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Expert Panel: Making the FDA- Friend, Not Foe: Tips & Tricks for FDA Engagement

Santa Clara Convention Center, Santa Clara, CA

Wednesday, November 30th 12:15 pm – 1:00 pm

This panel will discuss the various types of engagement that sponsors can have with FDA, along with do’s and don’ts for various types of interactions and the best times to engage. It will cover the sponsor side and FDA side of the relationship because when we can understand each perspective, we’re better able to work together.

Isabella Schmitt

Isabella Schmitt, MBA, RAC is the Director of Regulatory Affairs at Proxima Clinical Research, Inc., a contract research organization focusing on assisting emerging medical device and biotech companies in regulatory, quality, and clinical development. At Proxima, Isabella is responsible for overseeing over 100+ medical device and pharma projects. Prior to joining Proxima, Isabella served as the Senior Regulatory and Quality Manager for two medical device companies, where she outlined the regulatory strategy and put together design controls and quality documentation. As the Director of CMC and Quality at a biopharmaceutical company, she oversaw all product development and ensured CMC regulatory strategy was sufficient for filings in the US and Europe.

Outside of Proxima, Isabella is a partner, judge, mentor, and speaker for multiple healthcare accelerators, including M1 MedTech Accelerator, MedTech Innovator, TMCi, MassChallenge, gBEta, and Hatch.  She also serves as a pitch coach for SXSW Pitch Competition.

Pharoah Schnieber

Pharoah is the COO of Boomerang Medical and a former FDA Senior Lead Reviewer. She has spent almost 20 years focused exclusively on driving and leading complex regulatory submissions for Class III medical devices and drug/device combination products. Pharoah is recognized expert in regulatory affairs and complex PMAs with R&D leadership experience. Pharoah held leadership roles for venture-funded medical technology startups as well as large companies like Biotronik, Medtronic, and Philips/Spectranetics. She holds BS and MEng degrees in Biomedical Engineering from Syracuse University.

Scott Trevino

Scott Trevino is senior vice president of cybersecurity, and in this capacity, he leads efforts to define the strategy to deliver value, growth, and evolution of TRIMEDX’s cybersecurity solutions. He is responsible for identifying trends in cybersecurity, technology, as well as recognizing & anticipating the evolution of clients, market, and industry needs to translate them into market-leading solutions that meet the needs of and bring value to clients.

Prior to joining TRIMEDX, Trevino spent over 20 years at GE Healthcare holding multiple leadership positions in product management, product development, services, technology/engineering, operations, and quality & regulatory. Scott earned an MBA from The University of Chicago Booth School of Business, a Master of Science in Computing and bachelor’s degrees in computer science and psychology from Marquette University.