Sarmitha Sathiamoorthy
Sam Sathiamoorthy has over 15 years of diverse hands on and management experience working in R&D, pre-clinical, CMC and operational positions for industry leaders such as Sanofi Pasteur as well as in proof-of-concept environments and early phase immuno-oncology and cell and gene therapy companies. She is an expert in GMP/GLP compliant spaces with products under the purview of FDA, EMA and Health Canada.
Sam established AspireBio Consulting, a boutique consulting firm specializing in vaccines, cell and gene therapy and biotherapeutics. Aspirebio is in its third year of growth and is composed of 14+ consultants with areas of expertise in regulatory strategy, CMC technical support, CMC reg, quality, technical and regulatory writing, supply chain and conducting technology assessments and due diligence activities. Sam, as the principal consultant for AspireBio, has supported clients from early regulatory interactions all the way to market authorization, along with stage appropriate CMC regulatory and technical support.