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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

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

DIA/FDA Oligonucleotide-Based Therapeutics Conference

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

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

Biogen, Inc., United States

Senior Director

Nadim  Akhtar, PhD

ID Testing

Nadim Akhtar, PhD

AstraZeneca, United Kingdom

Principle Scientist

Rohit  Tiwari, PhD


Rohit Tiwari, PhD

Eli Lilly & Company, United States

Senior Research Scientist, Global Regulatory Affairs-CMC

Lubomir  Nechev, PhD


Lubomir Nechev, PhD

Alnylam Pharmaceuticals, United States

Cjief CMC Officer

Hiroshi  Takeda, PhD, MS


Hiroshi Takeda, PhD, MS

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Technical Officer

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