Ratanesh Seth, Ph.D. DABT

Independent Toxicologist specializing in in vitro/in vivo and mechanistic toxicology, including gut–brain axis research. Experienced in IND-enabling toxicology, nonclinical regulatory writing (IND/CTA/NDA, Investigator’s Brochure), and safety expert reports. Provide protocol review, study design input, sponsor-side toxicology oversight, and GLP study report/QA review. Also support SOP development, training of junior toxicologists, and advisory or expert opinion roles.

Serve on the board for advising on how to use AI in the workplace, recognizing potential pitfalls (what can go wrong) for a business, improving customer engagement with the business, identifying which business needs can be solved by AI, leveraging AI to reduce costs, and identifying how to use AI for creative innovation.

• Oversaw GLP-like in vitro and in vivo toxicology studies • Designed study protocols, optimized assays, and processes to meet regulatory standards. • Served as the primary client liaison, collaborating with bioanalytical, toxicology, and in vivo teams. • Mentored Toxicology scientists, fostering knowledge-sharing and technical growth. • Led innovative assay development for BBB, Neurotoxicity, and cardiac structural toxicity assays to fill the gap in the toxicology portfolio. • Provided scientific guidance during audits and ensured timely resolution of issues impacting data integrity or study delivery. • Led EHS and regulatory compliance.

• Directed $2M+ federally-funded clinical trials (VA), managing FDA-IND submissions, IRB/IACUC approvals, and VA ACORP compliance across 54+ multi-institutional collaborations • Authored regulatory documents, including SOPs, study protocols, and IND applications, achieving 100% on-time delivery and 95% first-pass approval rate • Led cross-functional teams of 7+ personnel implementing project management frameworks that improved milestone completion by 25% across academic and government research environments • Designed mechanistic studies on environmental toxin-induced pathology and gut-liver-brain axis, resulting in peer-reviewed publications and $1M+ follow-on funding • Mentored 10+ research professionals while improving lab productivity by 30% and maintaining zero major protocol deviations • Taught undergraduate coursework in Toxicology, Environmental Health Sciences, and People Safety as part of academic service.

• Executed in vitro and invivo experiments using cell culture, molecular immunology, biochemical techniques. Performed advanced biochemical assays with 95% data quality standards for grant-funded research programs • Published 49+ peer-reviewed manuscripts and presented findings at 25+ national/international conferences; contributed innovative research concepts that secured 3+ new funding opportunities • Coordinated multi-laboratory collaborations across 8+ institutions; provided grants management services for $2M+ portfolio while maintaining 100% compliance with federal reporting requirements • Taught 4+ courses annually including Environmental Pollution and Health (ENHS 321) and Molecular Techniques in Environmental Pathophysiology, maintaining 4.5/5 student evaluation scores and contributing to departmental teaching mission

• Conducted research on molecular mechanisms and immunological regulation in disease progression of environmental toxin-induced non-alcoholic fatty liver (NAFLD)/non-alcoholic steatohepatitis (NASH) in a murine model. • Performed molecular lab techniques to study modulations in DNA/RNA, protein, and biochemical pathways. • Presented observations/significant data in national/international conferences. • Prepared and published manuscripts of research findings. • Managed laboratory and ensured lab safety. • Supervised graduate students and trainees in the laboratory. • Assist the PI with grants management services; contribute novel research ideas for ongoing and future projects.

• Prepared regulatory submissions (IND, IB, ANDA) contributing to 10% revenue increase • Developed SOPs for regulatory filing improving documentation quality by 20% • Ensured 100% compliance with FDA guidelines and international regulatory standards

• Conducted research on molecular mechanisms and serum immunoglobulin regulation in Malaria infection. • Conducted field visit and sample collection from patients in malaria epidemic locality/state. • Conducted in vitro culture of malaria parasite (P. falciparum) and performed drug testing. • Developed and characterized a monoclonal antibody against the malaria parasite. • Presented observations/significant data in national/international conferences. • Prepare and publish manuscripts of research findings.