How PMV Gained Auditor Comfort and Operational Efficiency with Auxilius
"We rely 100% on Auxilius and our auditors are more than happy with it.”
Mike Carulli
SVP of Finance, PMV Pharmaceuticals
The Challenge: Addressing the limits of Excel at scale
"We were approaching clinical stage and Excel sheets quickly started to become cumbersome. Models start cracking and breaking, or just become a pain. So we began looking for systematic solutions."
- Difficult to conduct project-level tracking, versioning, and scenario modeling at scale
- Insufficient granularity and detail around vendor estimates and budget grids
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Difficulty surfacing certain variances (e.g. accrual estimates) quickly or in context
About PMV
PMV Pharma is a precision oncology biotech pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. With a lead program in clinic, additional programs in pipeline, PMV fully embodies the biotech ethos: Resourceful, innovative, and rapidly maturing.
Company Profile
Company Stage: Public
Therapeutic Focus: Oncology
Employees: 60+
Tech Stack: Netsuite, Bill.com, Namely, Cube Planning, Rave EDC
The Solution
Mike Carulli, PMV’s SVP of Finance, was responsible for building an effective process for accruals and forecasting, but without the perks of staffing or spend of big pharma. When Mike joined the team at PMV in the spring of 2020, he brought a decade’s worth of enterprise R&D finance experience from Celgene, giving him a unique lens from which to guide his team.
In early 2022, Mike identified Auxilius as a solution capable of managing study-level forecasting and accruals across vendors, investigators and sites. He wanted to move his team to the platform, but needed his auditors to embrace the new system. Here’s how he broke down the process:
1. Employ a staggered and strategic roll out
After a short initial implementation period for the Auxilius solution, Mike and his team were off to the races. Since they were mid-trial, they maintained their excel model in parallel to ensure a seamless transition, while validating that the Auxilius solution was calculating forecasts and accrual estimates correctly. Dependent on a number of disparate tools and data sources, ensuring that the entire technology stack is in sync was critical.
After comparing outputs from Auxilius against their legacy processes, the PMV team was quickly comfortable that the tool was calculating forecasts and accrual estimates correctly -- producing predictable, accurate, and reproducible results. In October 2022, they transitioned completely.
Looking back, Mike believes he could have transitioned even sooner. But for PMV, running parallel processes allowed their team and auditors to get comfortable with the Auxilius platform. The intentionality of his approach paid dividends -- ensuring alignment and trust before go-live.
2. Communicate with auditors early and often
Mike notified PMV’s auditors early-on that they would be making the transition from the legacy excel model to the Auxilius solution. Keeping communication lines open, providing examples/ exports and illustrating that forecast methodology remained consistently applied, Mike and the PMV team found success in driving auditor comfort.
Results
Though it wasn’t a surprise, the auditor liked the end results. Beyond comfort with the accuracy and reliability of the platform, EY also identified a number of additional benefits:
- More granular management (at the vendor grid level)
- Additional data points incorporated into the accrual estimation model
- User-based permissioning and controls
- Consistently applied methodologies, and a real-time audit log designed to track any deviations or changes, the impact of those changes, who made them, and why
“We talked them through it. Everything is exactly the same, we're just applying drivers at a more detailed level. After review they were comfortable and gave us the green light to go ahead. Then, they went off and replicated it on their own.”