Oracle Life Sciences Connect—Boston

March 13, 2024

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Why attend Oracle Life Sciences Connect?

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

Meet with your peers and gain perspective on industry trends from leading experts on artificial intelligence, cloud-based research, real-world evidence, innovative study-site selection/activation/analytics, and additional advances that are transforming and streamlining clinical and safety development.

Boston Theme: The future of clinical trials

Agenda

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Breakfast and networking

Welcome presentation: Better together

  • Michael Fronstin

    Global Head of Client Partnership & Commercialization, Oracle

The conundrum of proliferating data from decentralized clinical trials

With the emergence of decentralized clinical trials, we now have a window into the patients’ study experience like never before, collecting real-world data for research as they go about their daily routines. This greater access provides us with new, more accurate ways to measure outcomes. Not only are we collecting more (and better) patient reporting, but data is coming from a broader range of sources, such as sites, labs, devices, CROs and EHRs. A hybrid study design might make patient participation easier, but a new pain point has emerged. How do we ensure sponsors, sites and study teams can efficiently and easily manage this wealth of data to deliver actionable insights? How do we streamline complex data sets into a single and actionable source of truth?

  • David Blackman

    Executive Director Digital Trials Strategy, Oracle

  • Sean Roy, PhD

    Senior Consulting Practice Director, Oracle

Networking and refreshments

Sponsor presentation: Accenture

  • Kailash Swarna

    Managing Director, Accenture

Lunch

Diversity in patient recruitment

It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Both the NIH and the Food and Drug Administration have mounted numerous initiatives, including regulatory guidance aimed to enable and fulfill the law’s intent. Despite parallel efforts by biopharmaceutical innovators, the demographics of clinical trials today still do not reflect the racial, ethnic or gender diversity of target patient populations around the world. This is true for trial subjects, of whom an estimated 83 percent are white, but also the representation of investigators at many trial sites as well. This is critical because clinical care and medical product development are not yet currently representative of all patients. This poses a significant problem for the industry. Missing race and ethnicity data in medical assessments can lead to biased estimates of treatment effects due to a lack of exchangeability. People from diverse groups are underrepresented in clinical research. This is a concern because different people may react differently to certain medical products. Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. Does real-world data serve as the key to increasing diverse representation in clinical research? Why does technology play a pivotal role in this transformation?

  • Shruti Iyer

    Principal Innovation Architect, Oracle

Current Trends and Future Directions of Real-World Data Use for Drug Safety Surveillance

Real-world data (RWD) has been used for decades to generate real-world evidence (RWE) support postmarket surveillance and regulatory decision-making for pharmaceutical and biologic products. However, increasing generation of high-quality RWD, alongside regulatory guidance on the appropriate use of RWD, has catalyzed expanded use of RWD and RWE for regulatory, policy, and business decision-making. This presentation will examine some of the primary use cases for RWD and RWE to contextualize drug safety across the drug development pipeline, from premarket to postmarket surveillance. We will discuss some key methodological considerations, technical dimensions, and best practices for RWD use in evaluate drug safety, including as related to RWD data marketplaces, computable phenotypes, and external controls. We will also explore future directions for RWD use and RWE generation, such as the potential applications of artificial intelligence (AI)—including machine learning, natural language processing, and generative AI—to streamline processes and refine insights.

  • Patrick Saunders-Hastings, Ph.D.

    Senior Manager, Health Practice, Accenture

Networking and refreshments

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 andanalytics services.

  • Dan Spellman

    Director, Global AI Cloud, Healthcare and Life Sciences

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.

  • Amita Malik

    Senior Director of Life Sciences Product Management, Oracle

Networking and refreshments

Driving your organizations success and transformational initiatives in clinical trials

As clinical research and pharmacovigilance operations move away from multiple technology vendors that supply solutions on a myriad of infrastructures requiring costly integrations that do not deliver interoperability, they need a proven technology vendor committed to their success and guided by industry expertise. Learn how Oracle helps enable you to realize the value of your investments throughout the complete clinical trial continuum. This journey, including business assessments, best practices, enablement, mentoring, industry peer interaction, and professional services, allows you to drive greater value from Oracle and our partner ecosystem.

Closing remarks

  • Drew Zwiebel

    Vice President Alliances & Channels, Oracle

Networking reception

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

Accelerate your business with Oracle’s CRO Growth Initiative

Gain a competitive edge, win more sponsor business, and execute more clinical trials efficiently and cost effectively.

Welcome, I'm your host

Andy Effenson headshot
Andy Effenson Strategic Account Manager
    Event location
    Accenture Innovation Hub
    888 Boylston Street, Suite 1300
    Boston, MA 02199
  • +1.617.488.4000
  • Driving directions

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