Navigating AI in Life Sciences: FDA Directives, Risk Assessments and Litigation

Join King & Spalding in this session that will discuss how the FDA is shaping the use of AI in the life sciences sector, providing a roadmap for companies to meet evolving regulatory standards.
Presented by King & Spalding
From Disruption to Agility: Resilient Strategies for Medtech in a Shifting Global Order
September 8, 2025 1:00 PM – 2:00 PM ET
From Disruption to Agility: Resilient Strategies for Medtech in a Shifting Global Order
September 8, 2025 1:00 PM – 2:00 PM ET
This session will discuss how the FDA is shaping the use of AI in the life sciences sector, providing a roadmap for companies to meet evolving regulatory standards. Additionally, it will explore potential litigation challenges arising throughout the lifecycle of AI-driven products in the life sciences sector.
Topics To Be Explored:
- Navigating FDA guidance and policies on AI medical devices, including Predetermined Change Control Plans (PCCPs), clinical decision support software, and FDA’s generative AI program for scientific reviewers.
- Identifying areas of potential product liability risks for AI errors in commercializing medical technologies.
- How legal frameworks are evolving to address new technologies.
- Risk mitigation strategies companies can adopt to minimize post-commercialization regulatory and litigation risks.
Date: September 8th, 2025
Time: 1:00 PM -2:00 PM ET
Location: Online
RSVP now to stay ahead of the curve and uncover what’s next for MedTech in today’s dynamic healthcare landscape.
Meet The Speakers

Amanda Klingler – Partner, King & Spalding
Amanda Klingler is a partner in the firm’s Washington, D.C. and Chicago offices with more than 10 years of experience advising life science clients. As a partner in the firm’s FDA and Life Sciences practice, Amanda advises pharmaceutical, medical device and biotech companies and pharmacies, on a wide range of regulatory matters, enforcement actions, civil litigation, investigations, product liability litigation, and compliance counseling. As a co-leader of the firm’s AI/ML Tactical Operations team, Amanda also frequently advises clients on the use of AI/ML during the life cycle of drugs and medical devices, including digital health products.

Mark Sentenac – Partner, King & Spalding
Mark Sentenac is a partner with King & Spalding’s Trial and Global Disputes. Mark’s practice focuses on representing pharmaceutical and medical device manufacturers in complex products liability litigation throughout the country, including in federal multidistrict litigation and state coordinated proceedings. He has experience in all phases of litigation, including trials, taking depositions, working with subject matter experts in complex scientific fields, coordinating large-scale electronic discovery and drafting dispositive, pre-trial and appellate briefs. In his practice, Mark has assisted in advising companies in all aspects of product safety, including on risk assessments, government investigations, product recalls and indemnity issues.

Micha Nandaraj Gallo – Senior Associate, King & Spalding
Micha Nandaraj Gallo defends clients facing high stakes, complex litigations and investigations across a wide range of industries including pharma, tech, automotives, and sports. Micha routinely serves on a team of National Coordinating Counsel that manage uniform and consistent strategic defenses across multiple federal and state court proceedings. In addition to her litigation work, Micha also advises companies on emerging product liability risks and trends such as the use of artificial intelligence and machine learning in the development and production of consumer products.

Simran Modi – Associate, King & Spalding
Simran is an associate in King & Spalding’s Atlanta office and is a member of the Trial & Global Disputes practice group. Simran’s practice focuses on representing businesses in high-stakes commercial litigation, complex business disputes, and product liability litigation. She is a team member on several matters, including representation for Fortune 500 companies such as Coca-Cola, R.J. Reynolds, and Boehringer Ingelheim.

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