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

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

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.

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

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

• 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

• 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

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.

• 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

• 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

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