October 2 – 4, 2017
Loews Philadelphia Hotel, Philadelphia, PA
Register now!
2017 Veeva Global R&D Summit – Agenda
Agenda subject to change
Show All Tracks Clinical Quality Regulatory IT/Platform
Monday, October 2, 2017
Tuesday, October 3
Veeva Vision, Peter Gassner
Lilly’s R&D Journey to the Cloud, Robert Nist, Lilly
Regulatory Transformation at BMS, Cynthia Piccirillo, Bristol-Myers Squibb
Veeva Product Direction, Jen Goldsmith & Avril England
Speaker: Terry Murphy, Janssen Research & Development
Audience: Business
A unified clinical environment allows greater operational efficiency and provides a more complete view across clinical trials. Janssen discusses their journey to unify clinical operations and shares insights into how a modern solution transforms clinical trial execution.
Speakers: Melissa De Swaef and Jeff Wagner, Lilly
Audience: Business
As clinical trials become more complex, clinical development operations have become more specialized, making collaboration across internal departments and external partners even more important. In this panel, Lilly will explore trends in clinical collaboration and how a holistic strategy to deploying connected eClinical systems can help propel clinical development and build collaboration across team members.
Speaker: Homan Faraji, Avanir
Audience: Business
Hear how Avanir is leveraging Vault eTMF to optimize clinical trial outsourcing, including best practices for enabling seamless access and management of data across the partner ecosystem to reduce risk, breakdown silos, and improve collaboration.
Speakers: Jamie Toth, Daiichi Sankyo; Julia Lombardo, C.R. Bard, Inc.
Audience: Business
Legacy TMF processes are a thing of the past for C.R. Bard and Daiichi Sankyo. The companies share perspectives on optimizing clinical trial processes with Vault eTMF, including applying risk-based TMF procedures, and externalizing TMF processes for greater collaboration with CROs.
Speaker: Tracy Paster-Brown, Covance
Audience: Business
With an active TMF operating model, sponsors and CROs have access to trial documents, information, and processes in real-time. Covance shares how they are evolving their TMF business processes to drive greater collaboration and transparency in clinical trials.
Speaker: Brenda DeJesus, Edwards
Audience: Business
When fully employed, the eTMF can be a strategic asset that not only guides and automates the collection of documents but also reveals insights that lead to long-term process improvements that streamline the entire study process. Hear a first-hand account of Edwards’s journey to evolve their TMF business operations through adoption of enhanced Vault eTMF functionality over the course of their program. The case will include a review of process improvement areas, implementation considerations, and lessons learned along the way.
Speaker: Ed Leftin, Ora
Audience: Business
Ora, Inc. transformed their clinical operations by migrating from manual, paper-based processes to Vault CTMS in under 90 days. Learn how they improved study execution and quality by moving to one unified global system for managing clinical trials, including Vault eTMF, Vault Study Startup, and Vault CTMS, and hear lessons learned along the way.
Speaker: Dawn Anderson, Deloitte
Audience: Business
Improving clinical trial productivity is crucial to getting drugs to market faster, but disparate clinical systems hinder operational efficiency. Deloitte shares how a unified clinical operating environment makes clinical trials smarter and faster, and ensures data quality and regulatory compliance – all while promoting clinical trial cost effectiveness and productivity.
Speaker: Shayna Lambert, Janssen
Audience: Business
Utilizing Vault eTMF, MHRA inspectors conducted an efficient audit at Janssen, complimenting the company on the ease-of-use of their TMF. Join this session to hear a first-hand account of how a modern TMF, in combination with effective planning and strong collaboration between Janssen and Veeva, contributed to improved inspection readiness at Janssen.
Speaker: Scott McCulloch, BioMarin
Audience: Business
The impact of effective TMF management on clinical trial execution can be difficult to quantify. BioMarin will discuss their insights from incorporating Vault eTMF into their daily work processes and will examine the key clinical metrics that help evaluate TMF performance.
Speakers: Richard Young, Drew Garty, and Joanne Schmidt, Veeva Systems
Audience: Business and IT
Moving from paper CRFs to EDC has promised much, but unfortunately, clinical data management processes remain largely unchanged, take just as long, and cost more than ever. As data complexity increases with the rise of personalized medicine and adaptive trials, it is critical to accelerate ahead of these challenges. Join this session to see a next-generation EDC solution that enables you to run the trial you want, and learn how data can harmonize the overall clinical trial process.
Speakers: Janet Lloyd, BMS; James O’Keefe, Paragon
Audience: Business and IT
TMF management has evolved into a discipline rooted in compliance, operational efficiency, and partner collaboration. BMS and Paragon illustrate this evolution through a case study on the implementation of Vault eTMF, by focusing on business transformation, organizational change, and a shift in the CRO-operating model toward tighter collaboration.
Speaker: Olivier Melis, UCB
Audience: Business and IT
UCB migrated 17,000 internal and external users from multiple systems to Vault QualityDocs. The team shares how they support releases in a cloud environment and manage quality across 13 functional areas and with external parties such as contract manufacturers.
Speaker: Jerry Anderson, IONIS
Audience: Business and IT
Legacy quality solutions are inefficient and make it difficult to provide transparency across teams and sites. Hear how IONIS is advancing quality management with cloud and migrating from TrackWise and QUMAS to Vault Quality for greater visibility and alignment.
Speaker: Kim Carnes, REGENXBIO
Audience: Business
Unifying quality management provides a more complete view of quality operations and allows greater operational efficiency. Learn how REGENXBIO is using Vault QualityDocs and Vault QMS to streamline and improve quality operations.
Speaker: Elizabeth Van Sant Hoffman, Lilly
Audience: Business and IT
Embracing quality management strategies that balance level of effort with risk simplifies operations and improves control. Lilly and a SMB customer explore best practices for managing quality and quality systems, and approaches reflecting risk and company size.
Speakers: Jackie Chuk, bluebird bio; Praveen Vangeti, Gilead; Sandeep Chopra, Veeva Systems
Audience: Business and IT
Outsourcing of key processes creates complex operational environments. Gilead, bluebird bio, and Veeva provide a technical overview on how Vault Quality can simplify work streams, accelerate processes, and improve relationships with contract manufacturers.
Speakers: Chris Colucci and Mark Pellegrino, Insmed; Scott Barnard, UL
Audience: Business and IT
Empowering employees with the knowledge to perform their jobs at the highest level of proficiency is crucial to product quality. Insmed and UL illustrate how integrating content and learning management systems improves development programs – promoting a high-performing culture.
Speakers: Danielle Beaulieu and Raghunandan Satyanarayan, Bristol-Myers Squibb
Audience: Business
Bristol-Myers Squibb shares their global approach to submission planning and content planning – phase one of a multi-phase, multi-year, RIM transformation program. This presentation provides the business, technical, and architectural changes associated with their implementation, as well as expected benefits for their global network of affiliates.
Speaker: Monica Kennedy, Halozyme
Audience: Business and IT
Halozyme’s use of tracking spreadsheets couldn’t scale with the growth of their business. They now track submissions, regulatory activities, and registration details within Veeva Vault RIM and have end-to-end traceability between submissions. They can easily answer questions about their business, whether looking for outstanding commitments, FDA concerns on a specific submission, or AEs submitted to a particular study. Join to hear how they did it.
Speakers: Kate Wilber and Ann-Marie Gardner, Veeva Systems
Audience: Business
Vault Registrations can help you answer questions quickly. “Where is this product marketed? Or, what products are impacted by this manufacturing change?” This session provides an in-depth look at using Vault Registrations for greater visibility into your operations.
Speakers: Noelia Pacheco, Accenture
Audience: Business
Large scale change management is not a core competence for most regulatory teams. Accenture provides advice from their experience managing global transformation programs.
Speaker: Daan de Wildt, Merck Animal Health
Audience: Business
The statistics department at Merck Animal Health needed a validated repository to store clinical study documents and data relevant to submissions. Hear about the company’s broader decision to adopt Veeva Vault as their content management system, and the statistic team’s innovative use of Vault to store clinical SAS datasets, programs, and outputs. Learn how to use Vault’s bulk document handling capabilities for uploading, classifying, and approving files.
Speaker: Rich Fredericks, TESARO
Audience: Business
To support TESARO’s dramatic growth, the regulatory team banished file shares and hard drives, and deployed Vault Submissions as their central hub for regulatory content and collaboration. Learn about their process improvements in document authoring, working with partners, and business reporting.
Speakers: Sandra Komadinic, Rolando Sa, and Uri Reich, Veeva Systems
Audience: Business and IT
This session previews exciting new capabilities coming within each part of an end-to-end submission development process. Also, learn more about the continuous publishing process made possible with Vault Submissions Publishing.
Speaker: David Katzoff, Valiance
Audience: Business and IT
Global RIM migrations present unique challenges as companies standardize their data in preparation for IDMP. Due to their worldwide scope and additional technology sources, scoping becomes more difficult and more important. Valiance will discuss some of the scoping scenarios they’ve seen with current RIM migrations.
Speaker: Avril England, Veeva Systems
Audience: Business and IT
Join us to explore what’s new with Vault Platform and how your organization can leverage these capabilities. We’ll look ahead at the roadmap and explore our plans for the next 12-24 months.
Speakers: Anthony Di Stefano, PWC; Randy Hodge, Veeva Systems
Audience: Business
Modern enterprise applications bring together content and data onto one platform – eliminating functional silos and making it accessible to relevant parties. Regulatory teams can reuse TMF content such as 1572s for submissions or quality events can directly link to related documents. PWC discusses key use cases for leveraging information throughout the product development lifecycle and across functional areas, and how that is accomplished with Vault.
Speaker: Eric Makovsky, Veeva Systems
Audience: IT
When faced with a new application development project, how can you determine if Vault Platform will suit your needs? Join us to explore a decision framework that helps you understand if Vault is the right platform for new custom applications.
Speakers: Hetal Sheth and Howard Hsueh, Veeva Systems
Audience: IT
Veeva experts will outline what it takes to effectively manage Vault across the enterprise. Learn how to define a strategy, develop an approach and succeed in supporting a R&D business transformation.
Speaker: Graham Gelwicks, Veeva Systems
Audience: IT
Reports and dashboards in Vault Platform provide real-time visibility into your KPIs. This session will provide an overview on reports and details on new features like flash reports, export to pdf, and others. We will also look at the roadmap to explore what’s coming.
Speakers: Todd Culverwell, UCB BioSciences; Paul Crean, Valiance
Audience: IT
Succeeding with sponsor control of CRO-created data requires a well-defined strategy, preparation, and execution. In this presentation, UCB and Valiance will discuss the reasons, gains, and pitfalls of migrating CRO-managed eTMF data into the sponsor’s Vault. Join us to explore best practices based on lessons learned from both before and after the migration.
Wednesday, October 4
Speaker: Steve Harper, Veeva Systems
Audience: Business and IT
This session previews exciting new capabilities planned for Vault eTMF and Vault SiteExchange. Also, hear more about how you can capture documents on the go with Veeva SNAP, our latest mobile solution.
Speakers: Henry Galio and Steve Harper, Veeva Systems
Audience: Business and IT
The past twenty years have seen very little innovation in clinical trial management applications. Sponsors and CROs alike report systems that are costly, complex, and hard to use. As trials and resources have become more global and trial designs have become more sophisticated, sponsors and CROs are demanding a more accessible and flexible solution. Learn how Vault CTMS is changing the landscape of trial management through a user-friendly, adaptable application that works in concert with the rest of the Vault Clinical suite.
Speakers: Richard Young, Drew Garty, and Joanne Schmidt, Veeva Systems
Audience: Business and IT
Moving from paper CRFs to EDC has promised much, but unfortunately, clinical data management processes remain largely unchanged, take just as long, and cost more than ever. As data complexity increases with the rise of personalized medicine and adaptive trials, it is critical to accelerate ahead of these challenges. Join this session to see a next-generation EDC solution that enables you to run the trial you want, and learn how data can harmonize the overall clinical trial process.
Speakers: Henry Galio and Steve Harper, Veeva Systems
Audience: Business and IT
The past twenty years have seen very little innovation in clinical trial management applications. Sponsors and CROs alike report systems that are costly, complex, and hard to use. As trials and resources have become more global and trial designs have become more sophisticated, sponsors and CROs are demanding a more accessible and flexible solution. Learn how Vault CTMS is changing the landscape of trial management through a user-friendly, adaptable application that works in concert with the rest of the Vault Clinical suite.
Speaker: Ashley Davidson, Veeva Systems
Audience: Business and IT
Recent studies show that it takes one year, on average, to go from site identification to activation, and many organizations still use spreadsheets to manage complex start-up processes. Accelerating the time to first patient visit is crucial to delivering potential new therapies to market faster, yet study start-up time is no faster today than it was 10 years ago. See how Vault Study Startup is transforming the study start-up landscape through a modern, purpose-built application that speeds the collection, tracking, and management of study start-up activities.
Audience: Business
See how to leverage the advanced features of Vault eTMF to support TMF business process optimization and best practice approaches for the addition of Vault CTMS, Vault Study Startup and Vault SiteExchange. Open to all Vault Clinical operations customers.
Speakers: Sandeep Chopra and Chris Boschen, Veeva Systems
Audience: Business and IT
See Vault QualityDocs in action and get a preview of formatted outputs, atomic security, and other enhancements. You’ll also learn how we are further enabling quality business processes with a unified quality suite.
Speakers: Sandeep Chopra and Chris Boschen, Veeva Systems
Audience: Business and IT
Speakers: Wendy Goretski, Gilead; Heather McCormick, Karyopharm; Mike Jovanis, Veeva Systems
Audience: Business and IT
With increasing operational complexity and expanding global regulations, companies that adopt new business approaches and technology gain a competitive advantage. Join us as we examine ways to overcome key quality challenges and how modern solutions are evolving to improve quality management.
Audience: Business and IT
This meeting will discuss industry best practices and new approaches including risk-based change management, how to apply expected document lists (EDLs), and managing and using fillable forms. Open to all Vault Quality customers.
Speakers: Sandra Komadinic, Rolando Sa, and Uri Reich, Veeva Systems
Audience: Business and IT
This session previews exciting new capabilities coming within each part of an end-to-end submission development process. Highlights include creating binders from content plans, document-level security in archived submissions, and linking published submissions to their source documents. Also, learn more about the continuous publishing process made possible with Vault Submissions Publishing.
Speakers: Kate Wilber and Uri Reich, Veeva Systems
Audience: Business and IT
See what Veeva is adding to Vault Registrations to help manage complex global registration information. Preview highlights include: managing registered details including packaging, creating dynamic impact assessment reports, and bulk-creating registrations for complex products.
Speakers: Mike Burton and Bryan Ennis, Veeva Systems
Audience: Business and IT
Value engineering quantifies the potential value of new RIM capabilities and related process improvements. Companies can track the maturity of their processes and evaluate the potential benefit of new capabilities. Veeva’s value engineering team also helps companies build a quantitative business case for regulatory transformation.
Audience: Business
Learn about Veeva’s “preferred Vault practices” for submission tracking and content planning including process KPIs, regulatory objectives, tracking reports, and submission content plans. Open to all Vault RIM customers, tailored to small and mid-sized companies.
Speaker: Randy Hodge, Veeva Systems
Audience: IT
The Vault Platform provides a unified foundation for an expanding range of document and content management use cases. Join us for an overview of new enhancements to document management. The session will also include demonstrations of new features such as legal hold, version-specific attachments, and the Vault checkout desktop application.
Speakers: Andy Han and Karen Kestin, Veeva Systems
Audience: IT
Many enterprise customers have multiple Vault applications, each with its own multiple development, test, and validation environments. In this session, we will walk through the tools and best practices, including configuration migration, data loading, and configuration reporting. Understanding the available tools can help IT users streamline application implementation, testing, and compliance in production deployments.
Speaker: Avril England, Veeva Systems
Audience: Business and IT
Join us to explore what’s new with Vault Platform and how your organization can leverage these capabilities. We’ll look ahead at the roadmap and explore our plans for the next 12-24 months.
Speakers: Peter Thorson and JC Meriaux, Veeva Systems
Audience: IT
Vault Platform’s security model is optimized for regulated business processes. New features such as atomic security provide unparalleled control over when data can be accessed and by whom. Join us in the session to learn how this and other Vault features can help you securely collaborate across countries, organizations, and business partners.
Speaker: Peter Thorson, Veeva Systems
Audience: IT
Vault Platform provides a rich set of capabilities to manage structured, relational data. In this session, explore the power of the Vault Objects Framework and the Vault Java SDK. Learn more about how to create new applications, data objects, page layouts, and business logic with point and click configuration. Join us for this demonstration of the Java SDK and other platform features for adding custom code to your applications.
Audience: IT
This session is for power-users who want to go deep into the most advanced capabilities of Vault Platform and get up to speed on the new Java SDK. Open to all Vault customers.