Medidata Solutions expands management team

Source: Exec Digital Canada

Date :9/13/2007 10:59:16 AM

Medidata Solutions expands management team with key appointments in safety and quality assurance.

Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, recently announced the expansion of its senior management team with the appointments of Dr. Barton Cobert as Vice President of Global Regulatory Initiatives and Pharmacovigilance, Frances Nolan as Vice President of Global Quality Assurance and Dr. Tony Hewer as Senior Director of Global Quality Assurance for EMEA. These three executives bring a range of clinical development expertise to the Medidata group headed by Earl Hulihan, Vice President of Global Regulatory Affairs and Quality Assurance.

"The pharmaceutical, biotech and medical device industries have always adhered to the highest standards of safety and quality assurance, and we have made very strategic choices in our selection of the executives who will drive these key areas," says Tarek Sherif, Co-founder and CEO at Medidata Solutions. "Each of these three executives brings critical pieces of expertise and experience in the clinical arena that will support Medidata's growth into new global markets while ensuring customers' adherence to industry standards and regulations."

As Vice President of Global Regulatory Initiatives and Pharmacovigilance, Dr. Barton Cobert is responsible for interactions with regulatory agencies, oversight of Medidata's quality processes, knowledge and understanding of local and international regulations and company visibility in the international arena. Cobert has more than 20 years of pharmaceutical industry experience, specializing in product safety and pharmacovigilance. He most recently served as global head of drug safety and pharmacovigilance at Novartis' Consumer Health Division, where he was responsible for worldwide drug, device, cosmetic, nutritional supplement and adverse event reporting. He also has held various management positions in pharmacovigilance, medical research, medical safety and services at Hoechst-Roussel, Schering-Plough, Forest Research Institute and Becton Dickinson. Cobert received his M.D. from New York University in 1974 and served as a physician in a range of hospitals in both the U.S. and Europe. A frequent contributor to industry and medical journals, Cobert has also written two textbooks on drug safety.

Frances Nolan joined Medidata in December 2006 as Senior Director of Quality Assurance and was appointed Vice President of Global Quality Assurance in April 2007. In this new role, Nolan is responsible for ensuring Medidata products and services achieve and maintain compliance with industry standards and best practices. With more than 30 years experience in the pharmaceutical and software industries, Nolan has extensive expertise in regulatory compliance, including electronic records/electronic signatures (including US FDA 21 CFR Part 11), computer system validation and privacy and risk management. Nolan has held a number of positions in IT and quality assurance at leading companies including Taratec Development Corporation (now Patni), a regulatory compliance consulting company, where she drove compliance strategies and solutions. She also served as the worldwide head of Pfizer R&D's 21 CFR Part 11 Program and director of systems and services management for Pfizer's corporate clinical and regulatory systems group, and Oracle's U.S. director of customer satisfaction and quality. Nolan has been an active participant in the Industry Coalition on 21 CFR 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.

As the Senior Director of Global Quality Assurance for EMEA, Dr. Tony Hewer is responsible for refining and maintaining robust, up-to-date quality and regulatory standards for Medidata products and services. Hewer has more than 25 years experience in the pharmaceutical, IT, and management consultancy industries and most recently led a team of pharmaceutical IT QA professionals in Asia Pacific. He has held a number of senior IT management and leadership positions with Pfizer and also previously 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.