By Fran DeGrazio, executive editor
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In this Frankly Fran take, I am offering practical advice for biopharma sponsor companies to bolster their effectiveness when working with industry suppliers. When it comes to purchasing practices and supplier relationship management, effectiveness can be greatly enhanced if companies avoid the pitfalls and heed the words-to-the-wise I include below. They are shaped by my experiences and observations over the last 40 years, more than 30 of which I spent in various roles inside a supplier organization. I may not have “seen it all,” but I have seen plenty.
Believe me, the pitfalls I will discuss are likely to crop up at some point in your career if you interact with suppliers often enough. What is particularly frank about my commentary this time is that the scenarios for which I am offering advice, though common, are not commonly discussed. They are certainly not typically identified or revealed within perhaps the most standard component of a purchasing process; that is, the use of a Request For Proposal, or RFP. The tips outlined below may ultimately matter more to the ultimate success of your drug, device, or combination product than anything you could find on an RFP questionnaire.
Key #1: Do Not Assume Fit Between Suppliers And Needs
Quite often, a product or service is chosen because it has been used in the past. Regardless of any previous success with that supplier offering, it is imperative for developers of a biopharma product to define that product’s specific and likely unique needs prior to choosing any component, delivery system, or service for it.
For those of you involved in product development in roles such as formulation scientist, packaging engineer, or device engineer, instead of conveniently grabbing a product in your warehouse or jumping on a website to order a sample, you must first clearly identify your product’s needs, engage with your supplier’s technical teams, and align your needs with the correct product or service.
For a supplied product — for example, a device or a component — do not simply accept the specifications listed by the supplier. You may need the product to do more than it has been designed to achieve. The potential misalignment could become evident in aspects of delivery functionality or to chemical characteristics, such as particle loads. My advice: Get ahead of it. Trust me, identifying criteria and aligning with the supplier at the beginning of the process is more efficient than addressing issues later in development or, worse, after commercialization. Put another way, it requires much greater effort for pharmaceutical companies to manage a developed product that does not meet certain specifications than it does to invest upfront in fit with appropriate supplier products.
This same concept applies to choosing service providers. Consider, for example, an engineer working with an outside lab to generate test data to make decisions about a product in development. Quite often, the engineer’s company may be hoping to use an analytical laboratory’s “general” method to speed analysis and/or spend less money. The problem with unquestioningly applying the general method is that it is unlikely to address the specificity of what you are looking for and at what levels to make sound decisions. Don’t assume that the limit of quantification (LOQ) for a specific species is at the level you need it to be. For instance, if a screening method has an LOQ of .5ppm for impurity A but you need to understand if this impurity is present at .2ppm, then that method is not for you! This is a quite common issue that occurs even when working with in-house laboratories because engineers will not always be thinking about these aspects when they run their “routine” screening tests, or they assume the analytical chemist will know.
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In this Frankly Fran take, I am offering practical advice for biopharma sponsor companies to bolster their effectiveness when working with industry suppliers. When it comes to purchasing practices and supplier relationship management, effectiveness can be greatly enhanced if companies avoid the pitfalls and heed the words-to-the-wise I include below. They are shaped by my experiences and observations over the last 40 years, more than 30 of which I spent in various roles inside a supplier organization. I may not have “seen it all,” but I have seen plenty.