Bringing forward novel medicines to patients with fidelity and speed is more important than ever before. Increasingly, CMC components are on critical path to licensure to address unmet medical needs. In addition, the industry is also experiencing an unprecedented emergence of new modalities that add further complexity to the commercialization cycle. Various approaches are being applied, and lessons learned, to enable the acceleration of CMC deliverables to meet global regulatory requirements and deliver sound scientific understanding for the advancement of biopharmaceuticals to the patients waiting for them. This session will explore innovative approaches to achieve the goal of speed while maintaining process robustness, product quality, and competitive economics, while aiming to cover the following elements necessary to meet our common challenge statement:
• People – Staff are the most essential ingredient in achieving top line results. What are the essential human resources necessary to meet the needs of a dynamic, multi-modality portfolio? How do we prepare and train the workforce of the future to contribute and prosper in a risk based environment that is moving faster than ever before? How we ensure we have the right people in the right place at the right time? What are the behaviors and culture necessary to sustain success?
• Technology – Technology is a critical enabler for advancing biopharmaceuticals across the dimensions of cost, quality and speed. Significant advancements have been made in advanced manufacturing platforms, high-throughput and miniaturized laboratory technologies, and the advent of digital and big data analytics. How do we continue to reap the rewards of robust platforms while supporting multiple modalities? What are the hard asset technologies and in silico models that enable rapid commercialization? How do we overlay the use of digital manufacturing or harness the value of big data to amplify our understanding and knowledge?
• Business Processes – Standard work flows and commercialization deliverables are ubiquitous outputs that are often time critical. How do we adapt these processes (Process Design, Tech Transfer, Comparability, Stability, PPQ, etc..) to provide continued assurance of quality and safety while supporting the necessary speed element?
• Supply chain and operational agility – Examples of capacity modeling to ensure launch volumes are met without overcommitting plant capacity in early lifecycle, while enabling capacity expansion as market demands require through technology transfers or post-launch process improvements; Maintaining supply of high quality raw materials and components is critical to speed, continuity of supply and process robustness
• Regulatory strategy – strategies that allow for a risk balanced approaches to filings and approvals; also enabling strategies for Life Cycle management that provides flexibility in post-launch filings while maintaining compliance to global regulatory guidance