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DIA/FDA Oligonucleotide-Based Therapeutics Conference

Session 4 Track C: Developing Oligonucleotides with Current CMC Guidelines and an Introduction to EPOC

Session Chair(s)

Nigel R. Richardson, PhD

Nigel R. Richardson, PhD

  • Head Analytical Technology & Automation, CMC Analytical
  • GlaxoSmithKline, United Kingdom

There is currently no regulatory guidance specifically for the development of oligonucleotide therapeutic agents, and as a result existing small molecule guidance is interpreted by sponsors. This, and the lack of consensus in approach within the pharmaceutical industry can lead to duplication of effort resulting in inefficiencies for both industry and regulatory agencies. The session will provide an overview of key CMC development topics which would benefit from harmonization and sharing of prior knowledge and will contain detailed examples of industry collaboration on focused topics. The collaborative work discussed in the session has been initiated by the European Pharma Oligonucleotide Consortium (EPOC), an example of how industry is collaborating to pool experience, share data, and publish in oligonucleotide development topics to drive consensus and engagement with the regulator environment.

Learning Objective :

At the conclusion of this on session, participants should be able to:

  • Evaluate the impact resulting from the application of current small molecule regulatory guidance to oligonucleotide development
  • Identify and understand where within the industry, work is on-going to share prior knowledge to build a path to consensus and shared understanding for future oligonucleotide specific guidance


William F. Kiesman, PhD

Stating Materials

William F. Kiesman, PhD

  • Senior Director
  • Biogen, Inc., United States
Nadim  Akhtar, PhD

ID Testing

Nadim Akhtar, PhD

  • Principle Scientist
  • AstraZeneca, United Kingdom
Rohit  Tiwari, PhD


Rohit Tiwari, PhD

  • Chemist
  • FDA, United States
Lubomir  Nechev, PhD


Lubomir Nechev, PhD

  • Vice President, Process Sciences
  • Alnylam Pharmaceuticals, United States
Hiroshi  Takeda, PhD, MS


Hiroshi Takeda, PhD, MS

  • Technical Officer
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan