This session explores how organizations can advance AI innovation while meeting evolving global regulatory, risk management, and compliance expectations. It examines regulatory readiness, governance, and oversight for agentic and adaptive AI systems that operate autonomously and challenge traditional compliance frameworks.
Abbott Laboratories
1921 Hurd Drive
Irving, TX 75038
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CEO, AKRA TEAM
Dr. Bassil Akra is a distinguished leader in medical device and in-vitro diagnostic device regulation, with extensive expertise spanning R&D, manufacturing, testing, conformity assessment, and standards development. As Chief Executive Officer of AKRA TEAM since July 2021, he supports the various stakeholders in developing and executing compliant regulatory, clinical, and quality strategies in the EU, effectively bridging the language between legislators, notified bodies, and industry stakeholders. He also supports the various due diligence activities and court cases which require his independent and impartial subject matter expertise.
A recognized authority in the European medtech regulatory arena, Dr. Akra has been instrumental in shaping the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). His contributions to regulatory frameworks extend to active involvement in developing Medical Device Coordination Group (MDCG) guidance documents and participating in critical regulatory updates that continue to define industry standards and best practices. Dr. Akra contributed to the ongoing revision of the EU MDR and IVDR as an advisor during the survey initiated by the EU Commission and was contracted later when evaluating the impact of the proposed changes on the healthcare system.
Dr. Akra's impressive career includes nearly a decade of work at the largest notified body in the Union Market: TÜV SÜD Product Service, where he progressed from Product Specialist to Vice President, ultimately leading global strategic business development and focus teams across cardiovascular, orthopedic, active implantable, aesthetic, and clinical domains. His instrumental role in building Notified Body capabilities in these critical areas established him as a key architect of success for the organization. Prior to his regulatory career, he served as Head of the Research Group Tissue Engineering in the Department of Cardiac Surgery at Klinikum der Universität München for over eight years. In this role, he worked with key MedTech Industry and healthcare professionals on designing, testing, and developing innovation in the cardiovascular sector.
Currently, Dr. Akra holds multiple leadership positions, including Vice President of TEAM-PRRC, Chair of the Scientific Advisory Board at 3Aware, Co-Founder and Board Member at Raiana, Board Member at MEDDEVO, CEO of B2MAS Holding, Advisory Board Member at Milo Health, and Lecturer at TUM Munich.

Founder, LabScale AI
Alexa Kopf is the founder of LabScale AI, an education and advisory platform that helps life-science professionals adopt generative AI responsibly in regulated environments. As a biopharmaceutical manufacturing consultant specializing in CMC, quality, and cost-of-goods modeling, Alexa bridges the gap between technical expertise and practical AI use. Through her workshops and frameworks, she equips professionals to evaluate when and how to use AI effectively.

CEO & Co-founder, NyquistAI
Michelle Wu is the founder and CEO of NyquistAI. She has over a decade of experience in pharmaceuticals, medical technology, and digital innovation. She has been recognized as the Top 100 Women in AI in 2025, featured by Forbes, and given talks on AI in life science in various conferences. She is a book chapter author for AI in Healthcare by MIT Press.
Before founding NyquistAI, she was the youngest global strategy manager at Novartis AG, where she worked on the very first and so far the only asset swap deal in the history of the pharmaceutical industry among Novartis, Eli Lilly, and GSK, which led her to realize the universal pain point of manual and cumbersome data research and potential pitfalls if it is not done right. This experience inspired her to build NyquistAI. Prior to Novartis, she worked for the life science practice for BCG and served big innovative pharmaceutical and Medtech companies on their global strategy, product development strategy, and emerging market strategies. She received her MBA from Stanford University and BA from Peking University.
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