photo by Tom Wolken
Aerie Canal Consulting, LLC, founded by Monte Levinson, is based in Seattle.
In his 15-plus years in Regulatory Operations and Regulatory IT positions, Monte has been responsible for producing hundreds of submissions, including successful marketing applications for commercial products that currently generate over $7 billion in annual revenue.
Monte has experience implementing publishing and document management tools from several vendors, and was one of the first Regulatory Operations professionals to use outsourcing and staff augmentation services to produce regulatory submissions. He led enterprise document management programs at two of the top biotechnology companies in the US, and led a similar project at an early phase company.
Monte began his biotech career at Genzyme, where he published the clinical sections of the Cerezyme NDA, and then initiated and led the enterprise document management program that is still going strong, 15 years later.
After Genzyme, Monte moved to Amgen, where he led the publishing teams for Aranesp and then Neulasta, which was Amgen’s first fully electronic submission. He was the leader of the DECADE program, a Documentum-based system that included Clinical and Regulatory archives, submission management, and support for product development teams. While at Amgen, Monte started the IT Group at the Biotechnology Industry Organization (BIO) and was a BIO representative to the PDUFA III IT negotiations with the FDA.
Most recently, Monte worked at ZymoGenetics, in Seattle, where he led the transition to eCTD, published the Recothrom BLA, implemented the Electronic Submission Gateway, and led the implementation of Livelink to support Clinical, Preclinical, Regulatory, and product teams.
Monte has presented at industry conferences on subjects including “Document Management Vendor Selection”, “Paper vs. Electronic Submissions”, and “Preparing a Company’s First eCTD IND.” He and his Regulatory Operations team at ZymoGenetics contributed a chapter on eCTD IND to the book, Preparation and Maintenance of the IND Application in eCTD Format, which was published in 2008 by FDAnews.