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DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 3 Track 3: Platform Approaches and the Application of Prior Knowledge to the Development of Therapeutic Oligonucleotides

Session Chair(s)

Daniel Capaldi Capaldi, PhD

Daniel Capaldi Capaldi, PhD

  • Vice President, Analytical and Process Development
  • Ionis Pharmaceuticals, Inc, United States
Monica Cooper, PhD

Monica Cooper, PhD

  • Review Chemist, ONDP, OPQ, CDER
  • FDA, United States
Synthetic therapeutic oligonucleotides are commonly manufactured using the same basic unit operations, i.e., solid phase synthesis, cleavage, purification, and isolation. The platform nature of oligonucleotide manufacturing provides opportunities to streamline process development and expedite regulatory submissions through the application of prior knowledge. The session will include presentations from regulatory authority and industry scientists. The presentations will be followed by a panel discussion. Topics for discussion may include how best to define prior knowledge, the areas and extent to which prior knowledge may be applied, limitations and issues associated with the application of prior knowledge, and how such information might be presented in regulatory filings.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Define prior knowledge
  • Discuss how prior knowledge can be leveraged to facilitate therapeutic oligonucleotide development
  • Describe any limitations and issues associated with the application of prior knowledge

Speaker(s)

Dominik Altevogt, PhD

Speaker

Dominik Altevogt, PhD

  • Associate Director Regulatory Affairs CMC
  • Novartis, Switzerland
Brian Dooley, MPharm, MSc

Speaker

Brian Dooley, MPharm, MSc

  • Quality Specialist
  • European Medicines Agency, Netherlands
Ashley Boam, MS

Panelists

Ashley Boam, MS

  • Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
  • FDA, United States
Lubomir Nechev, PhD

Panelists

Lubomir Nechev, PhD

  • Sr. Vice President, CMC Development
  • Alnylam Pharmaceuticals, United States

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