Bharat Gurale

About

Dr. Bharat P. Gurale is the Associate Director of Drug Substance at Verastem Oncology, specializing in the lifecycle management of comlex Small Molecule APIs and ADC Pyload-Linkers. With a Ph.D. in Organic Chemistry (National Chemical Laboratory) and over 10 years of industrial experience (Piramal Pharma Solutions and ChemGenes), Dr. Gurale bridges the gap between R&D innovation and commercial manufacturing.

Core Expertise:

Late-Stage CMC: Leading Process Performance Qualification (PPQ) and commercial launch readiness for FDA-approved therapies (e.g., Seladelpar, Mobocertinib).

Technical Innovation: Inventor of the commercial manufacturing process for Seladelpar (WO 2026/030479) and lead author on high-impact papers regarding nucleotide analogs and antiviral therapeutics.

Operational Excellence: Expert in establishing Design Space, Impurity Fate & Purge strategies, and institutionalizing "tribal knowledge" into robust GMP control strategies.

Dr. Gurale actively contributes to the scientific community as an Editorial Board member and peer reviewer for journals such as Journal of Medicinal Chemistry and RSC Advances.

Employment

• Verastem (United States) Associate Director Drug Substance and CMC
  2026 - Present
• Piramal Pharma Solutions Riverview MI Manager, Research and Process Development
  2021 - 2026
• Ash Stevens (United States) Senior Scientist Process Development
  2020 - 2021
• Ash Stevens (United States) Process Development Scientist
  2017 - 2020
• ChemGenes Corp Senior Scientist-Production
  2016 - 2017
• Emory University Research Associate
  2015 - 2016
• Georgia State University Postdoctoral Research Associate
  2013 - 2015

Education

• University of Pune PhD
  2006 - 2012

Projects & Funding

Projects & funding information is unavailable.

Publications (15)

• Hierarchical nickel oxide nanoparticles grown on cobalt oxide micro-bricks as battery-type electrode for high-performance hybrid supercapacitors
  Nano Trends 2026 DOI: 10.1016/j.nwnano.2026.100223
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• Process for Making Seladelpar
  World Intellectual Property Organization (WIPO) 2026
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• Inositol to aromatics –benzene free synthesis of poly oxygenated aromatics
  Carbohydrate Research 2018 DOI: 10.1016/j.carres.2018.03.007
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• Simple in vitro assay to evaluate the incorporation efficiency of ribonucleotide analog 5=-Triphosphates into RNA by human mitochondrial DNA-dependent RNA polymerase
  Antimicrobial Agents and Chemotherapy 2018 DOI: 10.1128/AAC.01830-17
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• Synthesis of biotinylated bivalent zanamivir analogs as probes for influenza viruses
  Heterocyclic Communications 2017 DOI: 10.1515/hc-2017-0088
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• Indirect Detection of Glycosidases Using Amperometry
  Analytical Chemistry 2016 DOI: 10.1021/acs.analchem.5b03943
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• Synthesis and Evaluation of Biotinylated Bivalent HistoBlood Group Antigens for Capturing Human Noroviruses
  Bioconjugate Chemistry 2016 DOI: 10.1021/acs.bioconjchem.6b00226
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• Toward the Development of the Next Generation of a Rapid Diagnostic Test: Synthesis of Glycophosphatidylinositol (GPI) Analogues of Plasmodium falciparum and Immunological Characterization
  Bioconjugate Chemistry 2016 DOI: 10.1021/acs.bioconjchem.6b00542
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• Myo-Inositol 1,3-acetals as early intermediates during the synthesis of cyclitol derivatives
  Carbohydrate Research 2014 DOI: 10.1016/j.carres.2014.08.010
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• Chiral crystals from an achiral mol-ecule: 4,6-di-O-benzyl-1,3-O-benzyl- idene-2-O-(4-methoxybenzyl)-myo-5-inosose
  Acta Crystallographica Section C: Crystal Structure Communications 2012 DOI: 10.1107/S0108270112010001
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