Sathya Janardhanan

Sathya Janardhanan, MS, has over a decade of experience in setting up drug development programs and progressing those programs into Phase 1 and Phase 2 clinical trials. He has successfully contributed to multiple IND applications to the FDA, as well as to the EMA. Sathya specializes in early-stage programs and rapidly accelerating development timelines, cGMP manufacturing planning, facility development, and CDMO management. His background combines chemical engineering that aids with process research and molecular and chemical biology that aids with drug quality method development.

Most recently, Sathya founded and managed Apsis Healthcare, a Process & Analytical Technology startup that worked on design, development and consulting in Biopharmaceutical Manufacturing Technology areas. Here he secured NIH grants and partnerships in the area of online quality attribute detection for biopharmaceutical production processes. Previously, Sathya was a senior scientist at NextCure, where he worked on all aspects of process, analytical and manufacturing development while also leading a team that produced the facility’s Process Automation. Sathya is an active reviewer of biomanufacturing guidance documents at the American Society of Testing Methods (ASTM) and leads consortiums related to process quality detections at National Institute of Standards and Technology (NIST). Sathya secured a Master of Science degree in Chemical Engineering from University of Maryland and a Bachelor’s Degree in Chemical Engineering from National Institute of Technology in India.