On-Demand Webinar: Design and Development of Potency Assays for an Autologous Cell Therapy for Alzheimer's Disease
Duration: 46 minutes
Skin2Neuron's innovative technology converts adult skin into neurons to fight Alzheimer's Disease, showing success in animal studies. This research focuses on integrating Hair Follicle-derived Neuroprecursors (HFNs) into the brain to restore cognitive function.
Defining potency benchmarks is particularly complex due to the dynamic nature of living cells and their multifaceted therapeutic actions. In this webinar, we introduce innovative techniques such as:
- Chemotaxis assays to evaluate cell migration and homing capabilities
- Electrophysiological assessments to measure neurofunctional activity
As we approach human trials, understanding HFNs' Critical Quality Attributes is crucial. Prof Michael Valenzuela will discuss the approach to ensuring HFN cell quality and efficacy, highlighting the use of chemotaxis and electrophysiological assays, and introducing novel in vitro tests with the Incucyte® S3 system.
Cell Therapy Breakthrough: Transforming adult skin into neuronally-committed HFNs to reverse Alzheimer's effects.
Proven Preclinical Efficacy: HFN cells show promise in animal studies, improving memory and synaptic function.
Innovative Potency Assays: Introduction of chemotaxis and neurofunctionality assays to ensure HFN cell consistency.
Rigorous Quality Control: Leveraging the Sartorius S3 Neurosystem for high-standard clinical-grade HFN cell production.
Clinical Trial Readiness: Defining HFN cell CQAs to advance towards human trials and commercialization.
Webinar Speaker
Michael Valenzuela
CEO and Co-Founder
Skin2Neuron
Visiting Professor at the Centre for Healthy Brain Ageing, University of NSW, and former Professor of Regenerative Medicine at University of Sydney, Michael is one of Australia’s most distinguished researchers. Accolades include the Australian Museum Eureka Prize for Medical Research and the National Health and Medical Research Council of Australia Excellence Award, and others.
He is amongst <1% worldwide with research impact across stem cells, neuroimaging, clinical trials & cognition. Michael has led four clinical trials to completion, attracted >$16M in research funds and published 100+ papers with more than 10,000 citations, as well as a popular science book (Maintain Your Brain).
Michael is the primary inventor of the HFN technology, Co-Founder of S2N and Chief Executive Officer. He is an expert panel member of the Australian Dementia Network Memory Clinics initiative, a senior advisor to the International Federation on Ageing, and an advisor to the World Health Organization on healthy ageing and cognition.
