Driving Process Optimization with Unified RIM at DIA RSIDM

How has your definition of RIM changed over time? That’s one of the questions Veeva explored at the 2020 DIA RSIDM conference in a panel session titled “Driving Process Optimization with Unified RIM”. The session focused on how technology enables regulatory teams to centralize their activities and processes, and we heard perspectives from three industry thought leaders: Michael Sauter, senior director of regulatory operations at Alexion Pharmaceuticals; Ryan Hernandez, director of regulatory operations at Radius Health; and Lisa Pitt, head of regulatory affairs at Viela Bio.

The following is an excerpt from the panel:

Panel Background

Christina Kim: Ryan, can you take a few minutes to talk about your RIM journey, and how RIM has evolved over the last 15 years for you?

Ryan Hernandez: I moved from Octagon Research Solutions to Teva Pharmaceuticals about 10 years ago and at the time I didn’t even know what RIM was. Everything was done in [Microsoft] Excel sheets, file shares, and files on people’s personal computers. There wasn’t really much capturing of data or anything like that. But over the years we began to pull together all of our data registrations and it was really interesting to see over a span of my time there how it went from being just file shares to actual systems.

Christina Kim: Lisa, your background is in regulatory affairs and we talked previously about how the line between regulatory affairs and regulatory operations has been blurred. Can you take a few minutes to talk about your career, your background, and how RIM has changed your role?

Lisa Pitt: I was primarily a regulatory strategist for the majority of my career, but when I started at Viela Bio it was a new company, less than two years old, with just two regulatory employees. We had to figure out how to assume R&D sponsorship for six applications with the system. So, I had to think of something that was going to be fit for purpose so that we could begin our own document authoring, approval, reviewing, and most importantly tracking of all the applications. We needed to maintain those in our system and be able to access those historical files. So I had to figure out a simple solution that was going to be easily adapted by a small group of 35 employees to start.

Christina Kim: Michael, can you give us some background on your role and how technology has played a part in your career?

Michael Sauter: I started at Biogen more than 15 years ago, and I remember very early on the CEO asking me, “Can you tell me where our product is registered?” I looked around in regulatory and in IT but nobody had a clear answer. So, I think a week later we delivered some data but we had no clue if it was correct or where it came from exactly. So, registration tracking was born very quickly, but we didn’t call it RIM at that time. It was purely regulatory data registration, and then we very quickly moved to an integration with regulatory manufacturing. We learned that the systems were the easy part, but everyone still had different definitions for things so we needed data governance as well.

The Impact of RIM Technology

Christina Kim: Michael, would you say that your definition of RIM has evolved over the years?

Michael Sauter: Oh yes, for sure. The definition has definitely expanded. If you look at RIM systems now, I see so much potential for registration tracking, commitment tracking, labeling, etc. I think there is much, much more involved now than there was previously. We have to think about both internal and external clients. So for example with IDMP, that’s an important regulatory standard that we’ll have to deliver and RIM systems will help us get there.

Christina Kim: Lisa, I know you recently implemented a RIM system. What are some of the process improvements that you’ve seen in your time since then?

Lisa Pitt: We transferred all the documents over from our predecessor company and it worked out pretty well. I can honestly say that the migration was not that hard. So now we’re focused on building internal processes to support our functions as a business. Next, we’ll hopefully move forward to commercial products and that will broaden our scope as we start to work with our commercial colleagues and grow the company.

Christina Kim: Ryan, what value do you see with an end-to-end RIM system at Radius and what efficiencies have you created so far?

Ryan Hernandez: You think about how much time we spent at the beginning of our careers doing very laborious tasks like bookmarking, linking, filling out [Microsoft] Excel sheets, and developing content plans. The regulatory operations role was somewhat like an admin role. But with improvements in technology systems, it’s really helped us become stronger regulatory professionals. We’re getting away from the tedious tasks that would take literally hours and days to complete and it allows us to focus on more important things like content planning, project management, or regulatory strategy.

RIM as Part of the Larger Organization

Christina Kim: What are some non-implementation considerations that can determine the success of a RIM project?

Ryan Hernandez: I think one of the important things that I’ve noticed is getting stakeholder buy-in. And I know that sounds simple, but it can be very difficult, especially for people that want to work out of their [Microsoft] Excel sheets or file shares or personal drives. But if you can get regulatory affairs involved early on and have them become one of the trainers or one of the subject matter experts, then they will also become an advocate of what you’re trying to do. And they’ll be somewhat excited about making a change or implementing a new process.

Michael Sauter: Remember that RIM is not only regulatory data, there’s a lot of other data in there that regulatory should not own. Perhaps they house it but the data is owned by all the functions. So you need to consider the question “what’s in it for me”? And, so I take time to meet with those groups and we discuss how they can use the data. The more participation you have, the more successful the system.

Christina Kim: Lisa, I know you work closely with your clinical and commercial teams. What are some of your plans to connect those functions now that you have a system in place?

Lisa Pitt: What I like about RIM is that other teams have the ability to create and maintain their own documents for their purpose. They have the autonomy to manage materials and I can provide guidance and support on the compliance side. I like that I can push out that responsibility so I can focus on other things

Looking Forward

Christina Kim: Do you have any words of wisdom that you’d like to share with our audience?

Michael Sauter: Keep it simple. You can do anything with technology, that part shouldn’t be difficult. Move forward, learn, figure out what works and what doesn’t. Your RIM system will never be perfect, but it’s important to start.

Ryan Hernandez: Don’t be afraid to embrace new technology. I think regulatory in particular is hesitant to try something new or to try a new process. But if you let technology pass you by, then you yourself will become obsolete. And I think that’s something that people need to keep in mind.

Lisa Pitt: Having the ability to be flexible and make changes is really important. I think once the organization sees that then they’ll be more willing to learn how to use the system and figure out how to work together. It’s been fun learning along the way.

To read more about how the role of regulatory operations is evolving, check out this RAPS article with thoughts from Epizyme, ACADIA Pharmaceuticals, and bluebird bio.