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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

  • ODE 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

  • Senior Toxicology Project Leader
  • Roche, Denmark
Lauren  Mihalcik, PhD

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

Lauren Mihalcik, PhD

  • Senior Scientist, Toxicologist | Comparative Biology and Safety Sciences
  • Amgen, United States
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

  • Director, Toxicology
  • Bristol-Myers Squibb, United States
Yoko  Hirabayashi, MD


Yoko Hirabayashi, MD

  • Director, Center for Biological Safety & Research
  • National Institute of Health Sciences (NIHS), Japan