Director Clinical Systems Bayer

Robert Musterer is currently the Director of Clinical Systems Support and also the Head of Center of Excellence Clinical Systems in R&D IS for Bayer HealthCare. He has worked in the Pharmaceutical industry for over 25 years and 3 different pharmaceutical companies. Robert holds an MBA from New York University and a BS degree in Biology from Florida Institute of Technology. During his tenure in the pharmaceutical industry he has held a variety of positions primarily concentrating in the areas of data management and programming in support of clinical trials. He has witnessed firsthand the evolution of data processing techniques from almost a pure paper process to the current emphasis on e-Clinical. At Bayer his responsibilities include oversight of both systems and operational programming support for clinical trials. Areas of responsibility include systems for electronic data capture, data management, data analysis, and drug safety

Liaison to Healthcare CDISC

Landen Bain works with the Clinical Data Interchange Standards Consortium (http://cdisc.org/) in developing and implementing data exchange standards for healthcare and clinical research. As liaison between CDISC, the clinical research standards body, and the healthcare information community, he bridges two worlds that have common interests and common subjects, but significant barriers to interaction.

Mr. Bain leads a cooperative effort between CDISC and Integrating the Healthcare Enterprise (IHE), an industry initiative to improve the way computer systems in healthcare share information, which will promulgate standard interactions between Electronic Health Record systems and appropriate applications within the clinical research domain. An IHE integration profile, Retrieve Form for Data-capture (RFD), has been developed, tested, and demonstrated. Clinical research applications of the retrieve form profile were demonstrated at the HIMSS 2007 Interoperability Showcase, with sponsorship from Pfizer, Lilly, Novartis, Genzyme and SAIC, and participation from EHR, EDC, and core technology vendors. This was a new direction for HIMSS and IHE, the first time that EHR vendors (Cerner, Siemens, Allscripts, …) demonstrated interoperability with clinical research systems and biopharmaceutical companies. Trial implementations of the retrieve form profile using real world studies in live research sites are now underway.

During his tenure on the board of CDISC, Mr. Bain helped to restructure the relationship between CDISC and HL7. His efforts as a board member also launched the development of the BRIDG, a semantic model of the domain of research domain that has been adopted by CDISC, HL7, and NCI.

Mr. Bain served for over 20 years as Chief Information Officer of two large academic medical centers: Duke University Health System in Durham, North Carolina and Ohio State University Hospitals in Columbus, Ohio. He is a charter member of the College of Healthcare Information Executives. Mr. Bain received his Bachelor of Science degree in Industrial and Systems Engineering from The Ohio State University.

Founding Director CDISC Senior Vice President and Chief Quality Officer Lincoln Technologies Group

Mr. Kubick was a founding Director of CDISC who led development of the SDTM. A Sr VP and Chief Quality Officer of Phase Forward’s Lincoln Technologies Group, he was formerly CIO at PAREXEL and has worked for BBN Software Products and The Analytical Sciences Corporation. He possesses over 20 years of technology and business process experience in the pharmaceutical industry, with a BA from the University of Illinois and an MBA from Boston University.

Mr. Kubick can be contacted at Wayne.Kubick@LincolnTechnologies.com or wkubick@cdisc.org.

Director, Clinical Data Strategies Octagon Research Solutions, Inc.

Barry Cohen is Director of Clinical Data Strategies at Octagon Research Solutions, where he consults with life sciences organizations on implementation of CDISC standards. His work includes authoring CDISC roadmaps, designing CDISC-compliant clinical trials systems and metadata repositories, and developing internal standards governance organizations for the use of CDISC standards. Mr. Cohen has 20 years of system development experience in the clinical trials industry. He is a leader of the CDISC Global User Network and Delaware Valley CDISC User Network, and he is President of the Philadelphia SAS User Group. Mr. Cohen has his BA and MS degrees from the University of Pennsylvania.

Principal Consultant, Clinical Data Strategies Octagon Research Solutions, Inc.

Dr. Wood works for Octagon Research Solutions, Inc. as a Principal Consultant in the Clinical Data Strategies group. Much of his work involves consulting on the CDISC Study Data Tabulation Model (SDTM), and helping companies develop strategies for its implementation in their clinical data-flow process. Previously, Fred was the Global Data Standards Manager for Procter & Gamble Pharmaceuticals. Earlier in his career at P&G, he was a toxicologist in the areas of health care and nutrition. Fred has a B.S. in Biology from Springfield College, and M.S. and Ph.D. degrees in Biochemistry from the University of Massachusetts at Amherst.

Fred is one of the principal contributors to the CDISC Study Data Tabulation Model (SDTM), one of the authors of the SDTM Implementation Guide, and a founding team member of the CDISC Submission Data Standards (SDS) Team. He currently leads that team. Fred has also had a leadership role on the SEND (Standards for the Exchange of Nonclinical Data) Team since its inception in 2002. Fred is also involved in the PhRMA Best Review Practices Team and the PhRMA SDTM Implementation Team.

Senior Director, Clinical Development, Biostatics and Data Management Targacept, Inc.

Mr. Farr has over 22 years of clinical research experience, with the last 18 years in clinical trials project management leading large multi-center and global/multinational teams conducting studies in the US, Asia, South America, and Africa. Mr. Farr has significant experience working in reproductive and women’s health, including sexually transmitted infections (included extensive participation in the development of global HIV trial models and programs and contraceptive development and efficacy (including product development). Other therapeutic areas include pediatric Attention Deficit Hyperactivity Disorder (which included a roll-over, open-label long-term safety study for completers), depression, hypercholesterolemia, and oncology. Mr. Farr has extensive experience in all aspects of clinical trial development and management, including: data management, clinical monitoring, operations, statistical review, IDE, NDA and IDE preparation, project management staff training and supervision, protocol development and implementation, and clinical study report preparation and review. During his career, he has managed over 25 Phase II and Phase III multi-center, and/or multinational clinical trials for Family Health International, Worldwide Clinical Trials, Ingenix (now I3 Research), and Quintiles. He currently is the Director of Clinical Operations, Biostatistics and Data Management for Targacept, Inc., located in Winston-Salem, North Carolina.