Breakfast

Welcome and speaker introductions

• Michael Fronstin

  Global Head of Client Partnerships and Commercialization, Oracle

Redefining the patient voice

Depending upon the lens you look through, the patient's voice has various meanings. Often, the patient's voice is viewed as a one-time, individual description of a particular disease experience related to a therapeutic intervention, side effect, or impact on that person's quality of life. While essential and valid to capture this perspective, the broader perspective, and trends across a patient community or even across diseases are often missed, resulting in redundancy of data and missed critical points that can impact the project and save time and money. Ms. Thornton will highlight the importance of collaborations with patient organizations and patient thought leaders to bring innovative ideas to incorporate the patient experience into healthcare, focusing correctly on the patient.

• Susan Thornton, CEO

  Cutaneous Lymphoma Foundation

Stigmatized health conditions: missed diagnoses and poor treatment uptake

Stigmatized health conditions are often underdiagnosed and undertreated. These conditions can represent sources of shame for afflicted individuals (e.g., obesity, STDs, skin conditions, mental health conditions, etc.) and this shame may act as a barrier to diagnosis and treatment uptake. Moreover, the burden of illness for individuals with undiagnosed or untreated stigmatized conditions is substantial, highlighting an important unmet need for improving diagnosis rates and treatment uptake among individuals with stigmatized conditions. Oracle Life Sciences will share examples which quantify the size of the diagnosis and treatment uptake problem, assess the unique drivers and barriers to diagnosis and treatment uptake among those with stigmatized conditions, and guide our clients toward better and more targeted solutions for improving diagnosis rates, treatment uptake, and subsequent health outcomes in these stigmatized populations.

• Nate A. Way, PhD

  Senior Evidence Generation Lead for RWE, Oracle

Refreshments and networking

Voices to trials: Design for success by engaging patients in clinical trial design

Clinical trial protocols often focus on the clinical objectives of the trial and can miss key design elements that can motivate or discourage patient participation and retention. Voices to Trials is a structured approach to incorporating patient voices to optimize clinical trial design. This approach can include optimizing trial endpoints, where input, captured via interview or stated preference methodologies, can help confirm which outcomes matter most and their relative importance. We will share case studies resulting in regulatory acceptance thus accelerating enrollment, ensuring retention and success.

• Emily Mulvihill, MBA

  Associate Principal Real World Data & Analytics, Oracle

• Kathleen Beusterien, MPH

  Principal of RWE, Oracle

Community Engagement to Increase Diversity in Clinical Trials

In a discussion with clinicians focused on community engagement, we will start with an updated exploration of the challenges and barriers to recruiting and enrolling diverse populations in clinical trials. They will then illustrate the strategies and resources needed to connect diverse communities to research by sharing their work, successes, and evidence towards overcoming these barriers. Finally, we will consider the potential for AI in supporting equity in clinical trial participation.

• Emily Mulvihill, MBA

  Associate Principal Real World Data & Analytics, Oracle

• Dr. Carmen E. Guerra, M.D., M.S.C.E., F.A.C.P.

  Professor of Medicine, University of Pennsylvania

• Dr. Mylynda Massart, MD, Ph.D.

  Associate Professor, University of Pittsburgh

Lunch

Patient registries in the era of electronic health record big data

Patients’ registries are increasingly moving away from data collection that is duplicative to the care process to unified and EHR-integrated workflows whereby data can be collected once to be used for many purposes. In addition, there is a push for modernization of data dictionary models and workflow tools by leveraging new interoperability standards and adding emerging technology components that simplify, automate, and amplify Real World Data acquisition. Our vision for the future of registries focuses on the development of a single system able to extract validated, high-quality EHR data, collect primary data from clinicians and patients and ingest and link to other data sources. This system should enable us to collect data on patients regardless of where they are treated while reducing the data collection burdens on clinicians, researchers, patients and information technology staff alike.

• Tonya Hongsermeier, MD, MBA

  VP Chief Clinical Innovation Officer, Elimu

• Elise Berliner, PhD

  Global Senior Principal RWE Strategy, Oracle

Applications of machine learning to score freezing of gait in people with Parkinson's disease

There is a need for valid and reliable outcome measures for clinical trials in Parkinson's disease (PD) and other conditions. Freezing of gait (FOG) is a poorly understood heterogeneous gait disorder seen in these patients that contributes to significant morbidity and social isolation. FOG is currently measured subjectively by movement disorders specialists or through patient completed questionnaires (N-FOG-Q) that are unsuitable for use in clinical trials. Methods to quantitatively assess FOG through machine learning could potentially significantly improve precision of clinical trials as well as access to care. Drs. Kwon and McKay will present a recent study from their laboratory that applied state-of-the-art deep learning approaches to score FOG in people with PD.

• Lysel Brignoli (Moderator)

  Associate Principal, RWE, Oracle

• Dr. Hyeokhyen Kwon, Ph.D., M.Sc

  Assistant Professor, Department of Biomedical informatics, School of Medicine, Emory University

• Dr. J. Lucas Mckay, Ph.D., M.S.C.R.

  Assistant Professor, Department of Biomedical informatics, School of Medicine, Emory University

Refreshments and networking

Advancing patient-centered drug development and clinical trials 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 (e.g., 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. Bryan Barker, Ph.D.

  AI Cloud Senior Specialist, Healthcare and Life Sciences, Oracle

Big data and AI has finally come to commercialization in life science

We are now realizing the promise of healthcare expertise and quality data streams because we are bringing to bear the full force of Oracle real world data and technology. Our new approach to life sciences questions rooted in observed patient data will drive better decision making and enable broad improvements in patient health. Dani Niblick and Marie Giordano will discuss how we are harnessing healthcare expertise and data sources, including real world anonymized patient data to redefine the depth and speed of understanding available to improve decision making during the commercialization process.

• Dani Niblick

  Principal of Advanced Analytics, Oracle

• Marie Giordano

  Business Leader of US Commercial Research, Oracle

Closing speech

• David Fantini

  Vice President of Sales, North America, Oracle

• Michael Fronstin

  Global Head of Client Partnerships and Commercialization, Oracle

Networking reception

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