Background

Aerie Canal Consulting, LLC, founded by Monte Levinson, is based in Seattle.

In his 20-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, 20 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 published by FDAnews.

 

What's In a Name?

When I started work as a consultant, my office was near the junction of the Seattle Ship Canal and Puget Sound. I could see the Hiram Chittenden Locks that separate the fresh water of the Canal from the salt water of the Sound. Topping off the view is a railroad drawbridge that raises to allow boats to pass, and lowers to let trains go by. It's a non-stop canvas of centuries-old transportation operating with modern engineering efficiency. Presiding over this outlook is a bald eagle's nest, or aerie. In the summer, the eagles feast on salmon journeying up the canal to their spawning grounds. The most exciting time of year is when the baby eagles fledge. Since the young eagles don't fly well, they have lots of extra feathers, making them look even bigger than the adults.

This setting provides a model for my approach to Regulatory Operations: day-to-day operations must be robust, reliable, and efficient, like the Locks, but they must be developed with a far-reaching vision, like the eagle's. The strategies put in place today will become the operational norms of the future.