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DIRECTOR OF CMC - R&D

Dr. Shaunak Pandya

Dr. Pandya is the Director of CMC, R&D at Prolong Pharmaceuticals, and holds similar position at Kashiv Biosciences. He leads phase-appropriate product development of biologics programs.
Experience

• At Prolong Pharmaceuticals and Kashiv Biosciences, Dr. Pandya has spearheaded the Phase 2/3 manufacturing and development of PEG-Hb, PEG-GCSF, and immunology mAb biosimilars.

• Dr. Pandya’s research experience spans hemorrhage control biomaterials and hemoglobin-based oxygen carriers (HbOCs) for trauma and hypoxia. He was part of the collaborative team at the University of Texas at San Antonio (UTSA) and the U.S. Army Institute of Surgical Research (USAISR) that contributed to FDA guidance on cold-stored platelets.

Previous Roles

• Associate Director, CMC Development at Kashiv Biosciences.

• Principal Scientist, Product Development at Prolong Pharmaceuticals.

Education

• PhD in Biomaterials and Biomedical Engineering from the University of Texas at San Antonio.

• MTech in Bioengineering from the Indian Institute of Technology Kanpur.

• Bachelor of Pharmacy, Nirma Institute of Pharmacy, India.

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