Building the Industry Cloud for Life Sciences

Event Brief: Veeva R&D and Quality Summit 2022

Axendia’s Sr. Industry Analyst, Sandra K. Rodriguez, attended Veeva Systems R&D and Quality Summit in Boston, MA.   Nearly 2,000 attendees representing 280 companies participated in the event from October 18 – 20, 2022.

Building the Industry Cloud for Life Sciences

Peter Gassner, chief executive officer at Veeva Systems, opened the event and shared his vision for the future of the company, “Veeva is building the industry cloud for life sciences to be essential and appreciated by the industry.” Gassner also noted that 80% of pharma reps around the world are using CRM in Veeva’s Commercial Cloud, where the company started in 2007.  

Image Source: Veeva Systems. Wednesday, Oct. 19, 2022 Boston, MA. USA Veeva R&D and Quality Summit. Photograph by Alan Brian Nilsen Photographer

Over the past fifteen years, Veeva has expanded its platform to include R&D and quality functions.  To date, Veeva has over 500 Vault Quality customers, over 250 Vault QMS customers, and 240+ Vault Training customers.  “We continue to invest and innovate our quality offerings to enable unified and connected quality and help the industry drive efficiency and compliance,” explained Mike Jovanis, vice president of Vault Quality at Veeva. “With our announcement to build Vault LIMS, we’re now working across both QA and QC, a combination that we believe will be very powerful, bringing modernization to an area in need and creating an opportunity to accelerate batch release.”

Jovanis continued, “LIMS is the biggest investment we’ve made.  This has historically been a hard and complex space but is an area that presents many opportunities for innovation. Our offering will bring together unified quality data to maximize QC lab productivity, accelerate batch release, and increase reliability and accuracy in the data.”  Veeva is continuing to deliver innovations across its quality suite of applications, offering intelligent automation which checks for recurring quality events / duplication in events and applies robotic process automation to key business processes.

Jovanis also shared that early adopters are implementing Vault Validation Management. The solution allows customers to conduct validation activities digitally – without documents or paper – to save time and reduce compliance risks. 

Image Source: Veeva Systems

Veeva executives hinted at a big announcement that would be coming out shortly after the summit.  On November 1, 2022, a press release was issued announcing that Veeva and Merck had formed a strategic ten year partnership. Per the announcement, Robert M. Davis, chief executive officer and president at Merck stated, “Our strategic partnership with Veeva expands our capacity to leverage innovative technology and enhances our ability to deliver value to patients and all our stakeholders – this is key to how we measure success.”  Merck will also provide direct input to Veeva’s product roadmap.

Additional conference highlights are below.

Quality Makes Compliance at AstraZeneca

Anthony Morandi, vice president and head of Corporate Quality and Strategy at AstraZeneca (AZ) exclaimed, “Quality is about knowing what your disruptive sources of variation are.  When we drive right the first time, then quality makes compliance follow.”  What’s driven transformation at AZ is culture and mindset.  “We’re all aware of macro-drivers and need to accelerate disruptive technologies such as MRNA, personal therapies and CGT – which are all happening at scale,” said Morandi. 

How has the role of quality at AZ evolved? By building quality in for everyone.

“We’re moving from a decentralized approach to quality to a centralized one and thinking as a network and embedding best practices across the organization,” Morandi says.  His team is changing how the organization thinks about quality and is shifting from a reactive to a predictive state. “We’re getting signals earlier to prevent problems. This has been achieved by interconnecting quality processes – there are no boundaries between quality processes, risk, change control, deviations, and annual product reviews.”

Morandi also suggested working with partners who understand the business, not just the technology. “Some providers are happy to build you a rocket to the moon when you don’t need one,” cautioned Morandi.  His team is working with Veeva to take 30 internal sites and 11 different QMS solutions and bring them together on the Veeva Vault platform. 

During a Q&A with Jovanis, Morandi was asked how AZ has gotten faster.  “We’re using the digital platform to drive culture; we’re not doing digital just for the sake of digital but unlocking how organizations think and act.” He cautioned that every field and click needs to add value to the user, not just a nice to have.   

Within the next few years, AZ seeks to apply AI and ML to data sets. The company also seeks to create real-time control towers for suppliers to signal risk and use data directly from suppliers.  Morandi concluded with, “Master data must be managed or you won’t see the full benefit. Get clarity on governance and the need to maintain it. It’s also critical not to over-engineer things. Having the cloud allows us to control the variability of how things are used.”

GSK’s Center of Excellence

John Reilly, Head of Veeva Center of Excellence (CoE) at GSK shared how his organization is unlocking cross-functional value with multi-Vault governance.  GSK has improved clinical, quality, and regulatory process execution by prioritizing a multi-Vault governance structure to drive connectivity and collaboration across functions.

The business case for a cross team/cross Vault approach was the need to focus on user change management and training experiences.  Reilly suggested companies in the early stages of implementation should consider having teams dedicated to “cross Vault value.”

At GSK, the CoE focuses on optimizing data flows across the development lifecycle. Reilly concluded by sharing some big wins that the Veeva CoE initiatives have impacted since its inception in October 2021:  automated workflows, release management, usability, training simplification, risk and service management, user access management, community page and cross Vault agility.

Enabling Seamless Collaboration Across Internal and External Teams

Ashley Wentworth, senior director of Vault Quality Strategy at Veeva moderated a panel discussion and was joined by Jennifer Trundle, director of quality information systems at Gilead, Mary Alcazar, director of quality management systems at Resilience Biopharma, and Jen Willhide, director of IT QA platforms at a contract development and manufacturing services company.

Willhide shared her thoughts on the importance of improving external collaboration. “As a CMO that works with clients and sponsors, our ability to collaborate with our partners and across our vendors and suppliers is critical to our success. For us it’s about finding ways to optimize our processes so that we can collaborate with them in more real-time, getting the information we need, getting them the information that they need, and finding ways to work smarter, not harder is really what we’re trying to do…and that’s what I think everybody’s trying to do.”

Trundle spoke to the need for efficiency when collaborating with external partners. Improving external collaboration is so important for us, as the vast majority of our manufacturing and analytical testing work is outsourced to contract partners. So, if we don’t do that efficiently, if we can’t do that in the most effective way possible, then we might not be able to investigate issues as quickly as we need to. It may impact our ability to release batches quickly. That’s all reliant on the receipt and review and approval of information from our partners. So therefore, it’s a business imperative for us to make that as efficient and seamless as possible.”

Alcazar offered a different viewpoint on the topic.  “Coming from a CDMO, we want to also have the information stored in our Vault so that we can do investigations, we can do trend analysis. One of the biggest challenges is a seamless exchange of data and information, and also minimizing redundancies and duplicate data entry. For example, if Jennifer (Trundle) wants a data in her system, we want data in our system… how can we automate that so that it’s the same source of truth, and we’re handling the same data, and not compromising data integrity, but we both have access to the same information for what our uses are?”

Trundle then offered her opinion on what Veeva can do to enable external collaboration and support a shift towards increasing externalization. “I don’t have the answer of how to accomplish this, but what I’d like Veeva’s best practices and thought leadership to help us with is, how do we make it easier and more seamless to share information between two Vaults? Paradoxically, the times we have the hardest time convincing a contract partner to use our Vault is when they already have Vault, because they love it too. They configured it exactly the way they want it. It’s their workflows, it’s their metadata. It’s so easy to configure, that everybody configures their Vault a little bit different. We have our document types, they have theirs, we have our metadata, they have theirs, right? I don’t know why it’s so hard, then, to convince them to use another configuration. So if there was some way that the documents could more seamlessly move between the Vaults and change their identity like a costume…that is the biggest thing I think that we could use Veeva’s help with, is when it’s two different Vaults, how do they work and operate together?”

Willhide is looking to innovation as the answer.  “I think we’ve taken steps in the right direction to make external collaboration more accessible with things like dynamic access, and making sure that we are taking the functionality that we’ve built in little pockets and expanding it across the rest of the Vault so that we can use the functionality consistently across more than just that entry point at SQM.  I know it’s an early one, but whoever’s on the product team start writing it down. We want it for docs, we want it for the rest of QMS, we want it everywhere. I think those kinds of innovations make it more accessible, make it more cost-effective. For example, if a client is only going to interact with the system for a limited time, we need to make sure that the cost is worth the value we’re getting out of it.”

Alcazar also thinks that innovation will help. “I agree, making the interface better for external partners and clients, and also the segmentation of data. That’s something that we really struggle with, is how do we segment client data so that we’re only using one quality event versus having to create duplicate events so that each client can assess, or each client can approve? In addition, licensing. As a CDMO, we have multiple clients who want access to our system, but each one of them has a license. So how do we leverage that cost and how do we determine who gets access and who doesn’t.”

Vault QMS Roadmap

Nima Shah, vice president of product and Manaphan Huntrakoon, senior director of product management at Veeva Systems, shared what will be coming soon to Vault QMS.  “Customer input drives our roadmap, and we’re always looking to the industry to help us make sure what we’re delivering is innovative, easy to use, and solves the problem said Shah.

Image Source: Veeva Systems

Recent highlights and upcoming new features to Vault QMS include:

External notifications – the capability to send emails and docs to external people and non-vault users. Customers will also be able to send audit reports to users and suppliers via a dedicated link.

Intelligent automation for batch release – easily create batch release templates that define the documents and data to be collected. Create batch disposition records along with associated checks with a click of a button. Automatically populate related quality events associated with the batch.  Visual indicators will provide an ‘at-a-glance’ view of the work left to be done.

Duplicate detection for complaints – duplicate detection rule sets allow you to define one or many rules to identify a duplicate. Smart search algorithms identify potential duplicates along with a similarity score. A purpose-built, streamlined user interface to evaluate potential duplicates to arrive at a verdict. Automation links duplicates/follow-ups to the original complaint and performs a state change for duplicates/follow-ups.

Vault LIMS is Ready for Quality Transformation

Jason Boyd, senior director of Vault LIMS Strategy at Veeva Systems opened his session by speaking to how LIMS is mission critical, used every day in the lab, to drive QC operations, and how Veeva is investing to make LIMS easier to use and adopt and with a better return on investment.

Boyd acknowledged the industry, and existing Veeva customers need more than what legacy LIMS applications have provided. He continued with some additional points that resonated with the group.  “By adding LIMS to the Vault Quality Suite, our customers will be able to leverage QA content in QC within digital method execution in a unified user experience. Our customers will be able to bring together LIMS and QMS for change control, out-of-spec, and out-of-trend results. Additionally, our customers will be able to utilize training curriculum and execute workflows within QC LIMS with the full confidence of user qualifications. This is what Veeva means when we speak to the power of unified QA and QC.”

Image Source: Veeva Systems

Priorities for Vault LIMS include:

  • Step-based method execution that will lead analysts through testing
  • Workflows for analytic method development and qualification to seamlessly facilitate tech transfer
  • Platform-driven instrument integration
  • Stability study management right sized for all organization types
  • Fit for purpose mobile workflows
  • User training record-driven system access and testing assignments
  • Unification of change control inclusive of documents, LIMS static data, and impact on in progress batches

Boyd concluded with, “It is time for QC to contribute to the culture of quality by LIMS unifying with quality management systems.”

In Brief

In addition to the conference highlights listed above, Veeva also made several announcements to support clinical trials, including new Veeva Link applications which will give clinical teams real-time intelligence to optimize site selection and trial design. 

  • Link SiteBase identifies, filters, and ranks research sites (available April 2023)
  • Link TrialBase delivers clinical trial intelligence including current status, patient inclusion criteria, protocol design, and endpoints (available Oct. 2023)

The company also announced Veeva Clinical Database (CBD) application

  • Veeva CDB, a first-of-its-kind solution, harmonizes data from multiple sources for clean and concurrent clinical trial data
  • Veeva also established a first-of-its-kind CDB Data Provider Program to facilitate the efficient delivery of quality data in clinical trials

Additionally, Veeva introduced a new ePRO application for faster access to patient data. 

  • Makes it easier for patients to complete assessments and enables real-time data access for sponsors
  • A significant advancement in patient-centric digital trials

Veeva customers are leveraging Vaults and critical product and patient data across the product lifecycle.  No longer a nice to have, platforms are gaining the attention and adoption of not only SMBs but enterprise clients.  As innovators continue their digital transformation journeys to become data-driven leaders in the life-sciences industry, they will continue to seek out unified platforms to support digital sustainability.  As a result, platform wars will continue, and point solution providers will inevitably lose out.

Contact research@axendia.com to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this Event Brief reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.