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Oracle Health Sciences Connect—North America

March 23–24, 2021

Watch the replay

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

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 and GM

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

Next Generation Trial Management

Panel session discussing next generation Clinical Trial Management needs and how sponsors and CROs can collaborate on trial management and oversight within the same platform, eliminating data redundancy, integrations and status reporting needs.

  • Nicole Stansbury

    VP, Global Clinical Monitoring, Central Monitoring Services, Syneos Health

  • Jamie Toth

    CPM, MS, Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.

  • Jen Bush

    Director, Life Sciences Product Strategy, Oracle Health Sciences

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

Success with Clinical One—A Customer Perspective

Hear from customers on their experience and innovations utilizing the Clinical One platform for Randomization and Data Collection capabilities; including best practices, time savings and adoption methods for onboarding the platform.

  • James Ferguson

    Director, Global Programming Shared Services, Data Management, IQVIA

  • MJ Kuhn

    Associate Director, Programming Shared Services, IQVIA

  • April Mascia

    Director, Clinical Trial Materials Management, Sunovion

  • Lalitha Venkatasubramanian

    Associate Director, FHI 360

  • Jen Bush

    Director, Life Sciences Product Strategy, Oracle Health Sciences

Decentralized Clinical Trials: Why They Are Important, and How the Life Sciences Industry is Planning to Adopt Them

For a long time, the adoption of digital tools in clinical trial conduct has been slow, lagging even the pace seen in routine healthcare delivery. But recently, sponsors have begun to warm up to the opportunity to innovate their clinical development paradigm. In this session, Accenture will discuss the long-term trends observed in life sciences R&D productivity, and how embracing innovation in clinical trial conduct—with a focus on decentralized clinical trials—promises an important potential source of productivity improvement.

  • Alexander Simmonds

    Senior Management Consultant, Applied Life Sciences Solutions, Accenture

AI for Case Processing - Progress Made, Lessons Learned, and the Path Forward

In this panel session, hear from colleagues who have been working on Artificial Intelligence projects around case processing and get their insights on the progress the industry is making, what we have learned, and what they think about the path forward.

  • Denny Lorenz

    PV Digital Program Delivery Lead, Bayer AG, Germany

  • Richard Wolf

    Executive Director, Pv Operations, Global Clinical Safety & Pharmacovigilance (GCSP), CSL Behring

  • Michael Braun-Boghos

    Senior Director Safety Strategy, Oracle Health Sciences

  • Rave Harpaz

    Senior Director, Research and Data Science, Oracle Health Sciences

End-to-End Study Build Acceleration

Hear from study build experts with experience across multiple solutions such as EDC, DMW, and SAS. Discussion will include current challenges, impact of standards, and potential existing and future solution options, including MDRs and a platform-level designer for Clinical One.

  • Hernan Bordoni

    Delivery Management Director, Merck & Co.

  • Nagree Verma

    Director, Clinical Database Management, Data Monitoring & Management, Pfizer

  • Julie Smiley

    Senior Director of Life Sciences Product Strategy, Oracle Health Sciences

Modernization of Site Contracting Using Innovative Technologies, Including Activate

Innovative technologies, including the customization of Activate workflows and the use of Activate data in a document residency dashboard, has resulted in an increase in efficiency and quality, and a reduction of cycle times for PPD Study Start Up.

  • Lee Coram

    Associate Director, Clinical Innovations, PPD

  • Scott Lundy

    Senior Director, Global Site Contracting, PPD

Break

Clinical Data Management: Glimpse of the Future

With the ever increasing volume and complexity of data in clinical trials, there has been an evolution of data management towards data science. In this fireside chat, Pfizer's Demetris Zambas will discuss the challenges they are facing and their vision for data management in the future, including the impact on people, processes, and technology.

  • Demetris Zambas

    VP & Global Head Data Monitoring and Management, Pfizer

  • Julie Smiley

    Senior Director of Life Sciences Product Strategy, Oracle Health Sciences

AI for Case Intake - Safety One Intake

Safety One Intake brings machine learning to high-volume case processing, allowing customers to focus human efforts on high-impact activities rather than case intake. Join us to hear about the latest updates and for a brief demo.

  • Matt Kott

    Principal Solution Consultant, Oracle Health Sciences

Diversity: The Race to Innovate

In the development of the COVID-19 vaccine, Pfizer departed from traditional clinical development strategies and strove to demolish healthcare disparities and be more inclusive. As a result, the impact on the organization has led to a major paradigm shift in site intelligence, its data and approaches implemented to achieve greater inclusivity. We discuss the approaches implemented at Pfizer and how site intelligence adapted its model to technology to lead in the race for inclusivity.

  • Jonathan Crowther, PhD

    Director, Site Intelligence, Pfizer

  • Oriol Serra, MS, MBA

    Head, Site Intelligence & Selection, Global Product Development, Study Optimization, Global Study & Site Operations, Pfizer

How #NoGoingBack Might Apply to PV Initiatives

In the race to develop safe and effective therapies and vaccines for COVID-19, companies innovated to accelerate bringing products to market. In this session, we will explore what we learned from this global effort and apply it to PV initiatives from now on.

  • Bruce Palsulich

    Vice President, Safety Product Strategy, Oracle Health Sciences

  • Rob Kelle

    Senior Director Enterprise Safety Cloud Strategy, Oracle Health Sciences

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

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

Defining a Pragmatic Approach to Implement AI and 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

Industry Perspective on the Future of PV

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

  • Mirza Rahman, MD, MPH, FAAFP, FACPM

    Senior VP & Chief Global Pharmacovigilance Officer, Otsuka Pharmaceutical Development & Commercialization, Inc.

  • Bruce Palsulich

    Vice President, Safety Product Strategy, Oracle Health Sciences

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

Making Life Better: What Drives the “Fair and Effective” Vaccine Delivery?

March 30, 2020 set the USA on a path of partnership between federal agencies and private firms to develop, manufacture and distribute COVID-19 vaccines to patients more rapidly while adhering to standards for safety and efficacy. Tune in to hear the impact technology had on the effort to make sure that the logistics are in place for the various jurisdictions.

  • COL Robert J. Mikesh Jr.

    Colonel, U.S. Army, Information Technology Lead, Federal COVID-19 Response, Vaccines & Therapeutics

Advancing Science: Real World Data Driving Pandemic Actions

Keeping pace with real-world health events requires providing the necessary data to decision makers. This panel will reveal how this is repeatedly accomplished so rapidly across the USA amidst diverse environments, processes and systems.

  • Dr. Tanya Myers, PhD MSc

    v-safe Team Lead, COVID-19 Response, Centers for Disease Control and Prevention

Helping Sponsors Navigate the Clinical Cloud Ecosystem

In this presentation, you will hear about the factors driving the move to end-to-end clinical operations platforms as a strategy for biopharmaceutical companies, the responses from technology companies, and the criteria to apply when selecting and implementing solutions. Syneos' Nick Lakin will talk through a methodology for the evaluation of vendors, key strategic considerations, and best practices for implementation to achieve sustainable performance improvements.

  • Dr. Nick Lakin

    Managing Director, Syneos Health Consulting

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 siloed analysis views of the Data Sources.

  • Henrik Lynge

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

Regulatory Updates for Safety

Our Regulations and Audits Working Group stays on top of all of the regulatory impacts facing our customers. In this session, we will present the latest updates for the North American region and global regulators.

  • Una Kessi

    Product Management Director, Safety and Pharmacovigilance, Oracle Health Sciences

Connecting the Clinical Research Ecosystem

From Recruitment to Submission, clinical trials require a myriad of suppliers and service providers. Digitally connecting this broad ecosystem provides major opportunities to enhance, extend and optimize today's processes. Hear from key players in the ecosystem.

  • Sabrina Steffen

    Head of Innovation, Data Sciences, Safety & Regulatory, IQVIA

Argus Product Updates

In this session, we will take a closer look at near-term updates coming to Argus to meet regulatory needs and evolve its feature set.

  • Veena PC

    Product Management Director, Safety and Pharmacovigilance, Oracle Health Sciences

  • Lavanya Sathish

    Principal Product Manager, Safety and Pharmacovigilance, Oracle Health Sciences

Oracle Site Activate Implementation Update Drives ROI

Revised activation strategy implementation to improve SSU outcomes within a mid-size CRO in key therapeutics areas and specialty study types.

  • David Ebert

    VP SSU, Clinipace

  • Paola Ortiz

    SSU Manager, EU, Clinipace

  • Shilpa Williams

    Product Accountability and SSU Systems Manager, Clinipace

Safety One Argus: Customer-Driven Change

Come see how Safety One Argus is being shaped by direct engagement with our customers, and learn how you can contribute to a next-generation case management system that fits your workflow.

  • Guthrie Andres

    UX Designer, Oracle Health Sciences

  • Carrie Giannasi

    Vice President, Safety Product Management, Oracle Health Sciences

Unified Platform Integration with Select & Activate APIs

CSL to present on their implementation of Select and Activate integration with CTMS & eTMF through a comprehensive integration layer, resulting in end-to-end automated syncing of activities and documents from start-up to closeout.

  • Jennifer Arters

    eClinical Manager eTMF & Collaboration, CSL Behring

  • Ted Schmidt

    Senior Manager IT Development Applications, CSL Behring

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.

  • Karen Roy

    Chief Strategy Officer, Phlexglobal

Break

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

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

NextGen PV – A Digitalized Future

What are the opportunities for digital transformation in PV and how can the industry reach it’s potential? In this session, Navitas will explore the concept of NextGen PV in the context of today’s challenges in drug safety.

  • Louise Tan

    pvconnect Lead and Senior Consultant, Navitas Life Sciences

  • Ben Parsons

    Managing Consultant, Navitas Life Sciences

End-to-End Data: Moving from Flow to Unification

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

  • Jim Streeter

    Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences

  • Greg Jones

    Enterprise Strategy Architect, Oracle Health Sciences

Improving Signaling Workflow with Empirica and a VAERS COVID-19 Vaccine Data Analysis

With Empirica Signal and Topics 9.x bringing significant usability enhancements, this session will focus on improving signaling workflow with the latest releases. We will also share how we used the new tools to analyze the latest VAERS data on COVID-19 vaccines.

  • Rob van Manen

    Master Principal Solutions Consultant, Oracle Health Sciences

Oracle Argus Cloud Migration: End-to-End Drug Safety, Signal Management and Advanced Analytics Platform

Due to a 200% increase in reported cases, leading biopharma company, Alnylam, decided to upgrade its reporting system and look for a more robust platform that could meet its pharmacovigilance, compliance, and safety database reporting needs. In this session, Techsol will discuss how they helped Alnylam achieve its compliance and reporting requirements by creating an integrated PV platform with the Oracle Enterprise Argus and Reporting Tools platform on the Oracle Health Sciences Cloud, and the Oracle Empirica and Topics Signal Management Systems.

  • Satya S Sagi

    CEO, Techsol Corporation

  • Kimary Pomphrett

    AVP Client Partner, Techsol Corporation

Thank you to our sponsors and CROs

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