• Developing a robust manufacturing process to support clinical studies and pipeline expansion
• How continuous improvement methodologies are applied in biotech and large pharmaceutical companies to maintain product quality, increase efficiency, and reduce costs over the product lifecycle
• Driving operational efficiency and innovation in clinical and commercial manufacturing
• The importance of building robust, scalable manufacturing processes in biotech, especially in partnerships like Abata’s collaboration with ElevateBio, which has transformed clinical readiness

• Integrating human and organizational performance principles into the design of quality throughout the entire supply chain and ensuring effective implementation
• Embracing risk-based strategies to pinpoint and address potential challenges while prioritizing essential processes and adhering to regulatory standards
• Cultivating a culture of ongoing improvement by utilizing digital tools to streamline processes and elevate overall quality management
• Adopting a proactive stance on regulatory compliance and operational efficiency through effective problem-solving and regular self-assessments

• Overview of the importance of prioritizing patient needs in pharmaceutical logistics and its impact on overall healthcare outcomes
• Identification of key challenges in pharmaceutical logistics, such as delays, temperature control, and compliance with regulations
• Exploration of advanced technologies enhancing supply chain efficiency, including IoT, blockchain, and real-time tracking systems
• Discussion on navigating regulatory requirements and ensuring compliance while prioritizing patient needs
• Strategies for fostering collaboration between manufacturers, distributors, and healthcare providers to create a more responsive and patient-focused supply chain

• Pioneering Gene Therapy Manufacturing: Sarepta’s approach to scaling production and overcoming technical challenges in gene therapy
• Innovative Technologies in Rare Disease Treatment: How cutting-edge tools and platforms are driving the development of treatments for rare diseases
• Optimizing Supply Chain for Precision Medicine: Strategies for ensuring a reliable and efficient supply chain for complex, high-value therapies
• Regulatory Compliance and Quality Assurance: Maintaining compliance and quality in a rapidly evolving regulatory landscape for gene therapies
• Expanding Manufacturing Capabilities: Sarepta’s initiatives to grow manufacturing capacity while maintaining agility and innovation
• Workforce Development in Advanced Therapies: Empowering technical teams to support complex manufacturing processes through specialized training and talent retention Bottom of Form

Global Quality Takeda is reimagining their quality commitments across the value chain. By harnessing data, digital, and emerging technologies like AI, they aim to accelerate product delivery, foster a culture of learning and innovation, and ensure environmental sustainability. They are simplifying, standardizing, and digitalizing quality processes with increased automation and AI, demonstrated through case studies such as one-day batch release, investigation reports, and APQRs. These examples highlight how AI can enable sustainable quality transformation.

• Identifying key drivers of change in the pharmaceutical industry, with a focus on workforce engagement and development
• Strategies for building an organizational culture that prioritizes talent retention, continuous learning, and employee development
• Analyzing whether industry changes will lead to dramatic shifts in workforce dynamics or more incremental adaptations
• Proactive approaches to equipping teams for future uncertainties and maintaining operational resilience in a fast-changing environment
• How the interaction between advanced technologies and human talent will redefine processes and productivity in the next decade
• Ensuring long-term sustainability by focusing on employee well-being, skill development, and leadership empowerment

• Overview of leading one of the world’s largest manufacturing operations through rapid transformation while integrating cutting edge technology
• How GPS delivers value to the enterprise through the Product Development and R&D interface
• The integration of Cell Therapy into GPS and how the company is working to improve predictability long-term
• Establishing a competitive advantage for BMS from within GPS – an operational model built to last
• Examples of GPS’s evolution to support the New Product Pipeline

• Recognizing the pivotal role of quality assurance and quality control in driving key business objectives, ensuring they are strategically aligned
• Upholding adherence to cGMPs, established policies, procedures, and industry standards to maintain regulatory compliance
• Investing in personnel capabilities and knowledge to strengthen the effectiveness of the quality management system
• Ensuring the efficiency and efficacy of global quality management systems across varied operational landscapes
• Deploying advanced tools and techniques to enhance quality assurance and control practices

• Exploring how advanced data analytics and real-time monitoring can improve supply chain visibility, forecasting, and decision-making
• Utilizing digital twin technology to create virtual models of supply chains for better simulation, optimization, and real-time problem-solving
• Adopting digital tools to streamline compliance with regulatory requirements, ensuring product quality, safety, and adherence to evolving industry standards
• The role of AI and machine learning in predictive maintenance, inventory management, and risk mitigation across the pharmaceutical supply chain