Dr. Sweta Kumar, DVM, ERT, UKRT

Lead nonclinical development strategy across all stages of drug development, from early discovery through IND/CTA submission. Design and oversee fit-for-purpose toxicology programs, including repeat-dose toxicity, biodistribution, safety pharmacology, immunotoxicology, and reproductive/developmental risk assessments. Provide strategic risk assessment and first-in-human dose justification aligned with global regulatory expectations (FDA, EMA, TGA). Advise on nonclinical requirements for advanced therapeutic modalities including mRNA-LNP platforms, antibody–drug conjugates (ADCs), siRNA, T-cell engagers, and gene and cell therapies (AAV, CRISPR-Cas9, CAR-T). Support successful global regulatory submissions, contributing to multiple INDs across diverse therapeutic areas and routes of administration. Supported 15+ successful HREC and IND submissions across oncology, immuno-oncology, metabolic disorders, rare diseases, neurology, and infectious diseases. Collaborate cross-functionally with CMC, clinical, and regulatory teams to ensure integrated and streamlined development plans. Anticipate and mitigate regulatory risks for novel platforms, aligning innovative technologies with evolving health authority guidance.

Nonclinical drug development and regulatory consultation and preparation of IND packages and IBs for a range of therapeutics including small molecules, antibodies and cell and gene therapy products. Review of nonclinical data, gap analysis, and preparation of drug development plan. Resolution of queries raised by health authorities and ECs.

Regulatory oversight for Phase I to Phase III studies in the APAC region which included a range of therapeutic areas including oncology, neurology, and infectious disease trials and coordination among different teams across geographies. Review of submission packages, MTAs, regulatory plans, SMPs, and maintenance of regulatory documents necessary for study start up. Resolution of health authorities and ethics queries.

Regulatory consultation and preparation of briefing documents to different regulatory authorities. Preparation of different modules of CTD/eCTD, especially modules 2 including nonclinical overviews and summaries. Review of the nonclinical data and preparation of regulatory development plan.

Review of the nonclinical data and writing different modules of CTD, protocols, IBs and other toxicological reports such as PDEs. Drafting PMCF plans and reports for medical devices. Regulatory consulting.

Evaluation and consulting on the nonclinical aspect of Regulatory submissions documents. Compilation of 510(K), CER and De Novo submission documents.

Established a café cum pet saloon in partnership Undertook and delivered multiple medical & Regulatory writing assignments for different startups Convener of a Coaching institute, Career Counseling: Mentored kids and Young adults

University Merit Scholarship holder throughout the 9 semesters (2nd Rank). 32nd rank in Bihar Public Service Commission for the post of AHO/BHO (Gazetted Rank).