Ashwini Kadam, PhD

Ashwini Kadam, PhD, is a results-driven CMC scientist within pharmaceutical sciences and analytical chemistry, specializing in CMC activities for drugs at various stages of development, global manufacturing, technical transfers, and global regulatory interactions.

Ashwini held various roles at Eiger BioPharmaceuticals from 2021 to 2024, including Executive director of pharmaceutical sciences. During her tenure, Zokinvy was approved in the EU (2022) and Japan (2024) for treatment of ultra-rare Progeria indication.

Ashwini worked at Astex Pharmaceuticals, Inc. (US) (now Taiho Oncology, Inc.) from 2019 to 2021 and held responsibility for early phase small molecule oncology programs with focus on analytical chemistry. She managed the utilization of R&D laboratory to support process and formulation development of early phase drug substance and products. She also participated in CMC responses for Inqovi, a solid oral drug for treatment of myelodysplastic syndromes (MDS), including CMML, which was approved in the USA and Canada in 2020.

Before joining Astex, Ashwini worked within the interdisciplinary CMC team at Nektar Therapeutics from 2010 to 2019. Ashwini held positions of increasing responsibility during her tenure developing and managing control strategies for small and large molecule oncology and pain programs at different developmental stages. Ashwini contributed to the CMC regulatory sections of various molecules from early development to NDA/BLA.