Good Supply Practice Advancements–Big Strides Made by Xavier Health in the Wake of the Heparin Crisis

Xavier University, located in Cincinnati, OH, is typically not the first institution to pop to mind when thinking about important pharmaceutical industry work. The fact that Xavier has not historically been involved in the pharmaceutical industry and is not encumbered by capital intensive laboratories or other legacy infrastructure, however, provided the neutral ground needed to tackle the important topic of supply integrity. The goal of Xavier’s Integrity of Supply Initiative is to develop and implement pragmatic good supply practices (GSPs) that increase the reliability of the supply chain across the pharmaceutical and medical device industries.

I had the opportunity to speak with Marla Phillips, director of Xavier Health at Xavier University, to learn more about how their GSP work got started and the advancements that have been made. Marla will be presenting at CPhI North America in May 2017. The following is a preview of the work she will be presenting.

CPhI: How Did the Integrity of Supply Initiative at Xavier Health get started?

Phillips: For nearly seven years, I had worked at Merck and finished my career there as head of quality operations at the Wilson, NC facility. My family and I decided to move back to the Cincinnati area where I had earned my B.S. in chemistry at Xavier. I popped onto the campus one afternoon to touch base with a few people I knew and mentioned that I thought the chemistry department would greatly benefit from some direct connection to industry. I had not envisioned working for a university, but the next thing I knew I was working for Xavier and, in 2010, hosted conferences for the pharmaceutical and medical device industries.

It was during these early conferences that it became very clear that both industries were very concerned about risk in their supply chains. In 2012, we launched the Integrity of Supply Initiative with the goal of addressing blind spots in the supply chain by developing industry-wide GSPs.  I found that both industry and FDA team members really like the neutral ground of Xavier University, which has enabled us to get to the heart of the issues.  

CPhI: How were you able to assemble teams to do the work you are doing?

Phillips: We have FDA involvement and formal partnership with our two big conferences. Everything we are doing, FDA is either co-leading the work or on the team in some way.

Additionally, through the conferences and other networking, we’ve been able to assemble an amazing group of people from both the pharmaceutical and device industries. Industry members involved in our work include divisional vice-presidents from the largest companies, and executives, and other subject- matter experts from mid-size and smaller companies. When we identify an area of work where we feel we can make a difference, I reach out to people I know who are experts and have had an incredible level of enthusiastic engagement.

CPhI: Tell me about the early days of the Integrity of Supply Initiative.

Phillips: When we launched the Integrity of Supply Initiative in 2012, the industry was still reeling from the heparin crisis. Companies were concerned about patients being harmed as the result of criminal or accidental breaches in their supply chains. There was a fear that they would wake up and find their company’s name in the news because someone had been harmed.  The initial thoughts of the team was that we would go down the path of certifying suppliers, just as the food industry has done.

However, it became clear that we needed to better understand the root cause of the supply chain risks, so in the winter of 2012 and 2013, I took the team members through a series of exercises that involved gap analysis, cause and effect matrix, and Pareto analysis of risks throughout their supply chains.  I presented the results of this analysis back to the team in mid-2013 and they were as surprised as I was to learn that the root cause of risk pointed to themselves, not their suppliers.

It took about a year and a half for many of the participants to truly understand the fact that their operations were either causing the risk or could have prevented the risks from occurring-and that the answer was not focusing on supplier certification.

However, to me this revelation was very empowering. It really provided a sense of relief because it is much easier to change yourself than it is to change a complex network of hundreds of thousands of different suppliers around the globe.

As the team moved to thinking about how to adjust their own operations rather than simply revamping the process of their suppliers, three themes emerged: assuring understanding of their own products and processes, their own supply-chain management practices, and their interactions with their suppliers.

What has been the most successful is that given the way we developed the GSP framework, manufacturers uncovered pragmatic, actionable insights so they can determine what the right step forward for their company is given factors like: the maturity of their company, understanding of their products, the size of their company, the level of patient risk inherent to their products, the level of expertise within their company, the investments they can make, and other such factors. In the end, the solutions provide a plan of action that is commensurate with their need.

CPhI: Can you provide an example of a specific factor addressed by the GSP framework?

Phillips: A common complaint we hear from suppliers is that their manufacturing clients do not share information regarding how their clients intend to use the materials they are supplying. With an understanding of intended use, suppliers can better make recommendations of the materials they should actually use, or more appropriate specifications. Additionally, despite blanket industry declarations of the need for greater transparency, pharmaceutical manufacturers have historically kept a lot of information from their suppliers for confidentiality reasons. However, our solutions walk the manufacturer through the decision-making process examining the risks of sharing the information compared with the reward for sharing the information. There is no one-size-fits-all solution, but our system walks manufacturers through the process of making the best decisions for them.

CPhI:  How does the GSP framework help prevent malicious tampering with product or material supply as was the case in the heparin crisis?

Phillips: Again, our GSP system does not tell a company what to do, but does walk them through the decision-making process. For instance, the best decision for a small, young company with limited personnel and subject-matter expertise resources, producing a high-risk product might be to steer clear of suppliers in under-regulated markets where the risk of adulterated products is higher.

CPhI:  What other aspects of supply chain decision making does the GSP system your team developed address that might be a little different than historical industry practices?

Phillips: Historically, it was common for only quality or procurement professionals to be involved in supplier decision making. We have found that the key aspect in all of our work, and again our construct walks a manufacturer through the decision-making process, is to engage a cross-functional team in the supplier decision-making process throughout the total product lifecycle. There are functional groups that most companies never think to involve, such as environmental, health, and safety (EH&S), but this area can identify violations outside of FDA regulations that could shut the supplier down. Today’s supplier selection processes would be blind to these risks.

CPhI:  Thanks so much for talking with me, Marla. I am looking forward learning more about your work during your “Supply by Design–Global Good Supply Practices (GSPs) for Your Success” presentation at CPhI North America, May 16–18, 2017 in Philadelphia, PA.

Marla Phillips, PhD is the director, Xavier Health, Xavier University. After completing a bachelor of science degree in chemistry at Xavier University, she completed her doctorate in organic chemistry at University of North Carolina at Chapel Hill. She then worked at Merck's North Carolina facility as the head of quality operations. In addition to her work as the director of Xavier Health, she does FDA compliance consulting work.

Editor's Note: CPhI North America and Pharmaceutical Technology are UBM plc brands.