Life Sciences AI Summit Europe - DS

LIFE SCIENCES AI SUMMIT 25–26 March 2025

NH Collection Brussels Grand Sablon, Brussels

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The European Forum on Legal, Regulatory, and Compliance Frameworks for Safe Innovation in Biopharma and Medical Devices

Featuring a keynote presentation and participation from: Lucilla Sioli

Director, EU AI Office Directorate-General CONNECT European Commission

Associate Sponsor

Event Partners

Centre for Advanced Studies in Bioscience Innovation Law (CeBIL), University of Copenhagen, Denmark Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.

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The use of Artificial Intelligence (AI) has the potential to revolutionize the life sciences industry – from drug discovery and development, clinical trials optimization and disease diagnosis, to ultimately improve patient outcomes.

H

owever, to harness the full potential of AI, a range of challenges and considerations must be addressed to ensure its safe, responsible, and effective use.

The legal and regulatory landscape is complex and constantly shifting, with evolving strategies needed to address potential liability, data protection, and ethical challenges as technology advances.

Stay ahead of the curve by attending C5’s Life Sciences AI Summit – Europe. The knowledge, insights and connections gained will enable you to successfully navigate the complex and emerging array of issues.

YOU’LL WALK AWAY WITH: ĉ A deeper understanding of the legal, regulatory, compliance, liability and ethical concerns related to the use of AI, ML, and data analytics in life sciences. ĉ Real-world case studies and examples of best practices for addressing these concerns. ĉ The opportunity to engage in discussions with industry thought leaders and peers to share knowledge, solutions, and ideas. ĉ An expanded professional network and valuable connections.

You’ll benchmark and network with legal counsel and business executives working for and with the pharmaceutical, biotech and MedTech companies at the forefront of AI adoption. Don’t miss the opportunity to benefit from their expertise.

Be part of the revolution. Join us in Brussels, 24–26 March, to stay ahead in this transformative journey.

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Distinguished Speakers Conference Co-Chairs

KEYNOTE ADDRESS Lucilla Sioli

Director, EU AI Office Directorate-General CONNECT European Commission

Samo Eržen

Sonal Pai

Sara Gerke

Vicky Perez Riu

Amy Gibson

Senior Research Engineer Arctur

Sarah Korman

Associate Professor of Law University of Illinois UrbanaChampaign

Vice President of Legal BenevolentAI General Counsel & Head of Business Operations Isomorphic Labs

Erik Vollebregt Partner Axon Lawyers

Benefit from the insights and expertise of the esteemed speaker faculty Sharmini Alagaratnam, PhD

Programme Director, Healthcare Programme, Group Research and Development DNV

Alberto Arezzo

Distinguished Professor of Surgery University of Torino

Andreas Bender, PhD

Chief Technology & Informatics Officer PangeAI Professor for Life Science Informatics at the Centre for Molecular Science Informatics University of Cambridge

Peter Bogaert

Partner Covington & Burling LLP

Karl Broich

President Federal Institute for Drugs and Medical Devices

Ronan Cahill

Professor of Surgery University College Dublin

Olivier Guillo

CEO Smart Global Governance

Leo Hovestadt

Director Governmental Affairs EU Elekta

Carl E. Johnson, MD, EdM, MSc, FAMIA

Principal Scientist, GRACS, Global Evidence and Regulatory Policy Merck

Dipak Kalra

President The European Institute for Innovation through Health Data

Bruce Kessler

Digital Biology/Biotech Investor First Spark Ventures Lead Counsel Data Privacy & AI Global DP & AI Trust Office Takeda Pharmaceutical Company Limited

Jeremy Rollison

Head of EU Policy, European Government Affairs, Corporate, External and Legal Affairs (CELA) Microsoft

David A. Simon, Ph.D., J.D., LL.M.

Associate Professor of Law Northeastern University School of Law

Mirel Stelian

Vice President of Governance and Market Access Corti

Mimmi Gersbro Sundler

Senior Director, Lead Counsel Digital & Technology Thermo Fisher Scientific Inc.

Vice President Clinical Data & AI Governance Clinical Data Operations & Insights Novo Nordisk

Alexander Korenberg

Eric Sutherland

Partner Kilburn & Strode LLP

Isabelle Landreau

Group Data Protection Officer IDEMIA

Katie Lockwood

Co-Founding Partner Twin Path Ventures

Benjamin Meany

Manager for Digital, Software and AI Regulation MedTech Europe

Timo Minssen, LL.D., LL.Lic, LL.M, M.I.C.L., Dipl. Jur.

Senior Health Economist OECD.AI

Cécile Théard-Jallu Partner De Gaulle Fleurance

Aneta Tyszkiewicz

Director Digital and Data European Federation of Pharmaceutical Industries and Associations

Michael Watts, MBA MBChB BSc (Hons) Co-Founder and CEO Blüm Health Ltd

Xiaoyu Xing

Counsel Van Bael & Bellis

Founder & Director, Centre for Advanced Studies in Bioscience Innovation Law (CeBIL) University of Copenhagen

Jens Declerck

Emilia Niemiec

EIC Programme Manager for Medical Imaging and AI in Healthcare European Innovation Council

Thibaut D’hulst

Data Quality Manager The European Institute for Innovation through Health Data

Postdoctoral Researcher, Centre for Advanced Studies in Bioscience Innovation Law University of Copenhagen

AWS Solutions Architect Amazon Web Services

Federica Zanca

PRE-CONFERENCE WORKSHOP

Monday, 24 March 2025 WORKSHOP A 09:00–12:30 (Registration 08:30)

AI and ML Tech Boot Camp: A Guide to Understanding Artificial Intelligence and Related Technologies for Life Sciences Counsel and Executives This interactive workshop is designed to equip life sciences counsel and executives with a robust understanding of AI and ML technologies. Attendees will gain invaluable insights into the distinctions between generative and traditional AI, foundational AI concepts, realworld applications, and the complete AI lifecycle, all while addressing critical challenges and compliance considerations. By the end of this workshop, participants will be well-prepared to navigate the complexities of AI implementation within the European regulatory landscape of the life sciences sector. Topics of discussion will include: • Fundamentals of AI and ML » Defining Artificial Intelligence (AI) and Machine Learning (ML) » Differentiating AI from traditional programming » Understanding supervised, unsupervised, and reinforcement learning » Exploring natural language processing, neural networks, and deep learning • Generative AI vs. Traditional AI

Andreas Bender, PhD

Chief Technology & Informatics Officer PangeAI Professor for Life Science Informatics at the Centre for Molecular Science Informatics University of Cambridge

Jens Declerck

Data Quality Manager The European Institute for Innovation through Health Data (i~HD)

Xiaoyu Xing

AWS Solutions Architect Amazon Web Services

» Distinguishing characteristics and foundational technologies » Revolutionizing areas like drug discovery, bioinformatics, clinical trials and personalized treatments • AI Applications in Life Sciences » Real-world applications in drug discovery, clinical trials optimization, disease diagnosis, prevention or treatment, medical imaging, personalized medicine, and more • The AI Lifecycle: Data, Algorithms, and Model Training » Developing data collection and preprocessing: Quality, bias, privacy, liability and security considerations » Compliant reuse of data for AI development/operational purposes » Selecting appropriate algorithms and models for specific tasks » Harmonizing the training process: Supervised learning, validation, and testing • Challenges and Risks in AI and ML » Anticipating bias and fairness issues in AI algorithms » Integrating ethical considerations in medical decision-making » Meeting regulatory and legal challenges: EU AI Act, EU MDR, EU Health Data Space Regulation, GDPR compliance, intellectual property, and liability » Designing and implementing human oversight on AI • Business and Compliance Considerations » Identifying business opportunities and ROI through AI adoption » Exploring the shift from an ownership to service delivery/benefit model » Ensuring compliance with relevant regulations » Managing risks associated with AI implementation » Fine-tuning transparency – what it means and to whom

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PRE-CONFERENCE WORKSHOP

Monday, 24 March 2025 WORKSHOP B 13:30–17:00 (Registration 13:00)

AI IP Working Group: Understanding Unique IP Challenges for the European Life Sciences Industry in the Age of AI This workshop delves into the unique IP challenges faced by the European life sciences industry in the age of AI. Participants will explore a range of IP concerns, from trademarks and copyrights to patents and trade secrets, and gain insights through real-world case studies. Attendees will also learn strategies for ensuring compliance with data privacy regulations like GDPR while protecting innovations, and address the ethical considerations necessary for maintaining transparency and fairness in AI-driven advancements. Topic of discussion will include: • IP Challenges in AI for Life Sciences » Exploring common and complex IP concerns specific to AI in the life sciences

Alexander Korenberg Partner Kilburn & Strode LLP

Jeremy Rollison

Head of EU Policy, European Government Affairs, Corporate, External and Legal Affairs (CELA) Microsoft

» Examining case studies highlighting real-world IP disputes and lessons learned • Trademarks, Copyrights, and Branding in AI » Establishing how trademarks and copyrights intersect with AI technologies in life sciences » Understanding the role of copyrights in AI algorithms • Patenting AI in Life Sciences » Developing strategies for drafting robust patent applications for AI inventions • Trade Secrets and AI » Safeguarding proprietary AI algorithms and data as trade secrets » Best practices for maintaining secrecy and competitive advantage • Data Privacy and IP » Understanding the interplay between data privacy regulations (e.g., GDPR) and IP considerations » Ensuring compliance while protecting data-driven innovations • Ethical Considerations » Examining ethical considerations related to AI and IP in life sciences » Maintaining transparency and fairness in innovation

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MAIN CONFERENCE | DAY ONE

Tuesday, 25 March 2025 08:00

Networking Breakfast and Registration

08:45

Opening Remarks from the Conference Co-Chairs Amy Gibson

Vice President of Legal BenevolentAI

09:00

Sarah Korman

General Counsel & Head of Business Operations Isomorphic Labs

Erik Vollebregt Advocaat Axon Lawyers

Keynote Address Lucilla Sioli

Director of the EU AI Office, Directorate-General CONNECT European Commission

09:30

Navigating the EU AI Act: Understanding its Implications for Life Sciences

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:

Leo Hovestadt

• Analyzing the EU AI Act and classification of AI systems within the life sciences

Jeremy Rollison

Director Governmental Affairs EU Elekta

• Devising strategies for adapting to and complying with the new regulatory landscape

Head of EU Policy, European Government Affairs, Corporate, External and Legal Affairs (CELA) Microsoft

• Understanding the interplay between the EU AI Act, EU Data Act, EU MDR, EHDS and GDPR

Lucilla Sioli

• Reviewing best practices for risk management and AI governance

Director of the EU AI Office, Directorate-General CONNECT European Commission

Aneta Tyszkiewicz

Director Digital and Data European Federation of Pharmaceutical Industries and Associations (EFPIA)

10:30

Networking and Refreshment Break

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MAIN CONFERENCE | DAY ONE Tuesday, 25 March 11:00

GDPR and Data Privacy in AI-Driven Life Sciences: Balancing Innovation with Privacy

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 AI in

Olivier Guillo

Founder and CEO Smart Global Governance

Cécile Théard-Jallu

• Ensuring data protection and compliance with evolving policies

Partner De Gaulle Fleurance

• Balancing innovation with ethical use of health data in AI applications • Exploring opportunities for authorized reuse of health data under EHDS • Addressing cross-border data transfers and privacy challenges

11:45

Generative AI in the Life Sciences: Opportunities, Challenges, and Risks

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

Federica Zanca

EIC Programme Manager for Medical Imaging and AI in Healthcare European Innovation Council, European Commission

• Identifying industry advancement opportunities » Synthetic biology

» Clinical trials

» Medical imaging

» Natural language generation for clinical data

» Disease modeling

» Data augmentation in genomics

» Personalized medicine

» Document analysis

• Evaluating real and potential legal, ethical and liability impediments » Validating accuracy and reliability

12:30

Networking Luncheon

13:30

The Power of AI in Drug Discovery and Medical Device/Diagnostic Advancement

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 incdlue: • Highlighting how AI is revolutionizing drug discovery and the advancement of medical devices/diagnostics • Evaluating regulatory pathways for AI-enabled medical devices » Current regulatory framework under EU MDR » Interactions with EU AI Act • Comparing 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

Prof. Dr. med. Karl Broich

President Federal Institute for Drugs and Medical Devices (BfArM)

Sara Gerke

Associate Professor of Law University of Illinois Urbana-Champaign

Amy Gibson

Vice President of Legal BenevolentAI

Aneta Tyszkiewicz

Director Digital and Data European Federation of Pharmaceutical Industries and Associations (EFPIA)

» Regulatory approvals • Identifying best practices for life sciences companies to minimize legal risks and remain compliant

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MAIN CONFERENCE | DAY ONE Tuesday, 25 March 14:30

A Global Approach: Multi-Jurisdiction AI Adoption and Collaboration

Session leaders will examine AI adoption across jurisdictions and the required strategies for global collaboration. Topics of discussion will include:

Eric Sutherland

• Comparing AI adoption in the life sciences across multiple jurisdictions

Senior Health Economist OECD.AI

• Showcasing case studies of successful AI projects, transactions, and investment opportunities

Bruce Kessler

• Managing IP rights and data sharing in cross-border collaborations • Developing unified regulatory strategies for satisfying multi-jurisdiction legal requirements

Sonal Pai

Digital Biology/Biotech Investor First Spark Ventures

Moderator:

Lead Counsel – Digital & Technology Thermo Fisher Scientific

Kate Lockwood

Co-Founding Partner Twin Path Ventures

15:30

Afternoon Networking and Refreshment Break

16:00

Public-Private Partnerships (PPP) in AI: Opportunities and Barriers

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:

Carl E. Johnson, MD, EdM, MSc, FAMIA Principal Scientist, GRACS, Global Evidence and Regulatory Policy Merck

Dr Michael Watts MBA MBChB BSc (Hons) Co-Founder and CEO Blüm Health Ltd

• Highlighting examples of successful European AI and life sciences PPPs • Showcasing government initiatives and funding opportunities • Navigating legal and regulatory frameworks • Leveraging clinical evidence to drive success » Gaining insights into successful partnerships between large corporations and SMEs

17:00

AI for All: Ensuring Equity, Equality, and Fairness in AI Applications in Life Sciences

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 models in the life sciences • Exploring tools to enhance fairness and reduce disparities in AI models • Conducting impact assessments to prevent bias • Upholding ethical standards in place to address bias across Europe

Dipak Kalra

President The European Institute for Innovation through Health Data (i~HD)

Thibaut D’hulst

Counsel Van Basel & Bellis

Carl E. Johnson, MD, EdM, MSc, FAMIA

Principal Scientist, GRACS, Global Evidence and Regulatory Policy Merck

18:00

Networking Reception

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MAIN CONFERENCE | DAY TWO

Wednesday 26 March 2025 8:00

Breakfast

8:45

Opening Remarks and Recap of Day One from the Conference Co-Chairs

9:00

Assessing the Full Spectrum of AI Litigation and Privacy Risks in Life Sciences

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

10:00 IP Protections and AI Inventions in the Life Sciences:

Navigating Complexities in the European Context

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

Timo Minssen

Professor, Jur.Dr., LL.Lic., LL.M., M.I.C.L. Founder & Director, Centre for Advanced Studies in Bioscience Innovation Law (CeBIL) University of Copenhagen

Alexander Korenberg Partner Kilburn & Strode LLP

» 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

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MAIN CONFERENCE | DAY TWO Wednesday, 26 March 11:00

Morning Networking and Refreshment Break

11:30 CLASSICA Project Case Study: Bringing AI Into the Surgery Room:

Medical, Ethical, and Legal Challenges

This case study session will bring to life CLASSICA, an EU-Horizonfunded 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:

Alberto Arezzo

• The regulatory landscape pertaining to data privacy, AI regulation, and medical devices

Ronan Cahill

• Bias and how to mitigate bias in AI-assisted surgery • Liability in AI-assisted surgery (including comparison between the US and EU)

Distinguished Professor of Surgery University of Torino Professor of Surgery University College Dublin

Samo Eržen

Senior Research Engineer Arctur

12:30

Networking Luncheon

13:30

From Design to Outcome: Revolutionizing Clinical Trials with AI

• 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

Emilia Niemiec

Postdoctoral Researcher, Centre for Advanced Studies in Bioscience Innovation Law University of Copenhagen

David A. Simon, Ph.D., J.D., LL.M.

Associate Professor of Law Northeastern University School of Law

Peter Bogaert

Partner Covington & Burling LLP

Mimmi Gersbro Sundler

Vice President Clinical Data & AI Governance Clinical Data Operations & Insights Novo Nordisk

• 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

14:30

AI’s Role in the Transformation of Healthcare

Discover the role AI is playing in the transformation of healthcare, from patient monitoring to the future of digital health. Topics of discussion will include: • 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 • Exploring how healthcare might transform and how should it transform to make delivery more effective, in the digital age • Identifying steps needed to support a sustainable healthcare transition

Sharmini Alagaratnam, PhD

Programme Director Healthcare Programme, Group Research and Development DNV

Benjamin Meany

Strategic Initiatives Manager Digital, Software and AI Regulation MedTech Europe

Mirel Stelian

Vice President of Governance and Market Access Corti

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MAIN CONFERENCE | DAY TWO Wednesday, 26 March 15:30

Afternoon Networking and Refreshment Break

16:00

AI in Action: Enhancing Clinical Decision-Making with AI

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:

Erik Vollebregt Advocaat Axon Lawyers

• 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

17:00

Future Trends: Ethical AI Use, Sustainability, and Social Impact in Life Sciences

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

Isabella Landreau

Group Data Protection Officer IDEMIA

• 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

18:00

Closing Remarks and Conference Concludes

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LIFE SCIENCES AI SUMMIT 20–21 February 2025 | New York, NY

3rd Annual Conference on

AI Law, Ethics, Safety & Compliance Fall 2025 | Washington, DC

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