I have extensive experience in global clinical trial development, execution, and management. I have been involved in every aspect of the clinical studies from study development, protocol development, start-up, close-out, database lock, PMA submission, PMA Panel committee review meeting and Post-Approval studies. Most recent achievements include approval of the Cartiva SCI device, a venture capital backed start-up, that resulted in entity acquisition by Wright Medical for $435m.Additional Experience Highlights:• Managed largest study ever conducted for clinical condition of first MTP OA• Low lost to follow up rate over the 2 year study (98% data available) • No BIMO Site Audits required by FDA• No internal Cartiva clinical/regulatory audit by FDA • Overwhelming positive vote by Orthopaedic Advisory Panel Meeting• Successfully met study endpoint for all pre-defined and post-hoc analyses as requested by the FDA• First synthetic cartilage implant device ever approved by the FDA• First PMA supported by only OUS data since 1976• First PMA for any device used in the forefoot