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
Lucilla SioliDirector, EU AI Office
Directorate-General CONNECTEuropean Commission
Aneta TyszkiewiczDirector Digital and DataEuropean Federation of Pharmaceutical Industries and Associations (EFPIA)
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
Vicky Perez RiuLead Counsel Data Privacy & AI
Global DP & AI Trust OfficeTakeda Pharmaceutical Company Limited
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
Federica ZancaEIC Programme Manager for Medical Imaging and AI in HealthcareEuropean Innovation Council
In this session, discover the risks and rewards of generative AI relative to traditional models. Topics of discussion will include:
- Understanding how generative AI differs from traditional AI models and its specific applications in the life sciences
- Identifying industry advancement opportunities
- Synthetic biology
- Medical imaging
- Disease modeling
- Personalized medicine
- Clinical trials
- Natural language generation for clinical data
- Data augmentation in genomics
- Document analysis
- AI in life sciences risk assessment: Evaluating real and potential legal, ethical and liability impediments
- Validating accuracy and reliability
Networking Luncheon
Karl BroichPresidentFederal Institute for Drugs and Medical Devices
Sara GerkeAssociate Professor of LawUniversity of Illinois Urbana-Champaign
Amy GibsonVice President of LegalBenevolentAI
Aneta TyszkiewiczDirector Digital and DataEuropean Federation of Pharmaceutical Industries and Associations (EFPIA)
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
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 PolicyMerck
- 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 PolicyMerck
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
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
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
Alberto ArezzoDistinguished Professor of SurgeryUniversity of Torino
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
Peter BogaertPartnerCovington & Burling LLP
Mimmi Gersbro SundlerVice President Clinical Data & AI Governance
Clinical Data Operations & InsightsNovo Nordisk
Explore how AI is transforming every stage of clinical trials, from design to patient recruitment and outcomes predictions, while identifying the regulatory roadblocks and ethical landscape in Europe. Topics of discussion will include:
- 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
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
Discover the role AI is playing in the transformation of healthcare, from patient monitoring to the future of digital health.
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
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