Session-1A-Nonclinical-Track-OSWG-Summaries-and-the-Path-Forward

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Session 1A (Nonclinical Track): OSWG Summaries and the Path Forward

Session Chair(s)

Doug Kornbrust, PhD

President

Preclinsight, United States

Shwu-Luan Lee, PhD

Pharmacologist, Office of New Drug, CDER

FDA, United States

The Oligonucleotide Safety Working Group (OSWG) is an organization of industry and health authority professionals dedicated to advance the development of oligonucleotides. Included in this session will be OSWG summaries of recent activities and discussion from the OSWG Reproductive and Carcinogenic Risk Subcommittee and the Genetic Toxicology Subcommittee. The session will end with a panel discussion about future organizational and investigative directions for OSWG.

Speaker(s)

Considerations in Assessment of Reproductive and Developmental Risk for Oligonucleotide-based Therapies

Tacey E. White, PhD

Aclairo, Inc, United States

Senior Consultant

Final Recommendations of the OSWG Genetox Subcommittee: Standard Battery and Beyond

Cindy L. Berman, PhD

Berman Consulting, United States

Independent Consultant

Measurement and Prediction of Hybridization-induced Off-target Effects of Oligonucleotide Drug Candidates

Morten Lindow, PhD

Santaris Pharma A/S, Denmark

Group Leader, Integrative Systems Biology

Panelist

David H. Schubert

DH Schubert Regulatory Solutions LLC, United States

Panelist

Jennifer Marlowe, PhD

bluebirdbio, United States

Senior Director, Preclinical Development

Panelist

Arthur A. Levin, PhD

Avidity Biosciences , United States

CSO

Panelist

Scott Henry, PhD

Ionis Pharmaceuticals, Inc., United States

Vice President, Nonclinical Development

Panelist

Rosanne Seguin, PhD

McGill University, Canada

Panelist

Cindy L. Berman, PhD

Berman Consulting, United States

Independent Consultant

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