Management Team
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Senior Vice President, Regulatory Compliance
Earl brings more than 30 years of experience in quality assurance, regulatory compliance, drug development and clinical research to his role as vice president of global regulatory compliance at Medidata Solutions. In this position, Earl is responsible for maintaining the highest standards for all Medidata products and services and ensuring compliance with U.S. and international clinical and quality regulations.
Earl has held a variety of senior management positions in the global pharmaceutical environment serving both pharmaceutical companies and CROs. Prior to joining Medidata Solutions, Earl served as the senior vice president of regulatory consulting services at META Solutions Inc. and vice president of quality systems at EduQuest. In both roles, Earl provided regulatory consulting, auditing, and training services to the global pharmaceutical, biologics, and medical device industries. He has also provided advice and training to regulatory agency personnel within the U.S. FDA and European community and has more than 15 years of experience in clinical medicine as a research specialist, teaching specialist, clinical physiologist and investigator.
A frequently featured speaker, instructor and program chair at key industry events, Earl is currently the chair of the Drug Information Association’s Validation SIAC and co-chair of the 2006 Red Apple 2 Conference on Computerized Systems for Non-Clinical Safety Assessment. Earl also serves on the DIA Advisory Council for North America, on the editorial board of the Guide to Good Clinical Practice, and as a contributing author to the textbook New Drug Approval Process with sections on quality assurance and HIPAA. He has also served as an instructor for graduate programs including Robert Wood Johnson Medical School and Rutgers University.
In addition to advanced training in medicine, physiology, psychology and computer science, Earl also holds a masters degree in education with bachelor degrees in education and the sciences. Earl has received awards from various international organizations including the American Heart Association, the Drug Information Association, and the Joseph P. Kennedy, Jr. Foundation.
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Vice President, Global Quality Assurance
As Vice President of Global Quality Assurance at Medidata Solutions, Fran is responsible for refining and maintaining robust, up-to-date quality and regulatory standards for Medidata products and services and ensuring that the organization achieves compliance with these standards, as well as industry best practices.
With more than 30 years experience in the pharmaceutical and software industries, Fran has held a number of positions in information technology and quality assurance in drug development and clinical research. Fran has extensive experience and expertise in regulatory compliance, including 21 CFR Part 11, computer system validation, privacy and risk management, as well as direct experience in the clinical and safety arenas.
Prior to joining Medidata, Fran was responsible for driving compliance strategies and solutions across Taratec Development Corporation, a leading regulatory compliance consulting company, as well as providing consultancy and auditing services to clients. Previously, Fran served as the worldwide head of Pfizer R&D's Part 11 Program and director of systems and services management for Pfizer's corporate clinical and regulatory systems group. As Oracle's U.S. Director of Customer Satisfaction and Quality, Fran managed enterprise alliance programs and worked with cross-functional teams to solve customers' most critical issues. Fran also acted as the manager of U.S. operations for Apoloco Systems (now part of Instem LLS), a UK-based preclinical software development firm, handling budgeting, personnel management, operations, and product/project management.
Fran had been an active participant in the Industry Coalition on Part 11, a frequent presenter in global forums such as the DIA Annual Meeting and DIA Workshops, and a contributor to the 2006 Red Apple 2 Conference on Computerized Systems for Non-Clinical Safety Assessment. Fran received her B.S. in medical computer science from Downstate Medical Center in Brooklyn, NY and an MBA in pharmaceutical marketing from St. Joseph's University in Philadelphia.
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Corporate Security and Privacy Officer
Vice President, Global Information Security and Privacy
As Corporate Security and Privacy Officer and Vice President of Global Information Security and Privacy within Global Regulatory Affairs and Quality Assurance, Glenn is responsible for overseeing the security of data exchange with Medidata Rave, assuring awareness of and compliance to global regulations and standards for security and maintaining the privacy of client and employee data records.
Prior to joining Medidata Solutions, Glenn served as associate professor of computer science and director of the Computer Security Research Center at the East Stroudsburg University in East Stroudsburg, Pennsylvania, a National Security Agency (NSA) Center of Excellence University. Under Glenn's leadership, the university became the most successful Information Assurance Center of Academic Excellence in the Pennsylvania State System of Higher Education. Prior to his work in education, Glenn served as CEO of Backbone Security.com and was an officer in the United States Air Force, where he provided technical, senior management, compliance consulting, auditing and training services to the global computer security industry, the U.S. Department of Defense and the U.S. Government. Over his 21-year military career, Glenn has held positions such as deputy chief of network security research at the National Security Agency and director of computer security for Strategic Air Command.
Frequently featured in national media and industry events, Glenn has appeared on national broadcast outlets including CNN, published numerous security articles and delivered keynote presentations at multiple security conferences. Glenn has received several industry awards as well as a "Cyber War Hero" medal for his leadership during a cyber attack against U.S. computer systems in 1998.
Glenn received his undergraduate and graduate degrees in education, mathematics and computer science from Lehigh University's ROTC program. He is also a Certified Information Systems Security Professional, a Certified Information Security Manager, and is IAM and IEM certified by the National Security Agency.
TONY HEWER, Ph.D.
Senior Director, Global Quality Assurance for EMEA
As the Senior Director of Global Quality Assurance for EMEA, Tony is responsible for refining and maintaining robust, up-to-date quality and regulatory standards for Medidata's products and services and ensuring that the organization achieves compliance with these standards and industry best practices.
Tony has more than 25 years experience in the pharmaceutical, IT, and management consultancy industries. Most recently, he led a team of pharmaceutical IT QA professionals in Asia Pacific. He has considerable experience and expertise in IT risk management, quality assurance, and regulatory compliance.
Prior to joining Medidata, Tony has held a number of senior IT management and leadership positions with Pfizer, initially in Pfizer's R&D division, and more recently including Pfizer's corporate finance, sales, and manufacturing operations. Previously, Tony worked for Braxxon Technology Limited and Data Logic Limited in the wholesale banking industry in London, specializing in front-office systems as well as IT operational effectiveness.
Tony has a B.Sc. and Ph.D. in Astrophysics from the University of London.