Pfizer Transitions In Risk Managing Clinical API Supply
By Louis Garguilo, Chief Editor, Outsourced Pharma
Thomas Niemeyer leads a team for Pfizer that sources clinical API development and supply from Phase I through regulatory approval. That puts him in a transition zone when it comes to supplier risk management.
“There are teams that handle sourcing before us, for support of discovery workflows, and after us, for support of commercial operations,” explains Niemeyer, whose title is Team Leader/Sourcing Lead. “Both have established risk management programs. The relative importance of performance criteria varies with their respective business requirements. I’ve put the focus on where clinical development sits in the overall API life cycle.”
Sitting On The Basics
Niemeyer’s team sits, if you will, in transition. Accordingly, he needed to devise “a risk-management program that takes into consideration our initial engagement, and brings that together with an understanding of the expectations around supply chain robustness, and ultimately on to commercial operations.”
He knew where to get started. Pfizer has four critical performance criteria spread across every stage of API drug development and manufacture: quality, operations, technology, and value. Here’s an overview of Niemeyer’s application of these criteria.
Quality pertains to the holistic assessment of material, including reception of the materials, packaging, and documentation. “In the early clinical space we have limited scale-up experience. We also don’t have the contingency of counting on multiple, future deliveries of the same compound. It could be a one-time event,” explains Niemeyer. “It’s important that we get it right the first time.”
For operations, Niemeyer starts by saying, “EHS [environmental health and safety] assessment of our suppliers is critical.” He then moves to what more typically comes to mind first in this area. “A CMO’s track record for delivery performance is critical in the clinical space. Timelines are relatively short; end-users are waiting for the API. We’re relying on ‘quantity accuracy’ to advance the API, and move the clinical program forward.” He can’t, though, leave this subject without iterating: “I want to make clear that the EHS assessments of our CMOs and suppliers are a critical component of our vendor management program.”
When we get to technology, Pfizer’s third critical performance criteria, Niemeyer’s voice takes on an element of elevated emotion. “As well as the actual API, a major deliverable at this stage of the life cycle is the related technology to process it. Technical capability for our suppliers is vital. I look for a breadth and depth of technical expertise at the CMOs, and a track record in handling complex projects.” (More on technology below.)
Finally, value starts with two attributes: overall contribution, and cost competitiveness. Niemeyer describes the first as “the contribution the CMO makes to the entire supply chain through its efforts, as well as the overall cross-competitiveness in our vendor role.” That competitiveness, of course, includes the costs of services and materials. (For a recent dissertation on value in outsourcing, see here.)
These four critical performance criteria – quality, operations, technology and value – are the groundwork upon which Niemeyer then builds his risk management program for clinical API development and supply.
Supplier Risk Management In API Development
According to Niemeyer, supplier risk management for API development and supply starts with seven elements:
- Quality/Regulatory/Legal
- EHS
- Financial
- Delivery Performance
- Lead Time
- Technical/Scientific
- Capacity/Loading at Supplier
“In the earlier stage of discovery,” says Niemeyer, “there’s an increased focus on lead time and legal elements, particularly intellectual property protection. On the other side – commercial – we might point to quality, environmental, and safety. For my API development group, as you might expect, there’s an emphasis on ‘all the above.’ We’re focusing in terms of robust technology development, supplier flexibility, and predictable supply of clinical material, as it applies to all these overall risk elements.”
Niemeyer’s team – in a practice common across Big Pharma – makes use of supplier-risk scorecards to help keep track of all this. Supplier scores are calculated based on the seven risk elements above, “and the proper weighting of those elements, consideration of their severity, and the probability of each risk.”
“To me, the real value in the scorecard is not in ranking vendors in terms of risk,” Niemeyer explains. “It’s more around identifying what the specific risks are, and then working proactively with the vendors or suppliers to mitigate them. It’s a good way to focus on what’s really important, and what we should we be working on together to ensure we have a robust supply chain.”
Again, for Niemeyer’s group, it’s positional. “How do we apply those risk elements to support clinical supply requirements throughout the transition from discovery to commercial? We have to consider that full range of development. It’s everything from quality, legal, regulatory, to environmental health and safety, financial risks, and supplier specifics such as lead times and delivery performance.”
Don’t Risk Technology
Niemeyer steers us back to technology. “Technical strength is so important,” he says. “We’re counting on our suppliers to help develop the technology, not just provide the material. It’s a key for us, as well as more obvious considerations of capacity and loading at the supplier.” If Niemeyer had to pick out the key components of particular importance here, he’d go with technical capability of the project team at the service provider, demonstration of innovation, and complexity of projects developed and delivered.
“A disruption at the clinical stage can be severe,” he concludes. “A main purpose of understanding these risk elements, and undertaking appropriate mitigation, is to ensure we have a robust technology development with our suppliers, which provides a degree of supplier flexibility, and a predictable supply of clinical material. Supplier risk management is a way to maximize value and mitigate risk throughout the entire supply chain.”
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This article is based on a presentation given by Thomas Niemeyer, Director Global External Supply, Pfizer, as a part of the DCAT Week ’16 event at the Waldorf Astoria in New York City, on March 19th.