Thank you for a great 2017 Summit
Save the date: September 16-18, 2018
Philadelphia, PA

2017 Veeva Global R&D Summit – Agenda

Download Agenda


Select the track you wish to view:
Show All Tracks Clinical Quality Regulatory IT/Platform

Monday, October 2, 2017


6:00 p.m. – 8:00 p.m.
Welcome Reception

Tuesday, October 3


7:30 a.m. – 9:00 a.m.
Breakfast
9:00 a.m. – 11:30 a.m..

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

11:30 a.m. – 1:30 p.m.
Lunch
11:45 a.m. – 5:45 p.m.
Breakout Sessions
CLINICAL OPERATIONS
11:45 a.m. – 12:30 p.m.

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.

12:45 p.m. – 1:30 p.m.

Speakers: Melissa De Swaef, Terry Endress, 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.

1:45 p.m. – 2:30 p.m.

Speakers: Jamie Toth, Daiichi Sankyo; Rushil Sankpal, 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.

2:45 p.m. – 3:30 p.m.

Speaker: Brenda deJesus, Edwards Lifesciences

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.

4:00 p.m. – 4:45 p.m.

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.

5:00 p.m. – 5:45 p.m.

Speakers: Hugo Cervantes, Ray Letulle, 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

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.

QUALITY
12:45 p.m. – 1:30 p.m.

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.

1:45 p.m. – 2:30 p.m.

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.

2:45 p.m. – 3:30 p.m.

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; Sean Smith, Blueprint Medicines

Audience: Business and IT

Embracing quality management strategies that balance level of effort with risk simplifies operations and improves control. Lilly and Blueprint Medicines 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.

REGULATORY
11:45 a.m. – 12:30 p.m.

Speakers: Danielle Beaulieu, Matt Sweetman, and Raghunandan Satyanarayan, Bristol-Myers Squibb

Audience: Business and IT

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.

1:45 p.m. – 2:30 p.m.

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.

2:45 p.m. – 3:30 p.m.

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.

4:00 p.m. – 4:45 p.m.

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: Daan de Wildt, Merck Animal Health

Audience: Business and IT

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.

5:00 p.m. – 5:45 p.m.

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: Kimberly Gayle and 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.

VAULT PLATFORM
12:45 p.m. – 1:30 p.m.

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.

1:45 p.m. – 2:30 p.m.

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.

2:45 p.m. – 3:30 p.m.

Speakers: Chris Whalley, AWS; Andy Han, Veeva Systems

Audience: IT

With the ability of cloud computing solutions to support life sciences operations, IT developers, security managers, and compliance practitioners are looking to leverage automation capabilities to reinvent their processes and control mechanisms. In this session, Amazon Web Services will share how in-house compliance practices are being modernized using tools such as AWS Cloud Formation and how to support GXP software applications and data through policy and procedure changes.

Speakers: Hetal Sheth and Melissa Aron, 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.

4:00 p.m. – 4:45 p.m.

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.

5:00 p.m. – 5:45 p.m.

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.

6:30 p.m. – 9:30 p.m.
Evening Networking Event at the Franklin Institute

Wednesday, October 4


7:30 a.m. – 9:00 a.m.
Breakfast
9:00 a.m. – 12:45 p.m.
Roadmap and Breakout Sessions
CLINICAL OPERATIONS
9:00 a.m. – 10:00 a.m.

Speaker: Steve Harper and Yvonne Hsieh, 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.

10:30 a.m. – 11:30 a.m.

Speakers: Henry Galio, Sondra Pepe, 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: Hugo Cervantes, Ray Letulle, 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.

11:45 a.m. – 12:45 p.m.

Speakers: Henry Galio, Sondra Pepe, 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 and Brian Bialkowski, 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.

12:45 p.m. – 5:00 p.m..

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.

QUALITY
9:00 a.m. – 10:00 a.m.

Speakers: Chris Boschen, Veeva Systems

Audience: Business and IT

Join us to learn how Vault QualityDocs can make document management easier across the organization. Preview highlights include version specific attachments, bulk controlled copy, and enhancements to document anchors. We’ll also explore how controlled content in Vault can be shared with partners in an easy, compliant way and our future plans.

10:30 a.m. – 11:30 a.m.

Speakers: Sandeep Chopra, Veeva Systems

Audience: Business and IT

See Vault QMS in action and get a preview of formatted outputs, atomic security, and other recently delivered enhancements. You’ll also learn how we are enabling a complete view of quality with both internal and partner compliance indicators.

11:45 a.m. – 12:45 p.m.

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.

12:45 p.m. – 3:00 p.m.

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.

REGULATORY
9:00 a.m. – 10:00 a.m.

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.

10:30 a.m. – 11:30 a.m.

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.

11:45 a.m. – 12:45 p.m.

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.

12:45 p.m. – 3:00 p.m.

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.

VAULT PLATFORM
9:00 a.m. – 10:00 a.m.

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.

10:30 a.m. – 11:30 a.m.

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.

11:45 a.m. – 12:45 p.m.

Speakers: Peter Thorson and Bob Ng, 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.

12:45 p.m. – 5:00 p.m.

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.

12:45 p.m. – 2:00 p.m.
Lunch