Agenda
Day 1
March 25, 2025
Breakfast and Registration
Leo HovestadtDirector Governmental Affairs EU Elekta
Jeremy RollisonHead of EU Policy, European Government Affairs, Corporate, External and Legal Affairs (CELA)Microsoft
Aneta TyszkiewiczDirector Digital and DataEuropean Federation of Pharmaceutical Industries and Associations (EFPIA)
Kilian GrossHead of Unit AI Office, Artificial Intelligence Regulation and ComplianceEuropean Commission
Erik VollebregtPartnerAxon Lawyers
Join us for an in-depth exploration of how the EU AI Act is shaping the future of AI in the life sciences, from compliance challenges to opportunities for innovation. Topics of Discussion will include:
- Overview of the EU AI Act and classification of AI systems within the life sciences
- Strategies for adapting to and complying with the new regulatory landscape
- Understanding the interplay between the EU AI Act, EU Data Act, EU MDR, EHDS and GDPR
Morning Networking Break
Olivier GuilloCEOSmart Global Governance
Cécile Théard-JalluPartnerDe Gaulle Fleurance
Explore how life science organizations can leverage AI, while ensuring robust compliance with GDPR and protecting sensitive health data. Topics of discussion will include:
- Understanding GDPR implications and requirements for life sciences organizations using AI
- Strategies for ensuring data protection and compliance
- Case examples of GDPR-compliant AI applications
- Principles and stakes around European Health Data Space (EHDS) data
- Opportunities and considerations of authorized reuse of health data for the purposes of AI in health
- Industrial contracts around secondary use of health data
- Navigating cross-border data transfers
- Complying with NIS2
Peter BogaertPartnerCovington & Burling LLP
Mimmi Gersbro SundlerVice President Data & AI Governance
Digital Data Infrastructure & ProcessNovo Nordisk
- Building trust in AI: Ensuring ethical and responsible use of AI in clinical trials
- Leveraging AI opportunities throughout the R&D pipeline
- Examples of AI use cases where pharma is accelerating and driving benefits today
- Novo Nordisk approach to AI ethics and governance
- Addressing potential biases and ethical considerations in AI-driven recruitment strategies
- Incorporating the EMA’s guidance on Clinical Decision Support Software and its impact on trial optimization
- Understanding EMA’s stance on Clinical Decision Support Software and the impact on clinical trials
- Accounting for EU GDPR code of conduct on clinical trials, including for international transfers
- Considering the legal implications of AI-generated post-trial analyses and their acceptability in regulatory submissions
- Key trends for 2025 and beyond which pharma need to cater for
Networking Luncheon
Sara GerkeAssociate Professor of LawUniversity of Illinois Urbana-Champaign
Aneta TyszkiewiczDirector Digital and DataEuropean Federation of Pharmaceutical Industries and Associations (EFPIA)
Dr. Steffen HeßHealth Research Data CenterFederal Institute for Drugs and Medical Devices
In this session, learn how AI is advancing drug discovery and the development of medical devices, while reconciling legal and regulatory challenges across key markets. Topics of discussion will include:
- Highlighting how AI is revolutionizing drug discovery and the advancement of medical devices/diagnostics
- Regulatory pathways for AI-enabled medical devices
- Current regulatory framework under EU MDR
- Interactions with EU AI Act
- Comparative analysis – UK vs EU vs USA approaches
- Preparing for potential legal liabilities within AI-driven drug and device development:
- Innovation and IP
- Quality control and assurance
- Data integrity and privacy
- Accountability and transparency
- Regulatory approvals
- Best practices for life sciences companies to minimize legal risks and remain compliant
- Fueling AI with the Right Data: Identifying and accessing high-quality data sources for AI training
- The European Health Data Space (EHDS): Unlocking its potential as a key resource for AI development
- Balancing Innovation and Privacy: Overcoming challenges in AI training within the EHDS framework
Eric SutherlandSenior Health EconomistOECD.AI
Bruce KesslerSenior Director, Lead Counsel - Digital & TechnologyThermo Fisher Scientific Inc.
Katie LockwoodCo-Founding PartnerTwin Path Ventures
Sonal PaiDigital Biology/Biotech InvestorFirst Spark Ventures
Carl E. Johnson, MD, EdM, MSc, FAMIAPrincipal Scientist, GRACS, Global Evidence and Regulatory PolicyMSD
- Comparative discussion on life sciences AI adoption in different jurisdictions
- Case studies of successful AI projects
- Transactions and licensing examples
- PE and VC investment opportunities
- Managing IP rights and data sharing in cross-border collaborations
- Developing unified regulatory strategies for satisfying multi-jurisdiction legal requirements
Afternoon Networking Break
Michael Watts, MBA MBChB BSc (Hons)Co-Founder and CEOBlüm Health Ltd
In this session, panelists will review the opportunities and barriers in establishing PPP for AI in the life sciences, with a focus on European collaborations. Topics of discussion will include:
- Examples of successful European AI and life sciences PPPs
- Government initiatives and funding opportunities
- Legal and regulatory frameworks
- Clinical evidence
- Insights into successful partnerships
- Large corporate and SME
Dipak KalraPresidentThe European Institute for Innovation through Health Data
Thibaut D’hulstCounselVan Bael & Bellis
Carl E. Johnson, MD, EdM, MSc, FAMIAPrincipal Scientist, GRACS, Global Evidence and Regulatory PolicyMSD
Examine how AI can be designed to focus on equity, fairness, and inclusivity across Europe. Topics of discussion will include:
- Evaluating sources of bias in AI
- Exploring tools to enhance fairness in AI models
- Impact assessments to prevent bias
- Ethical standards in place to address bias
Networking Reception
Day 2
March 26, 2025
Breakfast
Peter Van DyckPartnerA&O Shearman
In this opening session, explore the growing landscape of AI litigation and privacy risks in the life sciences. Topics of discussion will include:
- Evaluating potential legal risks from pre-commercialization to post-commercialization
- Developing strategies to mitigate litigation risks and ensure robust data protection
IP Protections and AI Inventions in the Life Sciences: Navigating Complexities in the European Context
Alexander KorenbergPartnerKilburn & Strode LLP
Timo Minssen, LL.D., LL.Lic, LL.M, M.I.C.L., Dipl. Jur.Founder & Director, Centre for Advanced Studies in Bioscience Innovation Law (CeBIL)University of Copenhagen
Alex ShandroPartnerA&O Shearman
Katie LockwoodCo-Founding PartnerTwin Path Ventures
Join this session to understand the complexities of IP protections for AI-driven innovations in the life sciences within the European framework. Topics of discussion will include:
- Understanding AI’s Impact on Intellectual Property in the Life Sciences Industry
- Examining the patentability of AI-driven innovations and the specific challenges within the European Patent Office (EPO) framework
- Identifying the limits of IP protection for AI inventions under European law
- Evaluating IP Protections When AI is Part of the Inventive/Creative Process
- Determining ownership rights and inventorship when AI contributes to or independently creates solutions
- Exploring joint ownership scenarios and their licensing ramifications in the EU
- Assessing Infringement Risks of Existing IP When Used for AI Training, Selection, or Generation
- Analyzing the use of proprietary data for AI training and the associated IP risks
- Understanding the legal implications of using third-party IP in AI development
- Comparing the Complexities of AI-Generated Inventions, Data Ownership, and Copyright Infringement
- Distinguishing between proprietary data used for training and AI-generated datasets under EU regulations
- Evaluating the scope and risks when AI reproduces or builds upon copyrighted materials within the European legal framework
- Discussing fair use defenses in the context of AI and copyright laws in Europe
- Anticipating and mitigating liabilities arising from AI-induced copyright breaches, with a focus on EU-specific challenges and solutions
Morning Networking Break
CLASSICA Project Case Study: Bringing AI Into the Surgery Room: Medical, Ethical, and Legal Challenges
Ronan CahillProfessor of SurgeryUniversity College Dublin
Samo ErženSenior Research EngineerArctur
Emilia NiemiecPostdoctoral Researcher, Centre for Advanced Studies in Bioscience Innovation LawUniversity of Copenhagen
David A. Simon, Ph.D., J.D., LL.M.Associate Professor of LawNortheastern University School of Law
This case study session will bring to life CLASSICA, an EU-Horizon-funded project that evaluates an AI-based clinical decision support tool for cancer surgeons through clinical and technical validation. In addition, this session investigates the regulatory and legal aspects, including:
- The regulatory landscape pertaining to data privacy, AI regulation, and medical devices
- Bias and how to mitigate bias in AI-assisted surgery
- Liability in AI-assisted surgery (including comparison between the US and EU)
Networking Luncheon
Sharmini Alagaratnam, PhDProgramme Director, Healthcare Programme, Group Research and DevelopmentDNV
Benjamin MeanyManager for Digital, Software and AI RegulationMedTech Europe
Mirel StelianVice President of Governance and Market AccessCorti
- Examining AI-powered patient monitoring and remote healthcare
- Understanding AI and ML in software as a medical device (SaMD)
- Discussing outlooks on the future look like in terms of the delivery of digital health tools and solutions to patients
- Views on how healthcare might transform and how should it transform to make delivery more effective, in the digital age
- What do we need to put in place today to support the transformation healthcare for a sustainable tomorrow?
Afternoon Networking Break
Erik VollebregtPartnerAxon Lawyers
In this session, leaders will show how AI is changing clinical decision-making by advancing support tools, considering privacy requirements and regulatory challenges. Topics of discussion will include:
- Exploring AI’s role in clinical decision support tools
- Balancing data privacy requirements with AI training and dataset requirements
- Navigating the overlaps between AI Act and MDR/IVDR for successful market access or deployment in the clinic
Elisabetta BiasinDoctoral ResearcherKU Leuven Centre for IT & IP Law – imec
Delphine DogotAssociate Law ProfessorFaculté de Droit (FLD) Lille & Issy-les-Moulineaux
Director
Studio Digital/Law Lab
Isabelle LandreauGroup Data Protection OfficerIDEMIA
Join this closing session as panelists predict the future of AI in the life sciences, focusing on ethical use, sustainability, and the global social impact. Topics of discussion will include:
- Emerging ethical considerations in the deployment of AI
- The role of AI in promoting sustainability in life sciences research and healthcare delivery
- Addressing the environmental impact of AI technologies and promoting sustainable practices