Agenda for Day 2 - Tuesday 10 November, 2026Tuesday, 10 November 2026

Rare diseases represent a compelling opportunity with unique regulatory advantages, significant unmet need, and sustained investor interest across the biopharma ecosystem. This session offers a strategic overview of where the field stands today, examines scientific progress and market dynamics shaping the landscape, and explores the deal activity and partnership models driving innovation forward. As the rare disease space continues to mature, the session discusses investment trends, valuation considerations, and the factors that have and will define success in 2026 and beyond.

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.

30-minute thought leadership

Biotech innovation is increasingly shaped not only by scientific breakthroughs, but by the ability of multiple stakeholders to align around evidence generation, regulatory pathways, and access decisions in parallel rather than sequence. Yet today, these systems remain fragmented across regulators, HTA bodies, payers, and industry partners.

This session explores how emerging ecosystem-based models are breaking down these silos, enabling more coordinated approaches to patient access. From early integration of evidence planning and real-world data generation to closer collaboration between regulatory and reimbursement stakeholders, the discussion will highlight how biotech companies and their partners are rethinking how therapies move from approval to patient access.

Bringing together biotech leaders and ecosystem enablers, this panel will examine how cross-sector collaboration is transforming the traditional linear pathway into a connected ecosystem model, and what it takes to make faster, more predictable patient impact a reality.

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

• 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

• 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

• 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

• 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?

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.

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.

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.

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.

• 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

• 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

• Discuss Australia’s unique position as a global clinical trial hub

• Examine regulatory advantages, patient recruitment strategies and cost efficiencies

• Explore operational excellence in Australia’s clinical trial landscape

• Learn how to assess site feasibility and optimize performance using data-driven approaches

• Discover strategies for expanding trial footprints into diverse and underserved regions

• Understand best practices for streamlining study start-up processes and managing logistics effectively

• Explore innovative solutions, including decentralized clinical trials, to enhance trial success

• Highlight opportunities in Eastern Europe, MENA and medium- to low-income countries

• Explore the role of local partnerships in accelerating trial timelines

• Address infrastructure and resource challenges in emerging markets

• EMA guidelines to operationalise the implementation

• Adapting to the evolving EMA network and its role in shaping GPL processes

• Understanding the key changes under GPL and their impact on your regulatory approval

• Practical scenarios: share different perspectives, identify readiness challenges, and discuss recommendations and next steps

• Latest developments in EMA’s regulatory sandbox and the potential for innovation

• Leveraging the IHI BRIDGE project to advance innovative healthcare technologies

• MHRA’s AI airlock sandbox expansion and its implications for biotech innovation

• Evaluating the potential of in-silico technologies to replace pre-clinical and phase I testing

• 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

• Examining the current state of EU CTR and upcoming changes under the EU Biotech Act

• Comparing the key differences across the US, China, and UK

• Assessing 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