VP of Clinical Operations at NEXT Life Sciences
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