Customer Panel: Dynavax and Abcuro on Auxilius

Ricky:
So for us, I'll say we have primarily one asset in the clinic. One of the things with the indication that we have, the phase 2/3 trial in inclusion body myositis—it's a neuromuscular disease. The challenge we had as a company was that it was our first trial of that magnitude, where we were looking to enroll between two and three hundred patients. Previously, we had ongoing trials with fewer than thirty patients each. We had two trials ongoing.

The challenge we were facing—and I'll focus on this from a finance perspective—is how to manage the dollar amounts associated with that. Previously, we were looking at under ten million dollars of spend per trial. Now, we're looking at something upwards of fifty million dollars. How do we wrap our heads around the cracks that might have existed in our prior processes but have now become canyons when the dollars involved become so impactful?

Those challenges are unique to Abcuro. That's what we were looking at and trying to solve for preventatively.

How did that challenge of scale lead you to Auxilius?

Ricky:
When you think of clinical trial accruals, and I'll focus first on the accounting side before we get to the forecasting side, clinical accruals are the focus of all the auditors. At every audit committee meeting, clinical accruals come up. At the annual audit, they’re first and foremost—there's so much complexity and so many estimates involved.

Before even getting to that point, the accounting and finance team spends a significant amount of time coming up with that number. As we went into this phase 2/3 trial, we realized we needed a better process than what we had. We weren't concerned about our numbers, but we were concerned about scalability. Once we gathered all this information, putting it in an Excel spreadsheet was terrifying when considering something for years to come.

When we looked for a solution, we landed on Auxilius. One of the nice things we saw was that you could take all your Excel files, dozens of CTAs, work orders, CROs, and standardize them in one place.

That’s what led us to Auxilius. The customization Auxilius offers to fit your mold provided a lot of value. With larger solutions, not necessarily clinical trial financial tracking systems, but maybe ERPs, you’re often told, “Here’s how the system can do it,” and you have to compromise. Auxilius isn’t like that. It can handle whatever complexity you have and standardize it, track it, and manage it so you’re not doing everything manually.

Can you tell us about the trials Dynavax has and what challenges led you to Auxilius?

Dave:
A lot of what Ricky mentioned is similar to what Dynavax experiences. Many clinical-stage companies have those same challenges.

In particular, Dynavax has a number of vaccine candidates in development. We have a TDAP vaccine in phase 1. We have a shingles vaccine for older adults in phase 1. We’re also collaborating with the Department of Defense in a phase 2 clinical trial for plague.

Looking ahead, one of the things we wanted was a process and a solution that were highly scalable. What we found was that our current approach was not entirely sustainable. We have a relatively small finance and accounting team working on clinical accruals every month.

We were manually forecasting the R&D spend and calculating accruals based on spreadsheet trackers, which relied on data from CROs that could be untimely or lagging. One of the things we wanted to address was our limited bandwidth and finding a solution that would allow us to work through our close cycle in a shorter period.

There was also potential for error with manual spreadsheets. Relying on vendor estimates for accruals, which can be delayed or incorrect, slowed down the close process. We were getting billing information from CROs from different parts of the country, and it wasn’t always timely.

Every time we matched the CRO information with our accrual tracker, it was highly manual. While we love spreadsheets as finance professionals, we don’t want to spend so much time checking for quality issues. Bringing our clinical accrual process into a tool like Auxilius allowed us to ingest all the information and be comfortable with the assumptions set forth in our forecast methodology.

Partnering with our clinical operations team also helped us review the estimates and bring in EDC data to get a good sense of investigator spend in real time. Those insights were much clearer using Auxilius.

Ricky:
Yeah, the scalability that Dave mentioned—the ability to establish a process that can be used for future trials or multiple trials—is something that didn’t exist without a system.

Dave:
Exactly. It’s a large amount of dollars tied up in clinical accruals. As we progress to phase 2 and phase 3 studies, where the number of participants and clinical spend will expand drastically, we want to ensure that we have a process and a tool that can grow with us.

Kristen:
What I’m hearing from both of you is that you recognized growth in the future and many more studies coming down the line. Getting that process in place was crucial to setting you up for success at scale.

We hear that from many of our sponsors who are implementing Auxilius—recognizing that transition point and understanding the importance of bringing in a system like Auxilius.

Dave, what gave you the confidence you could implement Auxilius successfully given competing priorities and demands on the team's time?

Dave:
It’s all about preparation. Leading up to the close, we needed information both internally and externally from our CRO. Prepping the clinical accrual trackers and spreadsheets, and having conversations with our clinical operations team to ensure the right assumptions were made, were essential. We also partnered with our accounting team to ensure the correct accrual was in place.

We have a quick turnaround for the month-end close. The clinical accrual process was time-consuming and one of the issues that inhibited us from closing faster. With Auxilius, we don’t have to wait until the end of the month for vendor estimates or billing. Much of that is automated. We can start the close process and review the forecast before the end of the month, addressing issues with internal teams as needed.

Spreading out the work and preparing for the close in advance has been incredibly helpful, especially with a small team. The accounting team has many other tasks to handle during the month-end close.

Kristen:
That makes total sense. Even with a small team, implementing Auxilius worked in your favor because it allowed each role to manage tasks when they had capacity, rather than everyone scrambling to do everything at the same time.

Overall Implementation Experience (23:46)

How do you experience implementing Auxilius compare to the other implementations you've been a part of?

Emily:
Sure. I have done many system implementations in my past, and Auxilius is my latest one. I would have to say that it was the smoothest implementation I've ever managed.

When you do a system implementation, there are a few areas you worry about. One is customization—whether you need to customize the system to fit your needs. The other is integration points and how much work you need to put in to build out that integration. And, of course, people's availability from a project team perspective—in this case, Auxilius.

With Auxilius, we didn’t have to customize any parts to fit our business needs. That’s one thing. The other aspect is integration.

When you work with different data sources, external or internal, most of the time, you have to go out to those vendors and ask them to provide the data in a specific format. Then you go to the next vendor and request the same thing so that you can ingest it into your system. But with Auxilius, I didn’t see the need for that.

Whatever format you provide, Auxilius can consume it without requiring customization from the data sources. So that’s another plus. The other aspect is people’s availability.

It was key that Kristen’s team had dedicated resources to work with us to implement the system smoothly. Day in, day out, whenever we needed something, an email was sent out and responses came back within seconds. So, availability of resources and their expertise was very key.

Another aspect is the SOX controls.

A lot of times when you implement new systems, there’s a lack of controls in the system, which means you either have to build them out or introduce new manual controls. We didn’t have to do much of that. Auxilius is very robust with the closed checklist feature it has. Those are all the aspects that were positives in that implementation, and that’s why I said it was the smoothest implementation I’ve managed in the past.

What teams were involved in the Dynavax implementation?

Emily:
The people who had a seat at the table were the accounting folks—the accountants and the controller. We had David representing FP&A, and we had ClinOps, who worked with David directly. We obviously had your team, and we involved our internal auditors from the beginning of the process definition, which was very important. Most of the time, you wait until after defining your process before the internal auditors come in and point out missing controls. But we got them involved upfront. It’s very key to involve internal auditors at the beginning.

We also had IT to assist your technical team, Kristen, in building the integration to pull invoices from Dynamics 365—our ERP. That was the one area where we needed the technical team. Most of the other areas were handled within accounting, finance, and internal auditing.

Who was involved in the Abcuro implementation?

Ricky:
Similar functions, but we’re a startup, so it’s smaller. IT didn’t exist as an employee at Abcuro when we implemented Auxilius. Our team that got us live on Auxilius included FP&A, who manages our budget and handles the clinical accruals for the pivotal trial—both the accounting and forecasting sides. Myself, we had one person from ClinOps who voluntarily got involved in the process. They’re the main person running the trial.

We pitched Auxilius to them and asked if they were interested. They said yes—generally, ClinOps people do care about budgets. So they got involved. The Auxilius team was like having an auditor on the inside, helping us guide through how to handle things and troubleshoot problems. From an IT perspective, we use NetSuite as our ERP.

In terms of technical integration, there wasn’t much. It was a very easy process to get everything from our NetSuite environment into Auxilius. We use custom segments, so anything that could have been tricky wasn’t an issue for us.

We’re also private, so we have administrator access to NetSuite and could pull some strings if needed.

Kristen:
Amazing. I know you both mentioned Dynamics 365 and NetSuite. We’ve implemented integrations across both, and the feedback we usually get from customers is that they tend to be relatively off-the-shelf implementations that don’t take much work. It sounds like you didn’t even need IT involved on the Abcuro side.

Can you clarify how controls were a consideration as a part of the Dynavax implementation?

Emily:
In that area, I’d ask David to chime in. But when I say we didn’t have to do too much with the controls, I mean we didn’t have to customize Auxilius by adding system controls. That’s what I meant. Yes, we have controls—about ten or eleven. Some are existing, and some are new. I’ll let David elaborate on that.

David:
Certainly, we have controls. Working with our internal auditors during the implementation process helped identify the key areas and how we could ensure those controls were addressed by Auxilius, or tailor our existing and upcoming processes to fit those.

There are many controls, and it involves regular discussions and meetings between accounting and clinical operations to address them all.

Controls and Working With Auditors (32:33)

To quickly answer your question, Christy, does Auxilius have a SOC 1 report? Yes, we do. We're happy to share that with anyone interested in reviewing it. Just feel free to reach out, and I can put my email address in the chat to send it through afterward to anyone who needs it.

How has the use of Auxilius impacted the external audit process?

Dave:
You know, we’re still relatively new in terms of getting the implementation on board. So I think it’s been somewhat limited in terms of that. But we have walked the auditors through the process. I think it’s been relatively streamlined. One of the things that has been helpful for both external audit and Dynavax is having an audit trail and a monthly checklist in the tool. We have rules and responsibilities set forth in the system, so on a monthly basis, each person is responsible for reviewing a key area and locking that before you can complete the close cycle.

Those features are built into the technology, which is really helpful for us and for the auditors.

Emily:
The checklist in Auxilius is very robust, so we didn’t have to customize the system to add new controls. They’re already in Auxilius.

Kristen:
And yeah, the key is to walk your internal auditors through the process upfront to get their support before preparing for external reviews.

Ricky:
I’ll add one thing. So for Abcuro, we haven’t been through a year-end audit with Auxilius yet because we started our implementation in December 2023, so our 2023 financials were already cleaned using pre-Auxilius processes.

But what I will say is that we talked about Auxilius with our auditors before implementing. We use RSM and they were pretty excited about it. Our auditors also attended a webinar specifically for auditors about Auxilius. I can't believe it, but two of our audit team members actually attended it. So there’s a lot of openness to it.

From an audit perspective, beyond SOX controls, auditing the actual numbers is easier with Auxilius. In my experience at prior public companies, it’s sometimes difficult to substantiate to an auditor where the numbers are coming from for the financial statement audit side. Auxilius allows you to, if needed, pick an individual patient and show the cost accumulated for that patient at a specific date. An auditor could then go to a CTA, find the visit cost, and match it up. Thinking about how to do that outside of a system would be very challenging. So auditability, beyond SOX controls, is a huge benefit of Auxilius.

Kristen:
We actually had a webinar a week or two ago specifically focused on auditor comfort with Auxilius, as Ricky mentioned. His auditors were there. It’s a very common question we get, and we’ve definitely worked through getting auditors comfortable with the system and supporting customers through their year-end audits. So we’re happy to provide more context.

What you’ll find, as Ricky said, is that there are a lot of outputs directly from the system that allow you to provide your auditors with ongoing information, so they can see all the backup for every number in the system, down to an individual patient.

Our SOC also covers the key outputs of the system. One key output is the journal entry report, which many auditors get excited about. Auxilius’ SOC covers that report, so auditors don’t need to do additional reviews of the calculations that go into producing journal entries.

What ERPs does Auxilius work with?

Kristen:
Auxilius is relatively agnostic to the ERP we integrate with. We’ve worked with most ERPs—NetSuite, Sage Intacct, Dynamics 365, and other big systems—as well as P2Ps like Coupa. It really depends on whether or not they can expose an API to us. Our technical teams do all the work in setting up that integration, so there’s very little lift on the sponsor side. As you heard, Ricky’s team didn’t even involve IT in that process. Auxilius handles the setup as long as the data can be exposed directly from the ERP.

Does Auxilius support multiple currencies?

Ricky:
And we use multicurrency in case that’s helpful.

Kristen:
Yes. Exactly. There are multicurrency calculations within the system that can be leveraged, and we can also pipe in that data in multiple currencies from the integrations.

Materiality (39:02)

What happens if the implementation results in materially different numbers?

Kristen:
Another question from Christy is about the implementation resulting in materially different numbers than what was calculated in your Excel-based process, and how you got comfortable with that if there were differences.

Dave:
Sure. I can speak to that. I don’t think the implementation resulted in any estimates from the CRO. Sometimes, those estimates can be lagging, and the data may not be contemporary. We’ve found that forecasts or projections from the CROs can swing pretty wildly. It’s not the CRO’s priority to project expense numbers—that’s not their main job.

What we like about Auxilius is that we set the parameters and the forecast methodology. We also get real-time information based on EDC reports that are fed live. So, we’re confident that the expenses shown within Auxilius are timely and accurate.

Ricky:
In terms of concerns around materially different numbers, in Abcuro’s case—and I imagine this applies to others—the customizations we’re able to build into the model in Auxilius are closely aligned with our Excel-based processes. For our unusual invoiceable scenarios, we’re able to handle them in Auxilius, ensuring we don’t end up with auditors asking, “Why is this number vastly different from what you told us a year ago?”

That said, I don’t think it’s realistic to expect that if you have no process whatsoever, Auxilius will miraculously create the most robust clinical financial tracking software overnight. For us, the biggest value is that Auxilius takes our manual processes, which already provided the right numbers, and standardizes them, making them scalable. But it’s not a miracle solution. If, for example, you were implementing a purchasing system without an approval matrix, it wouldn’t work because the system needs rules to follow. The same goes for clinical accruals—if you don’t have a process in place, you can’t model it out.

Kristen:
That’s great context, Ricky. And just to add to that—one of the first things we do with sponsors during the implementation process is review your existing processes and map them. We want to understand exactly what your process is before implementing Auxilius.

We’ll then map out how you can leverage different modules within the system. So, if your current process involves getting vendor estimates from your CRO and using them as your expense estimate, you can replicate that within Auxilius. If you’re using EDC data and pulling specific reports, we’ll model that process out to look just like what you were doing offline.

Ultimately, our goal is to bring multiple data sources side by side so you can make the most informed decisions. Auxilius doesn’t enforce decision-making on behalf of the sponsor—it just makes the data available so you can continue making the same decisions you were making before implementing the system. Ricky, I think that’s similar to the point you were making, right?

Ricky:
Yes, exactly. Auxilius did immaterially improve things for us, helping us track things we hadn’t considered before simply because of limited time. But it wasn’t material in a negative way.

And if Auxilius does uncover something material—which it shouldn’t, but anything can happen—you ultimately want the right answer anyway.

Kristen:
Right. I haven’t heard of that happening with Auxilius—not for us or for any of the folks I’ve talked to who use it.

Implementing Investigator Model (43:51)

What was Abcuro's experience implementing their investigator model?

Kristen:
Ricky, on the Abcuro side, one of the key focuses with Auxilius, from my understanding, was getting the clinical model just right—having that investigator intelligence model built out and pulling in the EDC data. I’d love to hear about your experience setting that up with Auxilius, what worked, and what challenges you faced in building out that investigator model.

Ricky:
One of the things we did before Auxilius was we had three different points for investigator expenses, which is our most complex tracking. We had our EDC data, a report from IRT that our ClinOps team gave us, which provided a snapshot of how our patients were doing—who was active and the last visit—but not full EDC data. Then we had a manual Excel patient tracker. We would triangulate these sources manually every month to make sure we had the most complete data.

One of the things we did in our manual patient tracker was forecast. We knew the protocol and when patients started on our trial. So, if we were expecting eight visits in the month that we were closing and our EDC said seven, our manual tracker could tell us that a visit was missing.

For our model in Auxilius, the team built the same patient tracker—no longer in Excel but within Auxilius. It literally had visit one, two, three, four, and would highlight for us if a visit should have happened based on the protocol and dosing date but wasn’t in the EDC. That’s a big risk with clinical accruals—your EDC data could be lagging or missing. We used to do this in Excel, showed it to Auxilius, and now it’s automated in the system.

That’s a real value add for us. We’re hyper-focused on EDC completeness—not because it’s material if a visit is missing, but because if there’s a systemic issue with getting data into the EDC, we need to know before it gets out of control.

Kristen:
That makes a lot of sense and ends up being one of the areas where sponsors see the most value in implementing more automation, given how hard that process is to support directly within Excel.

Ricky:
We’ve been burned before in smaller trials when we realized that the EDC reports we were relying on had gaps we didn’t know about—something was missing or misrepresented. Auxilius helps solve that, ensuring we’re using the right inputs.

What was Dynavax's experience implementing their investigator model?

Kristen:
Dave and Emily, I’m curious—on the Dynavax side, you’re working in a very different therapeutic area. What was your experience implementing the investigator intelligence model? Was it a process you had in place before Auxilius, or was it net new intelligence for you?

Dave:
One of the benefits Ricky touched upon was having multiple sources of data to hone in on. For investigator grants, we pull in EDC information, consult with our clinical operations team, look at patient trackers, and use our internal forecast. Having those multiple data points helps us get comfortable with what we’re seeing in the system and what the CRO is telling us.

The customizability within Auxilius allows us to set our forecast logic for investigator grants, which is particularly helpful.

Auxilius Support Team (48:47)

How did Dynavax leverage the Auxilius support team?

Dave:
In terms of implementation and getting the trial set up within the tool itself, the team was extremely helpful in getting all the data, contracts, change orders, and various EDC reports ingested into the tool in a timely fashion. As we progressed, whenever we got new information, we either uploaded it into the tool or passed it on via email. The team was always very responsive. I’d usually get a notification through email or the tool itself that the information had been ingested and was ready for review and confirmation.

That’s been extremely helpful. We get a lot of data, information, and documents, and having it all housed in one central location as a single source of truth—without manual intervention—helps us sleep better at night.

The team has been responsive during hypercare and implementation. Whenever we had specific questions, they’d hop on a call to explain things or customize aspects if we needed something shown differently in the investigator module. If we had a protocol specific to a study, they’d help with that too.

How did Abcuro leverage the Auxilius support team?

Ricky:
For us, our implementation team, especially the technical accounting folks, really live and breathe clinical trial accruals and forecasting. I’d go crazy if I had to review site agreements all day, but we’d send over forty site agreements, and they’d get through them. I’m not even sure how long it took because it was ready whenever we needed it.

For us to do that would’ve taken a lot of time and probably led to manual errors.

The technical accounting team knows what to look for in these contracts. Work orders with CROs and site agreements are dozens of pages long, and sometimes you’re looking for a random sentence that mentions something like $5,000 in quarterly IRB fees. You might miss it, but Auxilius sees this from all their clients and trials, and they help you stay on track.

We’ve gotten a lot of value out of that. The general theme is that any question we ask gets a thoughtful response, and the team is always ready when we need them. Usually, they’re waiting on us because we have competing priorities—not the other way around.

Closing (53:37)

What did you wish you knew before implementing Auxilus?

Ricky:
Okay. So, for me, what I wish I knew—it’s often about talking to other people, talking to another company that had gone through the implementation. You just hear what to focus on, and that’s always helpful. Another thing for us is, from day one, take it seriously. You’re building a model here, and this isn’t the time to say, “It’s close enough” or “Let it go.”

Really focus on why something is different from your manual processes and make sure it works the way you want. That’s a critical success factor for the longevity of using a system like Auxilius. You’re setting something up to be scalable, so while it’s still small, make sure that scale is very accurate.

Dave:
Sure. I think something that Emily was responsible for and was aware of right away was getting all the key stakeholders involved early on and securing their buy-in.

Any new tool or system implementation can be challenging or time-consuming. I found it relatively smooth, but that’s because Emily was really responsible in identifying who needed to have a seat at the table, getting their input, and addressing potential challenges upfront.

Emily was critical in providing that path and ensuring we had the necessary meetings and got it right the first time. Emily, anything else?

Emily:
Yeah. Getting it right the first time also includes involving internal auditors to prepare for that external audit. That’s key.