John is the founder of the Strataca Group and President of 3ive Labs. He has spent the past 20 years bringing innovative therapeutics and medical devices to the market. Prior to founding Strataca Systems, he held roles of increasing responsibility in marketing, portfolio planning, pricing, health economics and epidemiology at St Jude Medical, Bristol Myers Squibb, Schering Plough and SmithKline Beecham. He earned his doctorate in epidemiology from the University of Pittsburgh’s Graduate School of Public Health in 1998. His dissertation on the cardiovascular risk associated with insulin resistance in adults with type 1 diabetes (double diabetes) earned him induction into Delta Omega (the National Honor Society for Public Health). In addition, he has published 17 peer reviewed articles, and has delivered dozens of conference presentations and invited lectures.
Bryan serves as the company’s Senior Vice President of Applied Science. He has had many roles in the pharmaceutical and medical device industry including Regulatory and Clinical Vice President positions at BD, Tripath Imaging, and LinguaFlex, CEO at CAC Health Fitness, COO at Neurognostics, and R&D positions in both start up and mid-level companies. In addition, he consults to the medical device and pharmaceutical industry. During the course of his career, he created and was head of Clinical Research at Aurora Health Care, a major health care organization in Wisconsin. Bryan started his career at the University of California, where he joined the faculty in the Division of Nephrology and Hypertension, Dept. of Medicine focused in renal pathophysiology and volume homeostasis, published over 55 peer-reviewed papers, 3 book chapters, more than 75 abstracts, and was PI on research grants from NIH, NASA, and pharmaceutical companies. Bryan has a MS in Bioengineering and a Ph.D. in Biomedical Sciences (Physiology and Pharmacology).
Jacob is the team’s director of research and development. His background bridges anatomy and physiology research with device design and development across numerous medical specialties. He earned a BS in biomedical engineering from Tulane University and earned a master’s degree from the Georgia Institute of Technology in the Master of Biomedical Innovation and Development program supported by Georgia Tech College of Engineering and Emory School of Medicine. He has co-authored multiple patents, one manuscript, and several journal articles in foci that span from nosocomial infection reduction to cancer detection, and has also conceptualized, built, and tested research medical devices for use by doctors and scientists across various clinical applications including biomechanical diagnostics, medical image processing, and interventional cardiology.
Gerri is the Director of Quality Assurance. Gerri received her degree at North Carolina State University in Applied Mathematics and Chemistry. She has served other roles over the past 25 years in the Pharmaceutical/Biotech, Medical Device, and Controlled Drugs industry in both the research and manufacturing settings focusing on Quality Systems/ Compliance. During her career she has held positions at Abbott Laboratories, Bristol Myers/Squibb, Burroughs Welcome, Glaxo SmithKline, Johnson and Johnson and several start-up companies. Gerri has strong expertise on establishing all aspects of quality systems and quality system processes to ensure full compliance with world-wide governmental agency regulations. She has liaised with FDA, DEA and Notified Bodies as well as Contract Manufacturers. Her background in Quality Systems/Compliance and Regulatory is key to the support of Product Design Development, Pre-Approval Audits, and Product Transfer to Product Commercialization and Post Market Surveillance.
Associate Director, Clinical Operations
Allison Fenderson, RN, MSHS, CCRP
Allison is the Associate Director of Clinical Operations. She has Bachelor degrees in Biology and Chemistry; Nursing, and a Master’s degree in Health and Sciences (Clinical Research). Allison is a registered nurse with a background that includes experience as a staff nurse for a Cardio-Thoracic Intensive Care Unit in a large tertiary care hospital. Prior to becoming a nurse, Allison was a Laboratory Specialist in a general hospital. Allison has over 21 years of diverse experience in clinical research that includes the pharmaceutical drug and medical device industries. She began her research career as a Clinical Research Associate for Clinical Research Organizations where she monitored pharmacological trials prior to moving into clinical trial management for a large medical device company. Allison has successfully managed several clinical trials that received FDA approval. One of many was a large clinical trial (medical device) with enrollment over 32,000 subjects, 80 clinical sites and 20 clinical laboratories which was submitted to the FDA for review and approval. Allison’s diverse background has enabled her to lead other successful trials that have received FDA approval.
Laura’s the office manager and direct support for the 3ive team. With degrees in accounting and business administration, she brings 25 years’ experience as a strategic minded specialist with a proven history of aligning business operations management successfully with ROI and KPI bottom-line objectives. Singularly focused in best practices, her business strategies and team first motivation directly impact productivity and performance. Effective in addressing problems, investigating root causes, and implementing successful resolutions. Laura drives organizational improvements through leveraging expertise in business research and system changes, enhancements and/or upgrades. Well-versed in collaborating with team and leaders to resolve control and procedural issues that can negatively affect business operations. Her dedication to cost, process, and resource optimization fits perfectly with 3ive’s business model. With extensive experience implementing all aspects of day-to-day operations, administration, policy implementation, financial management, accounting, human resources, payroll, and support; her every day is filled with work diversity and challenge.