ADME New Drug Development (Pk/PD/TK) Toxicology and Safety Consultant

Expertise

• DMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.
• Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.
• IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes fields.
• Designing, monitoring, interpreting, and trouble-shooting the IND enabling studies, including GLP toxicology and safety studies and monkey and dog PK studies in CROs, and non-GLP in vitro ADME (Absorption, Distribution, Metabolism, and Excretion) assays and in vivo PK, PD, and TK rodent animal studies in house.
• Finalizing study reports, gap-analysis of IND studies, and data summaries; major contributor on M2, M4 and M5 sections of IND submission package, and on identifying the first in human dose and designing the clinical PK studies for the clinical protocol and Investigator's Brochure.
• Monitoring the PK studies in clinical phase I/II trials in CROs; designing post-IND Toxicology, safety, and drug-drug interaction studies in CROs.
• Management experience in fast growing environment as team leader for scientific activities, CRO selection, due diligence of license in-and-out partnerships, and pharmaceutical trends/business development.
• In-vitro ADME assays and in vivo PK, PD, and TK animal studies using LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Tandem Mass Spectrometry) techniques and WinNonlink software.
• Investigative toxicology and toxicogenomics using molecular cloning, GeneChip and cDNA microarray, PCR, Western blot techniques.

Experience

IND Studies and Filing Services, San Diego, CA, Consultant, 2015 - Present

• Designing, interpreting, and trouble-shooting the IND enabling studies, including GLP toxicology, safety studies and non-GLP in vitro ADME assays and in vivo PK/,PD, and TK animal studies; Selection of the right CROs in China and U.S.
• Providing services for study report modification, gap-analysis of IND studies, and data summaries/conclusions in DMPK/PD/TK/Toxicology/Safety fields.
• As major contributor on M2, M4 and M5 sections of IND submission package, and on identifying the First in Human dose and designing the clinical PK studies for the Clinical Protocol and Investigator's Brochure. Recommendation and cooperation with experienced exports (including exports in CMC, Medical Writing, E-publishing, and Regulation) to take the responsibility of the submission of whole IND package.
• Designing post-IND toxicology/safety/drug-drug interaction studies in CROs. Analysis of the PK results from clinical phase I/II trials in CROs.
• Providing the high-quality services to meet the client's special requirements in a flexible, cost-effective and timely manner.

ACEA Biosciences, San Diego, CA, Director, 2011 - 2015

• Overseeing ADME PK, TK, and toxic-safety support included protocols, study design, reports, timelines, cost, and strategy of department as key player in the senior management team for the business development.
• Supervised 5 M.S. direct reports and 5 indirect reports to set-up and perform most of IND-required studies under the GLP guideline in house, included PK/TK/PD dosing in rodent animals and biological sample analysis using LC-MS/MS techniques/WinNonlink software, tissue distribution, excretion, metabolite ID, and Caco-2 permeability assays.
• Identified CROs and supervised scientists with Ph.D. and M.S. to monitor out-sourced GLP/non-GLP toxicology and safety and non-rodent PK studies.
• Delivered DMPK/Tox data and reports to help critical decisions making, due diligence of license in-and-out partnerships, and IND submission.
• Extensively interacted with internal medicinal chemistry, CMC, and biology departments for compound screening and SAR, successfully selected two candidate drugs in oncology and inflammation indications, completed the IND enabling studies with high quality, and obtained IND approval both in US and China without a single question to non-clinical parts.
• In charge of clinical PK study design and PK sample analysis of phase I/II of clincal trials for two candidate drugs. Designing post-IND Toxicology/safety/drug-drug interaction studies in CROs.

Medicilon-MPI Inc., Shanghai, China, Senior Director, 2010

• In charge of both in vivo and in vitro DMPK/ADME/Tox services; supervised up to 19 scientists including 6 PhD/MS direct reports to perform non-GLP studies under the GLP guideline; trouble-shooting for the study projects in integrated drug discovery and development.
• Overseen bioanalytical and formulation groups for project support.
• Represented department in senior management/marketing meetings for decision making and business development.
• Maintained and developed client relationship by visiting clients, supported exhibit booth, and presented data in international meetings.
• Prepared documents for regulatory filings and grant application.
• As department head: Responsible for implementing and overseeing protocols, reports, timelines, FTE, cost, and strategy of department.
• Member of IACUC in the company.

ASDI Inc., Newark, DE, Assistant Director, 2007 - 2009

• Set-up a lab and a team, and launched 17 assays in 7 months for in vitro ADME/Tox screening services.
• Supervised Ph.D and B.S. scientists in vitro non-GLP studies including compound solubility, equilibrium dialysis protein binding, and transporter studies using PAMPA assay (Parallel Artificial Membrane Permeability Assay) under the GLP guideline.
• Overseen in vivo PK/TK studies and modeling in rodents using LC-MS/MS techniques and WinNonlink software.
• Involved in decision making regarding the ADME/PK/Tox studies on senior management team meeting.
• Prepared documents for regulatory filings and grant application, and issued the study reports to clients;
• Prepared and Implemented protocols, timelines, FTE, cost, and strategy of department.

Encysive Pharmaceuticals-Pfizer, Houston, TX, Principal Scientist, 2007

• Provided ADME, PK, TK, and toxicology support for all research projects.
• Monitored out-sourced GLP and non-GLP studies, reviewed study reports.
• Supervised Ph.D and B.S scientists in vitro non-GLP studies including in vitro high-throughput CYP inhibition as well as ATPase-vesicular transport assays for ABC transporter studies.
• Represented DMPK and toxicology in project teams to provide data and tabulated summaries for making critical decisions, and prepared documents for IND submission and regulatory filings.

Valeant Pharmaceuticals International, Costa Mesa, CA, Senior Scientist, Drug Development, 2001 - 2006

• Worked as a project leader and study director with M.S. and B.S. direct reports for following projects:
• Profiling toxicology gene expression using microarrays (Affymatrix GeneChip® arrays);
• 14-day oral PK/TK/enzyme induction studies in rodents;
• Phenotyping and inhibition of main CYPs for lead selection;
• CYP kinetics and inhibition studies for IC50, Ki and Kinact determination;
• Protein binding assay by ultracentrifugation in couple with radio-LC-MS/MS;
• Plasma and microsomal stability assays using Tecan automation system;
• In vitro metabolite identification using cell lines and cryo-preserved hepatocytes;
• Transporter studies in human cryopreserved hepatocytes, as well as P-gp activity assay;
• Induction of CYPs using ex vivo rodent animals and in vitro human hepatocytes;
• Identifying covalent binding of carboxyesterases subfamilies to anti-hepatities B prodrug in human liver using isotope-labeling SDS-PAGE, immunoprecipitation and Western blot.

Honors & Publications

Languages

• Chinese-Fluent

Academic and Professional Affiliations

• Society for Biomolecular Sciences (SBS)
• Society of Toxicology (SOT-Full member)
• American Association of Pharmaceutical Scientists (AAPS)
• International Society for the Study of Xenobiotics (ISSX)
• American Association for the Advancement of Science (AAAS)
• New York Academy of Sciences

Publications and Patents

• Author of over 20 peer-reviewed original papers and over 25 meeting abstracts.
• Reviewer of Journal Publication: Brain Research, and BioTechniques.

Education

• Ph.D. Cell and Molecular Biology, Karolinska Institutet, Stockholm, Sweden
• M.S. Tumor Pathology, Fujian Medical University, Fuzhou, Fujian, China
• B.S. (M.D. equivalent), Medicine, Fujian Medical College, Fuzhou, Fujian, China