2023 Veeva R&D and Quality Summit Event Brief
Axendia covered the 2023 Veeva R&D and Quality Summit in Boston on Sept. 13 and 14. The Summit brought together more than 2,500 participants to share learnings across more than 90 sessions including keynotes from Amgen, Bristol Myers Squibb, Daiichi Sankyo, Merck, and Takeda. These industry leaders shared how they are leveraging new strategies and technology across clinical, regulatory, safety, quality, and manufacturing to move the industry forward with velocity and efficiency. (See: Veeva is Building the Life Sciences Cloud with High Speed and Velocity)
Veeva CEO Peter Gassner kicked off the opening keynote by announcing several advancements developed by Veeva that can help sponsors, contract research organizations (CROs), and research sites streamline product development to benefit patients.
Additional featured keynotes and sessions at the Summit included:
- Amgen shared its journey to simplify and improve the user experience across GxP quality management.
- Amylyx Pharmaceuticals and CRISPR Therapeutics showcased pharmacovigilance outsourcing best practices for better oversight and data control.
- Cerevel explained ways to automate and streamline clinical trial study training for improved inspection readiness.
- GSK detailed how it collaborates and shares information with research sites during clinical trials for faster execution and improved transparency.
- Jazz Pharmaceuticals and Sanofi shared strategies to implement submission content plans for greater speed and efficiency.
- Merck discussed its digital transformation across the enterprise to advance patient safety.
Continuing to Build the Industry Cloud for Life Sciences
In his opening remarks, Peter Gassner reiterated Veeva’s vision: “Building the Industry Cloud for Life Sciences.”
Veeva’s Industry Cloud for Life Sciences includes Development and Commercial Cloud offerings and spans across software, data, and services. The Development Cloud supports Clinical Operations, Clinical Data, Regulatory, Drug Safety, and Quality.
At the summit, Veeva announced seven new products expanding its offerings across the Development Cloud.
Veeva Extends Into Manufacturing
During his opening keynote, CEO Peter Gassner announced the launch of two new applications supporting Life Science manufacturing: Vault Veeva Batch Release and Vault e-Forms. Veeva expects Vault Batch Release will accelerate time-to-market and reduce cost by automating data aggregation, reviews, and traceability for greater efficiency and accuracy. Vault Batch Release will bring together data and content from ERP, QMS, LIMS, and regulatory systems for real-time visibility into batch release status. This represents a significant step for Veeva into the Manufacturing space.
Mike Jovanis, Vice President of Quality and Manufacturing at Veeva, shared the company’s focus and vision to unify Quality Assurance, Quality Control, and Manufacturing.
Vault Batch Release is a new cloud application that is intended to enable faster, more confident GMP release and market-ship decisions. Vault Batch Release aims to streamline the aggregation and review of data and content while simplifying collaboration with external partners to address increased manufacturing and supply chain complexities.
“Veeva Vault Batch Release will offer an automated, end-to-end solution for an underserved, complex process with compliance and cost risk,” said Jovanis. “Veeva Vault Quality and Vault RIM applications provide a unique foundation to accelerate batch release and market-ship decisions while driving consistency and transparency.”
Vault Batch Release will bring together data and content across QMS, LIMS, ERP, and regulatory systems for real-time visibility into batch release status. The application will be tightly integrated with and require Veeva Vault QMS and can accelerate time to value when used with Veeva Vault LIMS and Veeva Vault RIM. It also offers the flexibility for use with other third-party LIMS and regulatory solutions. By connecting systems and automating data aggregation, reviews, and traceability, Vault Batch Release can improve efficiency and speed time to market.
“Our purpose to deliver better everyday health with humanity requires continued modernization of quality and manufacturing systems and processes,” commented Vanessa Briand, Digital and Data Solutions Quality Head at Haleon. “A digitalized and automated batch release solution will help us deliver products to our customers consistently, quickly, and efficiently.”
Vault Batch Release will be part of Veeva Vault Quality. The application is planned for availability in the second half of 2024.
Veeva Vault LIMS Ready for Primetime
In a personal briefing, we asked Jason Boyd, Senior Director, Veeva Vault LIMS, about Veeva’s plans for lab equipment connectivity in this very heterogeneous space. “We do not want to be in the interface writing business,” asserted Boyd. Instead, Vault LIMS is leveraging its partnerships with Scitara and TetraScience to facilitate equipment integration.
Jason also shared that Civica Rx (Civica) has adopted Veeva Vault LIMS to optimize quality control. Civica had already implemented Veeva Vault QMS, Veeva Vault QualityDocs, and Veeva Vault Training as the foundation for unified lab and quality processes to support a new manufacturing facility.
“We guarantee generic drug volumes for our partner hospitals and health systems, so having a cloud LIMS solution is a top priority,” claimed Jay Benson, Chief Manufacturing and Supply Chain Officer at Civica. “Veeva Vault LIMS will simplify our internal manufacturing and testing while driving right first time, lead time adherence, and visibility across the value chain.”
Civica aims to improve productivity and speed with a unified quality ecosystem. Within Vault LIMS, lab professionals will be able to reference relevant methods and specifications stored in Vault QualityDocs and surface relevant quality events from Vault QMS during final QC review. The unification ensures up-to-date information and improves transparency.
“Veeva Vault LIMS will help Civica create an advanced quality control lab with a simple and efficient user experience,” affirmed Boyd. “We’re excited to partner with Civica to help them gain agility in delivering affordable generic medicines to patients.”
In Brief
Veeva continues to execute on its mission to build the Industry Cloud for Life Sciences. In addition to extending its Clinical and Regulatory offerings with new products, the company made significant announcements in the Lab and Manufacturing spaces adding new applications to its quality platform. We will continue to provide updates on Veeva as they become available.
To discuss how this initiative impacts your organization, contact research@axendia.com to schedule an Analyst Inquiry on this topic.
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