ED SEGUINE
General Manager, Trial Planning Solutions
As General Manager of Trial Planning Solutions, Ed is responsible for developing and executing strategies to deliver innovative products that make the clinical trial planning process more efficient and effective. As a member of the senior management team at Medidata, Ed oversees all development, implementation, and commercialization activities for Medidata CRO Contractor, Medidata Designer, Medidata Grants Manager and the proprietary benchmark data these products rely on.
Previously, Ed served as chief executive officer of Fast Track Systems Inc., where he successfully transformed the company into a customer-focused organization and guided the team to capitalize on a number of promising growth opportunities. Prior to Fast Track, Ed spent several years at Eli Lilly, where he was instrumental in establishing both e.Lilly and Lilly Ventures. While at Lilly, Ed actively invested in emerging technologies and business models to improve clinical development. These experiences served to develop a deep understanding of clinical development as well as an appreciation of the challenges pharmaceutical companies face as they adopt new technologies and business processes. Earlier in his career, Ed served as the chief financial officer of Action Target, a successful defense technology company.
Ed is active in the Clinical Data Interchange Standards Consortium (CDISC) as the chair-elect of the Industry Advisory Board, a non-voting member of the CDISC board, and Financial Oversight Committee. In addition, he has written several articles and is a periodic speaker at industry events.
Ed speaks fluent Spanish, earned his B.B.A. from Brigham Young University and MBA from Indiana University.
PETER ABRAMOWITSCH
Vice President, Development, Trial Planning
As Vice President of Development for Trial Planning, Peter is responsible for the development of Medidata CRO Contractor, Medidata Designer and Medidata Grants Manager products.
Peter's experience includes more than 20 years of involvement in a number of ground-breaking software projects, including dynamically-driven telephone interviewing software (now owned by SPSS, and adopted by Gallup, Neilson and ORC); one of the first non-linear feature film editing systems developed at Lucas Films' Skywalker Ranch, the EditDroid; a sophisticated clinical monitoring system for the operating room developed in Italy and pioneered at several European hospitals.
Most recently, Peter served as chief technology officer and chief architect at Fast Track Systems, Inc., where he designed and directed the development of the TrialSpace Enterprise Architecture platform for interconnected clinical trial applications using a mixture of rich client and web technologies. Prior to his role at Fast Track, Peter served as senior software architect at Oacis Healthcare Systems, a vendor of HL7 based clinical repositories and applications.
A specialist in metadata driven software design, Peter is an active modeler and participant in the Clinical Data Interchange Standards Consortium (CDISC) protocol representation activities. In addition, he is a guest speaker on rules-based clinical data modeling approaches at various clinical events, including the Drug Information Association (DIA) and the Healthcare Information and Management Systems Society (HIMSS) conferences, and is listed as a co-inventor on pending patent applications for innovations in this area.
Peter earned his B.A. in anthropology from the University of California at Berkeley and M.A. in film production from the London International Film School.
DAVID GEMZIK
Vice President, Information Services, Trial Planning
David brings more than 12 years of experience in software development and services to his role as Vice President of Information Services, Trial Planning at Medidata Solutions. David is responsible for the management and delivery of Medidata Designer services and information solutions.
David joined Medidata from Fast Track Systems Inc., where he served as director of implementation services and was responsible for establishing the implementation services organization and bringing TrialSpace Designer 1.0 to market as an application for the authoring, review and generation of clinical trial documents. David has also held a range of positions at Siebel Systems, including principal consultant, where he was instrumental in the evolution of the Expert Services consulting group that provided high impact, tactical advisory services in large scale implementations, specifically for the consumer products and life sciences industries.
An active member in the development of Clinical Data Interchange Standards (CDSIC), David is the CDISC team lead for the CDISC CORE project, which demonstrates the use of CDISC standards across the trial development lifecycle from protocol to submission. David has also been a featured presenter at various Drug Information Association (DIA) meetings and CDISC International Interchange conferences.
David received his B.S in industrial engineering from Lehigh University.
LORI SHIELDS
Vice President, Operations, Trial Planning
Lori Shields brings more than 17 years of experience in client services, database management and software design to her role as Vice President of Operations, Trial Planning at Medidata Solutions. In this role, Lori is responsible for data operations, client relations and product management of Medidata CRO Contractor and Medidata Grants Manager.
Lori previously served as vice president of operations for Fast Track Systems Inc., where she was responsible for implementing electronic data collection and storage, launching the company's customer care team and overseeing the conversion of PICAS® to TrialSpace Grants Manager, a solution which provides contracting and budgeting professionals with access to the largest, most up-to-date and relevant database of investigator grants and costs. Lori also managed projects within data analysis and validation, product management and client relations.
Lori has been featured as a key speaker at the Center for Business Intelligence Clinical Trial Forecasting and Budgeting Conference and has also held various speaking roles at Drug Information Association (DIA) and MAGI (Model Agreement Group Initiative) conferences.
Lori received her B.A. in 1984 from Shippensburg University.
