fda-approval
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Andrea Ashford-Hicks
Andrea Ashford-Hicks is the CEO of Cayuga Biotech, an early-stage platform biotechnology company developing biomimetic polyphosphate therapies for severe bleeding. She joined in 2022 after two decades in biopharma, including leading the FDA approval and commercial launch of RETHYMIC at Enzyvant Therapeutics and progressive roles at Johnson & Johnson, Pfizer, Agenus, EMD Serono and Schering-Plough. She holds dual degrees in biology and finance from the University of Pennsylvania and the Wharton School.
Phathom Pharmaceuticals
Phathom Pharmaceuticals is a commercial-stage biopharmaceutical company built around vonoprazan, a first-in-class potassium-competitive acid blocker (P-CAB) it licensed from Takeda in 2019 for the U.S., Europe and Canada. Its lead product, VOQUEZNA, won FDA approval in late 2023 - the first major innovation in U.S. GERD treatment in over 30 years - and is sold for non-erosive and erosive GERD plus H. pylori infection via its DUAL PAK and TRIPLE PAK regimens. The company reached $175.1 million in net revenue in 2025 and expects operating profitability in 2026.
John McCutcheon
John McCutcheon is President, CEO, and Director of EBR Systems, Inc., the Sunnyvale-based medical device company behind the WiSE CRT system - the world's first FDA-approved leadless solution for left ventricular pacing. With over 40 years in medical device sales, marketing, and general management, McCutcheon has shepherded EBR through pivotal clinical trials, FDA Breakthrough Device Designation, and the landmark FDA approval in April 2025. Before EBR, he led Ceterix Orthopaedics to a $105 million acquisition by Smith & Nephew. He brings a track record of building and selling medical device companies, now steering EBR's commercial launch of a technology that could transform how heart failure patients receive cardiac resynchronization therapy.