December 19, 2016 Clinical Informatics News will be attending the Summit for Clinical Ops Executives—SCOPE—in Miami, Fla. from January 24-26, 2017. We are looking forward to three days filled with clinical trials challenges, solutions, and advances. The Summit covers a broad range content spread over 13 different tracks and 2 symposia. We’re still working our way through the agenda with our highlighters, but here’s some of what we have flagged so far.

--The Editors

The Clinical Data Strategy and Analytics track is full of great speakers and we are especially excited to learn about analytics linked to strategy and execution, centralized monitoring, cloud and digital solutions and data visualizations. One of the esteemed pharma speakers, Gary Thompson from Eli Lilly, will speak on quality, risk, analytics, and speed and industry trends that impact on the direction of clinical data management. John Rodermund of AstraZeneca will speak on centralized monitoring in action.

As a continuation from the Clinical Data Strategy and Analytics track, the Clinical Technology track will focus on cutting edge technologies including mobile aps, virtual, and remote clinical trials. We’re particularly excited to hear Munther Baara of Pfizer, who will speak on how mClinical is changing the way that clinical trials are executed.  Christian Gossens, Roche, will discuss complementing clinical trials with digital biomarkers. As he uses real world smartphone data, he poses the question, is this science or still fiction?

The Managing Late Stage Research and Observational Studies track is designed to facilitate knowledge exchange around all aspects of observational research from the designing and managing of post-approval studies, to applying the obtained data to pivotal business and medical decisions. Cathy Critchlow of Amgen, will be the keynote speaker in this track. Her talk will highlight how to create synergy between observational studies and clinical trials and the organizational opportunities that result from that synergy. Christina Fawcett, a representative of PRA Health Sciences, will discuss managing late stage research, observational studies and registries. William Spalding of Shire will speak on the challenges and opportunities of using RWE to support product value propositions.

Just weeks after President Obama signed the 21^st Century Cures Act, real world evidence has never been more important. SCOPE’s Leveraging Real World Data for Clinical and Observational Research track is full of top pharmaceutical executives. We expect some outstanding talks that discuss challenges and solutions with secondary use of existing healthcare data for assessing the effectiveness and safety of medical products.

Craig Lipset of Pfizer is always a crowd favorite. (He gave the SCOPE keynote address last year.) This year he’ll take on the transformational opportunity for research when you combine empowered patients, electronic health records and data access together. Andrew Roddam of GSK will give a featured presentation on increasing effectiveness and studying the effects of medicines in usual care settings. Jane Fang, AstraZeneca/MedImmune, will use case examples on how to use real world evidence data and trial competition analytics to optimize clinical trial protocol development, patient population identification, patient recruitment and site/PI selection.

The concept of personalized or precision medicine—with medical decisions, practices, and/or products being tailored to the individual patient—has brought to life several types of clinical trials that involve biomarkers. Effective management of these trials can be complicated and requires specific operational approaches. In a symposium on Managing Precision Medicine Trials, Bardia Akbari, Genentech, will give a featured presentation on the operational challenges and opportunities in the design and implementation of biomarker selective clinical trials. Brenda Yanak of Pfizer, will give a complementary talk on operationalizing precision medicine trials.

A second symposium—Sample, Lab and Diagnostics Services in Clinical Trials—will highlight the availability of high quality biological specimens, laboratory access, and diagnostics services for biomarker-driven clinical trials and future research. With talks on technology solutions and outsourcing precision medicine trials from MedImmune, sample and bio specimen management talks from Merck, GSK and University of California, San Francisco, and sourcing lab and diagnostic services from BMS, Genentech, and Novartis, this forum will brings together leading experts, representing clinical sponsors, to discuss challenges and identify actions to improve infrastructure for biomarker driven clinical trials. To complete the symposia, there will be an interactive panel that will discuss how biobanks serve clinical trials.