Archives: Speakers

John has 15+ years of experience in the medical device and pharmaceutical industry with responsibility for people management/development, global clinical trial management, regulatory strategy, and leading product development processes with emphasis on comprehensive regulatory and clinical strategy and product risk management. John’s experience in clinical and regulatory includes leading multiple Investigational Device Exemption IDE Trials, regulatory submissions, and FDA communications in a variety of indications including spine, neurosurgical, cranial, pulmonology, gastroenterology, diagnostics (IVDs), women’s health, and vascular surgery devices.

Gabrielle DeBartolomeo is the clinical trial scientist at Alkeus Pharmaceuticals, a Boston-based biotech focused on developing treatments for rare and common forms of currently untreatable blindness including age-related macular degeneration and Stargardt disease. Wearing multiple hats in the company, she is responsible for clinical operations activities and coordinates operational and regulatory activities with private practice and academic sites, in addition to leading patient outreach and support. Through this role, she has witnessed firsthand the multidimensional impact of COVID-19 on clinical trials.

Brad Davidson has over 30 years’ experience in hospitality planning and design. He worked originally as an architect and interior designer on projects throughout Asia and the US. The projects he was involved in included hotels in Japan, Malaysia and Indonesia and resorts in the South Pacific Australia and New Zealand.

Since 2006 he has been based in Belgium and spent 13 years working on the operator side as a Senior Director of technical Services for Starwood. In this capacity Brad work across all of Starwood’s 10 brands and across Europe, Africa and the Middle East. This extensive experience has given brad a clear understanding of the complexity of planning, designing and opening a hotel property.

Since the beginning of 2018 Brad, along with his partner, Hilde Vandewalle, has opened Brad Davidson Consulting BV as a hospitality consultancy to assist owners, operators and consultants to deliver hospitality projects and to structure the tax, commercial and financial side of the hospitality business.

Lesley Schofield has been in the pharmaceutical industry for over 25 years, starting with preclinical drug development and then moving on to clinical trial management in late phase clinical research. As a director of US Medical Affairs Clinical Trial Operations, she has the responsibility to lead a team in driving the design and implementation of innovative clinical trials across therapeutic areas. Lesley’s experience and skills include clinical trial design experience (with an emphasis on late phase, neuroscience and cardiovascular clinical research); clinical trial management with a focus on innovating the clinical operations process, protocol development, CRO/vendor selection and management, forming and maintaining strategic collaborations; identifying programmatic challenges and opportunities and developing result-driven operational strategies.