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TIDES USA: Oligonucleotide & Peptide Therapeutics
SEE YOU NEXT YEAR: May 7-10, 2023 | In-Person + Digital
San Diego, CA, USA

Michelle O'Brien
Director Global Regulatory Affairs CMC at Biogen

Profile

Michelle O’Brien is an experienced regulatory professional with over 20 years in the globally regulated pharmaceutical industry within Regulatory CMC and Product Quality Management.  Michelle has worked to develop global CMC regulatory strategies for small molecule and antisense oligonucleotide (ASO) drugs at all stages of development: first in human through commercialization. Her focus has been on late stage synthetic molecules, leading several teams in successful global registration of multiple products in established and emerging markets. She currently has the role of Director, Global Regulatory CMC at Biogen. Michelle holds a BS and MS in Chemistry.

Agenda Sessions

  • Regulatory CMC Strategies for a Late Stage Oligonucleotide Program

    4:15pm