The FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing.

With over two decades of dedicated service in the biopharmaceutical industry, most recently serving as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos provided profound insights into the pivotal role of phase-appropriate quality systems in managing drug development from research to commercialization. Our discussion focused on how these systems facilitate the rapid delivery of treatments to patients in urgent need.

Discussion points include:

• Defining Phase-Appropriate Quality Systems: Carlos detailed these systems as strategic frameworks designed to adapt to the requirements of different stages of drug development, emphasizing their critical role in accelerating the development process.


• Regulatory Framework and Impact: Insights into how FDA guidelines are tailored to expedite the transition from laboratory research to market, highlighting the regulatory nuances that allow for such flexibility.


• Handling Variability in Drug Development: Strategies for managing the inherent variability in early development phases were discussed. Carlos emphasized the necessity of flexible, responsive quality systems that facilitate quick adaptations.


• Analytical Testing and Development Oversight: Carlos explored the significant role of analytical testing in early phases, focusing on controlling and understanding variability to improve assay development continuously.


• Challenges in Preclinical to Clinical Transition: He underscored the importance of maintaining consistency in the quality of preclinical materials to ensure seamless progression into clinical trials.


• Importance of Effective Change Control Systems: The conversation covered how early-stage quality systems should anticipate and manage frequent changes to support rapid learning and adaptation.


• Strategic Approach to Quality System Design: Carlos discussed designing quality systems that reflect the company's risk tolerance and the urgency of patient needs, effectively balancing speed, cost, and compliance.


• Future Trends in the Life Sciences Sector: Carlos provided predictions on the evolution of quality systems to meet the dynamic needs of ongoing and future drug development projects.

Carlos Yuraszeck is a distinguished leader in biopharmaceutical compliance, operations, and quality assurance, specializing in cell therapy manufacturing. Over his extensive career spanning more than two decades, Carlos has significantly impacted the biopharmaceutical industry through his leadership in various pivotal roles. As the Executive Director of GMP Operations at Astellas Pharma US, he led the transformation of research groups into fully operational GMP manufacturing facilities. Earlier, as Senior Vice President of Technical Operations at Talaris Therapeutics, he managed operations focused on groundbreaking organ transplantation therapies. At Celgene, Carlos directed clinical production and supply, where he scaled up manufacturing operations to support the delivery of life-saving CAR T-cell therapies. His tenure in the industry is marked by a commitment to excellence, deep regulatory knowledge, and strategic oversight, which have driven the successful development and commercialization of novel therapies. Carlos's leadership style emphasizes collaboration, transparency, and continuous learning, aiming always to enhance patient outcomes and advance the field of biopharmaceuticals through innovative and efficient manufacturing practices.