Shawn Roach

Associate Principal Consultant, Regulatory CMC at Halloran

Speaker

Shawn has been working in Regulatory Chemistry, Manufacturing, and Controls (Reg CMC) since 2012. Dr. Roach has a broad background in Reg CMC, spanning the development process from the very early stage, including preparation & submission of pre-IND packages through all phases of clinical development up to and including initial commercialization work immediately after approval. Therapeutic modalities he has provided Reg CMC support on include live biotherapeutic products (LBPs), oligonucleotides/RNAi drugs, nanoparticles, monoclonal antibodies, peptides, and small molecules.

Before transitioning to Regulatory CMC work, he worked in drug development as an analytical chemist at multiple startup companies in the US. Dr. Roach worked on one of the first oligonucleotide drugs to be approved, Macugen, and has provided Reg CMC support on two other of the dozen or so oligonucleotide therapeutics that have received marketing approval globally. As a post-doctoral fellow, Dr. Roach helped to develop a high throughput oligonucleotide synthesizer, the MerMade, in support of the Human Genome Project. The MerMade has since become an industry-standard technology for small-scale, high-throughput oligosynthesis.