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10:00 - 10:30 30 mins
10:30 - 10:40 10 mins
Chairperson's Opening Remarks
  • Susann Rosmus - Nucleic Acid Technologies-Head of Quality Management, BioSpring GmbH
10:40 - 16:30 350 mins
Oligonucleotide Therapeutics – Defining and Managing CMC Activities
  • Kevin Fettes - Principal and Founder, FTS Pharma Consulting, LLC
  • Yogesh Sanghvi - President, Rasayan Inc.
  • Susann Rosmus - Nucleic Acid Technologies-Head of Quality Management, BioSpring GmbH

Workshop will achieve the following:

This highly strategic, introductory workshop will address cost of raw materials, manufacturing challenges and manufacturing activities to support a successful IND/IMPD submission towards initiation of clinical studies for oligonucleotide therapeutics. Participants will gain broad understanding of the regulatory CMC requirements and hurdles for oligonucleotide therapeutics in the US, Europe, Canada and Asia.

Who should attend?

Anyone interested in preclinical/clinical development of oligonucleotide therapeutics including scientists in R&D, manufacturing, quality control, quality assurance, project management, business development and regulatory affairs.

General Workshop Overview:

  • 3 talks, 45 minutes each presentation followed by 15 minutes discussion
  • 45 minute open discussion
  • Manufacturing: Synthesis chemistry overview
  • Manufacturing: Raw material cost development
  • Manufacturing: Considerations to manufacture clinical trial materials for phase 1
16:30 - 16:35 5 mins
End of Conference Day 1