It was emphasized that close collaboration between Supply Chain, Commercial and Regulatory Affairs, with participation by Product/Program Management, is always important but critically so during launch planning and execution. The traditional autonomy of Clinical Trials, Manufacturing and Commercialization can be integrated to significantly improve cost, time, quality and success of drug development and delivery.

Several factors should be considered for a successful new product launch, namely...

Within the context of these elements, the Supply Chain team must consider and manage demand, supply, master data and the supply chain business processes.

 

Demand Management: As is standard practice in demand management, all sources of demand must be captured and integrated.

Supply Management: Product supply and availability can be risky during launch, particularly for global launches. Too little inventory of the correct label (country) can slow or stall an otherwise successful launch and too much inventory risks scrap costs from expired product or revenue impacts as payors lobby to discount short-dated product. 

Master Data & Process Management: Systems tools and organizational structure play a big role in successfully transitioning a product from clinical management to commercial management with minimal drama. Data integrity and visibility to the organization are critical to analysis and well-informed decision making and effective execution.  Having these structures and processes in place during the late-stages of the clinical program will minimize problems during commercial launch.

Summary

Regulatory approval and launch of a new product is an exciting time for a company. In addition to their routine activities, the Supply Chain team must be hyper-vigilant about many other activities beyond balancing supply and demand. Very often managing uncertainly, the “stock in trade” for the Supply Chain team, is put to its highest test. This is particularly true of smaller and less mature companies that may have limited resources, processes and technology. However, it can be equally true for larger companies that may be organizationally and geographically dispersed. Early initiation of planning, close collaboration, and providing clear information to company Leadership regarding capabilities is critical to ensure a successful, if not accelerated, product launch.