Sulochana Gawande PhD

Sulochana (Sulu) Gawande’s academic background is in clinical cancer research, having done her M.S. and Ph.D. work in the characterization of human leukemia and lymphoma cells. Her career in oncology drug development started at Eli Lilly & Company in 1999. There Sulu gained understanding of oncology publication and submission documents. She established and managed teams of medical writers both in the US and India. Later, as a Clinical Research Scientist at Lilly, she successfully partnered with the clinical lead physician to build a program to test a new Lilly compound for the treatment of colorectal cancer.

As a Submission Management and Regulatory Lead in Novartis Oncology from 2008-2013, Sulu submitted and gained approval for two INDs, led many interactions with the FDA and Health Authorities, and guided teams in the preparation of various regulatory documents including the DSUR, IBs, responses to deficiency or clinical hold, and more. Additionally, she supervised large teams of medical writers in India and the US, and contributed to the strategy and review of commercial and regulatory documents, including those contained in IND and NDA submissions.

Since May 2013, Sulu has been the Head of Oncology Medical Writing at Eisai. She has supervised the submission of the Lenvima NDA and the Halaven sNDA. With her passion in oncology and her experience in clinical, regulatory and scientific communication, she continues to improve the quality and efficiency of preparation of submission documents at Eisai.