The People of PaxMed

The People of PaxMed
he PaxMed International Leadership Team:

Floyd G. Larson, M.S., M.B.A.
Floyd is a leader in biomaterials technology and regulatory issues, with extensive experience in product development, regulatory strategy, marketing clearance, and the translation of ideas to commercial reality. His educational background in chemistry, materials science, and business management prepared him for a career that has included applied research, management of R&D, and, as Vice President, Scientific Affairs for a manufacturer of implantable medical devices, overall responsibility for R&D, Engineering, Clinical Research, and New Business Development. With PaxMed International, Floyd has served medical device manufacturer clients in directing and implementing market-oriented research, product development, regulatory strategy, manufacturing implementation, and quality system development. He currently coordinates programs on calcium phosphates and other ceramics for the American Society for Testing and Materials (ASTM) Committee F4 on Medical Devices, and serves as a U.S. delegate to ISO committees on medical devices. Floyd is the convenor of an ISO Working Group responsible for developing medical device testing standards. He is also the chair of a subcommittee of the US-Accredited Standards Committee (recommending and developing US National Standards) and of a US Sub-TAG to an ISO committee on medical device standards. He is a member of the American Ceramic Society, Society for Biomaterials, ASM International, and the Academy of Osseointegration. He also serves as the Industry Representative to the Dental Products Panel of the FDA Medical Devices Advisory Committee. Floyd was named one of MD&DI’s 100 Notable People in the medical device industry in 2008, and he has been a member of MD&DI’s Editorial Advisory Board since 1993. 

Leanna T. Cota, B.A.
Leanna is a Clinical/Regulatory Specialist for PaxMed, providing strong communication skills and clinical experience with a variety of studies and projects. Her bilingual capabilities provide the appropriate skills that can strengthen relationships with study center coordinators and staff. Utilizing Good Clinical Practice, she ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms and coordinates any data queries. Through careful management of your specific goals she ensures that the clinical data are reliable and accurate. 

Ellen R. Esterline, M.A.
Ellen specializes in helping medical device start-ups face challenging compliance issues for both US and international Quality Systems. She has extensive experience in organizational development and leadership training. Her published work includes articles, books, and training courses. She also writes operations manuals, quality systems, and procedures. Ellen has worked with diverse clients, including process industry manufacturers, nonprofit organizations, and medical device manufacturers. She has assisted manufacturers of implantable Class II and Class III devices in setting up quality systems to comply with requirements of the US FDA Quality System Regulations, ISO 9001, and the CE Mark. Her professional memberships include the Association for the Advancement of Medical Instrumentation (AAMI) and the Regulatory Affairs Professionals Society (RAPS). 

Deborah A. Moyer, R.N., B.S.N.
Deborah is PaxMed's lead data manager and a clinical research monitor. She is responsible for clinical site liaison for specific trials and has overall responsibility for PaxMed's clinical trial database development, implementation and data management. She specializes in the design of training material, and in conducting trainings for investigators, study site coordinators, and other professional staff. Her data management responsibilities include forms design, coordinating the design and development of custom study-specific database systems, managing the data entry and reporting process, and preparing data for statistical analysis. 

Christine L. Peterson, B.A.
Christine is PaxMed International's lead clinical trials manager. With overall responsibility for both administrative management and monitoring of a project, Christine is involved in the initial design of the study and forms, coordination of investigator and staff training, preparation of regular progress reports, and liaison between study-site personnel and sponsors. She maintains the integrity of your study through careful management and a conscientious focus on your unique scientific and regulatory goals for the trial. Christine has initiated and implemented a real-time monitoring system for clinical trials that emphasizes a close, ongoing relationship between the research site and the monitor. 

Linda K. Schulz, R.D.H., B.S.D.H.
Linda is a Sr.Clinical Research/Regulatory Affairs Specialist with special expertise in dental studies and radiographic interpretation. She has 14 years of hands-on clinical experience and a broad background in patient care. Linda has implemented a digital analysis system used for accurate measurement of bone loss around dental implants during clinical trial data collection. Her responsibilities also include coordinating IDE and Post Market studies tailoring them to the scope of the project; managing sponsor, investigator and data system needs. Along with the clinical aspect of dental research, Linda is our leading regulatory specialist for dental device submissions to the FDA with more than 30 Premarket Notification clearances. 

Paul Smith, M.B.A.
Paul is PaxMed's financial Controller, and contributes to strategic planning and project management. He will help ensure that your project is on track and responsive to your financial realities. 

Kevin A. Thomas, Ph.D.
Kevin is Vice President and Director of Regulatory Affairs and is responsible for providing oversight for all regulatory projects, including strategy, personnel, budgets, and timelines. He is also actively involved in preparation of regulatory submissions, including FDA 510(k) Premarket Notifications and Investigational Device Exemption (IDE) applications, Technical Files for Notified Bodies for CE Marking. He is also involved in preparation of quality system documents including device design history files and manufacturing quality system documents to cGMP requirements, and assisting clients with product development and specification, and material and component testing and characterization. Kevin is also responsible for management of new business development including preparation of estimates for new projects. Before joining PaxMed he had 7 years of experience with a manufacturer of bioresorbable medical devices, with responsibilities including R&D and product development. He previously was Associate Professor, Department of Orthopaedic Surgery, Louisiana State University Medical Center, and adjunct faculty of the Department of Biomedical Engineering, Tulane University. He is a member of numerous professional and honorary societies, including ASTM F04. He has authored or co-authored over 85 scientific journal articles and over 200 scientific paper or poster presentations at local, national and international meetings. 

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