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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)
Yann Tessier, DVM
Senior Toxicology Project Leader, Roche, Denmark
What Is Everyone Else Doing? Learnings and Surprises From the EFPIA Oligo WG Survey
Lauren Mihalcik, PhD
Senior Scientist, Toxicologist | Comparative Biology and Safety Sciences, Amgen, United States
Guiderails for Oligo Development: Industry Perspectives on an Oligo-Specific Guidance From the EFPIA Oligo WG Survey
William E. Achanzar, PhD
Scientific Executive Director, Nonclinical Safety, Bristol Myers Squibb, United States
Two Species or Not Two Species (And Other Toxicology Considerations): Insights From the EFPIA Oligo WG Survey
Yoko Hirabayashi, MD
Division Head, National Institute of Health Sciences, Japan
Panelist
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