Organizations and their supply chains that are preparing to launch a new compound (chemical or biologic) are often physically prepared to support the launch but are often relying on many non-supply related functional groups to provide key information and support.  This puts both the plans and launch success at risk.

Supply Chain launch success means two things: 1) shipping product to customers at the desired time (be it 24 hours or 2 months) post approval and 2) uninterrupted product supply after the first shipments are completed.

How can you ensure that your supply chain is ready to support a launch?  One method is to develop a risk based, cross-functional, integrated project plan that details the activities required to deliver commercial product after approval.  Along with all the detailed (down to the hour) activities, the plan would include the risk/cost/benefit tradeoff decisions agreed to by the business, and contingencies/scenarios for new information.  By understanding the risks and the costs, all functional groups can decide what activities to risk beginning with and what the potential costs are.  Types of activities companies can decide to do at risk are package printing, primary labeling and package inserts.

We recently had a client ship product <24 hours post approval.  By understanding exactly what needed to happen, planning the time down to the hour, and taking calculated risks regarding printed materials and packaging timing, the company was able to get new competitive product to the market to meet urgent patient need.

To get started on your supply chain launch plans:

1. Identify key activities required to prepare and deliver first commercial product
2. Understand the risks associated with starting each activity before official approval
3. Work with vendors to understand costs and notification requirements for expedited work
4. Develop contingency plans in case of delays

What other techniques have you experienced to ensure supply chain launch readiness?

Mark Stesney

Tags: Risk Management, Supply Chain

This entry was posted on Tuesday, July 20, 2010 at 9:43 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site, or  Forward