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Session 2 Track B: Non-Traditional Drug Modalities
Session Chair(s)
Sarah J. Ryan
Senior Research Scientist, Small Molecule Design and Development, Lilly Research
Eli Lilly and Company , United States
This session will focus on two classes of non-traditional drug modalities, peptides and oligonucleotides. CMC professionals from Eli Lilly and Biogen will present on novel manufacturing platforms for peptide and oligonucleotide APIs. The regulatory challenges and ambiguities that surround these drug modalities will be discussed. Regulatory proposals and solutions will be suggested to inspire open discussion on the topic
Learning Objective : At the conclusion of this session, participants should be able to:- Understand peptide and oligonucleotide, non-traditional drug modalities
- Understand how peptide and oligonucleotide APIs are manufactured
- Appreciate the regulatory ambiguity that surrounds these non-traditional drugs
Speaker(s)
Biogen Platform Manufacturing Process for Antisense Oligonucleotides
Xianglin Shi
Biogen, United States
Scientist
Convergent Synthesis of Peptides as an Alternative Means of Production
Jennifer Groh
Eli Lilly and Company, United States
Consultant Engineer