Agenda for Day 2 - Tuesday 10 November, 2026
- How Genmab transformed from a licensing company into a fully integrated global biotech
- Lessons from scaling commercial capabilities while maintaining innovation
- What European biotech companies must do to compete globally
- The evolving role of partnerships in an era of capital constraints and geopolitical uncertainty
- Hannah England - Partner, Ropes & Gray
- Margarida Duarte - Senior VP and General Manager, Europe and Emerging Markets, Genmab
CNS remains one of the most challenging yet promising areas in drug development, attracting selective but significant investment and partnership activity. This session analyses recent deal flows, explores what's driving transactions in CNS, and examines the strategic priorities shaping partnerships between biotech innovators and larger players. With new modalities and targets emerging alongside persistent development challenges, the session discusses where value is being created and what matters most for stakeholders creating and evaluating CNS opportunities.
- Millie Nelson - Editor of BioXconomy, Informa
- Olga Krylova - Head of S&E, Europe, Global Business Development & Innovation, Otsuka
- Jack O'Meara - CEO, Aerska
- Marine Beurdeley - Global Business Development Lead, Neurology, Servier
The cardiometabolic space is experiencing a surge in innovation beyond GLP-1 therapies, with emerging mechanisms and novel approaches addressing obesity, diabetes, cardiovascular risk, and metabolic health. This session explores what the latest data reveals about next-generation platforms, examines which targets and modalities are capturing scientific and commercial attention, and discusses where capital and partnerships are flowing. As competition intensifies and the market evolves, the session provides insights into differentiated opportunities and strategic considerations for key stakeholders in this high-growth area.
- Olivia Cavlan - Partner, LifeArc
- Samuel Bennett - Director - Search & Evaluation, Novo Nordisk
- Hamza Bokhari - Executive Director - Preclinical Strategy & Business Development, Atrogi
- Philip Brainin - CEO, IsoMab
- Willem Broekaert - Managing Partner, V-Bio Ventures
- Philip Janiak - CEO, Corteria Pharmaceuticals
What if you could move from target to candidate in a single click?
Discover how Biocytogen’s RenSuper Workstation seamlessly integrates large-scale in vivo RenMice immunization, NGS, AI-powered high-throughput screening, and experimental validation to deliver high-quality, development-ready antibody sequences.
Learn how this platform unlocks access to a rich library of experimentally validated, fully human antibodies complete with data packages to support faster, more confident decision-making. Explore how it enables rapid candidate identification, flexible antibody design, and data-driven workflows, reducing early discovery risk and compressing timelines from years to months.
- Icy Niu - Executive Director, Global Business & Marketing Head, Biocytogen
Germany’s biopharma ecosystem is home to a plethora of innovative players in academic and industrial innovation, biomanufacturing and in healthcare. This panel showcases 5 teams and their impact.
- Gabriel Flemming - Senior Manager, Healthcare Export Initiative, Germany Trade & Invest
- Susanne Gulden - Head of Business Development EU, Rentschler Biopharma SE
- Martin Krauss - Managing Director, FGK Clinical Research
- Markus Lang - Co-Founder CEO, CD4 Therapeutics
- Guido Mathews - CBO, Phinomics
Therapeutic breakthroughs are worthless if they do not reach patients. It often takes far too long for innovative therapies to be put into practice. This is because approval, benefit assessment, and pricing are handled by different decision-makers, and decisions are made sequentially rather than in parallel. But what if decision-makers collaborate, pursue a common goal, and make decisions in a single process rather than one after another?
Using case studies, this panel examines how the networked collaboration of decision-makers can facilitate the rapid introduction of medicines in Europe. It showcases how parallel, coordinated processes ensure that patients in Europe gain access to the therapies they need as quickly as possible.
- Tilo Mandry - Lead International Liaison Manager, IGES Institut
- Laurent Goux - Senior VP and General Manager Europe, Krystal Biotech
- Erwan Gicquel - Government Affairs Lead, Europe, Miltenyi Biomedicine GmbH
- Tina Taube - Head Strategic Market Access, EFPIA
- Bettina Ziegele - Liaison Officer Stakeholder Cooperation & International Relations, Paul Ehrlich Institute
- Overview of JETRO’s services for overseas companies seeking business expansion, partnerships, and investment opportunities in Japan
- Introduction to Japan’s major biotech ecosystems, focusing on the Kanto and Kansai regions
- Key strengths: universities, research institutes, pharmaceutical companies, startups, and biomanufacturing capabilities
- Major initiatives and opportunities for international collaboration and business development
- ENSEMBLExJ: A Government-Funded Virtual Japan Team for Global Biotechs Entering Japan
- Takashi Kawaguchi - Ecosystem Division, JETRO
- Rikako Morishita - Biotechnology and Medical Device Technology Promotion Division, METI Kansai
- Wakako Toga - Deputy Director, Strategic Planning Bureau, National Cancer Center Japan (NCCJ)
Have you ever wondered what the future holds for clinical operations? More importantly, how can we prepare for what lies ahead? This session gives the audience a glimpse into the future by exploring the challenges to come and recommending solutions to implement now, in preparation for tomorrow.
Explore how AI and global expansion are reshaping clinical trials, unlocking innovation and transforming operational efficiency across international markets
Discuss the role of community engagement in driving operational excellence, fostering trust and improving patient participation and retention
Identify disruptive pathways to accelerate trial timelines and navigate the evolving landscape of decentralised trials, patient diversity and digitalization
- Bernhard Glombitza - Head of Clinical Operations & Customer Engagement EMEA / LATAM, Bayer AG
Identify evidence gaps that could affect European development and market access, and the questions Western buyers should resolve with clinical, regulatory and HTA specialists before committing.
Assess whether China-origin clinical data meets European regulatory standards, identify critical evidence gaps, and determine what bridging studies or additional trials are required to support your regulatory and market-access strategy
Understand how data ownership rights, ongoing reliance on China-based CROs or trial sites, and regulatory responsibilities impact your clinical development timeline, budget, and operational control post-transaction
Determine when geopolitical factors—including export controls, supply chain constraints, and regulatory scrutiny of China-origin assets—require you to revise your development plan, restructure the deal, or walk away from the transaction entirely
- Chenchao Liu - Founder & Managing Director, SILREAL GmbH
Examine what Western partners must resolve on evidence, data access and policy risk before committing to a China-origin asset
Understand how to leverage China’s speed, patient access and regulatory flexibility to accelerate global development timelines
Explore the surge in licensing agreements between global pharma and Chinese innovators and what makes China attractive for global partnerships
Understand the regulatory evolution in the regional and their impact on development
- Chenchao Liu - Founder & Managing Director, SILREAL GmbH
- Darren Ji - Co-Founder, Chairman & CEO, Elpiscience
- Seemi Khan - Chief Development & Strategy Officer, Alkeus Pharmaceuticals
- Echo Hindle-Yang - Founder & CEO, MSQ Ventures
- Rebecca Lumsden - Head of Regulatory Science & Policy EU/AMEE, Sanofi
How will the GPL and the Biotech Act create additional incentives for market access?
Implications of initiatives on regulatory data protection and market exclusivity
Navigating changes to Supplementary Protection Certificates (SPCs) and their impact on market exclusivity
Regulatory strategies to maximise available incentives
Comparing key global differences in approaches to incentives
- Rainer Becker - Director for Medical Products and Innovation, DG SANTE, European Commission
- Ann Lindberg - Director General, Swedish Medical Products Agency
- Hugh Pullen - Chair, EuropaBio Healthcare Council and VP, Head of Public Affairs Region Europe, Novartis
Examining the enhanced incentives under updated GPL regulations
Understanding the baseline for data protection measures
How to qualify for rewards attached to new indications with significant clinical benefits
Analysing breakthrough definition for extending exclusivity periods
Key updates tailored to paediatric medicine advancements
- Katherine Tyner - Senior Director, Regulatory Policy Leader, EMEA & CMC, Johnson & Johnson
Regulatory pathways and benefits available for unmet medical need targeted products, and how can they accelerate development and approval?
How do you define unmet medical needs and that are the thresholds? Navigating the challenge of variable regulatory interpretations across diseases and therapeutic areas
Case study insight into different conditions and how they qualify for Unmet Need
Have the changes in the GPL really moved the needle when it comes to stimulating development for unmet medical needs?
- Sara Escola - Regulatory Affairs Europe Head, PTC Therapeutics
- Stefano Romanelli - Government Affairs Associate Director, EUCOPE
- Letizia Goretti - Partner, Primo Capital, Primo Biotech Lazio
This engaging fireside chat will feature insights from industry leaders on the future of biopharmaceutical manufacturing, exploring transformative innovations, emerging technologies, and strategic approaches shaping the next generation of production capabilities. The discussion will cover:
Designing scalable manufacturing processes that seamlessly transition from clinical to commercial production while maintaining product quality and regulatory compliance
Innovations in biopharmaceutical manufacturing technologies driving efficiency and advancing production capabilities
The role of automation and AI in streamlining production processes and enhancing operational decision-making
Addressing regulatory challenges in manufacturing to ensure compliance while maintaining agility in an evolving landscape
Sustainability in manufacturing processes as a critical component of responsible biopharmaceutical production
Preparing for the next wave of biopharmaceutical advancements including novel modalities and breakthrough therapies
- Kenneth Bilenberg - CEO, Avid Bioservices
As advanced therapies move closer to commercialization, companies face the challenge of aligning clinical development, manufacturing readiness, technology transfer, regulatory strategy, and market access planning. This presentation shares strategic lessons learned in preparing cell and gene therapy programs for launch and explores how integrated planning can accelerate patient access.
- Toon Overstijns - CEO & Managing Director, Miltenyi Biomedicine & Miltenyi Biotec B.V. & Co. K.G.
Examine the unique economic and operational challenges of manufacturing cell and gene therapies, mRNA products, and other advanced modalities. Explore strategies to achieve commercial viability and patient access.
Examining the unique economic challenges of manufacturing cell and gene therapies, mRNA products, and other advanced modalities
Exploring cost-of-goods strategies to achieve commercial viability while maintaining product quality and patient access
Addressing scalability and infrastructure requirements for transitioning from clinical to commercial-scale production
Leveraging platform technologies and process innovations to drive manufacturing efficiency and reduce unit costs
Navigating pricing, reimbursement, and market access challenges in the advanced therapy landscape
A forward-looking perspective on sustainable manufacturing models and their potential to transform patient care globally
- Birk Vanderweeen - Senior VP, Global Manufacturing & Supply, Legend Biotech
- Alex Bloom - CTO and CSO, AviadoBio
- Paul Bravetti - CEO, Brenus Pharma
- Joana Correia - Co-founder and CEO, Exogenus Therapeutics
Why now? The time is now. Must be positioned as a systemic market failure and the biggest commercial opportunity of the next decade.This is not about representation/feminism. It’s about missed revenue, broken clinical models, and outdated investment theses. This is not niche, its macro
Macro question:
How much value has the industry left on the table by designing healthcare around the wrong default patient?
- Dana Burduja - Head of Life Sciences and Health, European Investment Bank (EIB)
- Jessica Federer - Managing Director, Women's Health Fund
- Marie Teil - Global Head of Special Patient Populations, UCB
Join us for this interactive workshop designed for delegates experienced in partnering who are looking to elevate their skills. This session will explore best practices for collaborating with colleagues, saving time, boosting response and acceptance rates, and leveraging partneringONE’s advanced features to enhance partnering etiquette. You’ll leave with a clear understanding of how partneringONE can help your company maximize ROI from partnering, both at this event and in the future. There will be ample opportunities to ask our partneringONE expert any questions you may have. Attendance is limited to 40 participants, so be sure to reserve your seat by adding the session to your personal agenda. If you’re unable to attend, feel free to visit the partnering help desk with any questions.
This ever-popular session offers an in-depth look at the current state of the life sciences industry, guided by insights from top pharma dealmakers and venture investors. Join the discussion to gain valuable strategies for navigating the evolving biotech landscape and staying ahead in today’s competitive environment.
- Anton Gueth - Managing Director, EVOLUTION Life Science Partners
- Evonne Sepsis - Founder and Managing Director, ESC Advisors
- Anja Harmeier - Head of Roche Venture Fund, Roche Ventures
- Jenny Laird - VP Search & Evaluation, Eli Lilly and Company
- Nathalie ter Wengel - European Lead Worldwide Business Development and Global Scouting Team Leader, Pfizer
Explore the art of deal-making through the lens of recent successes.
Late-stage investment is where biotech innovation meets the demands of commercialization and global impact. This panel brings together top investors, executives, and industry experts to explore the unique challenges and opportunities of funding biotech companies on the cusp of breakthrough success. From navigating regulatory hurdles to scaling operations and preparing for IPOs or acquisitions, discover how late-stage funding is shaping the trajectory of biotech’s most promising ventures. Gain insider perspectives on the strategies driving growth, the risks involved, and the vision required to turn cutting-edge science into transformative solutions. Don’t miss this deep dive into the high-stakes world of late-stage biotech investment!
- Zina Affas Besse - Partner & Deputy Head of Healthcare Private Equity, BNP Paribas Asset Management
- Hubert Birner - Managing Partner, TVM Capital
- Magdalena Jonikas - Partner, JEITO
- Sander Slootweg - Managing Partner, Forbion
As biopharma dealmaking accelerates—driven by record licensing values, a $200 billion patent cliff, and a selective capital markets environment—companies and investors are turning to increasingly creative transactional structures to unlock value and maintain strategic optionality. This panel brings together three of Ropes & Gray's leading life sciences transactional partners for a forward-looking discussion on the trends reshaping how biotech companies capitalize their programs and bring assets to market.
The panelists will explore four interconnected themes driving today's most sophisticated biotech transactions:
- Product Financings and Synthetic Royalties: With royalty-linked transactions exceeding $7 billion annually, how are biotech companies leveraging non-dilutive capital to fund clinical programs while retaining operational control? What structural innovations—tiered royalties, capped returns, milestone-triggered tranches—are defining the next generation of product-level financing?
- Royalty Monetizations: As the royalty finance asset class matures and buyer competition intensifies, how are companies navigating the spectrum between true-sale and debt-like structures, and what considerations are driving those choices?
- NewCo Formation and Single-Asset Structures: From Pfizer/Biohaven to AbbVie/Gilgamesh, the single-asset deal—where acquirers carve out a lead program while spinning remaining assets into a newly formed entity—has become a defining transaction archetype. What makes an asset a strong NewCo candidate, and how are parties structuring governance, IP licensing, and equity arrangements to preserve value for all stakeholders?
- Reverse Mergers as a Path to Public Markets: With traditional IPO windows remaining unpredictable, reverse mergers have re-emerged as a critical tool for biotech companies seeking public listings. How are companies identifying the right shell or target, navigating the regulatory and governance complexities, and structuring these transactions to position the combined entity for long-term success?
Drawing on their collective experience advising pharma, biotech, royalty purchasers, and life sciences investors, the panelists will offer practical perspectives on how these structures are converging and what dealmakers should expect as the market continues to evolve.
- Hannah England - Partner, Ropes & Gray
- Matthew Byron - Partner, Ropes & Gray
- Abby Gregor - Partner, Ropes & Gray
Immunology continues to unlock therapeutic possibilities across autoimmune, inflammatory, and immune-mediated conditions, making it a hotbed for innovation and capital deployment. This session explores emerging targets and novel modalities reshaping the landscape, examines what recent clinical data reveals about efficacy and differentiation, and discusses the deal dynamics and partnership strategies defining the space. As competition intensifies and new frontiers open, the session provides actionable insights for stakeholders creating and assessing opportunities in this dynamic and crowded market.
- Sam Possemiers - CEO, MRM Health
- Renee Aguiar-Lucander - CEO, Hansa Biopharma
- Samuel Black - Senior Director, Merck
- Giulia Vestri - Partner, Claris Ventures
Longevity science is transitioning from research curiosity to serious commercial opportunity, with interventions aimed at slowing or reversing aging processes gaining scientific credibility and investor attention. This session explores the latest developments in aging biology and health span extension, examines what the emerging data reveals about therapeutic potential, and discusses the investment landscape taking shape around longevity. As funding flows into the space and partnership models evolve, the session provides strategic perspectives for evaluating opportunities in this nascent but rapidly growing field.
- Phil Newman - Founder & CEO, Longevity Technology
- Clara Campas - Managing Partner, Asabys
- Pedro de Noronha Pissarra - CEO, Chrysea Limited
- Carina Kern - CEO, LinkGevity
- Nikolaj Kulahin Roed - Global Project Leader, Novo Nordisk
Biotech company creation is evolving. Rather than simply financing promising science, a growing number of investors and operator-led platforms are actively building companies from the ground up, combining capital, translational expertise, operational infrastructure, and experienced leadership from day one.
This session will examine the rise of these next-generation venture creation models and how they are reshaping the path from academic discovery to scalable biotech company. Bringing together leaders from venture creation platforms, investment firms, pharma, and innovation ecosystems, the discussion will explore whether biotech company building can become more systematic, capital efficient, and repeatable.
Key themes include:
The emergence of operator-led biotech creation models
Institutionalizing company formation around academic innovation
The role of pharma and ecosystem partnerships
Fractional leadership and shared operational infrastructure
Europe’s opportunity to build globally competitive biotech ecosystems
The session will provide strategic insight into how the biotech industry is rethinking not just how companies are funded, but how they are built.
- Natalya Baltrukovich - Co-Founder & Vice Chair, BackingHerVenture e.V.
- Ayokunmi Ajetunmobi - Head of Ventures, Pioneer Group
- Simon Boulton - Founder & CFO, Altx Therapeutics
- Johanna Roostalu - Director, Human Health, Venture Creation, BioInnovation Institute (BII)
- Bobby Soni - CBO, Slingshot Therapeutics
- Korean biotech companies present their technologies, spanning formulation science, preclinical safety testing, microbiome-based innovation, and next-generation mRNA and gene-therapy delivery
- Each company shows how their platform is helping to revolutionize health and skincare, from novel drug delivery systems and antibody-guided mRNA/CAR-T therapeutics to next-generation safety and efficacy testing and recombinant toxin engineering for aesthetics
- A window into Korea's growing life sciences ecosystem, offering direct opportunities for licensing, partnership, and early-stage investment
- Gunsik Cho - CEO, Cellweaverse Co., Ltd.
- Jeong Ah Kim - CEO, CellNBetter
- Jongsuep Baek - CEO, BeNatureBioLab
- Yeumin Yun - CEO, Megalab Co., Ltd.
- Sangwon Jung - CEO, MVRIX
Join the European Investment Bank for a fireside chat exploring women’s health in the EU, with a preview into an upcoming study conducted under the InvestEU Advisory Hub in collaboration with the European Commission. The study aims to deep dive into Europe’s women’s health research, development, and investment landscape, identify critical unmet needs, and provide market intelligence to inform investment and policy considerations. It will also explore how instruments could be tailored to address the sector’s most pressing needs.
This discussion builds on the 2025 EIB Group Summit on Women Leaders in Life Sciences and Open Call for Applications on Advancing Innovation in Women’s Health.
- Dana Burduja - Head of Life Sciences and Health, European Investment Bank (EIB)
- Valeria Iansante - Senior Life Sciences Specialist, European Investment Bank (EIB)
For today’s biotech founders, building a company no longer starts with infrastructure it starts with access to the right ecosystem. Incubators backed by global pharma and industry leaders are playing an increasingly central role in shaping the next generation of biotech companies, providing not just space, but capital access, expertise, partnerships, and integrated support networks.
In this fireside chat, a leader from one of the industry’s leading incubator platforms will share what they look for in early-stage companies, how they support founders beyond the lab, and how startups can best leverage ecosystem partnerships to accelerate growth. From navigating early development decisions to building the right partner network, this conversation offers a candid look at how biotech companies are really built today and what founders need to succeed.
- Ruth Shah - Head of Bayer Co.Lab Berlin, Bayer
- Massa Shoura - Co-founder, CEO and CSO, Phinomics
China’s biotech sector is undergoing a transformative evolution, positioning itself as a global leader in drug development and innovation. This session will delve into the latest breakthroughs within China’s vibrant R&D ecosystem, from cutting-edge therapeutics to advancements in AI-powered drug discovery. Panellists will discuss how regulatory reforms, strategic investments, and cross-border partnerships are driving China’s rapid progress and reshaping the global biotech landscape. Discover how China’s innovation engine is creating unprecedented opportunities for collaboration and redefining the future of healthcare worldwide.
- Alicia Hong - VP, Business Development Asia, BioNTech SE
- Xueming Qian - Chairman & CEO, Transcenta
- Jia Zhuang - Executive Director, ATLATL Ventures
As the lifecycles of biotech startups accelerate, younger management figures and junior venture capitalists are increasingly taking seats at the board table. However, navigating deep-rooted boardroom hierarchy and power dynamics can limit their strategic impact. This panel examines how junior board members can systematically build trust with senior stakeholders and ensure their voices are driving decisions. Industry veterans and emerging investment professionals will share concrete case studies of successful board contributions alongside critical, avoidable missteps. Attendees will leave with essential takeaways for punching above their weight from both a management and investor perspective.
- Melina Hoffmann - Associate, Syncona
The EIC VentureMatch Pitching on Health Biotech spotlights 12 of the best health biotech companies backed by the European Innovation Council, working in therapeutics and advanced therapies, in technologies supporting research, development and clinical decision-making, and in adjacent health biotech fields. They have come through EIC evaluation, one of the most competitive selection processes in Europe, and hold EU grant funding, equity investment, or both. They will pitch to investors and pharma business development teams, followed by structured networking. If you would like to get involved or attend, please contact venturematch@bas.eic.eismea.eu.
Examine cost-benefit frameworks for bridging studies across Japan, Korea, Taiwan and ASEAN countries, balancing regulatory requirements, ethnic sensitivity considerations and commercial ROI to accelerate regional approvals
Explore the unique regulatory pathways and requirements across key Asian markets, including PMDA (Japan), MFDS (Korea), TFDA (Taiwan) and emerging frameworks in Southeast Asian nations
Discuss proven strategies for managing multi-country trials in the region, including site selection and engagement in mature and emerging markets, patient recruitment in heterogeneous populations and building sustainable partnerships with local CROs and research institutions
Future-Proof emerging opportunities across Southeast Asia's growing clinical trial ecosystem, the rise of decentralized and hybrid trial models adapted to Asian healthcare systems and how to leverage real-world evidence and digital health innovations tailored to local market needs
- Barbara Kienast - Head of Clinical Operations & Regulatory Affairs, Graythan Regulatory Services
Address unique regulatory hurdles and innovative approval pathways for rare disease clinical trials, including adaptive designs and strategies for generating robust evidence with limited patient populations
Examine the impact of political and leadership changes at the FDA and across global regulatory agencies, and how these shifts influence drug development priorities, review timelines, and enforcement approaches
Align trial design with evolving regulatory requirements by incorporating real-world evidence, digital endpoints, and quality-by-design principles that strengthen submissions and accelerate approvals
- Sinan Sarac - Senior VP, Head of Oncology Europe, Regulatory Consulting, Parexel
- Zoltan Magyarics - VP, Research & Development, AOP Health
Australia offers a compelling opportunity for clinical trials, with favorable regulatory framework, strong networks, excellent engagement with clinicians/researchers, and access to established and proven pathways of obtaining high-quality clinical data recognised by European and US regulators, and other global institutions. This speaking session will highlight how Australia’s clinical trials are a cornerstone for innovation and attractive environment for companies from around the world to develop their intellectual property.
Learn best practices for strategic trial hub positioning globally, CRO selection, and building local partnerships to accelerate trial timelines while navigating the balance between market access and recruitment feasibility
Address infrastructure and resource challenges in emerging markets by understanding the patient journey, establishing strong site relationships, and implementing effective strategies for working in diverse regions
Discover actionable approaches for expanding trial footprints into underserved populations, including conducting proper due diligence and research to identify optimal locations for clinical trial success
- Maya Zlatanova - CEO, FindMeCure
As Europe positions itself as a leading destination for clinical research, the ability to deliver clinical trials at scale requires robust operational frameworks and strategic site management. This fireside chat explores what it takes to transform Europe into a thriving clinical trials hub, examining the critical operational elements that enable successful trial execution across diverse European markets.
Assess the regulatory, infrastructure, and market factors positioning Europe as an attractive hub for clinical research
Learn how to evaluate site capabilities and optimize performance using data-driven approaches tailored to Europe's diverse healthcare systems
Understand best practices for streamlining study initiation processes, managing cross-border logistics, and accelerating timelines
- Pilar de la Rocha Mur - VP, Head of EMEA, Global Clinical Operations, BeOne Medicines
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
- Jay Smith - Head of Product, Trial Interactive, TransPerfect
- Jane Twitchen - Executive Director, Head Clinical Trial Accelerator Unit, Biogen
- EMA tools for innovation: discover key incentives and support mechanisms designed to accelerate innovative breakthroughs
- Learn how to leverage EMA resources to navigate regulatory pathways and drive innovation forward
- Practical scenarios: share different perspectives, identify readiness challenges, and discuss recommendations and next steps
- Virginia Acha - Associate VP, Global Regulatory Policy, MSD
- Leonor Enes - Senior Scientific Officer, European Medicines Agency
- Latest developments in EMA’s regulatory sandbox and the potential for innovation
- Leveraging the IHI BRIDGE project to advance innovative healthcare technologies
- Examining wider sandbox initiatives and their implications for biotech innovation
- Niklas Blomberg - Executive Director, Innovative Health Initiative
- Falk Ehmann - Head of the Innovation and Development Accelerator, European Medicines Agency (EMA)
- Dominika Misztela - Director, Global Regulatory Affairs Science, Policy, and Intelligence – Europe, CSL Behring
Understanding the impact of the EU Biotech Act, ATMP, and SoHO Regulations on ATMP development and Biosimilars
Building a unified approach to Hospital Exemption to accelerate ATMP access and drive Europe's innovation and competitive edge forward
Comparing the EU regulatory framework with the MHRA Rare Therapies Launch Pad and its support for innovation
Exploring the FDA’s framework for accelerating individualized therapies and its implications for global competitiveness
Identifying key strategies for biotech manufacturers to adapt to evolving regulatory requirements and seize new opportunities
- Simon Bennett - Director, Regulatory Policy Europe, Canada and Partner Markets, Biogen
- Marco Rafael - Policy Leader - Global Product Development Regulatory Science, Roche
- Examining the current state of EU CTR and upcoming changes under the EU Biotech ActAssessing practical impacts on regulatory approval processes and timelines for clinical trials
- Navigating divergent regulatory feedback: understanding similarities and differences in how key global regulators engage with sponsors throughout the regulatory journey
- Can Europe move faster without compromising confidence? How can we embrace global data, streamline approvals and maintain patient safety?
- Christine Mayer-Nicolai - VP, Global Regulatory and Scientific Policy, Merck Serono
- Anna Litsiou - Senior Director, International Regulatory Policy & Intelligence, AstraZeneca
This session highlights strategies and innovations to achieve excellence in biologics manufacturing. Key topics include:
Addressing capacity constraints and exploring strategies for expansion
Leveraging innovative technologies to enhance flexibility and efficiency
Innovations driving advancements in biologics production processes
Identifying and resolving bottlenecks in biologics manufacturing workflows
Case studies showcasing successful biologics manufacturing practices
- Ali Mohamed - SVP of CMC, Immatics
- Cecile Brocard - Head of Development Operations, Vienna, Boehringer Ingelheim RCV GmbH & Co KG
- Lena Romander - Director Business Development, Pfizer
- Hubert Scholze - CBO, Rezon Bio
Selecting strategies for commercially viable, future-proof products through multi-regional scale-up
Strategic timing and decision framework for manufacturing finalization at Phase II completion
Navigating CMC requirements across FDA, EMA, and global regulatory jurisdictions
Vendor based partnership - importance for business continuity and scaling
Technology transfer and process validation strategies for commercial-scale production
Capacity planning and manufacturing network design for global market launch
Risk mitigation approaches for maintaining process flexibility while meeting regulatory expectations
Real-world lessons learned from NEXTCELL PHARMA's journey to commercial readiness
- Lindsay Davies - CSO NextCell Pharma and CEO QVance, NextCell Pharma
what are the key considerations as you start developing your manufacturing process and setting up your network?
to patent or not to patent? The role of trade secrets
who are the potential partners going forward: a CDMO vs a collaboration partner
IP due diligence readiness: demonstrating IP strength and FTO clarity
- Natalia Wright - Head of IP for Patient Supply, UCB
The path to commercialization has become increasingly complex. While technical expertise, quality and speed remain essential, biopharma companies are now making manufacturing decisions against a backdrop of geopolitical uncertainty, shifting trade dynamics, regional market requirements and continued pressure on capital efficiency.
As a result, the criteria for selecting and managing manufacturing partners are evolving. Companies must balance resilience with flexibility, geographic diversification with operational efficiency, and short-term execution with long-term strategic value. At the same time, partnerships are becoming more strategic, requiring greater alignment, transparency, and shared accountability across the product lifecycle.
In this fireside chat, biopharma and industry leaders will discuss how outsourcing and manufacturing strategies are changing in response to today's realities. The conversation will explore how outsourcing priorities have evolved over the past three to five years, whether regionalization, friend-shoring and near-shoring are influencing partner selection, and how companies and manufacturing partners can best balance value, risk and reward to build resilient, long-term partnerships that support successful commercialization.
- Cristina Grigore - Director, Commercial Development INB, EMEA/APA, Lonza
Importance of fostering collaborative ecosystems to drive innovation.
Designing incentive structures like milestone-based models and risk-sharing agreements.
Promoting open innovation while balancing intellectual property protection.
Aligning stakeholders on shared goals through effective communication and trust-building.
Leveraging advanced technologies like AI and automation to support innovation.
Case studies showcasing successful partnerships that accelerated breakthrough therapies
- Matthias Mullenborn - Director Public Private Partnerships, Novo Nordisk
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
This talk focuses on innovation as a key driver of growth in the biopharmaceutical industry. It explores several interconnected dimensions:
- How innovation drives growth in biopharma
- Balancing innovation with scalability
- The role of emerging technologies in growth
- Case studies of innovative breakthroughs
- Future outlook for innovation in biopharma
- Tim Horlacher - VP, Head of Global Clinical Program Excellence, Clinical Development & Operations, Bayer
As geopolitical pressures, supply chain vulnerabilities, and shifting capital dynamics reshape the life sciences landscape, resilience has emerged as the defining principle for how biopharma operates and grows. The era of purely global, efficiency-driven partnerships is giving way to a more complex reality—one where strategic alliances must balance speed, scale, and security.
In this plenary session, leaders from WuXi AppTec and Evotec are joined by voices from global pharma and investment to explore how partnerships are being redefined across the value chain. From discovery through development and manufacturing, the discussion will examine how companies are adapting their collaboration models to navigate fragmentation while maintaining innovation momentum.
Together, they will address critical questions facing the industry: How can biopharma build resilient, future-proof alliances without sacrificing efficiency? What does strategic alignment look like in an era of regionalization and rising geopolitical complexity? And how will capital, capability, and control shape the next generation of partnerships?
Bringing perspectives from infrastructure, platform biotech, pharma, and investment, this session offers a forward-looking view on how the industry can move from reactive risk management to resilience by design—rebuilding the foundations of collaboration for a more uncertain, but opportunity-rich future.
- Helena Smolak - Pharma & Biotech Correspondent, Handelsblatt
- Regina Hodits - Managing Director, Angelini Ventures
- Deepa Talpade - Global Head of BD&L and Strategic Alliances, Oncology, Bayer
- Christian Wojczewski - CEO, Evotec
- Steve Yang - Co-CEO, WuXi AppTec
