Breakfast

Welcome and speaker introductions

• Michael McCann

  Global VP Sales HSGBU

• Janice Getchell

  Pharmacovigilance & Safety Application Sales, Oracle

EHR to EDC: How integration between Electronic health records (EHR) to electronic data capture (EDC) Accelerates Clinical Research

It has been a long-standing industry challenge that 50-70% of data collected in EDC is being manually re-entered from EHR systems by site staff who would rather spend their time on patient care and patient safety. As a result of the need for duplicative data entry, nearly 20-25% of study costs are related to manual transcription, often adding up to three minutes per data point (on data entry, validation, correction). This leads to an average loss of $8 million per day. Powered by Cerner, Oracle is working to transform the way that healthcare data is transferred to clinical trial systems for clinical research. By intelligently extract healthcare data from EHR systems to fuel clinical trials, Oracle is focused on creating a seamless experience for life sciences stakeholders.

• Wissam Kazan

  VP Oracle Clinical Trials, Oracle

• Amita Malik

  Senior Director, Health Sciences Product Management, Oracle

Refreshments and networking

Addressing Challenges in Patient Recruitment

Inefficiencies in patient recruitment continue to be a prevalent challenge in clinical research and significantly impact all stakeholders of the life sciences industry. Approximately $1.9 billion is spent on recruitment annually and 48% of research sites enroll one or fewer patients for a given trial. Oftentimes, 72% of trial participants are already patients at the site and 28% are new patients. Strong site relationships, deep clinical research expertise, and robust technology is key to achieving better study feasibility and high confidence in the eligibility of enrolled participants.

• Shruti Iyer

  Principal Innovation Architect, Oracle

Safety One Platform: Innovation Strategy & roadmap

• Bruce Palsulich

  VP Safety & Pharmacovigilance, Oracle

• Carrie Giannasi

  VP Product Management, Oracle—Precision PV

• Matt Kott

  Principal Solution Consultant, Oracle

Ignite data-driven insights with AI-powered cloud infrastructure

The convergence of science and emerging technologies, such as AI and machine learning, is enabling patient-centric approaches to clinical trials with data-driven insights to optimize study design, predict patient responses, improve patient adherence and retention, and to foster inclusiveness and diversity. Capturing the patient voice through the collection of real-world data (eg. EHRs, claims, disease registries, digital health apps, social media) is an integral part of this approach and critical for efficient post-marketing studies. AI-enabled applications and algorithms are also impacting the full lifecycle of therapeutic development, from discovery to commercialization, with the power to find patterns lost by conventional data analysis. Learn how Oracle is helping life science organizations unify data and analytics across the enterprise to unlock the full potential of their mission critical data through our Life Sciences applications, Oracle Cloud Infrastructure, and data & analytics services.

• Dr. Paul Brake, Ph.D.

  Executive Director, Market Development for Life Sciences, Oracle

Lunch

Oracle Safety Client Panel

Join industry peers in a Q&A session on hot topics in PV, including the future of precision pharmacovigilance—leveraging RWE/ RWD assets in revolutionary ways, customer perspectives on automation and AI in safety and signal detection, and innovating for the future with Oracle.

• Bruce Palsulich

  VP Safety & Pharmacovigilance, Oracle

• Carrie Giannasi

  VP Product Management, Oracle

Strategic Insights: WallabyPhenox’s Success Story using Oracle Clinical One RTSM in a Stroke Treatment Clinical Trial

Clinical One RTSM can support a randomization and trial supplies strategies for the simplest to the most complex studies without the need for programming or coding, which eliminates the need for prolonged user acceptance testing. The case study of Phenox Inc.’s use of Oracle Clinical One RTSM is no exception. Phenox’s executive consultant, Joel Harris and Oracle Senior Consulting Practice Director Sean Roy will discuss how Phenox chose Oracle Clinical One for RTSM and how Phenox and Oracle collaborated to configure and maintain the clinical trial software capable of handling the unique requirements of Phenox’s pRESET thrombectomy device trial. Joel and Sean will tell the story of the clinical trial journey and how the successful outcomes achieved in the study resulted in FDA clearance with a reduction of disability claim for LVO patients known only to 3 devices in the US.

• Joel Harris

  Medical Device Executive Consultant, WallabyPhenox

• Sean Roy PhD

  Senior Consulting Practice Director, Oracle

Refreshments and networking

Exploring operational efficiencies in pharmacovigilance

Explore the future of pharmacovigilance including challenges and opportunities faced by safety professionals, and advances in technology that can help address these needs. Join us and our global community of customer advocates and industry leaders at the for in-depth discussions about overcoming challenges specific to gaining insights to stay ahead in this ever-evolving field & ensure optimal patient safety.

• Dr. Sameer Thapar

  Strategic Client Advisor, Life Science Strategy, Oracle

How Freenome is Using Oracle Life Sciences Real-World Data to Generate Insights for Colon Cancer Early Detection

Freenome believes that outpacing cancer starts with early detection. The company takes a unique approach by combining molecular testing with insights derived from real-world data to transform cancer screening. Victoria Reid, Vice President of Corporate Development at Freenome, will discuss the breadth of Freenome’s partnership with Oracle Life Sciences, which includes advancing Freenome’s clinical trials via Oracle’s Learning Health Network, leveraging real-world datasets to help close care gaps, and preparing for the commercial launch of Freenome’s first product, a colorectal cancer screening blood test.

• Victoria Reid

  VP Corporate Development, Freenome

Closing remarks

Networking reception

End the day by joining Oracle for a fun filled networking reception with cocktails, conversations, and canapés!