Medical device executive with over 30 years of experience developing / commercializing first-in-kind medical technologies. President, Alpha Logic (developer of unique GI Biosensor); senior corporate roles w/Boston Scientific; Abbott Labs; Johnson & Johnson. M&A: BaroSense Inc. to Boston Scientific; Perclose, Inc. to Abbott; Spiration, Inc. to Olympus Medical; IPO of Northstar Neuroscience.
Diplomat, American Board of Internal Medicine and Gastroenterology. Dr. Annunziata is a practicing gastroenterologist, the principal and founder of Advanced Gastro Technologies and inventor of the Pylo-Sphere. He is the driving force behind AGT's mission: "To change lives by enabling patients to safely overcome obesity without surgery.”
Biotechnology, pharmaceutical, and CRO executive with over 28 years of experience in licensing transactions, fundraising, and global product launches. Senior commercial and public-facing roles with Wyeth-Ayerst, Savient, Capstone, and VIVUS.
Dr. Chang is associate professor in the departments of medicine and radiological sciences and director of the H.H. Chao Comprehensive Digestive Disease Center (CDDC) at the University of California at Irvine Medical Center. Dr. Chang oversees the Gastrointestinal Oncology Program in the Chao Family Comprehensive Cancer Center. He pioneered EUS-guided FNA and has written over 100 publications and book chapters on its utility in gastrointestinal and pulmonary malignancies.
Dr. Ganz is a board certified gastroenterologist, scientist, inventor and consultant to medical device companies. He is the Chief of Gastroenterology at Abbott-Northwestern Hospital and Associate Professor of Medicine at the University of Minnesota. A pioneer of leading edge medical technologies, he co-founded several medical device companies including BARRX Medical Inc., which is devoted to the treatment of Barrett’s esophagus and early stage esophageal cancer. Dr. Ganz was the first person in the world to perform balloon-based radiofrequency ablation of Barrett’s esophagus. He is repeatedly rated as among the best gastroenterologists in the United States.
Barbara Wexler is a chronic disease epidemiologist and medical writer with more than 25 years of experience as a clinician, administrator and researcher. She consults with biotechnology companies, hospital systems, payers and other healthcare organizations. The author of Weight in America, she writes books and articles for peer-reviewed journals and has prepared more than 250 clinical practice guidelines and treatment algorithms for private and public organizations. She designs clinical research studies, analyzes data and assists companies to navigate the regulatory process.
Deb Koeneman has 21 years of FDA-related medical device and pharmaceutical regulatory experience, including three years as an FDA employee. She has broad knowledge of US FDA regulations and guidance, including expertise in medical device strategy to market, design controls, 510(k), 513(g), PMA, pre-IDE, IDE, annual reports, establishment registration, listing, meeting briefing packages, pre-IND, IND, drug CMC high-level strategy/technical writing, clinical and nonclinical program development, medical/report writing, investigator brochures, informed consent development, and IRB submissions.
Timothy Stippick is a mechanical engineer with over 14 years of experience working in medical instrumentation, medical devices and automated machinery. He has developed automated medical equipment for slide staining, research instrumentation and robotics for non-invasive glucose monitoring, hearing aid design, research and manufacturing fixtures, design of food handling machinery and others.