2 Rx-360: What type of work have you done in the pharmaceutical
industry since then?
Over the years, I have worked in R&D, Procurement, Manufacturing and Quality for Suppliers and Biopharmaceutical companies.
I currently lead the Quality and Regulatory Affairs department for Sigma-Aldrich, a raw material supplier and a manufacturer. As we supply and manufacture products across many industries, I am able to work with the industry leaders within our company and with our manufacturing and supplier partners to define the expectations of an evolving supply chain. I am learning and sharing best practices to help in that evolution.
Having been a supplier and manufacturer, plus now working in a company that sits on both sides of the fence, it is clear to me that the expectations of our customers are reflected in the expectations we have of our own suppliers. I think this is a unique perspective that I bring to the work I do with Rx-360.
3. Rx-360: How did you get involved with Rx-360?
In 2008, I had just re-joined Sigma-Aldrich after working for several Pharmaceutical/Biopharmaceutical companies. I was presenting at an FDA/PDA conference, and the topic was supply chain issues from a suppliers’ standpoint. The hot supply chain issues at the time were melamine and heparin, and what needed to be done to prevent those sorts of problems from happening again. The last slide in my presentation posed the challenge that, with such critical security risks, we needed to pull together as an industry to resolve or mitigate them. Forming a “consortium” was a way to help us improve our industry supply chain.
During discussions at the meeting, participants learned that others had a similar idea. We needed an energy force like Martin VanTrieste to crystallize the concept, and soon after we all connected and formed Rx-360.
I was active in the early phases of the organization as one of the founding members on the board of directors. As I mentioned before, being a part of company who supplies and manufactures, I brought a couple of “voices”, or opinions, to the table.
4. Rx-360: What aspects of Rx-360 do you find you are most passionate about?
In a nutshell, making change happen.
We can easily give 10 reasons why something won’t work. But I want to look at the few reasons how it can work. And that’s what we do in Rx-360 – we make change happen.
I also care about finding the waste in our systems that add unnecessary effort and cost. We need to find what’s not working and identify a better solution, notably sharing audit data.
We represent the Pharmaceutical and Biopharmaceutical industry, and we have to take responsibility and determine ways to solve the problems we are seeing – we can’t wait for regulations to be put in place to fix things. This is what Rx-360 is all about.
5. Rx-360: What do you think has been Rx-360’s greatest achievements so far?
There are a number of efforts I’m proud that Rx-360 has achieved since it began. Our efforts to improve the audit program and the variety of important white papers we have published are a couple of those achievements.
The one that stands out most for me, though, is the work we did during the tsunami disaster in Japan. We came together as a cohesive group of industry leaders. We focused on what can be done to help the people impacted by the devastation, and then shared what we were doing within our companies in order to ensure we were collectively able to protect the supply chain and the patients. That open sharing of information really made a difference. That’s the power of the whole community.
And that’s how we should continue to collaborate. It’s not competitive – we have a common purpose and we work to help each other, help others. I’m proud to be a part of that.
We will always have natural disasters and political events – these are our opportunities.
6. Rx-360: What do you think Rx-360’s greatest opportunities are in the near future?
Just like we all do in launching new products, we need to stay focused and successful on our current projects to ensure they are complete, while having other ideas in the pipeline.
For instance, having more effective information sharing without diluting quality and compliance will make a big difference. All manufacturing companies are getting the same information from suppliers. If we had a common Rx-360 questionnaire to transfer data, we could simplify the process and continue to reduce waste, such as unnecessary time spent answering the same questions formatted several ways.
One of the items on our list of Rx-360 projects is working to develop vendor questionnaires that will help standardize and streamline the collection of data from vendors. We are looking at how we can move important data seamlessly, and agree on how to transfer data without duplicating what is being done with other companies.
We believe this will gain traction as more companies buy in to the idea and become committed to audit sharing. We believe that this will take hold quickly, so right now we are looking at how we can accommodate 100 / 1,000 / 10,000 or more audits as we expand the program.
7. Rx-360: What about the greatest challenges?
As we bring in new people and companies into the Rx-360 organization, the greatest challenge can be figuring out how we bring them to a comfort level where they will be open to challenging and supporting each other.
What I mean by that is, these are working meetings. These are not “suit and tie” meetings; we roll up our sleeves and get involved. We’re collaborative, and we move ahead by challenging the norm and each other.
In the end, we are trying to get to the right place with our mission, and it allows our team members to grow as well as our company’s supply chain to improve in compliance and efficiency.
8. Rx-360: Is there anything else you’d like to add?
We are making a significant change in our industry, and I’m proud of what we’re accomplishing. We cannot be complacent and wait for the next set of regulations to help the industry and the patients.
I look forward to moving ahead with that same enthusiasm and passion that has driven the organization to where it stands over the past five years.
We must continue to challenge each other going forward because our patients need us to be successful.