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

• Gene therapy products involve multiple modalities (4, 5, or 6 separate projects) converging into one final product, unlike traditional modalities with single projects

• This complexity requires CDMOs capable of managing multi-modality project programs effectively

• Novo Nordisk previously managed a program with five different CDMOs contributing to one therapy, which has since concluded

• The case study would provide a rounded perspective on Novo Nordisk's experience, covering both the search/selection process and the strategic partnership approach

• Confidentiality will be maintained, focusing on the process and the number of CDMOs involved rather than naming specific companies

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

• 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

This session focuses on strategic approaches to achieving seamless and effective technology transfer in biomanufacturing while building future-proof manufacturing capabilities from early development through commercial production. Key topics include:

• Best practices for ensuring smooth and efficient technology transfer processes across all development stages, from preclinical to commercial scale
• Strategies for overcoming common implementation challenges in tech transfer while maintaining flexibility for future manufacturing needs and regulatory requirements
• Leveraging digital solutions to optimize processes and enhance efficiency, creating a robust digital foundation that supports scalability from early development onward
• Exploring the role of automation in streamlining technology transfer workflows and building automated systems that can adapt to evolving manufacturing demands
• Ensuring scalability and reproducibility to support long-term success by implementing early-stage decisions that facilitate seamless transitions from clinical to commercial manufacturing
• Future-proofing manufacturing strategy by anticipating regulatory changes, market expansion requirements, and emerging technologies during initial technology transfer planning
• Developing training programs to empower teams for effective technology transfer execution while building organizational capabilities that support continuous improvement and adaptation
• Creating technology transfer roadmaps that align with product lifecycle stages and support multiple manufacturing scenarios for global commercialization

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