R&D and Quality Summit

Veeva R&D Summit

Powerful Community, Fresh Ideas

Agenda

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Sunday, Sept. 8
4:30 pm - 7:00 pm

Registration Open
4:30 pm - 7:00 pm

Welcome Reception
5:30 pm - 7:00 pm
Welcome Reception Innovation Hub
Monday, Sept. 9
7:00 am - 9:00 pm

Registration Open
7:00 am - 6:30 pm

Breakfast - Innovation Hub
7:00 am - 8:40 am

Opening Keynote
9:00 am - 9:50 am
Matt Studney Merck & Co. Inc.
Vice President, Merck Research Laboratories, IT
Kevin O’Brien Eikon Therapeutics
Senior Vice President, Clinical Development Operations
Peter Gassner Veeva Systems
Founder and CEO
Avril England Veeva Systems
General Manager, Vault
James Reilly Veeva Systems
Vice President, Development Cloud Strategy

Zone Keynotes
10:30 am - 11:20 am

Hear Moderna’s remarkable journey from a small scale biotech clinical manufacturer to a global commercial player during the Covid 19 pandemic and beyond. Jennifer White, Senior Vice President of Global Quality at Moderna will share how Moderna’s mission to create and deliver transformative medicines for patients was enabled through its innovation, technology, and quality culture.

Jennifer White Moderna
Senior Vice President, Global Quality
Michael Jovanis Veeva Systems
Vice President, Vault Quality & Manufacturing

Join the fireside chat exploring Vault RIM implementation challenges, insights for success, and organizational impact. Discover Roche’s journey to achieve global visibility and collaboration with a single, unified regulatory platform.

Joanne Byrne Roche
Global Head, Regulatory Operations and Business Excellence
Marc Gabriel Veeva Systems
Vice President, Vault RIM

Hear Veeva’s vision for clinical data and new innovations in patient capture. Learn how AbbVie and UCB are leading change and seeing the results of transformation in their organizations.

Seb Moity UCB
Head of IT Digital Clinical Operations
Kapil Gombar Abbvie
Director, Clinical Technologies and Innovation
Lance Kupka Abbvie
Director, Clinical Data Systems
Richard Young Veeva Systems
VP, Strategy, Clinical Data

AbbVie and Merck discuss transformation of pharmacovigilance operations. Hear how they are empowering teams, improving end-to-end processes within safety and across functional areas, and leveraging automation.

Angela Pufko Merck & Co. Inc.
AVP, PV Operations and Global Process Enablement
Tracey Boone AbbVie
Director, Veeva Community of Practice
John Lawrie Veeva Systems
Vice President, Vault Safety
Christina Kim Veeva Systems
Senior Director, Strategy – Vault Safety

Hear from an emerging and top biopharma on strategies to reduce cost, accelerate processes from clinical trials to product launch, and establish a foundation for growth using Veeva Development Cloud.

Kevin O’Brien Eikon Therapeutics
Senior Vice President, Clinical Development Operations
Jared Katz Veeva Systems
Senior Director of Strategy, Development Cloud
Brian Johnson Takeda
Vice President, Research & Development Technology

Astellas shares its holistic approach to improving end-to-end processes and the journey to building a unified clinical operations platform.

Kate Marshall Astellas
Business Strategy Lead, Clinical Operational Excellence
Abhishek Miglani Astellas
Lead, Enterprise Platform Veeva, Clinical Trial Operations Technology
James Reilly Veeva Systems
Vice President, Development Cloud Strategy

Lunch - Innovation Hub
11:30 am - 1:00 pm
Innovation Theaters, Networking, Demos, and More

See how Vault EDC and Veeva RTSM seamlessly connect to provide a better end-user experience for sites and eliminate data reconciliation efforts for data managers.

Jennifer England
Solution Consultant, Veeva RTSM

Discover how to seamlessly collaborate with external partners in real time on quality-related tasks. See this in action through supplier agreement reviews and SCAR interactions.

Paola DePaso
Sr. Director Quality Strategy
Shanul Srivastava
Manager, North America Solution Consulting, Quality

Discover how safety teams are automating post market case processing globally. See a demo of low touch case processing, seamless adverse event intake from Vault MedInquiry, and Japanese case localization.

Marius Mortensen Veeva Systems
Principal Product Architect, Vault Safety

Learn about the different hyperlink functionalities – automated hyperlinks, dynamic links, keyword linking, link annotations and link evaluator – and see use cases to streamline submission effort early, mid or even late in the process.

T.J. Hynes
Global Domain Lead, Vault Publishing

The information exchange from a Vault Clinical Operations to EDC Connection produces higher quality reporting, greater automation, and fewer manual tasks; e.g., site payments can be automated based on visit date, visit type, and procedure information coming out of Vault EDC. See what else the connection can do and the time-saving benefits for both teams.

Mollie Gaede
Senior Solution Consultant & SMB Team Lead, Clinical Operations

See how sponsors can improve site engagement with Vault Clinical Operations, including reducing email volume, streamlining document exchange and safety letter distribution, and automating training.

Rob Arnold
Solution Consultant, Clinical Operations

Simplify user experience by giving the right information, at the right time, to the right person with Vault Action Layouts.

Michael Ferrell Veeva Systems
Senior Product Expert, Vault Platform

Hear how unification between Vault LIMS and the Quality Suite drives efficiency and compliance by rendering documents from the Vault QualityDocs library on screen during test execution, automating creation of lab investigations in Vault QMS, and leveraging qualification within Vault Training to drive compliant work assignment.

Justin Lavimodiere Veeva Systems
Senior Director, Vault LIMS
Ashley McMillan
Senior Director, Vault LIMS Strategy

Learn how to streamline core/local risk management plan (RMP) authoring, maintenance, and tracking. Easily identify current content with version management and track implementation of aRMMs for improved compliance.

Eric Woolven Veeva Systems
Senior Product Manager, SafetyDocs
C.J. Hunter Veeva Systems
Senior Consultant

Learn how global content plans optimize dispatch processes to easily distribute submissions across countries and templates.

Christina Howe
Practice Manager, Vault RIM

Go beyond E2B with automated SAE reporting that transfers all relevant EDC data and allows safety users to choose what’s relevant. Safety case IDs are automatically added to corresponding SAEs so Vault EDC users can rest assured the SAEs were received. This deep connectivity eliminates duplicate data entry and time-consuming reconciliations.

Alice Foltyn
Solution Consultant, Clinical Data

See how clinical serious adverse events are automatically shared with safety reducing manual overhead and data reconciliation for greater efficiency

Ollie Cooksey
Solution Consultant, Safety

Sessions
1:00 pm - 1:50 pm

An expert panel shares how transitioning from legacy systems to a unified training solution enhanced compliance and qualification processes. Discover the tangible benefits of a unified approach, from streamlined quality management to improved data accuracy, and enhanced collaboration.

Brittany Recker Editas Medicine
Senior Quality Manager
Amy Benton Travere Therapeutics
Vice President, Information Technology
Shauna Greene ReciBio Pharm
Associate Director, Training and Document Management
Jennifer DiMinni Minaris Regenerative Medicine
Director, Documentation, ITQA and Training
Elizabeth Burger Veeva Systems
Senior Manager, Training Strategy

Discover how Takeda enhanced productivity and user access by consolidating and transforming the document management system after a major acquisition. Learn about their strategies to simplify access for casual users, including the implementation of Station Manager and Process Navigator.

Robert Bent Takeda
Head of QMS

Join experts from Amgen for an in-depth discussion on their adoption of a risk-based validation process to enhance risk management and data integrity governance. Discover their comprehensive strategy that places validation at the core of operational and data integrity programs. Gain valuable insights into how technology, processes, and people are integrated to support their Risk-Based Validation program.

Jim Gagnon Amgen
Director, Quality Systems
Thomas Craig Amgen
Associate Director
Sudhir Hanwat Amgen
Sr. Manager, DTI Global Quality
Maggie Mahaffy Amgen
Senior Specialist Quality
Nina Ricciardelli
Director, Vault Validation Management

Hear how Neurogene and Verve Therapeutics have modernized QC operations by adopting a cloud-based LIMS. Learn about the catalysts for change, what is critical when evaluating a solution, the ease and speed of implementation, what they have achieved so far, and where they are going next with Vault LIMS.

Luis Negron Neurogene Inc.
QC Analyst IV
Chris Manoogian Verve Therapeutics
Quality Control, Associate Director
Scott Hanton Lab Manager Magazine
Editorial Director

Roche, AstraZeneca, and Vir Bio share insights on their migration to Vault Submissions Publishing, evolving the publisher role and submissions process, and transforming their end-to-end publishing operations to reduce submission timelines.

Hardy Oh Vir Biotechnology, Inc.
Manager, Regulatory Operations
Goutham Reddy Kancharla AstraZeneca
Associate Director, Regulatory Publishing
Faizan Rahim Roche
Senior Regulatory Submission Manager

Hear from Mersana, Ocugen, and MacroGenics on optimizing regulatory operations through leveraging the right tools, choosing the right operating model – outsourcing or insourcing, streamlining processes, and better managing change. By understanding and defining success, organizations can better utilize resources to improve regulatory operations.

Rich Fredericks Mersana
Senior Director, Regulatory, Quality, and Clinical Solutions (RQCS)
Jose Acosta Ocugen Inc.
Director, Regulatory Operations
Wilesha Wright Macrogenics, Inc.
Associate Director, Regulatory Operations

Learn from an expert panel of sponsors and sites on ways that data management can improve the site experience. Hear how current efforts are being received in the site community — what is working, and what isn’t useful? Leave with recommendations to empower sites and gain flexibility in development workflows.

Jennifer Sheller Merck & Co. Inc.
Vice President, Global Clinical Trial Operations – Sites, Data, Quality
Peter Koefler Takeda
Director, CSSE Process Excellence and Delivery
Tina Bowdish Vanderbilt-Ingram Cancer Center
Senior Director, Clinical Research Administration
Alisha Garibaldi Skylight Health Research
Chief Executive Officer
Manny Vazquez Veeva Systems
Director, Vault CDMS Strategy

Hear the UCB journey from study-by-study to enterprise eCOA adoption. Explore how they accelerated delivery while standardizing patient data capture and management across their organization. Hear best practices from their experience including implementation, validation, library development, and end-user engagement.

Seb Moity UCB
Head of IT Digital Clinical Operations
Tim Davis Veeva Systems
Vice President, Strategy, MyVeeva for Patients

Join a panel of experts as they discuss the pivotal role of services in Randomization and Trial Supply Management (RTSM) development. Explore how early prediction of unknowns, building for flexibility, and streamlined mid-study amendments can impact your trials. Gain valuable insights into creating an adaptable and resilient partnership when working with Veeva RTSM.

Joseph Cooney Pacira BioSciences
Associate Director, Clinical Systems
Paula Bradshaw Immunity Bio, Inc.
Vice President, Clinical Business Operations
Brandy Bridges Alcon
Group Head, Systems and Standards

Hear how Haleon successfully established its global safety foundation and outsourcing strategy after separating from GSK. They’ll dive into their approach, lessons learned, as well as share the impact and value of establishing a new foundation for all safety case processing worldwide.

Michael Ramsden Haleon
Head of Safety Tech
Monica Teall Haleon
Operations and Support Director, Clinical & Safety
Cibele Rudge Haleon
Global Director of Case Processing

Learn about AbbVie and Bayer’s site engagement initiatives and how Veeva Site Connect enhancements will further improve efficiency and site choice.

Lorena Gomez AbbVie
Head of Global Business Operations
Emma Earl Bayer
Head of Clinical Trial Management Services and Solutions
Kenny Kong Veeva Systems
Vice President of Strategy, Site Connect

Hear how Cerevel automates study training with a purpose-built solution. They will share best practices for leveraging Vault Study Training, as well as tips to improve training effectiveness.

Grace DaFonseca Cerevel Therapeutics
Manager, Quality Operations

Abbvie shares how R&D IT leaders built initial business case for a Veeva Center of Excellence (CoE) and explains how it will transform operations, management, and business processes across Vaults. Astellas discusses the maturing and evolution of their CoE after initial setup, and how they optimized functions and roles as the organization matured.

Abhishek Miglani Astellas
Lead, Enterprise Platform Veeva, Clinical Trial Operations Technology
Tracey Boone AbbVie
Director, Veeva Community of Practice
Jared Katz Veeva Systems
Senior Director of Strategy, Development Cloud

Recommended approaches and lessons learned when leveraging Vault APIs, including Direct Data API, to export data for data warehouse, data lake, and AI use cases.

Mark Arnold Veeva Systems
Director, Product Management, Vault API & SDK

Connect
2:00 pm- 2:50 pm
Innovation Theaters, Networking, Demos, and More

Join us for an overview showcasing how Validation Management seamlessly connects with QMS to harmonize change and deviation management, supplier quality management, and quality risk management.

Robin Smallwood
Senior Manager, Vault Validation Management
Ruben Gottardi
Senior Solution Consultant, Vault Validation Management

Efficiently create and manage event details to streamline data entry. With Vault RIM’s first configurable bulk action, save time and resources with a guided UI to automate event relationship generation and management.

Abbey Sasdelli
Practice Manager, Vault RIM Professional Services

See how Veeva CDB increases transparency with a full view of patient data across sources and leverages automation to prioritize meaningful action.

Eric Jacobson
Senior Manager, North American Solution Consulting, Clinical Data

See how Vault Study Training brings sponsors, CROs, and research sites into a single platform to streamline and automate study training. This includes new automation to further reduce the time it takes to create a training plan matrix.

Kelsey Reuther
Solution Consultant, Clinical Operations
Shad Ayoub
Senior Director, Study Training

Learn how Veeva OpenData Clinical ensures accurate reference data through a clean, reliable, and global list of investigators and sites to streamline trial management.

Brian Bialkowski Veeva Systems
Director, Product Management, Clinical Operations

See a demo of Site Connect and learn about new functionality in the latest release, followed by Q&A with product management and strategy.

Kenny Kong Veeva Systems
Vice President of Strategy, Site Connect
Vincent Tuminelli Veeva Systems
VP, Site Connect Strategy

Learn how developers and admins can leverage open-source tools to view and edit configurations, execute VQL queries and export results, and easily summarize and delete Sandbox test data.

Eric Matelyan Veeva
Developer Support Engineer

Discuss practical steps for how to build a CoE – thinking through the who, what, when, where, and how.

Chris Dailey Takeda
Head of Veeva Center of Excellence
Rylan Collins
Vice President, R&D Business Consulting (NA)
Mohith Mittal BioNTech US
R&D Veeva Governance & Service Management Lead

Discover efficiencies gained from Active Dossier when it is integrated into the end-to-end business process.

Christina Howe
Practice Manager, Vault RIM

Discover how Veeva RTSM will deliver cross study reporting to proactively identify randomization and trial supply management issues.

Jennifer England
Solution Consultant, Veeva RTSM

Hear how Vault Disclosures leverages automation and unified clinical systems to streamline the sharing of study registrations and results disclosures with CT.gov.

Matt DeFranco Veeva Systems
Senior Director, Clinical Operations Strategy, Vault Disclosures
Kaitlyn Moore Veeva Systems
Senior Product Manager, Clinical Operations

Reduce notification overhead while ensuring users are promptly receiving information to stay current and get work done.

Michael Ferrell Veeva Systems
Senior Product Expert, Vault Platform

Sessions
3:00 pm - 3:50 pm

Veeva and PwC will share insights on the practical application of AI and advanced technology in Quality Management Systems (QMS). Learn specific use cases and see how PwC and Veeva work together to help organizations turn AI ambitions into actionable strategies that enhance quality management.

Sam Venugopal PwC
Partner, Global Quality Lead
Carl Ning
Sr. Director, Strategy – Vault QMS

Resilience, Agios, and ImmunityBio share their journeys of transitioning from paper and siloed legacy systems to Vault Validation Management. Discover the diverse drivers behind their decisions and explore the benefits, including enhanced efficiency, real-time data access, and lowered validation management costs.

Tamara Redondo Resilience
Director, Quality Applications
Jinit Parikh Agios Pharmaceuticals
Director, Digital Quality and Data Integrity
Jenni Chi ImmunityBio
Associate Director, Validation
Robin Smallwood
Senior Manager, Vault Validation Management

Moderna shares how it’s embraced technology and quality culture to effectively manage rapid growth. Discover how, with a digital approach, the quality organization drives operational excellence and innovates in achieving safety, trust, and delivery of mRNA medicine to patients worldwide. By adopting industry best practice processes, Moderna quickly matured its quality systems and processes to ensure the timely delivery of transformative medicines.

Shiraz Laufer Moderna
Executive Director, Digital Quality

Learn about a new approach to optimizing QC and increasing right first time. While legacy LIMS solutions have grown stagnant, see how Veeva is redefining LIMS and transforming QC operations with a unified solution.

Jason Boyd Veeva Systems
Senior Director, Vault LIMS

Learn how Apellis and Arcus leveraged a new data-centric approach to improve document management and regulatory processes.

Sumit Pancholi Apellis Pharmaceuticals
Head of Regulatory Information Management
Vijaya Hegde Apellis Pharmaceuticals
Senior Manager, Global Regulatory Operations
Kelly Kent Arcus Biosciences
Senior Director, Regulatory Information and Systems

To achieve sustainable, long-term integration of end-to-end RIM, organizations must embrace a new perspective. Join Roche as they explore challenges and ways to address change management, global system adoption, and data quality.

Jasmine Gil Roche
Informatics Product Manager
Abita Nanda Genentech
Innovation and Sustainment Leader

Explore how to overcome the top 5 barriers that constrain trial execution. Hear practical advice from Data Management leaders at Takeda, Alcon, GSK, and Syneos Health that have led change, achieved success, and continue to drive efficiency from build to submission.

Priya Gopal Takeda
Head of Clinical Data Engineering
Leianne Ebert Alcon
Head of CDO
Jo Koskinas GSK
Director, Clinical Data Management
Richard Young Veeva Systems
VP, Strategy, Clinical Data
Mike McDevitt Syneos Health
SVP, Head Customer Success, FSP360

Examine lessons learned after implementing decentralized clinical trials. Leave with practical solutions to move past the challenges of DCT, and uncover a new chapter of patient-centric trials.

Arshad Mohammed GSK
Head, Global Data Management
Kushal Gohil Parexel
Chief Strategy Officer
Christina Brennan Northwell Health
Senior Vice President, Clinical Research
Sam Bavery Veeva
Sr. Director CDMS Strategy
David Carruthers AstraZeneca
Vice President Clinical Operations, Clinical Data & Insights

Allucent illustrates the drug supply complexities involved with cell and gene therapy studies and how they relate to Randomization and Trial Supply Management (RTSM) systems. Explore the distinctive aspects of RTSM within this innovative field, emphasizing patient-centric approaches, intricate supply chain logistics, and regulatory considerations. Discover a custom solution built by Veeva RTSM that addresses the drug supply challenges of cell and gene study design.

Desmond Cabrera Allucent
Vice President, Head of Global Operations, Cell and Gene Therapy

Gain insights on how CRISPR achieved operational efficiencies and leveraged real-time data visibility for oversight and better decision-making. They’ll present best practices for managing in-house pharmacovigilance activities and resources with lean teams.

Sepideh Habibi CRISPR Therapeutics
Executive Director, Head of Global Pharmacovigilance and Risk Management
Janki Patel CRISPR Therapeutics
Senior Medical Director, Global Safety and Risk Management
Rabiah Choudhary CRISPR Therapeutics
Senior Manager

Moderna explores the benefits of TMF data standardization to support increased operational efficiency and improved collaboration with study partners.

Nick Hargaden Moderna
Director, Clinical Trial Systems and Operations

Regeneron discusses how Vault reports and dashboards improve visibility into operational processes, application usage, and KPIs. See recent enhancements as well as get a first look at the roadmap and key upcoming capabilities.

Dawn Esposito Regeneron Pharmaceuticals
Senior Manager, Global Development Quality Technology & Compliance
Graham Gelwicks Veeva Systems
Director, Product Management, Vault Platform

Biopharmas explore best practices for ongoing release management. Learn how their teams optimize the release processes and accelerate delivery of new business capabilities across multiple Vaults.

Todd Steppick Alcon
Director DevOps, Integrations and AMS
Amit Chachra Gilead
Sr. Director IT
Mano Das BMS
Director, IT Trial Operations
Janet Sherman Eli Lilly and Co
IT Senior Director – Global Regulatory Affairs and Global Scientific Communications
Ryan McCullough
Practice Director, Enterprise Application Management Services

Hear Lilly’s journey to automate end-to-end start-up in one system, including implementation pain points and successes, cycle time improvements, and lessons learned.

Liza Aldridge Eli Lilly and Company
Associate Director
Angela Minch Eli Lilly and Company
Director, Trial Capabilities

Connect
4:00 pm- 4:20 pm
Innovation Theaters, Networking, Demos, and More

How BASE Life Science builds GenAI capabilities into Veeva Vault for automating translations, content reviews, and audits.

Peter Nistrup BASE life science
Head of AI & Automation

Why does every biopharma need a CTMS? See how Vault CTMS streamlines trial management, enhances study oversight, and improves compliance for all operating models in this live demo.

Dana Kohls
Solution Consultant, Clinical Operations

See our new approach to significantly reduce the time and effort required for sites to complete feasibility surveys and enhance the overall survey experience.

Learn how connecting Veeva RTSM with Vault eTMF creates faster end of study processes and ensures eTMF data is always inspection-ready.

Jonathan Chalifoux
Senior Solution Consultant

Discover how VeevaID enables clinical research site users to authenticate to all Veeva systems with one login.

Bryan Lim Veeva Systems
Senior Product Manager, VeevaID

We have clinical research sites onsite! Meet representatives from Vanderbilt University, Mass General Brigham, SiteBridge, and others for informal networking. Learn about ongoing studies, therapeutic areas, experiences with trial technologies, and more from the site perspective.

Bree Burks
VP Strategy, Site Solutions

Sessions
4:30 pm - 5:20 pm

Discover CSL’s vision and journey towards enterprise learning management evolution, focusing on advancing people and technology and integrating Vault Training as part of their quality ecosystem. Learn about their governance model, GxP and non-GxP training management, and organizational changes for training success.

Pontaah Arbtan CSL Behring
Head, Enterprise Quality Training and Documentation
Rynita Julien CSL Behring
Senior Director, Information Technology

Forge facilitates efficient external collaboration within a controlled environment, enhancing client access to data and documents. Discover how this transparency empowers them to manage quality events with compliance, modernize quality processes, and connect QA and QC teams to effectively meet customer needs.

Ryan Heil Forge Biologics
Director, Quality Management

Bristol Myers Squibb shares its quality adoption journey and showcases the tangible benefits of recent supplier quality management (SQM), content management, and metrics reporting initiatives. Learn about their approach to integrating value metrics into their processes, demonstrating how quality systems can generate significant business value.

Joseph Varghese Bristol Myers Squibb
Senior Director, Digital Strategy and Governance, GQ

Hear how Alvotech pivoted from continuing to invest in its existing LIMS and processes to a better way of managing QC. They will share how they identified the right time to stop investing in a legacy LIMS and how Vault LIMS will modernize their QC operations with simplified processes.

Heidi Hoover Alvotech
Director, Vault Platform
Jason Boyd Veeva Systems
Senior Director, Vault LIMS

Human-driven translation rework delays submissions, increases risk of non-compliance in local labels, and impacts patient safety. Discover how Sanofi cut translation times by an average of 75% using AI-powered automated translations with Vault RIM as context.

Christine Glenn Sanofi
Head, Global Submissions Management
Jose Burgos TransPerfect
Senior Product Manager
Ty Trainer TransPerfect
Director, AI Consulting and Implementation

Discover how Biocryst streamlined complex report development with Vault RIM for high quality reports as well as best practices for report level content planning for clinical study reports, development safety update reports, and risk management plans.

BJ Witkin BioCryst Pharmaceuticals, Inc.
Associate Director, Global Regulatory Operations

See Veeva’s realized vision for connected clinical data through an end-to-end demo spanning patients, sites, and sponsors/CROs. This updated demo showcases enhanced eCOA patient interactions and the new Safety-EDC Connection. Experience the power of connection using Veeva’s EDC, CDB, RTSM, eCOA, CTMS, and Safety systems.

Drew Garty Veeva Systems
Chief Technology Officer, Clinical Data
Alexis Cavalli
Solution Consultant, Clinical Data
Alice Foltyn
Solution Consultant, Clinical Data
Nicholas Klatt Veeva
Solution Consultant, Clinical Data

Leaders at Praxis Precision Medicines and Karuna Therapeutics, a BMS company, describe their journey to bring eTMF in-house, including creating effective system processes. They’ll also share tips for driving efficiencies with sponsor-owned Vault eTMF.

Katie Kelly Praxis Precision Medicines
Associate Director, Clinical Study Business Operations
Teryn Maihiot Karuna Therapeutics, a BMS Company
Sr. Manager Clinical Documentation
Frank Lin
Director, Clinical Strategy

Join AbbVie and Sarepta for a panel discussion on how they improved management of pharmacovigilance system master files (PSMFs), pharmacovigilance agreements (PVAs), and additional risk minimization measures (aRMMs).

Ijeoma Emenike Sarepta Therapeutics
Executive Director, Global Pharmacovigilance Operations and Quality Management
Amy Macin AbbVie
Associate Director, Innovation & Technology
Mike Kruczek Veeva Systems
Senior Director, Vault Safety Strategy

Bayer describes how they replaced manual processes with Vault Study Training. They will share best practices to streamline and centralize training for research sites and internal study teams and drive inspection readiness.

Ellen Vanderlinden Bayer
Clinical Capability Strategy Lead

Gilead accelerated end-to-end change control and increased visibility across quality and regulatory teams with Quality-RIM connection. Learn implementation best practices and lessons learned as well as how the team decreased cycle times.

Amit Chachra Gilead
Sr. Director IT
Jared Katz Veeva Systems
Senior Director of Strategy, Development Cloud

Accelerate business processes and improve user experience with the latest capabilities including action layouts, advanced start workflow, notification categories and preferences, search synonyms and collections, and Vault Mobile.

Michael Ferrell Veeva Systems
Senior Product Expert, Vault Platform

Inhibrx, CG Oncology, and Biocryst will share their operating models and how Vault CTMS enables better study oversight and scalability.

Jamison Johnson BioCryst Pharmaceuticals, Inc.
Manager, Clinical Trials Systems and Processes (Contract)
Bonne Adams Inhibrx Biosciences, Inc.
Vice President Operations
John McAdory CG Oncology
Vice President, Clinical Operations
Silpa Reddy
Director, Vault Clinical Strategy

Evening Event
5:30 pm - 9:00 pm
Tuesday, Sept. 10
7:00 am - 4:20 pm

Registration Open
7:00 am - 4:30 pm

Breakfast - Innovation Hub
7:00 am - 8:45 am

Roadmaps
9:00 am - 9:50 am

Hear the roadmap and vision of Vault QMS. See demos of the latest innovations and get your questions answered.

Manaphan Huntrakoon Veeva Systems
Senior Director, Vault Product Management, QMS

Learn about Veeva’s GxP training vision and roadmap, see demos of the latest innovations, and get your questions answered.

Jason Hardin
Senior Product Manager
Graham O’Keeffe Veeva Systems
General Manager, LearnGxP

Hear Veeva’s vision and roadmap to modernize and accelerate validation management processes. See demos of the latest features in Vault Validation Management and get your questions answered.

Peter Alouche Veeva Systems
Director, Product Management, Vault Validation Management

Hear the roadmap and vision of Vault LIMS. See demos of the latest innovations and get your questions answered.

Joby George
Director, Product Management
Jason Boyd Veeva Systems
Senior Director, Vault LIMS

Hear key Vault Registrations, Submissions, Submissions Publishing, and Submissions Archive capabilities delivered over the past year and roadmap highlights. See how Vault RIM is further optimizing end-to-end processes and get an update on health authority question extraction and Active Dossier progress.

Rich Merrick Veeva Systems
VP, Product Management, Vault RIM

Learn what’s next for Vault EDC and Veeva CDB, including recent innovations and upcoming enhancements for this year. Plus, ask the Veeva team questions during an interactive Q&A.

Raymond Letulle Veeva Systems
Senior Vice President, Products, Vault CDMS

Learn how we’ve streamlined feasibility surveys and IRB submissions in Vault Study Startup, and how standard questions will allow you to reuse answers for sites. We’ll also share our plans to support periodic, risk-based QC in Vault eTMF, and how to better organize your documents using subartifacts.

Site Connect has changed to make it easier than ever to exchange documents and study information with sites! See how you can exchange documents with any site directly in Vault Clinical Operations, regardless of what eISF the site uses.

Learn about the innovations and enhancements coming to Veeva RTSM, and ask the Veeva team questions during an interactive Q&A.

Steve Simmerman Veeva Systems
General Manager, Veeva RTSM

See enhancements for global case processing, reducing case handling time, and new operational metrics. Get a sneak peek of Vault Safety Workbench, Vault Safety Signal, more Vault SafetyDocs use cases, and the next phase of safety automation.

Eldar Curovic Veeva Systems
Vice President, Product Management, Vault Safety

Explore recently released capabilities, including action layouts, and discuss upcoming platform plans focused on enabling new applications, making implementations easier, and ensuring scalability and availability.

Andy Han Veeva Systems
SVP Product Management, Vault Platform & Technology

Connect
10:00 am - 10:50 am
Innovation Theaters, Networking, Demos, and More

Hear the roadmap and vision for Vault QualityDocs and Vault Station Manager, see demos of the latest innovations, and get your questions answered.

Stephen Chelladurai Veeva Systems
Director, Product Management

Hear Veeva’s vision and roadmap to enable faster, more confident GMP release and market-ship decisions with Batch Release. See demos of the latest innovations, and get your questions answered.

Mike Edwards
Director of Batch Release Strategy
Brian Sohmers
Sr. Director, Product Management

Join the Vault RIM product team to discuss key features from the past year, the latest in regulatory guidelines and developments, and the future roadmap for Vault RIM.

Rich Merrick Veeva Systems
VP, Product Management, Vault RIM

Learn how we’ve made monitoring more flexible and enhanced support for outsourced trials with oversight issue tracking and streamlined data transfers between sponsors and CROs in Vault CTMS. See how we’ve improved site fee management and our plans to support master protocols and complex trials across arms and cohorts in Vault Payments.

Streamlining processes through automation is key in Vault Study Training – from released features such as automated user creation and training assignments to planned enhancements such as training completion monitoring and delegated responsibility training. Join this roadmap session to hear about all of the exciting new things coming to Vault Study Training!

Explore the functionalities of Veeva RTSM’s Enterprise Hub for cross-study reporting and analytics, focusing on both standard and ad-hoc reporting. With an initial focus on supply optimization, join us to see how this new tool can improve supply chain management and participate in an open discussion with other clinical supply experts.

Steve Simmerman Veeva Systems
General Manager, Veeva RTSM

Ask questions live with the Vault Safety product team.

Eldar Curovic Veeva Systems
Vice President, Product Management, Vault Safety
Marius Mortensen Veeva Systems
Principal Product Architect, Vault Safety
Tristram Liddiard Veeva Systems
Direction Product Management
Eric Woolven Veeva Systems
Senior Product Manager, SafetyDocs

Build real-time submissions and eliminate content duplication through automated document transfer from Vault Quality, Vault Clinical, and Vaults PromoMats to Vault RIM.

Jonathan Gaynor Veeva
Senior Solutions Consultant, Vault RIM

Discuss Veeva’s automation and AI strategy including Veeva’s plan to help customers leverage new technologies with the AI Partner Program.

Jared Katz Veeva Systems
Senior Director of Strategy, Development Cloud
Avril England Veeva Systems
General Manager, Vault
Andy Han Veeva Systems
SVP Product Management, Vault Platform & Technology

Discover how integrating Validation Management into operations streamlines the validation lifecycle and enhances C&Q activities across manufacturing, improving efficiency, traceability, and compliance.

Nina Ricciardelli
Director, Vault Validation Management
Bernat Rocarols
Solution Consultant, Vault Validation Management Europe

Report level content plans provide tools to author, compile appendices, hyperlink between documents, merge PDFs, publish, and match a multi-document report into a submission. No matter the size of your company or product development stage, join us to see the latest in RLCP and what it can do for you.

Mary Anne Potok
Senior Product Expert – Submissions, Archive, and Publishing

See how data flows in real-time from Veeva Randomization and Trial Supply Management (RTSM) to Vault Electronic Data Capture (EDC) and Vault Clinical Trial Management System (CTMS). Reduce duplicate data entry and ensure enrollment metrics and subject progress reports are always up-to-date.

Nicholas Klatt Veeva
Solution Consultant, Clinical Data

Sessions
11:00 am - 11:50 am

PPD and ImmunityBio share insights on strategic approaches for continuous innovation in quality. Learn how proactive roadmap planning supports evolving business and system needs through optimization and innovation, and discover tips for maintaining operational excellence on your continuous innovation journey.

Saubiya Kidwai PPD™ clinical research business, Thermo Fisher Scientific
Vice President, Quality Risk Management, Quality Enterprise Learning & EHS
Camille Denoga ImmunityBio
Sr. Director, Quality Systems & Compliance
Paola DePaso
Sr. Director Quality Strategy
Heather McHugh
Practice Manager, Enterprise Quality
Frankie Dharam
Practice Director, R&D Managed Services

Merck shares the advancements in it’s quality complaints management, showcasing streamlined operations through an interconnected system. Discover how this enhancement improves workflow efficiency and streamlines issue resolution.

Alison Brown Merck & Co. Inc.
Product Line Lead and Executive Director, DMMD Quality Operations
Carol Armstrong Merck & Co. Inc.
Associate Director, Digital MMD, Quality & Lab Value Team
Jwalant (JD) Vyas Merck & Co. Inc.
Sr. Director Technical Product Management
Samantha Yeats
Director, Quality Strategy

Discover how using a modern cloud-based LIMS with a cloud-based integration platform can automate data workflows and stream high quality, contextualized QC lab data to increase productivity and data value with measurable ROI. Learn how integrating these data repositories with other enterprise data can enhance insights through AI.

David Levy Scitara Corporation
Vice President, Strategy
Jason Boyd Veeva Systems
Senior Director, Vault LIMS

See how Eli Lilly and BeiGene set up a successful data quality program. Build a robust foundation for reliable and efficient regulatory processes by using a systematic approach to ensure high data quality and understanding the strategic importance of data stewardship and governance.

Laura Huff Eli Lilly and Company
Senior Director, Global Regulatory Affairs
Amanda Mason BeiGene
Director, RIM, Global Regulatory Operations

Staying current with Vault RIM to deliver better outcomes among evolving regulations, operating models, and organizational demands is not easy. Get practical guidance from Sanofi and Sarepta on agile release management, Center of Excellence models, and risk-assessment based validation of Vault RIM innovation.

Tejas Panchal Sanofi
Digital GRA Service Line Manager
Wim DHaeze Sarepta Therapeutics, Inc.
Senior Director, Regulatory Operations, RIMS/DMS Lead

Learn about the innovations and enhancements coming to Veeva eCOA, and ask the Veeva team questions during an interactive Q&A.

Michelle Marlborough
SVP Product Management, Sites and Patients

Hear how Acelyrin and Atorus successfully navigate trial complexity and diverse data sources to increase efficiency. Learn tips to eliminate redundant data collection, respond faster to protocol deviations, and achieve higher-quality data integration with upstream partners and downstream analytics.

Meg Richie Atorus Research Inc.
Vice President, Global Clinical Data Management
Pavel Burmenko Veeva Systems
Team Lead, CDB Strategy
Jamie Wildermuth ACELYRIN, INC
Associate Director, eClinical Programming and Solutions

Discover how Inhibrx is automating data flow between safety, clinical, and regulatory to reduce manual overhead, risk, and reconciliation as well as improve data quality. Gain best practices on connecting processes across business functions, safety outsourcing, and establishing a single trusted source of pharmacovigilance information internally and with partners.

Bonne Adams Inhibrx Biosciences, Inc.
Vice President Operations

Successful clinical trials depend on strong relationships between CROs, sponsors and other partners. This session will explore how strengthening these collaborations can help optimize clinical supply management and overall study design.

Michelle Lane Syneos Health Inc
Executive Director, Biometrics Technical Services

Discover the latest Vault Connections and enhancements and see how they are transforming biopharma processes, improving data quality, and simplifying compliance.

Jared Katz Veeva Systems
Senior Director of Strategy, Development Cloud

Merck shares their journey establishing a framework for realizing value from Vault Platform and Veeva Development Cloud. They‘ll discuss key metrics and framework to monitor, track, and communicate Vault Platform benefits delivered to the organization.

Erin Moeller Merck & Co. Inc.
Senior Director, Clinical Operations (ID/Vaccines)
Kevin Johns
Clinical Practice Manager, NA R&D BC

Parexel shares how the study-locking capability in Vault CTMS enabled data migration without any downtime.

Christie Wilkins Parexel
Senior Director, Solution Enablement
Naresh Khamesra Parexel International
Vice President, Data and Technology

Kura Oncology shares best practices for enabling CRO success in a sponsor-owned eTMF including developing effective oversight metrics, business processes, and governance.

Carolyn Jin Kura Oncology
Director, Clinical Systems/Document Management
Arlette Holland Kura Oncology
Senior Director, Operational Excellence
Frank Lin
Director, Clinical Strategy

Lunch - Innovation Hub
12:00 pm - 1:30 pm
Innovation Theaters, Networking, Demos, and More

Quantify gains from Vault RIM by aligning best practices and key metrics to achieve optimal use and efficiencies.

Kristina Capiak
Regulatory Practice Manager, R&D NA, Business Consulting

Learn how to overcome the shortcomings of paper-based data change requests processes through an automated, self-service process that enables real-time changes with full audit trails.

Alexis Cavalli
Solution Consultant, Clinical Data

NNIT will outline a new way of querying and understanding your data through F.R.E.D., Function Relay for Emulated Discovery, an intuitive ChatGPT-style interface that reduces spreadsheet wrangling and report creation. See how you can improve business operational visibility and insights with R&D examples that better leverage Vault data and external datasets.

Nagesh Sarma Valiance Partners, LLC
Associate Vice President
Janani Moni NNIT
Managing Consultant

Learn how to optimize your Document Change Control processes by leveraging the latest enhancements to the Document Change Control (DCC) feature in Vault QualityDocs, including Change Authorization and Workflow Initiation from the DCC

Jessica Kelley
Senior Product Expert

See how to extract questions from correspondence documents to efficiently create and manage Health Authority Question (HAQ) records.

Pam Pagnotta
Practice Manager, SMB Vault RIM

Learn how to address the shortcomings of historical approaches to eCOA libraries. Discover an innovative ability to easily incorporate assessments and translations with a single click.

Bipin Patel
Senior Solution Consultant

See how clinical and safety teams are reducing manual processes and data reconciliation using connections across Vault Safety, Vault EDC, Vault eTMF, and Veeva Site Connect.

Ollie Cooksey
Solution Consultant, Safety

Showcase how a new class of API simplifies and accelerates Vault data replication for external systems, data warehouses, and AI use cases.

Mark Arnold Veeva Systems
Director, Product Management, Vault API & SDK

Discover how Vault Batch Release automates the aggregation and review of critical data, enabling faster and more confident release decisions.

Mike Edwards
Director of Batch Release Strategy

Long-term vision for IDMP Viewer in Vault RIM and how it can support PMS data enrichment activities.

Kelly Finlan-Dansbury Veeva Systems
Senior Product Manager, Vault Registrations

See Vault EDC’s new Clinical Reporting to easily create single-form, cross-form, and exception listings with zero programming. Learn how users centrally access near real-time listings and navigate directly from listings to manage queries.

Nicholas Klatt Veeva
Solution Consultant, Clinical Data

Learn how to harmonize content and improve real-time oversight for QPPV teams using a modern PSMF management solution. Easily manage multiple PSMFs across regions by reusing content globally.

Eric Woolven Veeva Systems
Senior Product Manager, SafetyDocs

See how Vault Payments ensures timely site payments with accurate, real-time data from Vault CTMS and Vault EDC.

Joe de Laubrière
Solution Consultant

Maximize efficiency with Vault Mobile’s new features including uploading files, completing tasks, and annotating documents on-the-go.

Vicky Gyorffy
Senior Product Manager, Vault Platform

Sessions
1:30 pm - 2:20 pm

Steve Gens explains what constitutes a high-performing regulatory organization based on a decade of research on world-class RIM operations. Three biopharmas – GSK, Cerevel, and Sarepta – identified in the Gens & Associates benchmark will outline ways to achieve and sustain high regulatory performance.

Steve Gens Gens & Associates
Managing Partner
Sean McNiff GSK
Vice President, Global Regulatory Operations
Dee DeOliveira Cerevel Therapeutics (now part of AbbVie)
Senior Director, Global Regulatory Operations
Wim DHaeze Sarepta Therapeutics, Inc.
Senior Director, Regulatory Operations, RIMS/DMS Lead

Learn how the adoption of intelligent technologies like Generative AI are evolving clinical data management. Discover how Veeva Vault integrates with AI to remove efficiency barriers, and see innovative use cases for the Veeva Clinical Platform.

Allison Block Accenture
Senior Manager

Discover how Veeva RTSM revolutionizes Randomization and Trial Supply Management (RTSM) with its single-tenant approach and tear-off model. This presentation will show how our unique methodologies streamline RTSM product development, ensuring that your next study is always on the latest version of our core platform. Learn about our coordinated and precise validation approach, which ensures seamless and reliable operations, ultimately driving superior outcomes for our customers without the need for additional validation of the Veeva RTSM platform at any time.

Alyssa Williams
RTSM Program Director

See Vault Clinical Operations in action and the value of a unified platform in this live demo.

Join Vault Safety customers to share best practices, hear from product experts, and discuss latest and upcoming capabilities.

Mami Akebono Veeva Systems
Senior Director, Vault Safety Strategy
Marius Mortensen Veeva Systems
Principal Product Architect, Vault Safety

Learn about powerful open-source tools to view/edit configuration, execute VQL queries and export results, and easily summarize and delete Sandbox test data.

Eric Matelyan Veeva
Developer Support Engineer
Mark Arnold Veeva Systems
Director, Product Management, Vault API & SDK

Learn how union reports can help visualize and analyze complex data models and improve existing reports.

Graham Gelwicks Veeva Systems
Director, Product Management, Vault Platform

Discuss how different organizations approach managing users, both at a domain/cross-Vault level as well as Vault-specific level.

Michael Ferrell Veeva Systems
Senior Product Expert, Vault Platform

Learn how Vault Training expedites new employee onboarding by automatically managing access and job roles after training completion and qualification.

Laycee Mendez
Solution Consultant
Kent Malmros
Vice President, Training Strategy

Learn about the next major ICH eCTD version, how eCTD 4.0 addresses key drivers for change, and see eCTD 4.0 capabilities in Vault Submissions Publishing and Vault Submissions Archive.

Alessandro Sparacio
Product Manager, Vault RIM Submissions Archive
Jordan Williams
Product Manager, Submissions Publishing

See how Vault EDC’s new Study Grade helps teams optimize study design by evaluating builds against best practices, identifying potential improvements, and sending automated feedback.

Eric Jacobson
Senior Manager, North American Solution Consulting, Clinical Data

Automate and streamline safety letter distribution from creation in Vault Safety, flowing into the sponsor/CRO Vault eTMF, and lastly ‘distribution to’ and ‘acknowledgment from’ sites.

Billy Dee
Senior Solutions Consultant

Connect
2:30 pm - 3:20 pm
Innovation Theaters, Networking, Demos, and More

Learn how Recurrence Check Insights in Vault QMS streamline deviation investigations by simplifying data review and preventing duplicate efforts.

Carl Ning
Sr. Director, Strategy – Vault QMS
Manaphan Huntrakoon Veeva Systems
Senior Director, Vault Product Management, QMS

Join your peers as Veeva showcases the latest ideas for the Simplified Content Plan Mode feature. Share your feedback on the enhanced regulatory submissions user productivity and compliance to help shape future feature development. Vault RIM customers only.

Joseph Traficanti
Vault RIM Strategy Director

Join your peers and share your Vault Registrations processes, challenges, and suggestions for improvement. Veeva will highlight existing and planned features to streamline data management at the event level. Vault RIM customers only.

Lena Schafer
Director RIM Strategy

Join your peers as Veeva shares how to adopt and use Active Dossier to improve submissions lifecycle management and interaction with batch release processes. Discover customer use cases, Active Dossier implementation best practices, and how to best leverage it in daily operations. Vault RIM customer only.

Paul Attridge
VP Regulatory Strategy Europe

Explore the innovative features within Veeva RTSM such as resupply calculation visibility, dose probability management and other advanced supply settings that streamline clinical supply management for your trials.

Jonathan Chalifoux
Senior Solution Consultant

See how CTMS Transfer automates information exchange between sponsors and CROs using Vault CTMS, improving study oversight, eliminating custom reports, and strengthening study partnerships.

Join Vault Safety customers to share best practices, hear from product experts, and discuss latest and upcoming capabilities.

Mami Akebono Veeva Systems
Senior Director, Vault Safety Strategy
Marius Mortensen Veeva Systems
Principal Product Architect, Vault Safety

Explore the latest advancements in Vault Workflows including recently released and upcoming capabilities to accelerate processes and enhance operational efficiency.

Walid Abou-Chalha
Senior Product Manager, Vault Platform Workflows

See how sponsors can improve site engagement with Vault Clinical Operations, including reducing email volume, streamlining document exchange and safety letter distribution, and automating training.

Learn about Vault QMS’s latest features, including Visual Heatmap and Risk Builder, that enable proactive risk management. See how connecting risks to quality processes, such as complaints and deviations, enhances overall quality management.

Harshad Kamble
Sr. Solution Consultant
Carl Ning
Sr. Director, Strategy – Vault QMS

Discover how USDM’s AI-driven predictive analytics transforms clinical trial management by forecasting patient visit statuses, streamlining data entry, and optimizing data cleaning processes. Accelerate database lock, enhance data accuracy, and significantly reduce timelines, enabling faster, more informed decisions.

Hovsep Kirikian USDM Life Sciences
VP of Strategy and Operations

See the exciting changes to Veeva Site Connect, including site document exchange directly in Vault Clinical Operations and standardized sponsor/CRO study contacts, that streamline collaboration and improve site engagement.

Create and customize formatted outputs with only Microsoft Word. By eliminating the need for Adobe Forms Designer, you can easily and rapidly develop or modify templates.

Vicky Gyorffy
Senior Product Manager, Vault Platform

Sessions
3:30 pm - 4:20 pm
Sessions, Community Meetings, Group Discussions, and More

Join your peers as Veeva showcases the latest ideas for the Simplified Content Plan Mode feature. Share your feedback on the enhanced regulatory submissions user productivity and compliance to help shape future feature development. Vault RIM customers only.

Joseph Traficanti
Vault RIM Strategy Director

Join your peers and share your Vault Registrations processes, challenges, and suggestions for improvement. Veeva will highlight existing and planned features to streamline data management at the event level. Vault RIM customers only.

Lena Schafer
Director RIM Strategy

Join your peers as Veeva shares how to adopt and use Active Dossier to improve submissions lifecycle management and interaction with batch release processes. Discover customer use cases, Active Dossier implementation best practices, and how to best leverage it in daily operations. Vault RIM customer only.

Paul Attridge
VP Regulatory Strategy Europe

Go beyond E2B with automated SAE reporting that transfers all relevant EDC data and allows safety users to choose what’s relevant. Safety case IDs are automatically added to corresponding SAEs so Vault EDC users can rest assured the SAEs were received. This deep connectivity eliminates duplicate data entry and time-consuming reconciliations.

Alice Foltyn
Solution Consultant, Clinical Data

See Vault Clinical Operations in action and the value of a unified platform in this live demo.

Dylan Williamson
Solution Consultant, Clinical Operations

How to leverage Vault Connections to synchronize key common data elements of Study and Product data across Vaults.

John Tanner
Senior Product Manager, RIM
Matthew Coates
Product Manager

Bring questions on integrations, data warehouses, and DevOps as well as learn firsthand what features Vault offers for enterprise processes.

Mark Arnold Veeva Systems
Director, Product Management, Vault API & SDK