Key Sessions

Jorge Muñoz Fuentes

Manoeuvring Through Legal and Compliance Risks for Digital Health AI Tools Used for HCPs, HCOs, and Patients

Telix Pharmaceuticals

Iqbal Hussain

Structuring Licensing Deals for Platform Technologies

Centessa Pharmaceuticals

Day 3Thursday, 22 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

08:00 - 08:50

Registration

Showing 2 of 2 Streams

Data Privacy, Emerging Risks and Compliance

Commercial Transactions

08:50 - 09:00

Chair’s Opening Remarks

Hilary Jones - Vice President Legal, Global Commercial & Regulatory Law, BioNTech UK Limited

09:00 - 09:40

Key Developments and Implications of European Health Data Space

Progress and timelines for the European Health Data Space and its delegated acts/implementing regulations
Will IP give you sufficient protection for your proprietary data?
Legal frameworks for sharing digital patient data amongst multiple partners
How to prepare, what is the effect, status, etc

Kristof Van Quathem - Of Counsel, Covington & Burling
Martijn ten Bloemendal - Global Privacy Counsel, AbbVie
Guillaume Byk - Legislative Officer, DG SANTE, EU Commission

09:40 - 10:20

Challenges Surrounding the Collection of Race and Ethnicity Data for Clinical Research and HR Purposes

Conflicting global requirements regarding the collection and processing diversity data: examining obligations and divergence between the US and across Europe
EMA requirements and guidance on the processing of diversity data
Practical considerations and privacy limitations for HR diversity data

Chris Foreman - Associate Vice President, Chief Privacy Officer, Merck Sharp & Dohme
Partner ,, Private Practice

09:00 - 09:10

Chair’s Opening Remarks

Laetitia Szaller - General Counsel and Head of Compliance, Egetis Therapeutics

09:10 - 09:40

Transaction Trends and Deal Landscape in the Life Sciences Sector

Expected deal trends for 2025/2026 in light of current market conditions
Issues for deal makers arising from the EU Pharma Package
Hot areas for investment in the life science sector

Sally Shorthose - Partner, Bird & Bird

09:40 - 10:20

Navigating the Triple Impact of FDI, FSR and Merger Control

New developments for FDI rules
Latest developments and surrounding outbound investment controls
Foreign subsidies regulation obligations: lessons learnt a year on
How to manage and contract merger control filings for exclusive licensing: global variations and reporting considerations
Access to relevant documents outside the EU
Practical tips for managing multijurisdictional transactions including managing different timelines for the same transactions
How to prepare remedies, when there are different merger control and FDI concerns in the same transaction?

Orion Berg - Partner, White & Case
Cristina Alexandrescu - Assistant General Counsel, GSK Biologicals

10:20 - 10:50

Morning Networking Break

Showing 2 of 2 Streams

Data Privacy, Emerging Risks and Compliance

Commercial Transactions

10:50 - 11:30

Expanding Legal and Compliance Responsibilities and Priorities in the Era of AI

Benchmarking experience, best practice and common obstacles for AI compliance
Insight into developing a robust AI policy: governance models and practical dos and don’ts
Guardrails against confidentiality and copyright risk and to protect your data
Operationalising AI: benchmarking legal approach:

How can you screen and monitor what is going on with AI across your business?
How are you managing the use of ChatGPT and other online AI tools?
Application of AI tools within legal teams
Transforming training programs across your organisation to mitigate risk

Veronika Hughes-Bednar - Global Head of Legal Research, M&D and Global Contracting Office, Astellas Pharma Europe

11:30 - 12:10

Manoeuvring Through Legal and Compliance Risks for Digital Health AI Tools Used for HCPs, HCOs, and Patients

Legal considerations for the provision of services and products generated by AI
Overlaying the EU MDR, IVDR, and AI Act: where are the grey areas pharmaceutical companies need to have on their radar for market facing AI tools
Practical guardrails when contracting with third parties to gather and use data
The role of HCOs as suppliers of AI tools and your obligations to help them remain compliant

Jorge Muñoz Fuentes - Head of Legal & Compliance, Telix Pharmaceuticals
Alison Dennis - Partner, Taylor Wessing

12:10 - 13:30

Networking Lunch

13:30 - 14:10

Steering Cybersecurity Compliance and EU NIS2 Directive

Update on the Directive, requirements and progress across Member States on implementation of laws
Legal requirements to meet compliance in each jurisdiction
Practical experience of going through assessment and legal considerations: data privacy, IP and data sharing and governance

Janice Carling - Region Europe Privacy & Cybersecurity Counsel, Teva
Partner ,, Private Practice

14:10 - 14:50

Managing Additional Oversight of Compliance Risks in your Supply Chain

Increase of regulatory burden: given today’s environment how can you prepare for regulatory scrutiny across your supply chain?
Understanding your liabilities and risk from actions taken by suppliers and distributors
Experience of EU CSR and practicalities of meeting requirements
Insight into ESG requirements and wider environmental requirements
Oversight of distributors as part of adequate procedures for anti-bribery and combating corruption
Practical legal considerations across every step of your supply chain: from establishing relationships and due diligence to contracting and monitoring third parties
Navigate the tensions of obligations on pharmaceutical companies but not on suppliers

Caroline Stockwell - Vice President, Head of Legal – International, Amicus Therapeutics
Nicole Reichman - Vice President, Head of Legal, Mereo BioPharma Group
Partner ,, Private Practice

10:50 - 11:20

Examining New Deal Structures

Examining new approaches to deals, negotiations and provisions: hybrid deals and licensing, collaborations
Discussing the more challenging, yet common risks in license collaboration: true JVs, M&A and investment deals
Key market insight: what are killing commercial deals? Changing case law and emerging risks
Areas of risk: operational behaviour preceding the deal and practical things that crop up during and after the deals

Robbie McLaren - Partner, Latham & Watkins
Samantha Peacock - Senior Associate, Latham & Watkins

11:20 - 12:00

Practical Approaches to Draft a Robust License Agreement to Avoid Litigation

Analysis of key area that cause tension when drafting and negotiating deals
What is the rationale for licensing compared to other deals eg M&A, distributions etc
Key considerations: what is everyone’s roles, due diligence, risk and IP management, etc
Deal structures: exclusive licencing or not, milestones, royalties
Key terms: indication, scope, termination, governance, IP (including improvements), warranties, non-compete, US vs continental (best efforts, reasonable efforts) etc

Serena ter Kuile - Senior Legal Counsel, Corporate Strategy, Genmab
Tine Carmeliet - Senior Associate, Allen & Overy

12:00 - 13:30

Networking Lunch

13:30 - 14:10

Commercialisation Agreements: Distribution, Co-Promotion and Co-Marketing

Variety of collaboration agreements at the stage of commercialization in the pharmaceutical sector
Most common risks in commercialization agreements: exclusivities, non-compete, pricing, information exchange, etc.

Marion Provost - National Partner, Dechert

14:10 - 14:50

Governing Law, Arbitration or Court?

Comparing the UK and EU
Governing laws and interpretation of contract
What happens if things go wrong?
Practical insight and the inside track on common trip points and court experience to help inform your approach to drafting agreements

Adam Wallin - Director, Legal Dispute Resolution, BioNTech UK Limited

14:50 - 15:10

Networking Break

Showing 2 of 2 Streams

Data Privacy, Emerging Risks and Compliance

Commercial Transactions

15:10 - 15:50

Legal Developments in Corporate and Promotional Communication

Increased scrutiny across frameworks and codes of conduct governing communication for pharmaceuticals
Practically managing boundaries between scientific communication, advertising and corporate communications: tailoring your messages correctly for the recipient
Evaluating different sources of data after MA and how to optimise the commercial use: from real-world evidence to new clinical trial data
Understanding promotional rules for new data: assessing consistency, clarification or non-conflict with the existing label
Supporting communication teams with practical dos and don’ts: press releases and working with journalists

Arianna Greco - Senior Vice President, General Counsel Commercial, Alnylam Pharmaceuticals
Tinne Gilles - General Counsel, CSL Vifor
Jonas Lind Hansen - Senior Corporate Counsel, Global Legal & Patents, Novo Nordisk

15:50 - 16:20

Latest Developments on Anti-Corruption Law and Enforcement, Whistleblowing, Anti-Bribery

Update on the legislative procedure of the Directive on combating corruption
New developments for whistleblowing
What is the impact and what do you need to do?

Partner ,, Private Practice

16:20 - 16:25

Close of Data Privacy, Emerging Risks and Compliance

15:10 - 15:50

How to Manage Data and AI in Commercial Deals

Key considerations for the value in input, output of the system as well as the system itself
What and how to effectively protect developments made in improving and adapting AI and machine learning
Constructing value for AI in IP licensing negotiations
Key risks and considering future potential of your investment/IP
Monetising data in digital deals

Kathryn Robinson - Senior Legal Counsel, Isomorphic Labs
Ajita Shukla - Counsel, White & Case

15:50 - 16:30

Structuring Licensing Deals for Platform Technologies

Hottest trends for (bio)pharma licensing
Constructing value for platform technology in IP licensing negotiations
Carving up platform technologies and considering the future potential of your investment/IP
How to get the best value from in and out-licensing agreements

Iqbal Hussain - General Counsel and Chief Compliance Officer, Centessa Pharmaceuticals
Partner ,, Private Practice

16:30 - 16:35

Close of Commercial Transactions

Day 3Thursday, 22 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

Register Interest for 2025