Anand Khedkar, Ph.D

Anand Khedkar, Ph.D

 

Anand Khedkar has over 20 years experience spanning various functions in research and development.  He began his career as process development scientist at Biocon Limited, transitioning to formulation development and analytics for biological molecules.

Anand was instrumental in setting up a world class protein formulation and protein analytics group at Biocon R&D. He has led CMC development of several biosimilars (monoclonal antibodies, Insulin analogues) and novel molecules as per the requirements of US FDA, Health Canada, and MPA. He has successfully defended regulatory applications. His expertise includes process development and scale up, technology transfer, troubleshooting formulation development and protein analytical development and characterization, and CQA identification.

He was the innovator for oral insulin (Insulin Tregopil) at Biocon and led the program from lab to advanced clinical development, leading a large cross-functional team and engaging with a Clinical Advisory Board and Key Opinion Leader. He has additionally been involved in several joint development programs for novel molecules, including serving on joint development and steering committees. He is very passionate about development of alternative delivery systems for protein and peptides.

At Apobiologix, Anand was involved in mentoring a team of scientists engaged in biosimilar development; developing a strategy for biosimilars, antibody drug conjugates, and high concentration formulation of monoclonal antibodies; evaluating CROs and CDMOs; and performing due diligence of biosimilar products for in-licensing. He was also involved in developing an oncology product on a 505( b)(2) pathway.

Anand has a Ph.D in protein formulation and characterization from Deakin University, Australia, a Masters Degree from the Institute of Chemical Technology, India in Bioprocess Development, and a Bachelor’s degree in Pharmaceutical Sciences.