Satish Panchal

WORK HISTORY

EDUCATION

ABOUT SATISH PANCHAL

American Board of Toxicology certified (DABT) and European Registered (ERT,EU/UK) Toxicologist and Indian Board of Toxicologic Pathology certified Toxicologic Pathologist (DIBTP) having more than 24 years of experience with CRO and pharmaceutical industry in India. Experience in managing toxicology and toxicologic pathology functions and scientists; mentoring and coaching junior toxicologists and pathologists. Passionate about use of digital pathology in toxicology pathology and strong association with AIRA Matrix for the development of various digital pathology solutions for toxicologic pathology. Managed toxicology and toxicologic pathology data for 15+ IND and regulatory dossiers for supporting Phase 1/2/3 clinical trial applications globally. Demonstrable technical leadership skills and proven track record of significant achievements (e.g. IND filings, IBs, CTAs, NDA). Wide experience in planning and execution of toxicology and toxicologic pathology strategies for drug discovery and non-clinical safety assessment (small molecules, synthetic peptides, biosimilars and vaccines) in various therapeutic areas (Metabolic Disorders, Ophthalmology, Dermatology, Fibrosis and Oncology) with implementation of SEND and INHAND.Primary and peer review pathologist (150+ toxicology studies per GLP and ICH guidelines) for performing microscopic evaluation of tissues of rodent (rats, mice) and non-rodent species (rabbits, monkey) in non-GLP and GLP safety assessment studies (acute, chronic, carcinogenicity, developmental and reproductive toxicity). Regularly attending continuing education courses and conferences and excellent networking with experts in toxicology and pathology to maintain Toxicology and Toxicologic Pathology expertise. Excellent track of scientific publication (12+), regulatory and research pathology reports (150+) and presentations in scientific meetings/courses/seminars (50+). Well recognized as experienced toxicologist and pathologist in the CRO and pharmaceutical industry.Overseeing and managing Laboratory Animal Resource function, played significant role in achieving and maintaining accreditation and GLP certification.Recipient of SHINIG STAR award twice for successful submission of IND and NDA of a topical drug developed under 505(b)(2) pathway and recipient of WELL DONE award at Sun Pharma for successfully clearing DABT exam in short time.Species familiarity: Rat, Mouse, Rabbit, Dog, Guinea Pig, Non-Human Primates (NHP)