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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

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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

Speaker(s)

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

Panelist

Rohit Tiwari, PhD

Eli Lilly & Company, United States

Senior Research Scientist, Global Regulatory Affairs-CMC

Lubomir Nechev, PhD

Panelist

Lubomir Nechev, PhD

Alnylam Pharmaceuticals, United States

Sr. Vice President, CMC Development

Hiroshi Takeda, PhD, MS

Panelist

Hiroshi Takeda, PhD, MS

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Technical Officer

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