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Session 9: ON Therapeutic Survey Sponsored by EFPIA
Session Chair(s)
Paul C. Brown, PhD
Associate Director for Pharmacology and Toxicology, OND, CDER
FDA, United States
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.
Speaker(s)
What Is Everyone Else Doing? Learnings and Surprises From the EFPIA Oligo WG Survey
Yann Tessier, DVM
Roche, Denmark
Senior Toxicology Project Leader
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
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
Panelist
Yoko Hirabayashi, MD
National Institute of Health Sciences, Japan
Division Head