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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)
Identification of Starting Materials for Oligonucleotides by Applying ICH Q11
Timothy Watson, PhD
Gilead Sciences, United States
Vice President- Head of CMC Regulatory Affairs
Integrating LNA Phosphoramidites into the Regular Supply Chain
Christoph Rosenbohm, PhD, MBA
Roche Innovation Center Copenhagen, Denmark
Vice President, Head of Discovery Operations
GalNAc Solid Support as Starting Material for Oligonucleotide Manufacturing
Lubomir Nechev, PhD
Alnylam Pharmaceuticals, United States
Sr. Vice President, CMC Development
Panel Discussion
All Session Speakers, United States
Panelist
Olen M. Stephens, PhD
FDA, United States
Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP
Panelist
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
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