Agenda for Day 3 - Wednesday 11 November, 2026
The Asia-Pacific region is rapidly emerging as a transformative force in global biopharma, evolving from a manufacturing hub and clinical trial destination into a powerhouse of innovation, investment, and commercial opportunity. This session explores how APAC is reshaping the industry landscape through homegrown biotech innovation, increasing R&D capabilities, and growing capital markets that are attracting global attention. The discussion examines key trends driving the region's ascent, including regulatory modernization, cross-border partnerships, and the rise of China, Japan, South Korea, Singapore, and Australia as innovation centres while addressing the strategic considerations for Western companies seeking to access APAC markets and technologies. As deal flow between APAC and the rest of the world accelerates, the session provides insights into partnership models, investment opportunities, and the geopolitical and commercial factors that will define the region's role in shaping the future of global biopharma.
- John Copeland - Head of International Business Development & Transactions, MSD
- Uli Stilz - Strategic Advisor, Flagship Pioneering
Explore the art of deal-making through the lens of recent successes.
This session offers an informal yet incisive look into how a leading pharma company is shaping their dealmaking playbooks, revealing what drives strategic choices in today’s evolving biotech landscape.
Respiratory medicine is evolving beyond traditional therapies and delivery methods, with novel modalities and emerging targets attracting renewed investment interest. This session explores the changing landscape across asthma, COPD, pulmonary fibrosis, and other conditions, examines what recent data reveals about next-generation approaches, and discusses where partnerships and capital are flowing. As innovation accelerates and market dynamics shift, the session identifies differentiated opportunities and strategic considerations for stakeholders in the respiratory space.
- Ahmed Mousa - CEO, Vicore Pharma
Ophthalmology is entering a new era of innovation with emerging therapies, novel delivery systems, and technological advances transforming the prevention and treatment of vision-threatening conditions. This session explores what the latest data reveals about new approaches to retinal diseases, glaucoma, and other ophthalmic conditions, and examines the investment and partnership activity driving the field forward. As deal flow accelerates and commercial opportunities expand, the session provides insights into valuation trends, strategic considerations, and where the most promising opportunities lie in the field.
The Ones to Watch sessions at BIO-Europe spotlight emerging biotech companies, innovative startups, or groundbreaking projects that are poised to make a significant impact in the life sciences industry. These sessions provide a platform for showcasing cutting-edge ideas, novel technologies, and promising business models, offering attendees a glimpse into the future of biotech innovation. They are an excellent opportunity for investors, partners, and industry leaders to discover the next big players in the ecosystem.
If you would like to get involved, please contact partneringsponsorship@informa.com
This year’s Ecosystem Innovation Track at BIO-Europe dives into the transformative forces reshaping biotech and pharma collaboration. From open innovation platforms and cross-border networks to AI-powered ecosystems and regulatory advancements, the agenda brings together global leaders to explore how partnerships, innovation, and integrated strategies are accelerating drug discovery and patient impact.
If you would like to get involved, please contact partneringsponsorship@informa.com
The Most Favoured Nations (MFN) principle has the potential to transform the landscape of partnering and investment in Europe’s biotech and pharma sectors. This session examines how MFN clauses influence deal structures, pricing strategies, and cross-border collaborations, offering both opportunities and challenges for investors and innovators. Panellists will explore the practical implications of MFN agreements, including their impact on valuation, market access, and competitive positioning in a rapidly evolving business environment. Discover how companies can strategically navigate MFN considerations to optimise partnerships, mitigate risks, and drive sustainable growth in Europe’s interconnected biotech ecosystem. Whether you’re negotiating deals or planning investments, this session provides actionable strategies to thrive in the era of MFN-driven decision-making.
This year’s Ecosystem Innovation Track at BIO-Europe dives into the transformative forces reshaping biotech and pharma collaboration. From open innovation platforms and cross-border networks to AI-powered ecosystems and regulatory advancements, the agenda brings together global leaders to explore how partnerships, innovation, and integrated strategies are accelerating drug discovery and patient impact.
If you would like to get involved, please contact partneringsponsorship@informa.com
Explore critical lessons learned from failed and successful clinical trials
Gain insights into improving trial design and operational processes
Examine real world case studies to enhance future trial outcomes
- Rahul Agrawal - Chief Medical Officer and Head of R&D, Cereno Scientific
• Explore how cellular therapy platforms are expanding from oncology into autoimmune diseases, leveraging translational and clinical insights across therapeutic areas
• Review the evolving clinical and study landscape, including emerging efficacy and safety data across oncology and autoimmune indications, and discuss lessons learned for future development strategies
• Examine how benefit–risk expectations, endpoints, regulatory considerations, and development paradigms fundamentally change when moving from oncology into chronic autoimmune diseases
• Address organizational challenges of working across multiple departments with different priorities and stakeholder expectations, including governance, resource allocation, manufacturing considerations, and portfolio prioritization
- Tobias Kampfenkel - VP, Early Clinical Development and Translational Research, Miltenyi Biomedicine
Learn how to engage CROs as part of the team
Minimize risks and enhance clinical trial partnerships
Building relationships between vendors and biotech companies
Explore bold and innovative strategies for Phase 3 trials in rare diseases, focusing on risk-taking and challenging existing literature to achieve groundbreaking results.
Learn how to design clinical trials that differentiate first-in-class therapeutics and position novel therapies for success.
Discover adaptive, platform, and basket trial designs to enhance efficiency and accelerate the development of breakthrough therapies
- Ermir Kalaj - CEO, Cellula Therapeutics SA
European Health Data Space: sharing digital patient data
GDPR, anonymization, and secondary use of data considerations
How does the AI Act interact with GDPR, particularly regarding the use of patient data in AI models?
Addressing global data-sharing challenges and regulatory considerations
- Niklas Blomberg - Executive Director, Innovative Health Initiative
Update on Darwin Project: full data pilot for non-interventional studies
Member States’ independent approaches to RWE and its impact on EU-wide consistency
Intersection of Darwin and EHDS: navigating global transparency and data-sharing challenges
Addressing regulatory questions in pre- and post-marketing spaces with RWE
- Almath Spooner - Head of Europe Regulatory Policy & Intelligence (RPI), AbbVie
What specific regulatory obligations will companies need to meet under the AI Act?
How will the regulatory burden of the AI Act impact innovation in drug discovery and development?
EMA and FDA common principles for AI in medicine development
Impact of the AI Act and EMA & FDA common principles on the use of AI in drug development and clinical trials including patient recruitment, monitoring, and data analysis
- Mariam Jamali - Head of Regulatory Affairs Iberia & Regulatory Policy Manager, Bayer
This fireside chat will feature industry leaders who have successfully co-developed innovative therapies, sharing their experiences, challenges, and the transformative impact of collaboration on innovation. Key discussion points include:
Co-development models for advancing therapies through strategic partnerships
Joint ventures as a catalyst for technology innovation in the CDMO landscape
Strategies to foster open innovation and drive collaborative breakthroughs
Addressing challenges in collaborative R&D and ensuring alignment across stakeholders
Case studies highlighting successful co-innovation projects and their outcomes
A forward-looking perspective on the future of collaborative innovation in CDMO partnerships
- Marion Hitchcock - Managing Director Gene & Cell Therapies Incubator, Bayer
- Ximena Stawsky - Healthcare Supply Chain Head Europe, Merck KgaA Germany
- Denes Zalai - Director Technology, Eleva Biologics
Discover how digital technologies, AI, and advanced analytics are revolutionizing biomanufacturing strategy. Learn how leading organizations leverage data to drive decision-making, optimize operations, and create competitive advantage.
How digital tools are reshaping manufacturing processes
The impact of AI and machine learning on production efficiency
Cybersecurity challenges in digital manufacturing
Data-driven decision-making in biopharma
Future outlook for digital transformation in the industry
China's Rise as a Global Manufacturing Powerhouse - How Chinese CDMOs are transforming from contract manufacturers to strategic innovation partners for Western pharma
Bridging East-West Regulatory Frameworks - Aligning NMPA requirements with FDA/EMA standards for seamless global commercialization
Diversification Without Disruption - Leveraging China's manufacturing scale while building geopolitical resilience into your supply chain
Co-Innovation for Novel Modalities - Unlocking collaborative opportunities in cell and gene therapy development through Chinese partnerships
Accessing China's Expanding Infrastructure - Strategic approaches to tap into China's growing biomanufacturing capacity for clinical and commercial production
Future-Proofing Your Asia-Pacific Strategy - Building sustainable partnerships that balance IP protection, market access, and long-term growth in China's evolving landscape
- Dan Zhang - CSO, Peking Union Innovation Hub
Biotechnology is entering a defining period of reset.
Scientific capability has never advanced faster, yet the systems that sustain innovation are being challenged from every direction: shifting capital markets, geopolitical competition, pressure on research institutions, declining public trust, and the emergence of new platform-driven models that are redefining how biotech companies are built and scaled.
This plenary fireside chat will explore whether biotech is simply evolving or being fundamentally rewritten.
At the center of the discussion is a critical question: what will the next biotech model look like, and who will shape it?
The conversation will examine:
Whether the traditional biotech model can still sustain breakthrough innovation
The rise of platform-based company creation and its growing influence on global biotech
Why long-term scientific risk is increasingly difficult to finance in short-term markets
How AI, computation, and engineering are transforming the innovation ecosystem
Whether Europe and the U.S. risk losing leadership as talent, capital, and innovation shift globally
Why rebuilding trust with patients, policymakers, and society may become as important as scientific discovery itself
This is not a retrospective discussion about the state of the market. It is a strategic debate about the future architecture of the biotech industry from how innovation is funded and scaled to how leadership, trust, and competitiveness will be defined in the next era of biotechnology.
Expect a candid, provocative, and forward-looking conversation between two of the industry’s most influential thinkers as they stress test the assumptions that have defined biotech for decades and debate what comes next.
- Jeremy Levin - Executive Chairman, Ovid Therapeutics Inc
Biotech startups face unique challenges in securing the capital needed to drive innovation and growth. Traditional venture capital isn’t the only option—this panel dives into alternative financing strategies tailored to the biotech industry, including venture debt, royalty financing, private equity, and more. Hear from industry leaders and experienced founders as they share insights on how these models work, when to use them, and how to maximize their impact. Discover how biotech startups can leverage creative funding solutions to scale operations, reduce dilution, and accelerate their path to success in a competitive market.
- Sonia Benhamida - Managing Director, BlackRock
- Joey Mason - Venture Partner, Claret Capital Partners
- Dimitrios Weedon - Managing Director, OrbiMed
Dermatology is experiencing a surge in innovation and investment interest, driven by advances in biologics, precision medicine, and the growing recognition of skin health's connection to overall wellbeing. This session examines the expanding therapeutic landscape across inflammatory skin diseases, rare dermatologic conditions, and aesthetic medicine, explores what recent data reveals about market dynamics and patient demand, and discusses the deal activity and partnership opportunities emerging in the space. As the field gains commercial momentum, the session highlights strategic considerations for evaluating dermatology opportunities.
Antimicrobial resistance poses one of the most urgent global health threats, yet traditional market dynamics have failed to incentivize adequate investment in new antibiotics and alternative approaches. This session assesses where innovation stands today, identifies critical gaps in the development pipeline and funding landscape, and explores emerging partnership structures, policy incentives, and novel investment frameworks designed to address this challenge. As stakeholders work to align public health imperatives with commercial viability, the session discusses actionable strategies and opportunities for stakeholders committed to combating resistance.
- Achim Plum - Managing Director, HTGF
Artificial intelligence is transforming biotech ecosystems, from accelerating discovery timelines with digital CROs to enabling virtual experimentation through AI-native platforms. This panel will explore how AI is reshaping collaboration across the drug discovery value chain, the infrastructure needed for AI-driven partnerships, and how pharma, biotechs, and tech companies can build effective AI ecosystems.
Panelists will discuss key challenges, including data governance, model validation, regulatory hurdles, and the skills required to thrive in AI-enabled innovation networks. They will also examine barriers to AI-led innovation in preclinical and clinical development, emphasizing the contrast between early-stage discovery "easy wins" and the cost-intensive, high-risk post-IND stages.
This session will provide a comprehensive view of the opportunities and challenges in leveraging AI to transform the drug discovery and development process.
- Karim Galzahr - Managing Partner, OKG Capital
- Jue Wang - VP, Business Development, Insilico Medicine
The Ones to Watch sessions at BIO-Europe spotlight emerging biotech companies, innovative startups, or groundbreaking projects that are poised to make a significant impact in the life sciences industry. These sessions provide a platform for showcasing cutting-edge ideas, novel technologies, and promising business models, offering attendees a glimpse into the future of biotech innovation. They are an excellent opportunity for investors, partners, and industry leaders to discover the next big players in the ecosystem.
If you would like to get involved, please contact partneringsponsorship@informa.com
This year’s Ecosystem Innovation Track at BIO-Europe dives into the transformative forces reshaping biotech and pharma collaboration. From open innovation platforms and cross-border networks to AI-powered ecosystems and regulatory advancements, the agenda brings together global leaders to explore how partnerships, innovation, and integrated strategies are accelerating drug discovery and patient impact.
If you would like to get involved, please contact partneringsponsorship@informa.com
Explore financial barriers in clinical trials and their impact on operations
Discuss cost-saving strategies and innovative approaches to streamline trial processes
Highlight mission driven investments that balance capital and clinical impact
Discover how AI streamlines clinical trial operations- from intelligent protocol development and patient recruitment to digital twin technology that reduces patient requirements while maintaining regulatory compliance
Learn strategies for shifting from traditional site-centric approaches to patient-focused trial designs that improve accessibility, diversity, and retention through decentralized and hybrid methodologies
Explore real-world case studies and expert predictions on AI's future impact in precision medicine, regulatory evolution, and the transformation of clinical research operations
- Paul Little - CEO, Atrogi
Impact of Biotech Act changes on product development and regulatory timelines
Adapting to combined assessments for notified bodies
Addressing delays and inconsistencies in device and diagnostic approvals
Ensuring compliance with updated MDR and IVDR requirements while fostering innovation
Navigating market access and competitiveness for advanced therapies and diagnostics in Europe
- Olga Van Grol-Lawlor - Global Regulatory Policy & Advocacy Associate Director, Boston Scientific
Key industry learnings from Joint Clinical Assessment procedures
Addressing legal challenges and rare disease economic models
Understanding Member States’ early responses to HTA implementation
Evaluating whether HTA regulation will streamline market access or introduce new hurdles
- Inka Heikkinen - Regulatory Policy Lead, Director, Lundbeck
- Explores how partnerships between Big Pharma, SMEs, and suppliers can address sustainability challenges across the biopharma value chain.
Highlights industrial challenges that requires transformative technologies for reducing environmental impact.
Tackles Scope 3 GHG emissions and the increasing environmental demands on suppliers, offering scalable solutions for deep decarbonization.
Showcases a proven innovation ecosystem that accelerates technology development from TRL 4 to TRL 9, fostering cross-sectoral collaboration.
Discusses next-generation partnership models and public-private collaborations.
Provides actionable insights into sustainable innovation, balancing operational efficiency with environmental responsibility to drive long-term growth
- Magnus Bjorsne - CEO, AstraZeneca
Developing strategic alliances with CDMOs and biopharma companies to accelerate growth and innovation.
Exploring scalable and adaptable models tailored to the needs of emerging companies.
Securing funding and optimizing resources to support growth and innovation.
Overcoming regulatory hurdles and aligning with industry standards to ensure compliance and efficiency.
Driving technological advancements and differentiation through co-development opportunities.
Case studies of successful strategies leading to breakthrough therapies
- Massimiliano Cesarini - CEO, Biogenera SpA
A forward-looking address that synthesizes the conference themes and challenges industry leaders to think boldly about the future. Explore emerging trends, disruptive innovations, and the collaborative mindset needed to shape the next era of biomanufacturing excellence.
Future-proofing manufacturing capabilities to adapt to evolving market demands, regulatory landscapes, and technological disruptions
Creating resilient supply chains that ensure business continuity in the face of challenges
The impact of emerging technologies on biomanufacturing processes and efficiency
Market consolidation trends and their implications for the biomanufacturing landscape
Next-generation models for scaling and optimizing biomanufacturing operations
Breakthroughs in drug delivery systems and their integration into biomanufacturing workflows
The role of AI and machine learning in enhancing biomanufacturing precision and decision-making
Predictions for the future of biomanufacturing, including opportunities for innovation and overcoming challenges
- Steven Howe - VP, Process Development, Resolution Therapeutics
- Simone Kardinahl - Global Head Biosimilar Technical Development, Sandoz
- Michela Silacci Melkko - Senior Director, External Innovation, Johnson & Johnson
- Hanneke Schuitemaker - CSO, Valneva
Location: TBC