phosphoramidites
Session Chair(s)
Fran Wincott, PHD
President, United States
There has been a dramatic increase in the complexity of drug candidates being promoted into preclinical and clinical development. These oligonucleotides often have significant chemical modifications requiring specialty starting materials. Furthermore, recent communications from regulatory authorities regarding the selection and justification of starting materials have been issued. This session will address the general starting material principles outlined in Q11 and the accompanying Q&A document. In addition, strategies for defining and sourcing non-standard oligonucleotide-specific starting materials will be presented. The presentations will be followed by a 30 minute panel discussion.
Learning Objective :
Speaker(s)
Timothy Watson, PHD
Vice President- Head of CMC Regulatory Affairs, Gilead Sciences, United States
Identification of Starting Materials for Oligonucleotides by Applying ICH Q11
Christoph Rosenbohm, PHD, MBA
Vice President, Head of Discovery Operations , Roche Innovation Center Copenhagen, Denmark
Integrating LNA Phosphoramidites into the Regular Supply Chain
Lubo Nechev, PHD
Chief CMC Officer, Alnylam Pharmaceuticals, United States
GalNAc Solid Support as Starting Material for Oligonucleotide Manufacturing
Panel Discussion
, All Session Speakers, United States
Olen M. Stephens, PHD
Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP, FDA, United States
Panelist
René Thürmer, PHD
Quality Assessor, Federal Institute for Drugs and Medical Devices, Germany
Panelist