Lindsay Pierle
Senior Manager, Lifecycle Management MSAT Johnson & Johnson
Lindsay is currently a Sr Manager at JNJ, where she leads the end-to-end strategy for polymeric materials within the advanced therapies MSAT organization. She has been at JNJ for 2 years and has prior experience in medical device, combination product, and primary container development. She graduated from Virginia Tech B.S. in Mechanical Engineering and minors in Economics and Biomedical Engineering, and graduated from Johns Hopkins with an M.S.E. in Bioengineering Innovation and Design.
Seminars
Cell and gene therapy manufacturers are increasingly constrained by particulate contamination introduced through single use systems, without the safety net of terminal sterile filtration. At the same time, regulatory expectations continue to reflect standards written for large molecule drug products, creating a disconnect between what is technically achievable and what is formally required. This workshop focuses on how manufacturers are interpreting guidance, engaging regulators, and redefining risk in a way that prioritises patient outcomes while maintaining quality and compliance.
This workshop will discuss:
- Assessing the real clinical risk of visible and subvisible particles in cell and gene therapy products
- Interpreting legacy particulate standards and test methods that were not designed for cell and gene therapies
- Balancing regulatory expectations with manufacturing limitations and patient access pressures
- Defining what clean enough means for single use systems without driving unsustainable cost or waste
