Archives: Speakers

Lisa Griffin Vincent Ph.D., has more than 30 years of experience in scientific, regulatory, and business leadership across the healthcare ecosystem within medical technology and combination products, payers, data analytics and population health, and management and diligence consulting. Her career began serving patients as a clinical and research nurse in neonatology, neurology, cardiovascular, and infectious diseases. Her current role is Chief Regulatory, Quality, Clinical at GT Metabolic Solutions, where she serves on the executive management team. GT Metabolic is the leader in development of magnetic compression anastomosis technologies, setting a new standard in minimally invasive surgery. Dr. Vincent has expertise leading and growing functional talent and organizations along the product lifecycle, including research, clinical, regulatory, health economics, reimbursement, medical affairs, and market access. In addition, she has served in business leadership roles including, as chief operating officer for two global research companies, and as president of an outcomes research division. Her industry trajectory includes early-stage companies, such as Seismed Instruments, and PatientPoint, and large multinational organizations, such as UnitedHealth Group (UHG), Medtronic, BD, and GE Healthcare. Dr. Vincent has significant experience in the policy area and was appointed in January 2022 as an industry representative to the U.S. Department of Health and Human Services (DHHS) CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Dr. Vincent holds a B.S. in nursing, M.A. in kinesiology, and Ph.D. in health services research and policy, all from the University of Minnesota. She was awarded full scholarships from the U.S. Agency for Health Care Policy and Research and DHHS for her doctoral training, and her dissertation focused on patient adherence to complex medical therapies to maximize health and economic efficiencies and reduce disease burden

Monika McDole-Russell is a regulatory affairs leader at Medtronic, a global leader in medical technology. She has over 17 years of experience in the medical device industry, spanning R&D, Regulatory Affairs, and Quality.

As a global regulatory affairs leader, Monika develops and executes regulatory strategies for devices within Medtronic’s Endoscopy portfolio, including SaMD and devices that incorporate artificial intelligence (AI) and machine learning (ML). She works with cross-functional teams, external partners, and regulatory agencies to ensure compliance with global regulations and standards. She also advises on regulatory best practices and emerging regulatory trends.

Monika is passionate about advancing medical device innovation and improving patient outcomes. She has presented on topics relating to leadership, AI/ML, and regulatory affairs at national and international conferences, workshops, and webinars.

Pat Baird works at Philips as a Sr. Regulatory Specialist, with a focus on the use of AI in healthcare. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs multiple committees related to artificial intelligence, is a sub-team lead for IMDRF AI committee, and current standards projects include risk management for ML systems and cybersecurity considerations for ML systems.

Victoria has worked at Eli Lilly and Company for 16 years across drug safety and clinical operations. In her current role, she leads a team of Clinical Research professionals who work to identify, evaluate, and set up investigator sites across the UK and Nordics. They are responsible for delivery of patients into trials, by forging close site relationships, across the full Lilly portfolio. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are advancing new discoveries to address some of the world’s most significant health challenges.

Christine Mohlberg has been with Novotech (formerly EastHORN Clinical Services) since 2013, when she joined as Director of Clinical Operations, Germany. Over the years, she has advanced to roles including Director, Head of Project Management, and Country Head, Germany. She currently serves as Vice President of Project Management, where she oversees the operations of the European Project Management Department with full accountability for successful project and program delivery.

In her role, Christine develops strategic plans to ensure optimal allocation of human, system, and financial resources within her area of responsibility. She defines the department’s strategic goals and objectives, ensuring alignment with senior management priorities. Additionally, she leads key functional initiatives and collaborates with stakeholders to drive effective implementation.

Prior to joining Novotech, Christine held leadership roles in both CROs and pharmaceutical companies, working on international and global projects. With over 20 years of experience in clinical research, she brings a deep understanding of the industry’s structure, challenges, and evolving needs. Her expertise ensures that project teams deliver the highest quality services to clients, maintaining excellence in execution and operational efficiency.

Stephanie trained initially as a food technologist and worked for 25 years in a variety of technical and commercial role in the UK; specifically working in the sectors of chilled ready meals, pizza and pies for companies including Northern Foods, Premier Foods and Greencore. Stephanie joined Sealed Air 13 years ago in the UK and Ireland Business Development team, she had a period working as the Senior Marketing Manager for Convenience Foods for EMEA, Business Development and Retail Manager for North West Europe before being promoted to the role of Business Development Director or EMEA at the beginning of 2024.

LeRoy Stafford is a life science industry veteran, with over 15 years of experience working on both sponsors and clinical research organization in various individual contributor and leadership roles within the data management function. LeRoy is the Director of Data Management for Fractyl, a leader in pioneering metabolic disease treatments.

Isaac Erickson is the Vice President of Consulting Services at Zelta, where he leverages his extensive 16-years of experience in the life sciences industry in various roles (statistics, consulting, operations and executive management). Isaac holds an M.B.A and is certified Lean Six Sigma Black Belt.