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Boston Oct. 19-20, 2022
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Agenda

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Tuesday, October 18

4:30 p.m.

Opening Reception
4:30 p.m.

Wednesday, October 19

7:30 a.m. – 6:00 p.m.

Breakfast
7:30 a.m.

Opening Keynote
9:00 a.m.
Peter Gassner Veeva
Founder and CEO

Zone Keynotes
10:00 a.m.

Boehringer Ingelheim shares its strategic vision for a “One Medicine Platform” to bring treatments to patients faster. They’ll discuss how they are unifying development processes and data in a centralized platform to reduce complexity and drive a new mode of patient-centric digital trials.

Uli Broedl Boehringer Ingelheim
Head of Global Clinical Development & Operations
James Reilly Veeva
VP, Development Cloud Strategy

AstraZeneca shares how industry trends are influencing quality and quality management systems. Hear their transformation journey and vision for the future.

Anthony Morandi AstraZeneca
VP Corporate Quality & Strategy
Michael Jovanis Veeva
VP, Vault Quality

The regulatory zone will kick off with a fireside chat featuring Sean McNiff from GSK. Now that his team has unified dozens of systems onto the Vault RIM platform, he will talk about the next steps in their journey to optimize the end-to-end process. Learn about GSK’s strategies for measuring process improvement and speeding the overall go-to-market timeline.

Sean McNiff GSK
VP Regulatory Platforms and Systems
Marc Gabriel Veeva
VP, Vault RIM
Linda Scarazzini AbbVie
Vice President, Pharmacovigilance and Patient Safety
John Lawrie Veeva
Vice President, Vault RIM and Vault Safety
Kelly Traverso Veeva
VP, Vault Safety Strategy

Join a fireside chat with CSL Behring to learn how they unified multiple organizations and systems by adopting a single platform for the full product lifecycle. After the discussion, business leads from CSL’s different domains will take questions from the audience.

Rynita Julien CSL Behring
Senior Director of Information Technology
Jared Katz Veeva
Development Cloud Architect

Connect
11:00 a.m.

Join our demonstration on setting up regional binders that link to global content and providing oversight of all PSMFs with Vault SafetyDocs. We’ll show tracking of periodic reviews, collaborative updates, and how to automatically bring together content into a single PDF file for review and approval by the QPPV.


Lunch
11:30 a.m.

Sessions
1:00 p.m.

Astellas outlines how their risk-based approach transformed TMF management. They share best practices for streamlining inspection readiness checks and focusing study teams on reviewing the most critical documents.

Noreen Bouchard Astellas
Associate Director, TMF Management Office
Jonathan Bissell Astellas
Associate Director, TMF Management Office

AbbVie embarked on an enterprise-wide initiative to define and measure KPIs to improve performance. Join this session to learn a 4-step methodology to operationalize study start-up metrics, AbbVie’s approach to activate sites faster, and how they use Vault Study Startup to successfully reduce cycle times.

Vasthi Becerra Abbvie
Associate Director, Study Start Up Operations
Anusha Shetty Veeva
Director, Strategy, Site Startup and Engagement

A top 20 pharma will discuss how they are preparing for the digital future and their CTMS transformation journey from both the IT and business perspectives. Learn about their implementation strategy, how they overcame challenges, and lessons learned deploying Vault CTMS organization-wide.

Learn how a top pharma company gained end-to-end control and visibility by harmonizing quality processes globally with Vault QMS. Hear about their quality vision, implementation roadmap, and key lessons learned so far.

Tolmar shares how Vault Training can help streamline business processes and increase training effectiveness when it is unified and connected with quality. Hear how the resulting efficiency gains enable organizations to focus on what truly matters – improving processes, people, products, and patient outcomes.

Nicole Donovan Tolmar Inc
Director Organizational Development

PwC discusses how building a strong digital foundation — rooted in industry best practices — prepares quality organizations for automation and advancements in artificial intelligence.

Patrick McMahon PwC
Director, Pharma-Life Sciences Cloud, Quality, & Clinical Systems

Syneos Health R&D Advisory Consulting will share how a focus on process development and alignment between sponsor and CRO partners can be used to establish a reproducible level of leading performance in Clinical Data Management using Veeva CDMS. The opportunity to extend this into co-development to drive innovation is discussed.

Nicholas Lakin Syneos Health
Senior Managing Director

Data democratization empowers speed and collaboration as users feel more confident to make data-driven decisions. Hear how Sanofi plans to leverage data democratization to enhance authoring of PQ CMC and Module 3 documents. They’ll discuss key considerations for facilitating health authority decisions by creating a single source of truth with the flexibility to produce multiple output formats.

Joe McLaughlin Sanofi
Head of Regulatory Business Process & Innovation

This panel will bring together Agios, Intellia, and Turning Point Therapeutics (a wholly owned subsidiary of Bristol Myers Squibb Company) to summarize their top lessons learned for maximizing user adoption. They’ll share how they prepared their organizations for change, interacted with different user groups, and addressed challenges leading up to and after the business go-live.

Kirstin Popov Agios Pharmaceuticals
Associate Director, Regulatory Operations
Milagros Vitor-Butzen Intellia Therapeutics, Inc.
Sr Director, Regulatory Operations
Kelsey Edwards Turning Point Therapeutics (a wholly owned subsidiary of Bristol Myers Squibb Company)
Associate Director, RIM & PromoMats

Gain insight into how CSL Plasma and CSL Behring, partnering with Accenture, evaluated a new safety solution and why they chose Vault Safety for a newly acquired and approved product. Sharing objectives, decisions, and insights on business process optimization and automation, they’ll discuss how they are approaching Touchless Case Processing for non-serious adverse events.

Richard Wolf CSL Behring
Executive Director, Global Head of Pv Operations
Grishma Sharma Accenture
Managing Director

GSK will describe how they’ve improved clinical, quality, and regulatory process execution by prioritizing a multi-Vault governance structure. They’ll share their approach to rolling out cross-functional initiatives like Vault Connections through their center of excellence and the intended benefits.

John Reilly GSK
Head Veeva CoE
Jared Katz Veeva
Development Cloud Architect

Hear about Endo Pharmaceuticals’ risk-based approach to computer system validation. They’ll review the framework they use to manage implementations, Vault releases, and self-driven updates to streamline activities and accelerate user enhancements.

Greg Rosen Endo
Executive Director, IT

Connect
2:00 p.m.

Sessions
3:00 p.m.

Learn how Merck & Co., Inc. and Cerevel use the TMF Bot to automate trial processes, increase document classification accuracy, and enable teams to focus on strategic tasks like post-approval quality reviews. They’ll also share how they quantify the value of AI in TMF.

Bryan Souder Merck & Co., Inc.
Senior Director, TMF Head
Stephen van Arcken Cerevel Therapeutics
Senior Clinical Oversight Lead

Vertex shares how a well-orchestrated path to clinical trial technology adoption enabled them to achieve step-change gains in trial efficiency while enhancing patient and site engagement. They’ll discuss their approach to capability prioritization, vendor selection, and deployment – focusing on making informed decisions that enable real-world improvements.

Chris McSpiritt Veeva
Senior Director, Vault Clinical Strategy

Takeda will share their ‘Future Fit’ vision and how Vault Clinical Suite helps them achieve their goals. Learn considerations when taking ownership of data and operational systems as part of the evolution of trial delivery, Vault Clinical innovations that support their transformation program, and the technology they have implemented to optimize end-to-end clinical trial execution.

Melissa Umbehauer Chiasson Takeda Pharmaceuticals
Alta Petens – Trial Operations Data Lead
Samantha Kitchen Takeda Pharmaceuticals
Operational Data Technology Lead

Veeva and Accenture discuss why digital strategy is foundational for creating business value through quality transformation. This fundamental change in how quality is managed will contribute to business agility and efficiency. Learn how unifying quality addresses the critical aspects of compliance, right first time, automation, and laboratory cycle time.

Jason Boyd Veeva
Senior Director, Vault LIMS Strategy
Brian (B.J.) Brunner Accenture
Managing Director, Accenture Scientific Informatics Services

Hear how top pharma companies are taking a structured approach to identify, assess, and mitigate strategic and operational risks to reduce the number of quality issues and drive continuous quality improvement.

Come join a panel of SMB decision makers discussing how to build a foundation around CDMS, branch outwards to other systems, and how it can make data management more efficient.

Moderna will share how they quickly scaled operations by incorporating label management functionality into their end-to-end regulatory solution. They’ll discuss how they identified business requirements, leveraged labeling concepts, and socialized the new streamlined process with users.

Jennifer LaFleur Moderna
Executive Director, Global Regulatory Science Operations
Colleen McGraw Moderna
Sr. Director, Global Regulatory Labeling

ICON will share how sponsors can balance objectives of data quality, operational efficiency, and organizational alignment when deploying a regulatory solution. They’ll discuss a range of options in the continuum of centralized, hybrid, and decentralized data management approaches and what impacts that may have on the overall regulatory operating model.

Rachel Kelly ICON
Exec. Director, Global Head of Reg Ops

AbbVie discusses their rapid migration to Vault Safety, change management best practices, and lessons learned on implementation and data migration. Hear AbbVie’s approach and how their safety and IT teams are partnering with Veeva to accelerate deployment and ensure success.

Jennifer Koeller AbbVie
VP, Strategic Operations, Patient Safety
Sandra Strauss AbbVie
Senior Director
Kelly Traverso Veeva
VP, Vault Safety Strategy

Improve your organization’s visibility into operational processes, application usage, and KPIs with Vault reports and dashboards. Learn about Vault reporting’s core tools and how to use them to convert an idea for a metric into an actionable dashboard. Review the notable features released over the past year and planned on the 2023 roadmap.

Graham Gelwicks Veeva
Director of Product Management, Vault Platform Services
Pukar Bhandari Veeva
Senior Product Manager

Hear from two top pharmas on how they incorporated multiple acquisitions into their technology landscape. They’ll discuss how they assessed individual Vaults, standardized data across environments, and streamlined overall business operations.

A CRO shares experiences on selecting and partnering with Veeva RTSM for repeated successful project delivery


Connect
4:00 p.m.

Sessions
4:30 p.m.

Global Blood Therapeutics (GBT) embarked on a journey to establish a framework for TMF health. They share how they leveraged well-defined metrics, reports, dashboards, and cross-functional partnership to drive accountability and improve TMF quality.

Sally Ton Global Blood Therapeutics
Business Operations Manager

Bayer shares their experience as an early adopter of Veeva Site Connect. Hear about best practices to implement technology, drive change, and improve collaboration with sites.

Emma Earl Bayer
Head of Systems Support
Jason Methia Veeva
VP, Vault Clinical Operations Strategy

Incyte shares their holistic quality transformation case study, including its justification for modern cloud solutions. Learn how harmonizing quality systems improved collaboration across all GxP stakeholders and increased adoption, efficiency, and visibility.

Natasha Polevoy Incyte Corporation
Sr. Director, Global QMS

Industry leaders share best practices for fostering effective collaboration across internal and external teams. Hear how to streamline processes, where to store data, and which systems to leverage.

Discover how GSK accelerated drug development by modernizing clinical data management with Vault CDMS and the positive impact it had on clinical trials. They will share their implementation journey, key learnings, and the most effective ways to ensure successful adoption.

Mayank Anand GSK
VP and Global Head of Data Strategy and Management

Sarepta and Vertex will share how they’re improving cross-functional processes by connecting key data points between regulatory and quality teams. They’ll discuss why they decided to implement the Vault Quality to RIM Connection, how they transformed legacy variation management processes, and their top lessons learned for other companies that are considering a similar project.

Kate Wilber Vertex
Director, Regulatory Information Management
Wim DHaeze Sarepta Therapeutics, Inc.
Director, Global Regulatory Operations, RIMS/DMS Lead

Hear how Cerevel increased visibility and collaboration between their regulatory and clinical operations teams. They’ll share tips for gaining buy-in across the organization, assimilating product, study, and site data, and driving stronger compliance in Vault.

Dee DeOliveira Cerevel Therapeutics
Senior Director, Head of Global Regulatory Operations

Join our fireside chat to hear how Vault Safety is streamlining PV workflows, provides real-time visibility, and enables oversight when outsourcing. We’ll also discuss ways to manage new releases, address resource changes, and use Vault cross-linking to eliminate duplication of PV content.

Jason Maze Dermavant Sciences
Sr. Director, Regulatory Systems, Info Mgmt., and Validation
Tawny Landtiser Dermavant Sciences
Pharmacovigilance Manager

Hear from our migration experts on what tools are currently available to aid companies that are moving documents and data into Vault Platform. They’ll review Veeva’s migration methodology, top lessons learned from past projects, and how Veeva will support migration efforts in the future.

Learn how Roche defines success for organizational changes beyond an initial project go-live. They’ll review incentives, goals, and systemic support structures that mitigate productivity gaps associated with new functionality.

Nadine Hammer Roche
Senior Organizational Change Lead

A biotech company shares how they are fulfilling complex adaptive trial designs by leveraging Veeva RTSM.


Evening Event
6:00 p.m.

Thursday, October 20

7:30 a.m. – 5:00 p.m.

Breakfast
7:30 a.m.

Sessions
8:30 a.m.

Come see how Veeva provides a complete and connected technology ecosystem that spans patients, research sites, and trial sponsors. You’ll see first-hand how the Vault Clinical Suite, SiteVault, and MyVeeva for Patients enable seamless execution and flow of data across all stakeholders.

Steve Harper Veeva
SVP Product Management, Digital Trials
Annie Linker Veeva
Product Manager, Clinical Operations
Vinny Tuminelli Veeva
Principal Product Manager, Site Connect
Marc Biondi Veeva
Senior Product Manager, eConsent

Sessions
9:00 a.m.

See how new features like TMF Bot, Email Ingestion, EDL and milestone automation, and monitoring enhancements drive informed decisions and streamline processes. We’ll also share upcoming innovations for Vault Clinical Operations Suite that enable intelligent study start-up planning, end-to-end document QC, and more.

Tom Dekker Veeva
VP Product Management, Vault Clinical Operations
Annie Linker Veeva
Product Manager, Clinical Operations
Brian Bialkowski Veeva
Director, Product Management, Clinical Operations

Get a demo of External Notifications, Annual Product Quality Review automation, and Quality Risk Management enhancements in Vault QMS. Also, see how upcoming features like Duplicate Detection and Quality Event Recurrence Check will improve decision making and enable proactive quality management.

Nima Shah Veeva
VP, Product Management, Vault Quality
Manaphan Huntrakoon Veeva
Senior Director, Vault Product Management, QMS

Hear Veeva’s vision and roadmap to simplify life sciences training with solutions that meet the needs of trainers throughout an organization. Also, get a demo of recent enhancements and upcoming features like Curriculum View, Admin Alerts, and new Classroom Training that advance this vision.

Hear about upcoming innovations and enhancements in Vault CDMS, including:
• Vault EDC improvements in the study build & amendment process, bulk locking and freezing, and other new features such as file attachments.
• Veeva CDB data provider query workflow, the clean patient tracker dashboard, and automated query management.

Ray Letulle Veeva
Senior VP Product, Vault CDMS
Richard Young Veeva
VP, Strategy, Vault CDMS
Pavel Burmenko Veeva
General Manager, CDB

The Vault RIM product team will highlight key features from the past year including detailed roadmaps for Vault Submissions, Archive, and Publishing. They’ll also demo the new Submissions Archive Viewer designed to improve navigation, filtering, and searching.

Rich Merrick Veeva
Director, Product Management, Vault RIM
Cindy Ling Veeva
Product Manager, Vault RIM Submissions
Vera Lvovich Veeva
Senior Product Manager, Vault RIM Submissions Archive

Hear Veeva’s vision and roadmap for Vault Safety. See touchless case processing, capabilities to make reporting and compliance easier, and get a first look at how Vault Safety is connecting to Vault RIM and Vault Clinical. We’ll also discuss our automation strategy.

Marius Mortensen Veeva
VP, Product Management, Vault Safety
Asi Roll Veeva
Director, Product Management

Explore what’s new with Vault Platform and Veeva Development Cloud. We’ll review how upcoming releases will help organizations improve scalability, workflows, reporting, and integrations with Vault Connections.

Andy Han Veeva
VP Product Management, Vault Platform

Hear how new functionality on our Veeva RTSM roadmap will drive innovation.

Natalie Townsend Veeva
VP Strategy, Veeva RTSM

Connect
10:00 a.m.

Sessions
11:00 a.m.

Join us for a preview of Veeva eConsent, Veeva ePRO, and Veeva SiteConnect. See how Veeva is streamlining study execution for sponsors and clinical research sites, and making trial participation easier for patients.

Steve Harper Veeva
SVP Product Management, Digital Trials
Bonnie Bates Veeva
Senior Product Manager
Kyle Stephenson Veeva
Director of Product Management, ePRO

See a demo of how Vault Validation Management will accelerate validation and reduce costs. Also, hear about upcoming investments in product excellence, innovation and automation, and collaboration.

Nima Shah Veeva
VP, Product Management, Vault Quality
Stephen Chelladurai Veeva
Director, Product Management
Peter Alouche Veeva
Director, Product Management

Hear how Vault LIMS will modernize quality control lab operations for faster batch release and reduced inventory carrying costs. Get a demo of how it enables manufacturing organizations to connect their QC labs with the broader quality ecosystem.

Jason Boyd Veeva
Senior Director, Vault LIMS Strategy
Jenn Lambert Veeva
VP Product Management, Vault LIMS

The Vault RIM product team will share the latest developments related to DADI and IDMP for Vault Registrations and they’ll also provide a sneak peek into a new usability initiative. See how we’re building compliance, automation, and productivity into upcoming releases to optimize the overall Vault RIM experience.

Eldar Curovic Veeva
VP, Product Management, Vault RIM
Nicolas Tasse-Guillen Veeva
Principal Product Manager, Vault RIM – MedTech
Kelly Finlan-Dansbury Veeva
Product Manager, Vault Registrations
Sara Hendershot Veeva
Product Manager, Vault Registrations

See upcoming capabilities for Vault SafetyDocs, including expanded PSMF management, PVA management, and literature review. Get a demo of modular PSMF management, logbook tracking, and compliant eSignatures to help make compliance easier and remain inspection ready.

Eric Woolven Veeva
Senior Product Manager, Vault SafetyDocs

Join this session to learn how Vault APIs and the Spark framework enable organizations to integrate external tools with the Vault Platform. Mulesoft will also share how to manage middleware to create a bridge between applications.

Mark Arnold Veeva
Senior Product Manager, Vault API & SDK

Last year, EQRx shared how they built a core development platform in only 12 months. Hear how they’ve grown those initial capabilities through synergy between their Informatics and Business teams to deliver innovation to end users.

Casey Gresh EQRx
Director, GxP Systems
Charlene Lang EQRx
Senior Manager Quality Systems
Nicholas Meghri EQRx
Veeva Vault Technical Lead

Join Sean Parr from the Veeva RTSM team to hear how to minimize the cost of wastage and shipping during trial design and execution via data driven approaches.


Lunch
12:00 p.m.

Sessions
1:00 p.m.

Learn how Celerion is leveraging the Veeva Digital Trials Platform to improve participant experience during clinical trials and increase efficiency for sites and study teams. They’ll discuss their implementation journey with MyVeeva, eConsent, and ePRO and share lessons learned along the way.

Staci McDonald Celerion
Vice President, Global Scientific Clinical Operations
Tim Davis Veeva
VP of Strategy, MyVeeva for Patients

Learn about this top 20 pharma’s journey to simplify monitoring and track recruitment more effectively with the Vault Clinical Operations to CDMS Connection. They will share their implementation journey, key learnings when automating data transfers, and the most effective ways to partner with Veeva to ensure successful adoption.

Hear how a modern approach to technology is supporting the rapid expansion of Forge Biologic’s manufacturing facility to meet growing demand for gene therapy manufacturing. Learn how unified quality systems helps them accelerate quality processes and build trusted partnerships.

Ryan Heil Forge Biologics
Associate Director, Quality Management

Industry leaders share examples of how Vault Quality supported their organization’s goals during acquisitions, mergers, and spin-offs. Learn best practices and lessons learned to help navigate the implementation of Vault Quality solutions during M&A and to create business value.

Join us for a preview of Vault Signal and learn how Veeva is streamlining signal detection, analysis, and management.

Vault workflows help streamline and automate regulated processes. Learn how to use the tools workflow offers and the benefits of OneWorkflow. Review impactful features being released like Multi-Record Workflows and what is targeted on the 2023 roadmap.

Walid Abou-Chalha Veeva
Senior Product Manager, Vault Platform Lifecycles & Workflows
Graham Gelwicks Veeva
Director of Product Management, Vault Platform Services

This is your second chance to explore what’s new with Vault Platform and Veeva Development Cloud. We’ll review how upcoming releases will help organizations improve scalability, workflows, reporting, and integrations with Vault Connections.

Andy Han Veeva
VP Product Management, Vault Platform

Sessions
2:00 p.m.

The pandemic highlighted opportunities for clinical teams to more effectively respond to crises, such as quickly identifying active sites in a particular region that can still operate and understanding patient status to decide if they should be moved to a different site to continue treatment. Learn Vault CTMS configuration suggestions from Veeva and Accenture that will enable your organization to proactively prepare for global conflicts and events.

A top pharma shares their quality transformation journey, and dives deep into how Vault QMS is helping them streamline processes and systems, improve external access and collaboration, and harmonize across multiple sites and business units. Hear their business drivers, lessons learned, and guiding principles for quality systems projects.

Sarepta Therapeutics shares the value of taking a systematic approach to implementing key enhancements and adopting new Vault Quality features. Learn the importance of establishing a robust process and best practices for engaging stakeholders, managing implementation timelines, and defining change management.

Megan Girard Sarepta Therapeutics
Manager, Global eQMS & Administration

Join other Vault Safety customers to share challenges, industry trends, and best practices.


Sessions
3:00 p.m.

Learn how to build Vault eTMF reports and dashboards for key TMF health metrics. In this interactive workshop, you will connect with other Vault eTMF customers and have the opportunity to request demonstrations of customized reports and dashboards.

Join this interactive demo and Q&A session to learn how to enable seamless and efficient collaboration with partners on external audit findings with Vault QMS.

Join this customer panel to learn best practices for configuring and implementing Enhanced Periodic Review in Vault QualityDocs.

Engage with Veeva’s Vault Training solution experts and get your questions answered.

We’ll wrap up the regulatory zone with an interactive discussion around the Vault RIM user experience. Eldar Curovic, VP of Product Management for Vault RIM, will share several new ideas and collect live feedback from participants.

Eldar Curovic Veeva
VP, Product Management, Vault RIM