Bob has over 32 years of regulatory and product development experience in the pharmaceutical and cardiovascular implant industry. He has extensive experience in formulating and executing regulatory, clinical, and product development strategies, interfacing with regulatory agencies, and filing regulatory submissions. He led the effort to establish a new regulatory path for a chronic kidney disease drug reaching agreement with the FDA and European Regulatory Agencies on a new endpoint for the Phase 3 trial that significantly reduced clinical development time and cost. He has led multiple programs through all stages of product development.
His therapeutic area experience includes chronic kidney disease, acute kidney injury, pulmonary arterial hypertension, acute pain management, cancer and heart failure. He also has extensive experience developing vascular and endovascular implants.