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Young professionals share why they choose to pursue a career in life sciences.

Moderator: Sabrina Urwyler (Luminance Health)

Keynote: Strategic keynote setting the stage for MPP 2026, addressing global regulatory shifts, convergence, and market access challenges.

This session builds on regulatory, clinical, and commercial realities to anchor a credible discussion on patient-centred innovation, linking patient value to feasibility, focusing on the full care pathway, and highlighting human-centred, compliant, and lifecycle-oriented approaches.

Scope & rationale

• Prevents abstract patient discussions disconnected from feasibility
• Links patient value to regulatory, clinical, and commercial realities

Core elements

• Patient experience across diagnosis, treatment, and monitoring
• Human-centred design under MDR/IVDR and pharmaceutical compliance
• Diagnostics and digital tools as enablers, not starting points
• Lifecycle innovation, post-market evolution, and adaptive models

Chairs: Marianne Silkjær Nielsen (Compcure) Erhard Huesler (Ypsomed)

Speakers

• Antonia King (CompCure)
• Horacio Pace Bedetti (Novo Nordisk)
• Tobias Theiler (Ypsomed)
• Steve Bourke (Patient Advocate)

BREAK

This session explores how regulatory frameworks, international reliance initiatives and evidence expectations are evolving to support timely patient access to combination products while maintaining scientific robustness, accountability and effective coordination across medicines, medical devices and digital technologies.

Scope & rationale

• Examines the intersection of regulatory reform, international reliance and evidence expectations
• Explores implications for combination products, companion diagnostics, software and digital health components
• Highlights global regulatory cooperation, reliance models and international convergence initiatives
• Addresses evidence generation strategies, launch sequencing and cross-framework coordination

Core elements

• International reliance initiatives and regulatory cooperation
• Regulatory pathway choices and their impact on development, approval and patient access
• Evidence generation requirements and expectations across medicines, devices and combination products
• Coordination challenges between medicines authorities, notified bodies and other stakeholders

Speakers

• Sebastian Fuchs (Swissmedic)
• Alberto Gañán Jiménez (European Medicines Agency)
• Madeleine Szeluch (MHRA)
• Andreas Emmendörffer (Roche)

LUNCHBREAK

• Global developments and convergence
• Regulatory reliance and collaboration
• Role of Notified Bodies and authorities
• Future outlook for combination products

Moderator: Thomas Wejs Møller (Chair, Novo Nordisk)

Speakers

• Vincenza Trivigno (Swissmedic)
• James Bertram (U.S. Food and Drug Administration)
• Paul Piscoi (European Commission)
• Ivo Schauwecker (EUPATI)
• Sabina Hoekstra (TÜV Süd)
• Manfred Mäder (Novartis)

BREAK

This session moves deliberately from policy to practice, keeping CDx and IVD topics central while explicitly integrating digital and connected components into the discussion.

Scope & rationale

• Translates regulatory policy into operational reality
• Focuses on interface management across frameworks and actors

Core elements

• Co-development and co-launch of drugs and CDx
• Software, AI, and connectivity as regulated components
• Roles and responsibilities across sponsors, manufacturers, Notified Bodies, and authorities
• Case-driven discussion of approvals, labelling, and lifecycle obligations

Chairs: Malte Kladiwa (Novartis)

Speakers

• Daniel Latham (Orchard)
• Mélodie Kahl (Kahlity)
• Hicham Majd (Novartis)
• Andy Pidgeon(42 Technology)

Adress by Kaspar Sutter (Canton of Basel-Stadt)

Wrap-Up and concluding remarks

APERO