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Bethesda North Marriott Hotel and Conference Center

Apr 25, 2022 7:00 AM - Apr 27, 2022 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!

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

Session Chair(s)

Daniel  Capaldi, PhD

Daniel 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


Dominik  Altevogt, PhD


Dominik Altevogt, PhD

Novartis, Switzerland

Associate Director Regulatory Affairs CMC

Brian  Dooley, MPharm, MSc


Brian Dooley, MPharm, MSc

European Medicines Agency, Netherlands

Quality Specialist

Ashley  Boam, MS


Ashley Boam, MS

FDA, United States

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER

Lubomir  Nechev, PhD


Lubomir Nechev, PhD

Alnylam Pharmaceuticals, United States

Cjief CMC Officer

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