Director
Kashiv BioSciences LLC
Ganesh Sangle PhD, Kashiv BioSciences LLC
An innovative, result-oriented scientist with 15+ years of cross-functional research experience in leading drug discovery teams developing NCEs, 505(b)2, and biosimilars/biobetter products. Experienced pharmacologist with PhD/post-doc from Canadian universities (University of Toronto & University of Manitoba) having expertise in multiple therapeutic areas. Proven ability to understand the unmet medical needs, current competitive therapeutic landscape, and identification of novel products/portfolios. Demonstrated capabilities across preclinical pharmacology, cell/molecular biology, drug discovery initiatives, clinical development, pharmacokinetics, nonclinical safety, and IND-enabling studies. Expertise in standardization and validation of various animal models. Core competencies include excellent and broad scientific background with proven expertise in multiple therapeutic areas such as metabolic disorders (diabetes, obesity, NASH/NAFLD), oncology, pain, and inflammation. Well-versed in scientific and medical writing including regulatory support (USFDA, EMA, DCGI, COFEPRIS), human PK/PD studies (phase I), report writing & IP. Project development activities in coordination with SMEs, KOLs, senior management, CROs & cross-functional teams. Performed scientific evaluation for several academic and industry early-stage projects (NCE/505b2) for collaboration/in-licensing opportunities. Leading collaborative projects with several reputed research/academic institutions in India (IIT-Gandhinagar, IIT-Mumbai, IISC-Bangalore), Australia (Bond University) & US (University of Utah, Cleveland Clinic). As a member of the senior management team involved in the identification of novel products/pipelines, research strategy development, planning and execution. To date, 14 publications in peer-reviewed journals, five published patents and 23 scientific abstracts (oral/poster) were presented at various symposiums (US, Canada & India). Contributed to pharmacological profiling of Lipaglyn (Saroglitazar) approved in India & Mexico. Pharmacological profiling of novel dosage forms based on PK/PD correlation from product ideation till marketing authorization (Viltab SR 50mg, O Vildalog 100 SR). Recipient of several fellowships during PhD and post-doctoral training at Canadian Universities.
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Friday, April 28, 2023
7:00 AM – 9:00 AM CST