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Oracle Health Sciences Connect— Europe

31 March 2021

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With programs specifically developed for Oracle’s regional customer communities, this multifaceted event provides compelling sessions led by Oracle customers and industry thought leaders.

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Agenda

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The Forces of Change: From Passenger to Driver’s Seat

Has the global pandemic disrupted our journey or cleared the path for us in advancing clinical research? Hear from Oracle Health Sciences SVP and General Manager, Henry McNamara, as he explores the answer to this question.

Henry Mcnamara
Oracle Health Sciences SVP & GM

Regenerative Medicine: New Advances for Healthcare

You will hear from a world-renowned bioengineer, surgeon, and investor focusing on the science of regenerative medicine, a practice that aims to refurbish diseased or damaged tissue using the body's own healthy cells. Regenerative medicine repairs and replaces damaged tissues and organs by bioprinting either entire or partial tissues and organs. These miniaturized organs, or organoids, can be engineered to create microphysiological systems and unleash new advances for drug development. These organoid systems can generate critical data to generate insights in drug toxicity, disease modeling, biomarker discovery/validation, and personalized medicine.

Dr. Anthony Atala
W.H. Boyce Professor and Director of the Wake Forest Institute for Regenerative Medicine

Clinical One/Safety One Roadmap/Update

This session will provide an update on both Clinical One and Safety One from both a usage and directional viewpoint. A review of the roadmap and new innovation in both platforms will be covered along with the latest breakthrough on how the One platform is rethinking how to run clinical trials.

Jim Streeter,
Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences
Sujay Jadhav,
Global VP for Product and Development, Oracle Health Sciences
Bruce Palsulich,
Vice President, Safety Product Strategy, Oracle Health Sciences
Chidhi Arunachalam,
Global Vice President of Development, Oracle Health Sciences

The Importance of the Unified Platform Approach

This session will review the differences between a unified platform and an integrated eClinical platform in detail and why a unified platform brings greater quality and innovation to both the front end and back end office.

Jim Streeter,
Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences
Greg Jones,
Enterprise Strategy Architect, Oracle Health Sciences
Steve Lyons,
Vice President, Development, Oracle Health Sciences

Helping Sponsors Navigate the Clinical Cloud Ecosystem

This session will showcase the benefits of a unified approach for managing and streamlining your data.

Dr. Nicholas Lakin,
Managing Director, Syneos Health Consulting

Break

Orchestrating the Data Flow for Unified eClinical Analytics

Exploring real-time data flows from all systems providing data sources for each study and modern technologies to deliver Unified eClinical Analytics to do away with traditional silo’d analysis views of the Data Sources.

Henrik Lynge,
Vice President, BDP MARS, GD, DRD, Novo Nordisk

The Significant Impact of Delivering On-Cloud Solutions and Business Transformation

In this session, Accenture will present a case study where they collaborated with Oracle Health Sciences to create value with an on-cloud solution implementation for one of their clients, highlighting their PV transformation journey. This presentation focuses on the key areas that led to significant improvement in process efficiency with database migration and streamlining other features, which delivered better integration and seamless user interactions.

Sumanta Ghosh
Senior Manager, Accenture Life Sciences
Seshadri Iyer
Application Development Manager, Accenture

The Safety One Evolution

Hear our latest strategy to evolve our suite of safety products (Argus, Empirica, and Safety One Intake) to modernize the industry-leading safety applications and bring them closer to Clinical One to form one source of truth across clinical and safety.

Bruce Palsulich,
Vice President, Safety Product Strategy, Oracle Health Sciences

Continuous GxP Compliance for Oracle Clinical One

Learn how to enable continuous GxP compliance of the Clinical One platform and leverage USDM’s validation accelerators to minimize your regulatory compliance burdens and fast-track innovation.

Stepheni Norton,
Director of Product Management, Digital and Cloud Solutions, USDM

Unifying Saama’s Smart AI Applications with Oracle's Clinical One Platform

Learn how to enable automated data cleaning and SDTM creation with integrated, pre-trained clinical AI/Machine Learning models.

Jonathan Burr,
Senior Vice President, Clinical Platform Strategy, Saama Technologies
Aamir Jaka,
Vice President, Life Science Strategy, Saama Technologies
Marlon Traille,
Senior Solution Consultant, Oracle Health Sciences

Defining a Pragmatic Approach to Implement AI & ML in Clinical Development

In this session, Pfizer will review the pragmatic journey of AI/ML implementation in Clinical development, implementation through investments and how to embrace and capitalize with AI/ML with the Oracle partner ecosystem.

Prassana Rao,
Head, A.I. and Data Science, Data Monitoring and Management, Global Product Development, Pfizer

Decentralized Trials - No Going Back

Decentralized trials are fast becoming the new norm. This session will explore decentralized trials and the impact on Patients, Sites and Sponsors as well as examine how can we simplify adoption, and maximize this new approach to accelerate research.

Ching Tian, ,
Senior Vice President, Strategy and Solutions, Medable Inc.
Jim Streeter,
Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences
Kathy Vandebelt,,
Global Vice President of Innovation, Oracle Health Sciences

Industry Perspective on the Future of PV

Join us for a discussion about the future of pharmacovigilance operations and systems.

Mirza I. Rahman,,
MD, MPH, Senior Vice President & Chief Global Pharmacovigilance Officer, Otsuka Pharmaceutical Development & Commercialization Inc.
Bruce Palsulich,,
Vice President, Safety Product Strategy, Oracle Health Sciences

Next Generation Trial Management: CRO & Sponsored Collaboration

In this panel session, hear what is important in next generation Clinical Trial Management needs, as well as how sponsors and CROs can collaborate on trial management and oversight within the same platform and eliminate data redundancy, integrations and status reporting needs.

Jamie Toth
CPM, MS, Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Nicole Stansbury
VP, Global Clinical Monitoring, Central Monitoring Services, Syneos Health
Jennifer Bush
Director, Life Sciences Product Strategy, Oracle Health Sciences

Innovation through Integration of SSU, CTMS and eTMF: Increase Speed without Compromising Quality

In this session, Phlexglobal's Karen Roy will take a deep dive into the power that comes with an integration of "best-of-breed" SSU, CTMS and eTMF designed to unify data and maximize efficiency of processing.