Janice has over 20 years of experience, both in the biopharmaceutical industry and with the Food and Drug Administration (FDA). As a regulatory toxicologist, she developed small molecule as well as biologic therapies, including monoclonal antibodies, bispecifics/trispecifics, ADCs, fusion proteins, cytokines, cell and gene therapies, peptides, enzyme replacement therapies, and ASOs/DNA/RNA based therapies for a broad range of indications (e.g., rare disease, oncology, neurology, pain, psychiatry, ophthalmology, anti-infectives, and immunology). She has authored the nonclinical sections of numerous pre-INDs, INDs/CTAs (>60), Investigator Brochures, annual reports, BLAs/ NDAs, and package inserts/product labels for biopharmaceuticals. She has also represented a number of clients in regulatory authority meetings (US and ex-US).

Ayesha is a pharmacologist with 20+ years of industrial experience in cell biology and pharmacology as well as 5+ years of experience in toxicology. She has developed several biologic therapeutics including monoclonal antibodies, bispecific TCE, ADC and cytokines for oncology, immune-oncology, and immunology targets. Prior to joining ToxAlliance she was at Amunix where she oversaw the preclinical development of multiple lead molecules for oncology including the in vitro characterization and safety/tox evaluation. She also has extensive experience developing murine in vivo pharmacology models (bispecifics and ADCs) as well as the design, monitoring and interpretation of toxicology studies (non-GLP and GLP). Ayesha has authored nonclinical reports and summaries for pre-IND, IND, Investigative Brochures, Annual Reports and BLAs/NDAs.

As a seasoned professional with over 12 years of experience in animal health, laboratory research, and nonclinical studies in areas such as hemato-oncology, gene therapy, and biologics, Gabriela provides tailored solutions within a framework of strict regulatory requirements. Her focus is on study monitoring and contributing to projects from study design to report review, literature search analyses, regulatory submissions (IND) and SEND datasets, while ensuring compliance with GLP standards. Her strong analytical skills and commitment to quality service have not only driven successful outcomes in complex projects for the pharmaceutical and environmental toxicology sectors but also cultivated excellent client relationships. She consistently promotes excellence through rigorous regulatory compliance, effective project management, and innovative problem solving.

Rafael is a board-certified toxicologist with more than 25 years of experience in the biopharmaceutical sector, regulatory bodies, and scientific consulting. He has spearheaded nonclinical safety strategies across a range of therapeutic approaches, including small molecules, biologics, gene therapies, and vaccines. His involvement with small molecules addresses cancer, autoimmune conditions, and infectious diseases, managing toxicology packages from candidate selection through to IND and NDA submissions. Rafael has been instrumental in the design and analysis of nonclinical toxicology studies, such as GLP safety pharmacology, repeat-dose, reproductive, and carcinogenicity studies. He has contributed to over 50 regulatory submissions, spanning INDs to BLAs, in the U.S., EU, and other regions.