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Ben McLaughlin, MSE

Principal Consultant
Amylaza Consulting, LLC

Ben McLaughlin is the Principal Consultant at Amylaza Consulting, where he provides Reg CMC and CMC operations consulting services to advance programs across the development lifecycle. Ben has played a key role in helping clients bring numerous novel therapies to first-in human clinical trials and has helped receive commercial regulatory approvals across the globe. Ben has successfully led teams in gene-to-clinic programs, late-stage tech transfers, and in authoring CMC sections for various regulatory submissions, including INDs, BLAs, MAAs, and post-approval variations for biologics and combination products. He has than 20 years of industry experience crossing multiple modalities: small molecules, enzyme replacements, antibodies, fusion proteins, ADCs, plasma-derived, and cell and gene therapies.
Ben has a BS, and MS in Chemical Engineering. Prior to entering consulting, Ben held CMC positions of various levels of responsibility at Eli Lilly, Alnara Pharmaceuticals, Altus Pharmaceuticals, and Millipore Corporation.

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