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Management Team
The clinivation management team has global experience in the development and commercialization of new medical products. Our senior management team includes:
- Joe Kozikowski, M.D., President & CEO
- Richard Morroney, R.A.C., Quality & Regulatory Solutions
- Phil Welton, Chief Technology Officer
- Roger Mazzella, M.S., Global Sales
- Michael Harrison, CPA, CPT, Finance
- Danielle LeBon, Marketing
President & CEO
Dr. Kozikowski has over 20 years of successful clinical and industry experience in medical devices, diagnostics, and biopharmaceuticals. He has designed and led development and approval programs from the preclinical stage through commercialization for a wide range of new products from every major medical specialty. Representative clients include Johnson & Johnson, Biogen, Millennium, Mallinckrodt, and Baxter.
He crafts and implements highly efficient, turnkey projects that integrate and deliver well-negotiated Rx and OTC FDA approvals, tightly-executed preclinical and clinical studies, and adoption-driving peer-reviewed publications. He has designed and directed Phase I through IV clinical and outcome studies, and has been responsible for all related functions of protocol development, IRB submission and approval, investigator recruiting, trial site auditing and management, data management and biostatistics, and report and publication authorship. He has written and supported numerous U.S. and international regulatory submissions, and represented his client companies at meetings with U.S. and European regulatory authorities and advisory panels. His biomedical research has resulted in more than 20 clinical and scientific publications.
Dr. Kozikowski studied finance at The Harvard University Graduate School of Business Administration, and regulatory law at the Food and Drug Law Institute in Washington, D.C. He was Principal Investigator at The Massachusetts General Hospital of a NIH SBIR grant, and he holds active medical licensure in medicine and surgery. He was a Tau Beta Pi National Engineering Fellow and graduate of The Johns Hopkins University School of Medicine, where he was awarded NIH, USPHS, and other grants for new medical products. He graduated summa cum laude from Villanova University, where he completed undergraduate and graduate coursework in electrical engineering and physics, received national awards for biomedical innovation, and was named the nation's top biomedical engineering undergraduate by the Alliance for Engineering in Medicine and Biology.
Dr. Kozikowski is a director of several private biomedical companies.
Quality & Regulatory Solutions
Mr. Morroney combines certifications in regulatory affairs, compliance auditing, and quality systems with more than 15 years of industry experience in regulatory affairs, clinical operations, quality, and IT to effectively deliver new medical product approval and compliance solutions.
Mr. Morroney has led a broad range of projects for large multinationals and development-stage medical products companies. His casework typically includes U.S. and international regulatory strategy and product registrations, product engineering, quality systems development and implementation, GMP compliance, and clinical development. He has successfully obtained U.S. and international marketing approval for various medical products.
Mr. Morroney designed and implemented numerous enterprise quality systems for emerging companies, and his representative clients include The Dial Corporation, PhotoElectron, MDI Instruments, ViaCirq, Enact Health Management Systems, Medical Digital Photography, LifeChart, ACMI, Mosaic Technologies, and Innercool. His experience includes senior supervisory positions in manufacturing, production, and process development at Boeing, where he received numerous industry awards for quality engineering, production, and process improvement and design.
Mr. Morroney holds a Regulatory Affairs Certification in Medical Products
from The Regulatory Affairs Professional Society, and a Quality Auditing
Certification from The American Society for Quality. He holds numerous
quality certifications from and memberships in the American Society
of Quality, The Society of Manufacturing Engineers, and The Quality,
Engineering and Manufacturing Association. Mr. Morroney studied regulatory
policy and law at the Food and Drug Law Institute in Washington, D.C.,
and he was awarded a Bachelor of Science in Electrical Engineering,
cum laude, from Chapman University.
Chief Technology Officer
Mr. Welton applies a broad variety of IT experience from both the public and private sectors, to provide comprehensive solutions that include application and database design, security, and networking.
Prior to joining clinivation, Mr. Welton served in various IT capacities, including programming, network management, project management, as well as managing other IT personnel. He served in IT for 9 years in the private sector and 12 years in the public sector.
He has extensive experience with VB/VBA, ODBC, ADO, DAO, SQL, XML, HTML, and numerous Microsoft development tools and applications. He also has experience with a variety of database platforms, ranging from smaller applications using dBase, FoxPro, and Access to larger applications utilizing the capabilities of SQL Server and Oracle.
Mr. Welton received his B.S. degree in Chemical Engineering from Rose-Hulman Institute of Technology, where he graduated magna cum laude. His training since college includes PowerBuilder (application development), FoxPro (application development and database), and Cognos (Business Intelligence tools).
Global Sales
Mr. Mazzella has extensive experience in sales and service management of solutions for the biomedical industry.
Prior to joining clinivation, Mr. Mazzella worked as a senior Account Manager for Intertek-ETL Semko and Hitachi High Technologies America, where he delivered quality engineering solutions and products for numerous multinational and Fortune 500 customers. As an engineer in the Quality and Regulatory department of Siemens Medical Systems, he made significant contributions to the validation and verification of patient monitoring systems.
Mr. Mazzella received his Master's degree in Biomedical Engineering
from Worcester Polytechnic Institute, where his focus of study was
on medical device design and FDA regulatory law. He received his Bachelor
of Science in Electrical Engineering from Lehigh University, where
he won awards in electronic design from the Institute of Electrical
and Electronics Engineers.
Finance
Mr. Harrison has over 20 years of experience in a broad range of roles encompassing software development and implementation, acquisitions and divestitures, business financing and traditional financial management roles.
Prior to joining clinivation in 2007, Mr. Harrison worked for Rogers Corporation in various senior financial management positions where he was responsible for analyzing and facilitating the execution of large corporate transactions including business reorganizations, acquisitions, and divestitures; developing and executing domestic and international tax strategies; obtaining and negotiating bank financing, ensuring compliance with external reporting requirements; developing and implementing operational reporting mechanisms; and developing and executing business strategies for business in the hi-tech manufacturing segment.
In addition to his accomplishments at Rogers Corporation, Mr. Harrison has also been the Corporate Controller for a publicly traded cruise line and has benefited from extensive experience as an auditor while with Arthur Andersen & Company. Mr. Harrison also assisted with the development and sales of industry leading software addressing regulatory changes in healthcare reimbursement regimes while at Arthur Andersen & Company.
Mr. Harrison obtained his Masters of Science in Taxation with Honors from Bryant University and a Bachelor's of Science in Business Administration, summa cum laude, from Bryant University. He holds professional designations of Certified Public Account and Certified Treasury Professional.
Marketing
Ms. LeBon has extensive experience in marketing, sales, and client service management for a broad range of new product initiatives in the medical device, diagnostics, and pharmaceutical industries. Her representative clients include Boston Scientific, ACMI, Viacirq, ART, Medex, InterCure, Maxygen, and Cubist Pharmaceuticals.
She has designed and executed numerous primary and secondary market research programs that evaluated product, market, and pricing environments in North American, European, and other major world markets.
Her extensive networking capabilities enable access to all key constituencies, including front-line and thought leader clinicians, leading Group Purchasing Organizations and benefits managers, third-party payors, distributors and service providers, hospital purchasing and materials management executives, and biomedical industry executives.
Ms. LeBon holds certifications in numerous multimedia and productivity applications, and studied marketing and finance at the University of Colorado, where she earned a Bachelor of Science in Business Administration.
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