past Tuesday Autodesk conducted its annual Manufacturing Analyst Day event in
Lake Oswego, Oregon, and I had the opportunity to catch up with executive
leaders across the company’s spectrum of product brands (i.e. Alias for
conceptual design, AutoCAD and Inventor for engineering design, and, more
recent acquisition additions, MoldFlow and Algor for simulation). Contrary to
my original perception that Autodesk offers affordable, no-frills product design
tools to lots of smaller, mom-and-pop companies, I learned that their business
is significantly shifting to include more direct sales to large,
enterprise-level manufacturers like Intel, Nestle, and Parker Hannifin. In
fact, approximately a quarter of Autodesk’s manufacturing business now comes from
customers with over $2 billion in annual revenues, and it’s their fastest
growing segment within this vertical.
This Tuesday, the California State Board of Pharmacy decided to delay the implementation of electronic pedigree requirements for prescription drugs from the previous 2009 deadline to 2011. The state’s announcement carries some added significance at a national level; under direction from the FDA, other states like Florida and Utah have moved forward with similar pedigree rules as a means to thwart counterfeiting, but California’s e-pedigree legislation — and particularly the requirement to serialize all packaged items of prescription drugs sold within the state — is the most comprehensive and far-reaching to date. Companies at every stage in the pharmaceutical supply chain (e.g. manufacturers, distributors, and pharmacies) as well as other stakeholders (e.g. technology firms, standards organizations, other regulatory bodies, etc.) have been keeping tabs on California’s industry-leading legislation and enforcement timeline with keen interest.
Forrester sees the implementation delay as being inevitable. California’s serialization rule requires that each sellable unit of prescription drugs must have a unique identification number established at the point of manufacture. Then, as these items are distributed throughout the pharma supply chain, ePedigree requires information on the packaging hierarchy (i.e. which items are packed in each case) and master data context (i.e. original batch, lot, expiration, and NDC data), and change of ownership (i.e. shipping and receiving transactions) must be is captured electronically by each trading partner through an interoperable system. It’s by no means simple, and two fundamental questions have remained largely unresolved, and are thus standing in the way of pharma companies agreeing on a consensus technology approach: