Amy Siu Email & Phone Number

Watertown, MA, MA, US

Watertown, MA, MA, US

North Chicago, Illinois, US

DMPK project representative

Nutley, NJ, US

• Lead drug metabolism group. Manage in vitro ADME screening and mechanistic studies for regulatory submission. Serve as DMPK representative for discovery, development, and clinical projects. Supervise group of associate.
• Design, plan, and execute in vitro and in vivo studies, investigating impact of drug metabolism in disposition of NCEs.
• Represent DMPK department in oncology, neuroscience, and tropical disease project teams from early discovery into clinical stage, providing DMPK strategies, designing mechanistic studies, analyzing data, and.
• Work as preclinical lead in Integrated Product Team (IPT) for clinical program, participating in discussion on weekly phase 1 activities, biomarker, and translational strategies.
• Serve as study director for drug metabolism studies with external CRO, ensuring reports are generated based on timeline of project and requirements of regulatory agencies.
• Participate in International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) CYP induction working group, reviewing regulatory guidelines and contributing to white paper.

Nutley, NJ, US

• Led drug metabolism group. Managed in vitro ADME screening and mechanistic studies. Served as project representative for discovery and development projects. Supervised 2 associate level scientist.
• Interpreted comprehensive DMPK data, assisting SAR in early discovery project, and driving project strategy and decision making.
• Contributed to nonclinical section writing in IND submission to FDA, drug development plan, investigator’s brochure, and Phase 1 trial protocol for oncology clinical development.
• Mentored 2 direct reports, supervising development, productivity, and compliance.
• Provided metabolite identification and structure elucidation using high resolution mass spectrometry, guiding chemist for SAR in early discovery project.
• Performed various in vitro ADME experiments, characterizing and minimizing DMPK liabilities, including enzyme kinetics, reactive metabolite trapping, plasma / blood stability, and CYP inhibition / TDI / induction, and.

Nutley, NJ, US

• Served as project representative and drug metabolism team member.
• Provided DMPK guidance to project team from discovery stage toward clinical development.
• Performed various in vitro ADME experiments, including metabolic stability using microsomes and hepatocytes, CYP inhibition / TDI, CYP induction, protein binding, and reaction phenotyping for potential DDI assessment.
• Interpreted and communicated ADME study results to project teams, enhancing decision making for the project team.
• Wrote in vitro metabolism reports for regulatory submissions.
• Developed, optimized, and implemented quantitative LC-MS / MS bioanalytical methods for in vivo PK studies and generated results using WinNonlin.

Cambridge, Cambridgeshire, GB

• Performed bioanalytical sample testing for in-vivo PK and PD studies.
• Generated PK and PD reports using WinNonlin for discovery projects.
• Developed bioanalytical methods for small molecules using LC-MS / MS.
• Provided bioanalytical support for in-vitro assays (metabolic stability of microsomes and hepatocytes, and CPY450).
• Conducted plasma protein binding assays using RED devices.

Brentford, Middlesex, GB

• Managed in vitro ADME screening. Performed drug metabolism and drug-drug interaction studies.
• Generated in-vitro ADME results for project team, including S9, microsomes and hepatocyte stability, and CYP inhibition and time-dependent inhibition studies.
• Performed specialized mechanistic studies, such as reaction phenotyping and enzyme kinetic assays, based on project need.
• Designed and conducted induction assays for various CYP450 isoforms in fresh and cryopreserved hepatocytes, using RT-PCR and automating assay on BiomekFX.
• Developed single-point CYP450 inhibition assay that doubled assay throughput.
• Provided bioanalytical support for bioassays using API4000 Triple Quandrupole systems.

Brentford, Middlesex, GB

Developed and patented drug-sensitive assay for Lp-PLA2 activity in human plasma (Patent# US7741020B2)Transferred assay to central testing labs to support clinical trials and epidemiology studies.Supported Lp-PLA2 epidemiology studies with radiometric and colorimetric assays.Received “Exceptional Science Award” for contributions to the Lp-PLA2.

Brentford, Middlesex, GB

Validated immunocytochemical cell-based assays (P38, Erk and Mitotic Index) using Cellomics ArrayScan II imaging technology.Developed automated high throughput assays for IL-6, BrdU, and Erk on Titertek MAPC-II and Biomek FX platforms for comprehensive compound profiling.Created in-house Erk detection kit for Cellomics ArrayScan technology using automated.

Master, Nutritional Biochemistry

B.S, Biochemistry

B.A., Chemistry