Moving an allogeneic cell therapy from breakthrough research at the bench to a multi-center, global Phase 3 clinical trial is incredibly complex. If you don't have a proven roadmap for international commercialization, your therapy risks stalling in regulatory limbo. A single misstep in scaling manufacturing or clinical translation across diverse markets can bleed your startup's capital dry, scare off crucial investors, and prevent life-saving treatments from ever reaching the bedside. You need practical, hands-on guidance from someone who has actually crossed the finish line. You will learn the exact strategies used to run successful pipelines across the US, Canada, Japan, and South Korea, so you can confidently navigate Phase 3 hurdles, accelerate your path to market, and build a commercially viable global therapy.

As the race to develop next-generation cell and gene therapies accelerates, one of the biggest bottlenecks remains patient identification and trial recruitment. Increasingly, sponsors are looking beyond traditional clinical trial markets to regions with unique genetic populations and higher prevalence of inherited diseases that can accelerate translational research. Countries such as Saudi Arabia are gaining attention for their genetically distinct populations, strong rare disease clusters, and expanding genomic initiatives, creating new opportunities for early-phase advanced therapy trials. When combined with emerging clinical infrastructure and leading specialist hospitals, these environments can provide faster recruitment, deeper genetic insights, and stronger clinical datasets. Join clinical and research leaders as they explore how global trial sponsors can strategically engage with emerging patient populations to accelerate development timelines and generate meaningful clinical insights. Key takeaways include: How unique genetic populations can accelerate rare disease and advanced therapy trials Strategies for identifying and activating high-potential trial regions and sites The role of genomic initiatives and population datasets in trial design Best practices for partnering with leading hospitals and research institutions to accelerate recruitment and translational research

Building a fully integrated cell and gene therapy ecosystem is one of the most complex challenges facing emerging biotech markets today. But translating academic research into scalable, sustainable infrastructure is even harder. Saudi Arabia is rapidly emerging as a leader in building a fully integrated cell and gene therapy ecosystem, connecting research, clinical development, and manufacturing into a coordinated national strategy. But turning scientific excellence into scalable, real-world impact requires more than investment; it demands alignment across every layer of the ecosystem. With strong foundations already in place, from world-class research institutions to growing GMP and manufacturing capabilities, the Kingdom is uniquely positioned to accelerate the development and delivery of advanced therapies. The focus is no longer just on innovation, but on enabling that innovation to reach patients at scale. This session will explore: - A clear understanding of how Saudi Arabia is structuring its end-to-end CGT ecosystem; from research through to commercial manufacturing - Insight into the practical steps required to move from academic innovation to scalable infrastructure - Real examples of how biotech hubs like Boston, Ireland and China connected GMP facilities, research institutions, and clinical centres. Join leading voices of who built ecosystems and how Saudi Arabia can turn strategy into execution.

Today, most cell and gene therapies are manufactured in a small number of locations in the US and Europe, creating global supply bottlenecks that delay patient access and increase costs. Across the world, new regions are investing in localized manufacturing capacity to build more resilient supply chains and bring advanced therapies closer to patients. This session explores how emerging biotech ecosystems'including those in the Middle East'are building advanced therapy manufacturing capabilities through strategic partnerships, technology transfer, and public'private collaboration. The real impact of global supply dependency on patient access in MENA How localisation can reduce time-to-treatment and improve outcomes The role of public-private partnerships in accelerating access Why MENA has a unique opportunity to lead in region-specific gene therapies

In the Kingdom, investment decisions are increasingly shaped by long-term national priorities aligned with Saudi Vision 2030 and the National Biotechnology Strategy. Investors are not only evaluating financial returns, but also how a company can contribute to building domestic capability, improving patient access, and strengthening healthcare infrastructure. This session will explore how biotech companies can reposition their value proposition to align with Saudi Arabia's strategic goals ' from enabling clinical trials in the Kingdom and transferring knowledge, to supporting workforce development and local manufacturing. We'll unpack what Saudi investors are truly looking for, where founders often go wrong, and how to move from a data-led pitch to an impact-driven partnership."

In this session, learn how early stage biotechs can design scalable manufacturing platforms from day 1 with the ultimate goal of driving therapy costs under $20000 and discover key lessons and mistakes to avoid during early stage scale up.

What would convince equipment providers, GMP modular builders, and platform developers to establish local operations? A discussion on incentives, partnerships, and long-term strategic positioning.

The global advanced therapy market is highly fragmented. While Europe possesses world-class scientific research, complex regulatory bottlenecks have historically choked commercialization'causing the EU to capture a mere 7% of global health biotech venture capital. At the same time, Saudi Arabia is rapidly building state-of-the-art biomanufacturing infrastructure but requires established translational pathways to co-develop and import these breakthrough assets. If therapeutic developers and regional investors fail to align with the massive legislative shifts happening right now, they risk being locked out of the next wave of global innovation. Europe's forthcoming Biotech Act is fundamentally rewriting the rules for clinical trials, biomanufacturing, and market access over the next 5 years. Ignoring this overhaul means missing out on lucrative cross-border partnerships. For ecosystem builders in the MENA region, failing to capitalize on these newly opened European pipelines jeopardizes the National Biotechnology Strategy's goal of contributing $34.6 billion to Saudi Arabia's non-oil GDP by 2040. You need to understand how to turn global policy shifts into regional commercial pipelines. In this keynote session, a leading European legislative and market translation expert will decode the EU Biotech Act and the new network of Centres of Excellence for ATMPs (Advanced Therapy Medicinal Products). You will discover how Europe's sweeping regulatory overhaul creates unprecedented co-development and investment opportunities for the Middle East, so you can align your cross-border strategies, leverage Saudi Arabia's booming infrastructure, and position your organization at the forefront of the global advanced therapy market.

Discover how investors can create meaningful returns while supporting Saudi Arabia's biotech ambitions. This session dives into early-stage portfolio strategies, risk management, and how to select ventures that combine cutting-edge science with scalable commercialization potential.

' Step by step pathway for regulatory, clinical, manufacturing, commercial entry ' What documentation, partnerships, and timelines global biotechs should expect ' Practical do's/don'ts based on typical mistakes founders make in KSA ' Workshop-style session, structured walkthrough with templates/handouts

China has become one of the fastest-growing cell and gene therapy markets in the world, with a rapidly expanding pipeline, significant investment, and a growing number of clinical trials. However, regulatory complexity and market access challenges still shape how international collaboration unfolds. This session brings together Chinese biotech leaders and global investors to explore partnership opportunities, technology exchange, and how companies can navigate collaboration between China and emerging biotech regions

For decades, the US has been the undisputed engine of biotech innovation'dominating venture capital flows, clinical development, and the commercialization of breakthrough therapies. But as costs rise and competition intensifies, a new question is emerging across the industry: can US biotech still scale without looking outward? At the same time, emerging markets'including the Middle East'are no longer passive destinations for innovation. They are actively competing to become strategic partners in clinical development, manufacturing, and investment, offering capital, infrastructure, and access to rapidly evolving healthcare systems. This panel will challenge conventional thinking on global biotech expansion, exploring whether US companies are strategically expanding'or being forced to globalize'and how this shift is reshaping investor behavior, deal flow, and the future geography of advanced therapies. Key themes: Is US biotech still the dominant global growth engine'or just one of many hubs? Are emerging markets becoming essential partners or opportunistic alternatives? What is truly driving cross-border expansion: strategy, capital efficiency, or necessity? How will global investment flows shift as biotech becomes increasingly decentralized?

What types of global tenants KSA should attract (CDMOs, modality specialists, platforms) What tenants require: incentives, infrastructure, labor, demand guarantee Lessons from Singapore, Ireland, Korea on anchoring manufacturing clusters