April 13, 2018 | Next month in Boston, the Clinical Trial Innovation Summit with bring together leaders and innovators across pharma, biotech, and academia to discuss the real-world experiences and best practices needed to optimize clinical trial management. Presentations spanning six conference programs will address the most complex areas of trial management, including risk-based monitoring, patient recruitment and site selection, big data analytics, machine learning, outsourcing, and clinical trials driven by tech. Here are just a few of the talks that get us excited for the summit. –The Editors

Ashish Atreja, Chief Technology Innovation and Engagement Officer at Mount Sinai, will give his keynote address on how value-based healthcare and outcome-based contracts are reshaping the entire health industry and major players including health systems, payers, and pharma. Atreja will provide an overview of current state of the art of digital medicine, review the challenges faced in digital medicine adoption and demonstrate how prescription of digital medicine can support care and research transformation.

During his session of the Patient Recruitment & Site Selection program, Chris Hoyle, Executive Director of Elite Research Network, will tackle why clinical trial sites are so reluctant to move from paper to electronic source. Hoyle will explain the hesitation to transition away from paper and how the industry can work together to expedite the adoption of e-source. 

Alexandra Dumitriu, Manager of Genome Sciences and Technologies at Pfizer, will share how Pfizer applied machine learning and text mining methods to identify and extract predictive features from patients’ medical histories for poorly labeled conditions of interest. Real-World Data, such as electronic medical records (EHRs), are valuable resources to inform our knowledge of disease trajectories, outcomes, and costs, Dumitriu will argue. But to take advantage of these resources, it is important to identify patients correctly, which is a difficult task for conditions that are under-diagnosed by physicians.

Jennifer Turgiss, Vice President of Behavior Science and Analytics at Johnson & Johnson, will moderate a panel discussing the challenges and considerations when using digital solutions in clinical trials. The panel will discuss how to ensure the adoption of digital solutions and involving stakeholders cross departmentally to address concerns around consent, evolving technology and user experience as the study progresses, and integrating wearable/app data into the trial. Panelists will include Elena S. Izmailova from Takeda, Georgia Mitsi from Sunovion, Margaretta Nyilas from Otsuka Pharmaceutical Development and Commercialization (OPDC), and Charles Wolfus from MyoKardia.

With the industry’s need to comply with recent changes in the ICH E6 R2 addendum, how is pharma balancing oversight with their desired number of suppliers? Melissa A. Hurst from CSL Behring, Michele Stonier from BMS, and Dennis Salotti from The Avoca Group will discuss setting up governance structures, vendor quality, and oversight in light of the new ICH E6 R2 changes.

Adoption of new technology across a range of sectors has improved processes and efficiencies in significant ways. Tony Rees, Director of SQN Clinical, will discuss how the clinical space is acknowledging that technology can have an impact on data quality, reduced timelines, and savings in costs. With a drive toward patient centricity, the data collection paradigm has to shift to meet regulatory, clinical, and commercial needs. Enabling cloud based and mobile technology will remove historical constraints and liberate data collection, reporting, and management processes, Rees argues.