Sam Sathiamoorthy, Ph.D.
President
With over 15 years in the biopharmaceutical and medical device industry, Sam Sathiamoorthy, President & Principal Consultant at AspireBio, provides expert consulting services in CMC, pre-clinical, manufacturing, and regulatory aspects. Sam also serves as VP of Business Development & Biological Operations at Ultra Small Fibers, LLC, developing nanofiber-based drug delivery and tissue engineering technologies.
Sam supports early innovators as an advisor for the SPARK program, as well as acting as an expert advisor for the Innovate Calgary program. Previously, Sam led R&D and program management for Vital Bio, creating a SARS-CoV-2 serology product line, built and lead the analytical team at an early phase immuno-oncology company and worked in the analytical research and development at Sanofi where she led the implementation of using NGS for adventitious agent testing.
Sam’s career showcases a strong track record in delivering high-quality products and services from discovery to commercialization in various therapeutic areas. She is highly passionate about customer success and believes in tailor made solutions to fit individual client needs.
Larissa has over 10 years experience in the immuno-oncology field, with industry experience developing and implementing immuno- and cell-based assays to support process development, product characterization and potency. In addition to this expertise, Larissa supports the development and implementation of Quality Management Systems for multiple early phase biotech companies, market and gap assessments and vendor management.
Prior to joining AspireBio, Larissa worked as the Associated Director of Immunology at Turnstone Biologics leading the design, process development, product characterization and tech transfer of early-stage cell therapy products. Larissa received her Ph.D. in Interdisciplinary Oncology from the University of British Columbia and was a post-doctoral fellow at the Ottawa Hospital Research Insititute.
Sindhu Arivazhagan, Ph.D.
Senior Consultant
Sindhu is a Senior Cell and Gene Therapy Consultant at AspireBio Consulting, with over eight years of experience focusing on QC and analytics for oncolytic viruses and cell & gene therapy. Her expertise includes authoring CMC Module 3 sections for IND, IMPD, and BLA submissions, providing critical reviews of analytical strategies, and managing regulatory commitments.
She has led the qualification of various assays, supported process development, and set up Quality Control qPCR labs. Sindhu’s technical writing skills are showcased in her development of analytical method summaries, study protocols, and comparability reports. Her prior roles include positions at Turnstone Biologics, Ology Bioservices, and Brammer Bio (now Thermo Fisher Scientific).
Sindhu holds a Ph.D. in Medical Sciences from University of Florida Gainesville. Her certifications include regulatory affairs training from Duke University and courses on cGMP applications from the University of Florida’s Center of Excellence for Regenerative Health.