Christopher Sheth

Background

About Christopher Sheth

Drug development expert in the nonclinical to clinical translation of drug, biologic, and advanced cell and gene therapy products from discovery, first-in-human dose selection, nonclinical study support for Phase 1-3 clinical trials, nonclinical drug product labeling, and fulfillment of post-marketing commitments and requirements (PMR/PMC). FDA experience included nonclinical (pharmacology [primary pharmacodynamics / secondary pharmacology / safety pharmacology], pharmacokinetic [PK/ADME], and toxicology study) review or oversight of more than INDs, 250 pre-INDs, 175 NDAs and BLAs and/or supplements (CDER/OND/DHOT). Led nonclinical review team for marketing authorization and labeling for more than 40 new molecular or new chemical entities (NME/NCE) and 4 biosimilars, including 21 marketing approvals with pediatric indications. I provide critical analysis of nonclinical pharmacology, PK, and toxicology study plans, toxicology species selection, non-GLP and GLP toxicology study (design, monitoring, and interpretation), developmental and reproductive toxicology (DART) study strategies, drafting and/or review of Special Protocol Assessments (SPA) for carcinogenicity studies, plans for implementing new approach methodologies (NAMs), waiver requests, and preparation of nonclinical drug safety documents for global submissions. My drug regulatory review and drug development experience extends across modalities including therapeutic amino acids, antibody constructs (monoclonal antibodies [mAb], antibody-drug conjugates [ADC], bispecific antibodies [bsAb], etc.), CD marker-directed cytotoxins, cytolytic antibodies [with Fc effector functions, e.g, ADCC, CDC, ADCP], duobodies, Fab fragments, immune checkpoint inhibitors [ICI], T-cell redirectors, trispecific killer engagers, etc.), anticoagulants (e.g, heparins, and direct oral anticoagulants), antifibrinolytics, antihemophilic, chelators, complement inhibitors, cytotoxic chemotherapies, epigenetic modifiers, immunomodulators, immunosuppressives, inhibitors of antiapoptotic proteins, iron replacement products, glucocorticoids, kinase inhibitors, oligonucleotides, oxidation-reduction agents, proteasome inhibitors, retinoids, anesthetics, analgesics, antidepressants, antipsychotics, antibiotics, gene therapies, and cell therapies.