Christopher Sheth Email & Phone Number

FDA experience included non-clinical (pharm/tox) review or oversight of more than 1,000 INDs, 250 pre-INDs, 175 NDAs and BLAs and/or supplements.Expertise in non-clinical to clinical translation of drugs and biologics have enabled successful Phase 1 starts for >100 products to treat malignant and non-malignant hematological diseases.Trained and supervised FDA pharm/tox staff to independently review submissions to the Division of Hematology Products leading to approval of >40 new molecular entities and 4 biosimilars, including 21 with pediatric indications.Critical analysis of non-clinical study plans have led to successful: toxicology species selection and toxicology study durations supporting FDA approval, strategies to assess developmental and reproductive toxicology (DART) and/or use of literature in lieu of DART studies (and PLLR labeling), and agreements on carcinogenicity protocols and/or FDA acceptance of requests for waivers of carcinogenicity studies.Pharm/tox review and development experience with amino acids, antibody constructs (e.g., monoclonals, antibody-drug conjugates, bispecifics, CD marker-directed cytotoxins, cytolytics, duobodies, Fab fragments, immune checkpoint inhibitors, T-cell redirectors, trispecific killer engagers, etc.), anticoagulants (e.g., heparins, and direct oral anticoagulants), antifibrinolytics, antihemophilics, chelators, complement inhibitors, cytotoxic chemotherapies, epigenetic modifiers, immunomodulators, immunosuppresives, inhibitors of antiapoptotic proteins, iron replacement products, glucocorticoids, kinase inhibitors, oligonucleotides, oxidation-reduction agents, proteasome inhibitors, retinoids, and novel therapies.

Listed skills include Toxicology, Pharmacology, Clinical Development, Regulatory Affairs, and 46 others.