The Story of Pathway

Pathway’s journey from the very beginning has always been grounded in our passion to make a difference in the lives of patients around the world. Every decision is vetted through our purpose, and every action is rooted in our why.

As can be seen from our “story” below, Pathway is constantly looking for ways that will break the cycle of failures we have experienced in our industry for decades. It doesn’t take long to realize that the top FDA findings year-after-year are the same. And it is clear to industry veterans that good quality drives business excellence and patient success. So to leave the cycle of failure behind, we have to approach problems with new thinking.

In 2006, Marla Phillips returned to her alma mater, Xavier University, and met with her longtime friend, John Kucia.  John was the Administrative Vice President for the university when Marla was a student, and continued in this role for many years.  Marla had her 2 oldest sons with her as very small children, since she and her family had just moved back to Cincinnati after being gone for 14 years.

Marla suggested to John that Xavier should connect the chemistry department to the outside world.  Being a chemistry graduate of Xavier, and having worked for Merck in the pharmaceutical industry, Marla saw an amazing opportunity to expose students to such a thriving, mission-driven industry.

John said “Sounds great.  Do it.”  Marla reminded him that she just left the workforce to raise her children.  But then a year later, Marla said “Ok.  Let’s do it”.  Thus launching “Xavier Health”.

For 14.5 years through Xavier Health, Marla and her team brought the pharmaceutical and medical device industries together with global regulators to address challenges in a new way.  This led to conferences that would convene thought-leaders, and initiatives that could be shared across the industry, which expanded into combination products and artificial intelligence - often in full partnership with the FDA.

Often called the “Little Engine that Could”, the Xavier Health Team of Heather Harwood, Kathy Kircher, Tom Meyer, Michelle Rich and Marla Phillips poured their hearts into everything they worked to accomplish.

During her leadership of Xavier Health, Marla recognized that Chief Quality Officers from major companies were engaged in their efforts.  In 2017, Marla had a discussion with Corlis Murray, who at the time was serving as the Chief Quality Officer for Abbott.  Marla said “I think we can bring together a team of Chief Quality Officers, and advance the entire industry.  What do you think?”  Corlis agreed and helped engage her colleagues, which is how Chief Quality Officer Forum was born.

The Pathway Chief Quality Officer team was intentionally created to cut across industries (pharma, device, diagnostics, animal health and consumer goods), and Marla often points out that “even Gary Workman (CQO of illumina) comes from the auto industry.”  Leaders at this level often want to know what other industries are doing, so we decided to create this ecosphere on the team.

The open discussions and sharing of challenges and ideas has been invigorating.  The mission of the team – mobilizing enterprise-wide effectiveness - demonstrates our combined passion to drive patient success through product, process and systems excellence.

When the team identifies challenges that need to be addressed, Marla responds with “Let’s do something about it”, which is exactly what this team does.  This is a true “Team in Action”.

In 2018, Chief Quality Officer Team discussions often converged on strengthening the culture of quality across the organization.  Efforts across the industry at that time were focused on trying to get cross-functional groups to own quality with the Quality Department, and to figure out how to measure culture. 

Marla suggested a new approach:  (1)  let’s teach students what we are doing in our industry and why, so when they join your company, they will be quality champions for you – no matter where they go in your organization, and (2) let’s teach your current employees the end-to-end “why”, so they can co-own patient and business success with you.

In 2019, the Quality Science Education Program was launched as a pilot program with 13 students at Xavier University.  Strategic partnerships have accelerated Pathway’s reach to students all over the world.  As a result, in just 4 years, over 1,000 students from over 220 universities on 5 continents have gone through the program, and everything Pathway does for students and universities is 100% free! 

True to the initial mission, this education was expanded to industry professionals at all levels to upskill, cross-train and to bolster their understanding of end-to-end “why”.  By preparing the next generation and advancing current employees, the expansion of patient success co-ownership is exciting.

The Pathway Chief Quality Officer Team continues to launch industry initiatives that advance adaptability and agility in a world of rapidly evolving technology and expectations. 

For example:

1. QMS Agility: When discussing the desire to establish a Fit-for-Purpose approach to Quality Management System implementation, Pathway launched the QMS Agility Initiative with a Fit-for-Purpose model. 

2. Annex 1 Team: When concerns were expressed about how to implement new expectations for aseptic processing, Pathway launched the Annex 1 initiative, which provided a collaborative forum for companies to share “how can we…”, “did you consider…” and “what are your thoughts about…”. 

3. Quality Culture: When exploring how to strengthen the culture of quality, Pathway launched the Quality Maturity initiative, which started with “What is the role of Quality, what should it be, and what could it be”?  Pathway recognizes that the Quality Department is often responsible for shutting down the exact behaviors it is trying to drive!

4. Maturity Model: When interest was raised in creating a Maturity Model that could actually advance their organizations, Pathway launched the Quality Maturity Model initiative with actions to implement across the total product life cycle…and tied the actions to desired business outcomes!

There’s still so much more we can do together.  Pathway believes in the power of people, the power of collaboration, and the power of passion.  In 2022, Pathway launched the Quality Operations Forum to engage global quality professionals in meaningful discussions all year long. 

Through world café meetings, external intelligence sessions and 24/7 discussion boards, the ability to share paradigm-shifting approaches has become extensive.  Putting your solutions into motion is the only way we can create a better tomorrow.