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Cell and gene therapies have complex – and evolving – testing requirements that must be met to bring these exciting new treatments from bench to clinic, where they can benefit the patients who need them. Testing for cell and gene therapies poses scientific challenges in relation to the inherent variability of the starting material, the small volumes available for testing and rapid turn-around times required for autologous cell therapy testing in particular. But on top of these scientific challenges, the regulatory requirements are evolving too.
Working with an organization with a reputable testing service and expert regulatory support, such as WuXi Advanced Therapies, can help innovators navigate the challenging testing and regulatory landscape as smoothly as possible.
Watch this webinar to learn more about:
Executive Director, Analytical Development and Testing Technologies
WuXi Advanced Therapies
Dr Heather Malicki is Executive Director, Analytical Development and Testing Technologies at WuXi Advanced Therapies. Following an undergraduate degree in biology from The University of Indianapolis and a PhD in Microbiology and Molecular Virology at Thomas Jefferson University Hospitals, Heather began her career in industry at Dupont Pharmaceuticals and Merck, before joining WuXi AppTec in September 2006, and then WuXi Advanced Therapies in 2016.
Executive Director, Testing Operations
WuXi Advanced Therapies
Dr Mike Stump is Executive Director, Testing Operations at WuXi Advanced Therapies, where he brings 15 years of experience in product development, quality assurance, and management of biological products across the CRO, Central Lab and Instrumentation R&D spaces. Mike joined WuXi Advanced Therapies in March 2021, following several years of operations management experience at SME Bio, Eurofins Bioanalytical Services and LabConnect.
Vice President of Quality Assurance and Regulatory Affairs
WuXi Advanced Therapies
Jennifer Cheung is Vice President of Quality Assurance and Regulatory Affairs at WuXi Advanced Therapies. When she joined WuXi Advanced Therapies, Jennifer brought to her role nearly 27 years of quality, compliance and regulatory experience in biotechnology and pharmaceutical manufacturing. In her current role, she supports cell and gene therapy clients by interpreting and applying the phase appropriate GMP regulations and requirements to accelerate development and manufacturing timeline, focusing on client satisfaction and the right first time performance. Jennifer is passionate in promoting GMP convergence, inspection reliance, and data driven, risk based decision-making to maximize patient benefit.
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Informa Pharma Intelligence
