Commercial drug distribution in an increasingly global market requires special skills that are sometimes underestimated. With the increase in large molecules, therapeutic vaccines, tighter temperature ranges and new customs regulations, the risk is increasing as well. Management of the supply chain will become more complex and there is room for service companies to help, by giving clients the tools they need to take control and streamline the supply chain. 

Complex Logistical Processes Demand Continuity 

The global supply chain requires many ‘links’ between raw material sources, synthesis/fermentation, finishing, warehousing, drug product, and packaging. Each of these links requires work. As pharma sponsors seek to optimize the sourcing for its supply chains, it is clear that the ‘links’ will increase in number and complexity. A drug product, from its birth, will require more and more hand-offs, more storage, more potential for loss and risk.

Using one logistics provider to handle the ‘hand-offs’ makes sense to me. Think about how many hours you spend on screening, selecting, contracting and training the firms selected to manage each link. Why not use a single provider with a network of offices and depots for global handling, movement, tracking and storing of intermediates, finished API, and drug product? It reduces risk, minimizes administration and saves money.

Don't Waste Time with Multiple Relationships

Let’s consider time spent building separate relationships and confidence in their expertise. One minor logistics mistake in the supply chain can have a catastrophic impact on the market. Errors in distribution can lead to product contamination, regulatory issues and stock-outs, all of which can result in a potential loss of market share. Using a single source partner or preferred provider puts the control back in your hands. This is not a new concept; the CRO industry has been doing this for years and has seen the value this model provides.

Build a Strategic Partnership

Putting a strong partnership in place with one provider allows you to be in control of your supply chain. You should be able to trust one source to understand your current needs and anticipate your future challenges. The biopharma company of today needs partners that can manage the continuous temperature monitoring, documented transit custody with a worldwide network of advanced, direct-controlled depots, for end-to-end quality. 

I recently read an article in which Steve Arlington of PriceWaterhouseCoopers wrote, “The most successful pharma companies will be those that recognize the underlying value locked in their supply chain and can leverage it as a value and brand differentiator rather than just a cost.”

How can you leverage your supply chain for success?

Comprehensive and Clean Chain of Custody

Global transportation in our industry demands safe handling and validated documentation. Your preferred provider of supply chain services must provide the clean ‘chain of custody’ to save you time and money without sacrificing quality. 

Considerations for Selecting a Preferred Supply Chain Provider

Wynn Bailey, also of PriceWaterhouseCoopers, in an article written in this magazine,¹ advises the industry, “Shift from supply chains to supply networks. The industry needs a new way of looking at the supply chain. In fact, it needs to think not about supply chains — with their conventional one-way and sequential orientation — and more about supplier networks with multiple points for obtaining information and taking action.” 

So what should you consider when selecting a supply chain partner? Here are 10 criteria:

1. Manufacturing supply chain expertise and broad geographic coverage
2. On time performance record, within time and temperature
3. Documentation and declarations expertise
4. Real-time reporting capabilities
5. End-to-end quality assurance and quality management
6. Worldwide network of life science fit for purpose depots
7. Innovative temperature controlled packaging solutions
8. Regulatory expertise: current and relevant
9. Regulatory and import/export license assistance
10. Customs pre-clearance 

That is my Top 10 List for selection of a global API supply chain solution. What would you add?  

Reference

1 Contract Pharma (2011, January/February) Supply Chain Focus: New Strategies
 

Wes Wheeler is the chief executive of Marken. Mr. Wheeler has worked in the pharmaceutical industry for more than 25 years, and has held senior executive positions in four companies during the last 15. By helping develop a strategic vision and then using his leadership skills to implement strategies that achieve that vision, he has been instrumental in the success of these companies. During Mr. Wheeler’s 30-year career, he has been involved in virtually every key functional area, including manufacturing, marketing, logistics, R&D, and engineering.