Patient-Centric Technology for Better Trial Outcomes

Andy Lee, Deputy Head of Clinical Sciences and Operations, Sanofi

Andy Lee is the Deputy Head of Clinical Sciences and Operations at Sanofi. He is responsible for the execution of clinical trials, across diverse phases and therapeutic areas, around the world to deliver clinical trials to high-quality international GCP and regulatory standards in a timely and cost effective manner.

Andy has ~20 years industry experience conducting clinical studies ranging from pre-clinical to phase IV drug development, across multiple platforms such as devices, small molecules, biologics and gene-therapies. Andy is interested in Human Subject Protection, Multiregional Studies, Quality and Compliance, Operational Excellence and finding more efficient ways to run clinical trials. At Sanofi he Sponsors the Innovation team in Clinical Operations

Glen De Vries, President, Medidata Solutions

Glen is one of the founders of Medidata Solutions and the original architect of the Medidata Rave® system. Since the company’s inception, Glen has been responsible for driving Medidata’s technology vision and the delivery of a growing platform of cloud-based clinical solutions, inspiring the growth of the organization’s world-class development team and building the company’s critical sponsor and partner relationships. Under his leadership, Medidata is leading the transformation of the industry’s approach to clinical development and helping to define the future state of life sciences.

Prior to his work with Medidata Solutions, Glen’s pioneering efforts in online physician/patient relationships included over 10 years of experience in medical software development, including electronic health records and consumer-targeted products. As a research assistant at Columbia University, he focused on both research science and medical informatics, working on a blood assay for the detection of micro-metastases in prostate cancer patients and creating a paperless CDM system. His peer-reviewed papers have been published in Applied Clinical Trials, Cancer, The Journal of Urology, Molecular Diagnostics, Urology and Urologic Clinics of North America.

Glen received his BS in molecular biology and genetics from Carnegie Mellon University and also studied probabilistic algorithms at the Courant Institute of Mathematics (New York University). In addition to authoring issued patents for clinical trial innovations, he has received many accolades for his industry commitment, including FierceBiotech’s Top Ten Biotech Techies in 2012, the PharmaVOICE 100 Most Inspiring People in 2006, Crain’s New York Business 40 Under 40 of 2010, and the Ernst & Young Entrepreneur Of The Year award for the metro New York area in both 2006 and 2010. He is chairman of the board for Dancing Classrooms, a not-for-profit organization that seeks to cultivate essential life skills in children through the practice of social dance.

Andy has ~20 years industry experience conducting clinical studies ranging from pre-clinical to phase IV drug development, across multiple platforms such as devices, small molecules, biologics and gene-therapies. Andy is interested in Human Subject Protection, Multiregional Studies, Quality and Compliance, Operational Excellence and finding more efficient ways to run clinical trials. At Sanofi he Sponsors the Innovation team in Clinical Operations

Randy Spaulding, Founder and President, Spaulding Clinical Research, LLC

In 2007, Randy Spaulding founded Spaulding Clinical Research. His vision created the most technologically advanced, fully-automated Clinical Pharmacology Unit in the world, which includes a 100% paperless EDC system. In 2010, Randy added Spaulding Cardiac Safety Solutions and designed the Spaulding Electrocardiograph, a handheld, proprietary 12-Lead ECG device and cloud-based management system, with the goal to cost-effectively centralize diagnostic ECGs for clinical research. In 2012, Spaulding Medical was formed, taking this mHealth cloud-based technology into the healthcare market. Between all business units, Randy is driving year-over-year growth at a rate of 300% with industry-leading quality metrics.

In September of 2013, Spaulding Clinical and Medidata were named Disruptive Innovator of the Year for their collaboration on the use of Patient-Centric Technology to drive improved clinical trial outcomes. In 2012 Randy was named “CEO of the Year” for Southeastern Wisconsin, in 2011 was honored with the award for “Best Company Direction,” and Spaulding Clinical was acclaimed as a “Top 5 Workplace” for 2011 and 2012. Randy has been published numerous times and has presented at many scientific conferences, specifically related to the topic of cardiology and QT interval measurements.

Previously, Randy was the Vice President of Clinical Research at Mortara Instrument from 2004 to 2007, where he oversaw product development, support, sales and marketing of cardiac safety products for the clinical research market. From 1998-2004, Randy served as the General Manager of Global Cardiology Services at GE Healthcare and became a Six Sigma Master Black Belt. Randy began his career in 1983 as an engineer for Marquette Medical Systems. Over the next 10 years, he was involved in the design, signal processing, manufacturing, quality control, marketing, and selling of many award-winning global diagnostic ECG products.