How Halozyme Tracks Regulatory Information to Maximize Visibility into Their Business

Monica Kennedy, Director, Regulatory Operations at Halozyme

Halozyme is growing and our methods for managing regulatory information weren’t scaling with the rest of our business. Regulatory needed an efficient way to capture an accurate record of our products, activities, and partnerships. That simple business need triggered a substantial overhaul of our information management processes. Now, we can easily answer questions about our business, whether looking for outstanding commitments, locating FDA concerns on a specific submission, or providing a list of all adverse events submitted to a study during a specified period.

Before Vault RIM, we used 35 Excel workbooks to track submissions and correspondence by product. The workbooks contained separate tabs by country where relevant. While there were many spreadsheets, each one only tracked eight fields. Our tracking was limited to critical items, such as date, sequence number, description, and content hyperlinks. In some cases, related information was captured elsewhere in a separate spreadsheet. In most cases, non-critical items didn’t offer sufficient value when maintained in a spreadsheet, therefore they weren’t captured.

We now use Vault RIM and have comprehensive visibility across regulatory activities and information. We track 17 different dimensions of our business, including drug products, active substances, submissions, promotional pieces, registrations, and more. Each dimension (or tracking object) has its own set of unique tracking fields and relationships. For example, our submission tracking object has 15 descriptive fields and eight relationships. The relationships connect submissions to things like clinical studies, drug product, and related correspondence. From the correspondence, we can now navigate to related applications, submissions, health authority questions, commitments and back to the correspondence.

There are immediate benefits, such as it being substantially easier to find a piece of information in question, and it being substantially easier to generate status reports and performance metrics. Yet the biggest benefit is the ability to answer questions about the business. Put simply, the visibility enables me to be more efficient, effective, and credible as I can substantiate my requests and claims with data. When I need to highlight an increase in workload to justify additional headcount, craft a performance review, or submit a promotion for someone on my team, I can run a report that showed how many submissions were produced during a given period and how the volume of submissions has increased as compared to another period. That would have taken hours to produce before we had Vault RIM.

As we embarked on this RIM transformation, the biggest question from my team was “How are we going to possibly collect all this additional information?” I answered that question in detail during my presentation at the Veeva 2017 R&D Summit. But in a nutshell, the information is collected progressively as it is needed and only if relevant. We’ve designed new business processes for things like managing correspondence and questions from health authorities. We’ve also centralized data collection – Regulatory Operations and Regulatory Affairs used to maintain separate spreadsheets, each for their own responsibilities. Now, Regulatory Operations is the custodian of all regulatory Information and Vault RIM is where it is housed and consumed.