Veeva Event Brief
Axendia was pleased to have been invited to cover the 2024 Veeva R&D and Quality Summit in Boston from September 9-10. Veeva’s portfolio has grown significantly since Axendia’s first Summit coverage in 2016, with notable expansion to Veeva Vault Clinical and Vault Quality. The theme of “Powerful Community, Fresh Ideas” was evident in the discussions and energy that permeated the event, with leaders from Veeva and the life sciences industry sharing strategies that have enabled organizations to move digital modernization forward.
Embracing Process Excellence
Veeva Systems Founder and CEO, Peter Gassner, kicked things off with a discussion of Veeva’s standing as a public benefit corporation (PBC) and how that conversion in 2021 has served to reinforce both its values and its vision of “Building the industry cloud for life sciences,” an ongoing commitment that began in 2012.
Veeva Development Cloud, which spans solution areas for Clinical Operations, Clinical Data, Regulatory, Drug Safety, and Quality, sits upon the foundation of the Veeva Vault platform for life sciences. The team has continued to build out these portfolios, but 2024 marks one of the few R&D and Quality Summits where Veeva did not announce anything brand new. The focus, instead, has been on significant progression for some of its newer offerings, including those highlighted in yellow below, including Vault LIMS and Vault Batch Release.
Veeva’s solutions have continued to be modular, by design, explained Gassner, as they recognize that even when a client is interested in multiple products, it is unlikely they can or will commit to the whole portfolio up-front, nor should they have to. A theme we continued to hear at the event was the intentional “balance of efficiency with speed and innovation,” while affording “autonomy AND alignment.”
These are the principles that support Quality as a whole and enable connections across departmental functions and exemplify what many leaders consider process excellence (PEx). Gassner shared his view that every company should have a team dedicated to PEx and that it’s critical that this team sits on the business side, regardless of company size. In an analyst roundtable, Mike Jovanis, Vice President, Quality and Manufacturing, commented that even though it can be challenging to change behaviors and work across different departments, enforcing a holistic PEx framework is just as valuable for a company developing software as it is for a pharma or medical device company developing therapeutic products.
Minimizing the Need for Customization
Fully embracing PEx would help to minimize the inherent silos we see in the life sciences industry, as this is a key factor to successful digitalization. In a digital landscape that has become increasingly complex, simplicity is sought out by end users, whether in a laboratory, manufacturing or at a clinical trial site. Simple enhancements can often make all the difference in user experience and even boost user compliance. A theme we heard was that making seemingly insignificant tasks really simple, e.g. not having to hunt for collaborators’ contact information or links to other applications, allows the user to focus on what is most deserving of their time and attention.
Avril England, General Manager, Vault at Veeva, led a great discussion with Kevin O’Brien, SVP, Clinical Development Operations, Eikon Therapeutics, and Matt Studney, VP, Merck Research Laboratories IT, about their modernization journeys. Given Merck’s long history, it is no surprise that they have navigated many digital initiatives. Current leadership is driving a complete technical and business process modernization. However, this is an incredibly difficult task, given that the legacy systems and processes that were best-in-breed 20 years ago are not scalable today. Studney remarked that all work in clinical development and regulatory operations will change, in some way, and that their teams have been asked to recognize that. Fundamental to Merck’s success is really listening to those performing the work and then ensuring the Veeva team has the same access. This ongoing program is part of a partnership that Veeva and Merck announced in 2022.
Eikon represents the other end of the spectrum, in that the company’s operations are new, and they have the luxury of starting fresh. Both companies are now working with Veeva to build out the capabilities that they need to be successful. From past experience at other companies, the Eikon team knew they had to push for standardization and to avoid customization. O’Brien added that this approach requires crystal clear alignment on what success looks like and a commitment to doing what it takes to get there.
In the Quality keynote, Jennifer White, SVP of Global Quality at Moderna, shared their story of pushing convention to move from “No Way” to a “Why Not?” mindset. That shift has allowed them to deliver system transformations with incredibly aggressive implementation timelines, unlike anything White had witnessed previously. A key outcome was moving away from overly customized workflows because, like Merck and Eikon, they just weren’t scalable for the long term.
Enhancements of the Veeva Vault Quality Program
Veeva Batch Release
“Unifying Quality” is an ambition the Veeva team put forth starting with the launch of Vault QualityDocs in 2013. This vision progressed to unifying QA, QC, and Training when Veeva announced Vault LIMS in 2021, and since then, they have continued to evolve towards more manufacturing-centric areas of Quality.
Mike Edwards, Director of Batch Release Strategy at Veeva, outlined the challenges that surround the batch release process. This activity continues to be very labor-intensive and more often than not, paper-based or with custom developed solutions. Veeva’s vision is to enable fully automated, end-to-end batch release for the industry. As companies consider what this would mean for them, Edwards has found that most teams have difficulty defining batch release cycle time and/or quantifying FTE requirements. This observation was reinforced by the audience’s show of hands when prompted. Uncovering the hidden costs of batch release is therefore very attractive to teams looking to improve efficiencies.
Although the batch release space covers a smaller footprint than LIMS or QMS, the value it brings is no less significant. Supply chain resilience continues to be a considerable challenge in the industry, with suppliers at a range of digital maturity levels. Being able to systemically aggregate all the data – such as from ERP, MES, LIMS – to inform product availability is the critical step in being better informed about the status of the operations.
Achim Schultze, Executive Director GMP QA, Madrigal Pharmaceuticals, is in the Veeva Batch Release early adopter program and spoke about what this solution brings to their organization. Madrigal started its Veeva journey with QualityDocs and Training, but based on prior experience, knew they would need much better visibility to all dimensions of their processes. For them, the Batch Release Dashboard allows for a simple way to connect all the dots and visualize what is happening in real-time, and each graph links to the data for more in-depth analysis. Most importantly, having visibility to all aspects of the batch release process helps the company reduce errors and save time.
When asked whether Batch Release links to Madrigal’s ERP, Schultze stated that they currently do not have one but that Veeva can be integrated if Madrigal decides to pursue an ERP system. Edwards remarked that although Batch Release is not meant to substitute or replace inventory management systems, it does indeed provide some of the same benefit for those that do not have one today. This can be especially attractive to more cost-conscious and/or start-up companies.
Veeva continues to invite those interested in their early adopter program to join.
Veeva Vault LIMS
As part of their digital modernization, a fast-growing company who had already implemented applications from Veeva across Quality (QualityDocs, QMS, Training), Regulatory (RIM) and Clinical (eTMF), determined that investing in Veeva’s new LIMS was a natural next step. The company moved forward with Veeva Vault LIMS and have especially liked being able to provide input into the roadmap as an early adopter. One of the reasons they chose Veeva LIMS is that it is scalable with new features added regularly, unlike their previous LIMS solution. Added benefits are the reduction in paper and a considerable improvement in employee satisfaction.
Veeva’s AI Strategy
Unlike many of its competitors, Veeva has not announced any new tools using Artifical Intelligence (AI), and that has been by design. Gassner presented their high-level AI strategy in the opening keynote and acknowledged their conservative approach as they explore what the most valuable use cases will be.
In a separate briefing, Jovanis stated that they will most likely invest in applying generative AI in established areas, like QMS, before they bring those capabilities into their newer offerings, like LIMS. Some use cases Veeva and its ecosystem of AI partners are investigating are automated translations, auto categorization and routing, as well as summarizing complaints. Jovanis feels good about their current level of focus on AI and was optimistic with the opportunity to add capabilities over time.
In Brief
Veeva currently has a footprint of nearly 600 customers in Quality, with a common entry point for customers being Vault QualityDocs. Veeva has continued its commitment to life sciences and has experienced a nearly ten-fold increase in Summit attendance since the first R&D and Quality Summit in 2014 in Philadelphia, which is evidence that their solutions are resonating with their base.
For more coverage of the Veeva LIMS and Batch Release solutions, please check out our in-depth analyst briefing here. We will continue to provide updates on Veeva as they become available.
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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.