Noriaki Tatsuta

Leading Drug Metabolism and Pharmacokinetics/ Bioanalysis

Led nonclinical DMPK, nonclinical Safety, and Bioanalytics (GLP bioanalysis, metabolomics, and exploring biomarkers)

Led Nonclinical DMPK/Safety and Bioanalytics

Provide consulting services to small and mid-size pharmaceutical companies - Discovery DMPK support (triage for lead selection and optimization). DMPK related data analysis (including GLP bioanalysis and PK/ TK data) and interpretation. Support CRO selection and protocol review. Report writing and review. Strategic consulting of DMPK/Clinical Pharmacology in preclinical and clinical stages. Gap analysis in regulatory documents (IND, NDA, GLP report, Module 2/4/5 etc). Communication support between companies (in Japanese and/or English).

Provide consulting services to small and mid-size pharmaceutical companies : indication includes oncology, inflammation, infectious disease, and orphan drug- DMPK related data (including GLP bioanalysis and PK/ TK data) analysis and interpretation. Protocol review and CRO selection. Report writing and review. Strategic consulting of DMPK/Clinical Pharmacology in preclinical and clinical stages. Gap analysis in regulatory documents (IND, NDA, GLP report, etc).

Supervised DMPK group Characterized ADME properties and feedback to the chemistry/biology team in timely fashion to help to create a new molecule with favorable drug-like property. Served as the DMPK group (in vivo/in vitro ADME, GLP bioanalytical and PK) representative; developed strategies to ensure effective achievement of lead-optimization, candidate selection and clinical development (IND, NDA filing, etc.) within Synta, and served as a co-leader with strategic partners. Facilitated activities and project timelines/priorities across multi-functional groups to meet departmental and corporate objectives. Managed resources (FTEs, equipment, outsourcing), budget and priority forecasting for R & D projects; established scalable internal DMPK team or collaborative management of outsourcing. Interacted with other functional areas such as Clinical Pharmacology, Clinical Operations, Data Management, Quality Assurance Unit (QAU) and Regulatory Affairs to ensure effective achievement of drug development.  Prepared, reviewed, and approved documents (SOP, protocol, report, regulatory document, etc.). Monitored and ensured solid GLP benchmark quality system in conjunction with QAU along with continued improvements to meet GxP regulations/guidelines. Mentored and developed staff members to ensure the efficient operation of the function.

Created and supervised DMPK group (15FTEs: Discovery DMPK and GLP group). The group covered discovery DMPK (early drug discovery and lead optimization) and preclinical/ clinical DMPK activities including GLP bioanalysis.  Built up and supervised in-house GLP group. The GLP group conducted bioanalysis, dose formulation analysis, and pharmacokinetic analysis using WinNonlin under GLP conditions. Preparation and review of ADME section in regulatory documents such as IND, IB, CTA and IMPD.

Created and led DMPK group (4FTEs). The group covered discovery DMPK (early drug discovery and lead optimization) and preclinical/ clinical DMPK activities. The group conducted in vivo DMPK using rodent for PK characterization of molecules, and in vitro screening assays including CYP inhibition, metabolic stability and metabolite identification for lead optimization and candidate selection Established and implemented in vivo PK screening using rodent and in vitro assays. Study Monitor of DMPK studies in CRO: Study design, protocol review, communication and report review. Contributions to the preparation of ADME section in regulatory documents such as IND, IB (3 INDs).

Established SBR DMPK group. The group covered discovery DMPK (early drug discovery and lead optimization) and development (preclinical/ clinical) DMPK activities