Tuesday, APRIL 25, 2023

Algorithm-Based Clinical Decision Support (ABCDS) Oversight:
A framework for the oversight of algorithms to be deployed at Duke Health that fosters regulatory compliance

Algorithm-Based Clinical Decision Support (ABCDS) Oversight is a framework for the governance, evaluation and monitoring of algorithms used at Duke Health. This framework introduces checkpoints throughout the development lifecycle of algorithmic tools as well as after deployment to ensure regulatory compliance, safety, fairness, and high-quality care..

Speakers:
Amanda Parrish, PhD, RAC,
Executive Director of Regulatory Affairs and Quality, Duke University,
and
Nicoleta Economou, PhD, Director of the Algorithm-Based Clinical Decision Support (ABCDS) Oversight, Duke University

Amanda Parrish, PhD, RAC is the Executive Director of Regulatory Affairs and Quality in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Parrish oversees a team of Regulatory and Quality professionals who provide guidance on FDA regulations for product development, clinical trials research, and manufacturing at Duke.  Dr. Parrish is responsible for managing the groups that provide support and guidance to Duke investigators regarding the regulatory and quality requirements relevant to their clinical research activities. She oversees and performs a variety of services including regulatory/quality education, regulatory/quality consultation, and implementation of new educational, operational, and collaborative initiatives throughout Duke. She has conducted numerous meetings with the FDA, and her regulatory/GMP experience includes a variety of therapeutic areas, including drug, biologics, and devices, and ranges from early Phase 1 activities through product licensing. She was the primary regulatory project leader for the US approval of the Carolinas Cord Blood Bank BLA and continues to oversee the regulatory and quality assurance activities associated with the Duke BLA. Dr. Parrish obtained a PhD in Molecular Cancer Biology from Duke University and then transitioned into her first regulatory role as a Regulatory Affairs Scientist at Duke University.

Nicoleta Economou, PhD, serves as the director of the Algorithm-Based Clinical Decision Support (ABCDS) Oversight leading the operations and framework design effort for the governance, evaluation, and monitoring of ABCDS software at Duke. She is also leading all Duke AI Health initiatives relevant to evaluation and governance of health AI technologies, and leads operations of the Coalition for Health AI, a coalition establishing the guidelines and guardrails for health AI technologies. Previously, Dr. Economou led projects supporting a learning health system at Duke working alongside faculty and health system leadership to bring together people, processes, technologies, and data streams required to drive evidence-based continuous improvement and innovation in health care delivery and operations. Before joining Duke, she worked in the life-science and pharmaceutical industry, where she managed clinical analytics portfolios to drive data-informed decisions for drug development with key focus on clinical data review, clinical safety review, and clinical operations. Additionally, she developed, validated and deployed risk models and helped design and define metrics for monitoring clinical trials using analytics software. Dr. Economou did her postdoctoral training at the UNC Eshelman School of Pharmacy and received her PhD from Drexel University College of Medicine.

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Live sessions were held from June-September and are now complete.

Recordings of all sessions are still available.  

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