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CMC 00:00 - 00:30
Development of novel modality peptide drug: tissue regeneration-inducing medicine
- Roman Hillebrand, Ph.D. - Senior Innovation Scientist, Nitto Denko Avecia
CMC 00:30 - 01:00
Preparation of Anti-Sense Oligonucleotide (ASO) via Hybrid Synthesis
- Xuan Zhou - Associate Director, ASO Process Chemistry Lead, Biogen
CMC 01:00 - 01:30
Next Generation Manufacturing Process for siRNA
- Joshua Brooks, PhD - Director, Process Sciences, Alnylam Pharmaceuticals
CMC 01:30 - 02:00
Solvent and Reagent in-situ Reuse in Solid Phase Oligonucleotide Synthesis
- Jessica Zelinski - Senior Engineer, Process Development, Eli Lilly and Company
CMC 02:00 - 02:30
Emerging Approaches to Enzymatic Synthesis of Nucleic Acids
- Marcel Hollenstein, PhD - Head of Research Unit, Institut Pasteur
CMC 02:30 - 03:00
Meeting the Manufacturing Needs of Nucleic Acids Used in Modern Medicines: Novel and Efficient Enzymatic Processes for mRNA and Oligonucleotide Synthesis
- Helge Zieler - CEO, Primrose Bio
CMC 03:00 - 03:30
Solving the Scale Problem: Template-independent Enzymatic Synthesis of siRNA Oligonucleotides
- Daniel Ahlstedt - Chief Operating Officer and Co-Founder, EnPlusOne Bio
CMC 03:30 - 04:00
Merging New Technologies to Advance the Synthesis of Oligonucleotides
- Scott May, PhD - VP Chemistry - Genetic Medicine, Eli Lilly and Company
CMC 04:00 - 04:30
Purification Scale up: A Case Study of Volume-Based Scale-Up Approaches in Oligonucleotide Chromatography
- Stephen Dietrich - Associate Director, RNA Process Development, Sarepta Therapeutics
CMC 04:30 - 05:00
Regulatory Guideline Development for Oligonucleotides
- René Thürmer, PhD - Deputy Head, BfArM Federal Institute for Drugs & Medical Devices
CMC 05:00 - 05:30
Comparing Analytical Strategies for Diastereomer Profiling of a Fully Thiolated ASO
- Matthew Quinn - Manager, Analytical Development, Global Nucleic Acid Therapies, Novo Nordisk
CMC 05:30 - 06:00
Development of a Kilogram-Scale Manufacturing Route for Guadecitabine: A Dinucleotide DNA Methyltransferase Inhibitor
- Yogesh Sanghvi, PhD - President, Rasayan Inc.
CMC 06:00 - 06:30
NMA Manufacturing Process Development
- Carter Cooperman - Research Associate II, Ionis
CMC 06:30 - 07:00
Oligonucleotide Purification and CMC Strategies – Increasing Efficiencies/Overcoming Challenges
- Robert Gronke, PhD - Senior Principal Scientist, Biogen, Inc
CMC 07:00 - 07:30
PMO Impurity Characterization and Control Strategy
- Bao Cai, PhD - Executive Director, Process Development, Sarepta Therapeutics
CMC 07:30 - 08:00
Sustainable Manufacturing: Considerations for mRNA Therapeutics vs mRNA Vaccines
- Harris Makatsoris - Academics Professor of Sustainable Manufacturing Systems, King's College London
CMC 08:00 - 08:30
The Impact of Manufacturing Innovation on Clinical Development: Manufacturing Controls and Regulatory Strategy
- Martin Johnson, PhD - Vice President, Engineering, Eli Lilly
CMC 08:30 - 09:00
Establishing an RNAi Production Strategy for Large Indications
- Kurt Vagle - Senior Director - Chemical Development RNAi CMC, Novo Nordisk
CMC 09:00 - 09:30
A Unified Platform for the Online Determination of Multiple mRNA Quality Attributes
- Alexandre Goyon, PhD - Principal Scientist, Genentech
CMC 09:30 - 10:00
ISPE Baseline Guide for Oligonucleotide Facility Design
- Francis Ring - Director of Manufacturing & Operations, Ionis Pharmaceuticals
- Jim Love - Life Sciences Market Director, Oligo/Peptide, CRB