Venkatesha Udupa Mvsc

WORK HISTORY

EDUCATION

ABOUT VENKATESHA UDUPA MVSC

In-depth knowledge of safety assessment and regulatory path for small and large molecules development, novel formulations, impurities, specialty products, excipients, branded generics and understanding of health-based risk assessment. A recognized expert on strategic planning, designing and managing nonclinical toxicology and investigative studies and regulatory submissions and/or agency interactions. Experience in leading cross-functional teams tasked with investigating and resolving specific toxicity issues that are critical in advancing clinical trials for multiple therapeutic areas. Experienced in establishing, managing and oversight of CROs collaborations; monitoring toxicology studies, interpretation of study result, identifying toxicology issues and designing investigative studies to address safety concerns, risk assessment, ensuring conducting studies to meet scientific and regulatory requirements, handling regulatory inquiries, interact with KOLs etc Managed team of scientists and fostered collaboration with cross-functional teams to generate key toxicology & PK/TK data to prioritize nonclinical development portfolios and shape strategy in an emerging and competitive landscape.Established credibility in assessing businesses by identifying improvement opportunities and developing cost reduction programs. Managed generation of the preclinical package as per ICH and GLP compliance for regulatory filings, authored and reviewed nonclinical regulatory reports (CTD Module 4) and supporting nonclinical (CTD Module 2) and clinical documents for INDs and other regulatory filings; prepared pre-IND and CTA briefing documents. Steered agency interactions through pre-IND meetings, type A&C meetings, CAC, etc. Offered services of environmental and human health risk assessment, program management, position document development, deficiency regulatory submissions, and strategy.I am trained in interpreting anatomic pathology, clinical pathology findings from short and long term studies, and vivarium management. Continue to influence the profession and the regulatory environment by serving as VP -Indian Board of Toxicologic Pathology, Past Secretary and Conference Organizing Secretary for STPI, and member STP Scientific & Regulatory Policy Committee, SPS Regulatory Forum Committee, SOT’s Risk Assessment Specialty Section.