David Brott Email & Phone Number

Tokyo, JP

Using strategies, tools, processes, and external/internal experts to predict, identify, characterize and minimize risks within a product, both across medicinal products and across the life cycle.- Predict - based on medicinal product target, modality, patient characteristics, manufacturing quality (and more) predict the risks and develop the clinical.

• Advance the science to better predict, identify, evaluate and mitigate risks (organ specific and non-organ toxicity), based on a risk-benefit approach using medical and patient perspectives as well as innovate and.
• Backup person responsible for benefitr-risk profiles across the company portfolio using the BRAT Framework.
• Translational safety: Developed vision and then piloted a process to advise non-clinical safety and capture risks (with mitigation plans) for clinical safety strategy development and updating from Target Identification.
• Led a cross-functional (matrix) and international team that evaluated “Translational renal biomarkers in diabetes”. Led the strategy development and oversaw the research project. Included vendor assay comparison
• Led and project managed 16 different Predictive Safety projects and budget (including “Translational renal biomarkers in diabetes”)

Cambridge, Cambridgeshire, GB

• Responsible for discovery, translational project support and biomarker efforts to determine toxicities in preclinical studies and troubleshoot potential clinical risks
• Member of a translational problem-solving team that helped EMA approval of Ticagrelor. We determined there was no human relevance of the increased uterine tumors observed in the rat 2-year carcinogenicity study.
• Involved in regulatory inspections
• Led the formation of a translational renal biomarkers in diabetes cross functional and international AZ team
• Developed and validated assays to evaluate organ specific toxicities (e.g. kidney, muscle/cardiac and vascular) using robotics, flow cytometry, multiplex biochemical assays (Meso Scale Discovery [MSD]; Rules Based.
• Developed and was the preclinical lead of the hematology (bone marrow) SKG: Developed a three-tier assay approach to predict and detect hematotoxicity. Developed the assays and data analysis procedures and then.

Brentford, Middlesex, GB

• Due to transition of SB to GSK, I had six different roles ranging from biomarker development in infection, clinical biomarker validation for a clinical sepsis collaboration, to initiating a high throughput secondary.
• Biomarker development and assay validation in imaging, flow cytometry, robotics, ELISA and multiplex.
• Biomarker: Coagulation instrument and assay validation under CLIA ‘like’Biomarker assay development for discovery project support in Infection. Efficacy and secondary assays in oncology

Doctor Of Philosophy (Ph.D.), Toxicology

Master Of Public Health (Mph), Toxicology