Neel Kamal Sharma

• Lead and oversee nonclinical safety studies for ADCs, from study initiation through execution, reporting, and regulatory submission, ensuring compliance with FDA, ICH, OECD, and GLP standards. • Evaluate and manage CRO partnerships, including on-site monitoring, study quality oversight for nonclinical toxicology, pharmacology, and DMPK studies. • Contribute to regulatory filings with robust scientific review and interpretation of toxicology data. • Provide leadership in project management, cross-functional team coordination, SOP development, report writing, and strategic planning of toxicology programs.

• Design, execution, and oversight of GLP and non-GLP toxicology studies supporting global regulatory submissions. • Provide scientific and strategic leadership, integrating toxicology with pharmacology, DMPK, pathology, and regulatory affairs to guide program development. • Oversee CRO partnerships — protocol development, study monitoring, data analysis, and report finalization — ensuring compliance with FDA, ICH, OECD, and AAALAC standards. • Mentor and manage junior scientists, study monitors, and technical staff, fostering growth and maintaining excellence in toxicology study conduct.

• Execute and manage preclinical toxicology and efficacy studies across multiple therapeutic areas, including gene therapy, immunology, oncology, radiation countermeasures, medical devices, surgery, and infectious diseases, using small and large animal models. • Prepare study protocols, IACUC submissions, reports, and regulatory documentation; develop and implement standard operating procedures (SOPs). • Provide scientific and strategic input to cross-functional project teams, contributing to the advancement of programs from early discovery through developmental and regulatory stages. • Prepare and present detailed project updates to stakeholders, facilitate decision-making, and ensure alignment with overall program goals.

• Execute and manage toxicology and efficacy preclinical studies on radiation countermeasures for hematopoietic acute radiation syndrome. • Serve as study monitor while collaborating with external CROs to ensure compliance and data quality. • Provide training and mentorship to junior scientists and technicians. • Conduct testing and validation of radiation countermeasures for safety and efficacy. • Prepare study protocols, IACUC submissions, final reports, and communicate the findings with sponsors.

• Exome sequencing in a family with age-related macular degeneration (AMD), identifying a rare variant predicted to disrupt Fibrillin2 (FBN2) gene function. Developed a point mutation mouse model (Glu1137Lys) and MEFCs to study mechanisms of retinal degeneration, and applied AAV gene therapy to successfully rescue retinal degeneration. • Investigated the role of CP110 protein in centrosome duplication. Generated and characterized a CP110 knockout mouse model, demonstrating that loss of CP110 leads to postnatal lethality in homozygous null pups and that CP110 is essential for anchoring basal bodies to the membrane during ciliogenesis.

 Worked in a clinical trial of AMD patients related to genetic screening to elucidate the factors that may be involved in the development of the age related macular/retinal degeneration and to find if any of those genetic factors are associated with the clinical and socioeconomic status of the patient population and analyzed the effect of drug on improvement of disease.