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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 9: ON Therapeutic Survey Sponsored by EFPIA

Session Chair(s)

Paul C. Brown, PhD

Paul C. Brown, PhD

Associate Director for Pharmacology and Toxicology, OND, CDER

FDA, United States

Laurence  Whiteley, DVM, PhD

Laurence Whiteley, DVM, PhD

Senior Director, Global Pathology Team Leader

Pfizer Inc, United States

Representatives from the European Federation of Pharmaceutical Industries and Associations (EFPIA) will present findings of a recent survey they conducted about oligonucleotide therapeutic development. Industry insights will be presented on considerations related to the toxicological evaluation of oligonucleotides. The industry perspective regarding the need for and possible content of a regulatory guidance on oligonucleotide therapeutics will be presented. A group of regulatory and industry representatives and the audience will discuss the need for possible content of a regulatory guidance on oligonucleotide therapeutics. This discussion will draw on the EFPIA survey and other information presented earlier in the meeting such as the PMDA presentation.


Yann  Tessier, DVM

What Is Everyone Else Doing? Learnings and Surprises From the EFPIA Oligo WG Survey

Yann Tessier, DVM

Roche, Denmark

Senior Toxicology Project Leader

Lauren  Mihalcik, PhD

Guiderails for Oligo Development: Industry Perspectives on an Oligo-Specific Guidance From the EFPIA Oligo WG Survey

Lauren Mihalcik, PhD

Amgen, United States

Senior Scientist, Toxicologist | Comparative Biology and Safety Sciences

William E. Achanzar, PhD

Two Species or Not Two Species (And Other Toxicology Considerations): Insights From the EFPIA Oligo WG Survey

William E. Achanzar, PhD

Bristol-Myers Squibb, United States

Director, Toxicology

Yoko  Hirabayashi, MD


Yoko Hirabayashi, MD

National Institute of Health Sciences, Japan

Division Head

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