Expert Details

Expert in PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design

Expert ID: 722626 North Carolina, USA

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He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring analysis plans met study needs, and maintaining quality. Studies included bioequivalence, dose ascending trials, dose proportionality, and drug interaction studies, analgesia efficacy studies, among others. He was responsible for maintaining compliance with current regulatory guidance and regulations.

He was responsible for all non-clinical and preclinical statistics, as well as clinical development of in vitro diagnostics devices and bioequivalence studies. Specific studies included process optimization via experimental design (DOE), quality control of manufacturing and assay processes, design and analysis of guardband studies, process validation and assay validation, and assay and bioassay development.

Designed multifactor studies to estimate expiry dating, including bracketing designs. Analyses included in many NDAs. Have expertise in both human and veterinary products.

Designed and analyzed response surface designs in fields such as drug manufacturing, formulation design, assay (measurement system) development, gage studies, and computer simulation. Taught courses in RSM to industrial clients.

Have simulated Rensselaer County's sheriff department, several clinical trials, PK/PD models. Simulation models are very useful to understand any complex, dynamic system. Clinical trial simulations, for instance, can allow for the development team to properly power the trial, estimate the effects of inclusion/exclusion criteria, and even help optimize the supply and manufacturing of clinical trial drug supplies.

He has performed population PK/PD modeling for a pharmaceutical company. As part of this work, he reviewed the tables, listings, figures, and study report from a CRO.For a vivarium CRO, he has analyzed mice data for various endpoints. Services included review of the data, generation of table, listings, and figures, analysis of the data using appropriate statistical techniques, and writing the statistical section of the study report.He has analyzed toxicology study. He performed the appropriate analysis, generated the tables and listings, and wrote statistical section of toxicology report.

Expert may consult nationally and internationally, and is also local to the following cities: Raleigh, North Carolina - Greensboro, North Carolina - Durham, North Carolina - Winston Salem, North Carolina - Fayetteville, North Carolina - Cary, North Carolina - High Point, North Carolina - Greenville, North Carolina - Concord, North Carolina - Rocky Mount, North Carolina

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Education

Year Degree Subject Institution
Year: 1990 Degree: Ph.D. Subject: Statistics Institution: Virginia Polytechnic Institute and State University
Year: 1987 Degree: M.S. Subject: Operations Research and Statistics Institution: Rensselaer Polytechnic Institute
Year: 1985 Degree: B.S. Subject: Mathematics and Statistics Institution: Utah State University

Work History

Years Employer Title Department Responsibilities
Years: 2004 to 2007 Employer: PharmaLinkFHI Title: Sr. Biostatistician Department: Biostatistics Responsibilities: Consult with clients to design clinical trials in Phases I through III, analyze and interpret trials, represent clients at FDA. Also engage in PK/PD analyses, including population modeling, for clients.
Years: 2003 to 2004 Employer: PPD Development Title: Associate Director, Phase I Biostatistics Department: Biostatistics Responsibilities: He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring analysis plans met study needs, and maintaining quality. Studies included bioequivalence, dose ascending trials, dose proportionality, and drug interaction studies, analgesia efficacy studies, among others. He was responsible for maintaining compliance with current regulatory guidances and regulations.
Years: 2002 to 2003 Employer: LipoScience Title: Director Experimental Design,Analysis, and Quality Department: Research Responsibilities: He was responsible for developing data analysis techniques for better characterizing lipids. He also was responsible for quality control methodology and training. While at LipoScience, Expert wrote a patent in the metabolomics field.
Years: 1999 to 2001 Employer: Pharsight Title: Scientific Software Strategist Department: Software Responsibilities: He was responsible for providing the scientific expertise and guiding the scientific development of the industry leading WinNonlin for single subject PK/PD modeling, WinNonMix for population PK/PD modeling, and Trial Simulator software products. Responsibilities included leading the scientific advisory committees for these products, designing and implementing new algorithms, validating the code, and providing statistical training to the consultants and to external clients. He also implemented the individual and population bioequivalence algorithm, the details of which are in his paper on bioequivalence, and implemented the linmix/average bioequivalence procedure.
Years: 1996 to 1999 Employer: Chiron Title: Biostatistician III Department: Biostatistics Responsibilities: He was responsible for all nonclinical and preclinical statistics, as well as clinical development of in vitro diagnostics devices and bioequivalence studies. Specific studies included process optimization via experimental design (DOE), quality control of manufacturing and assay processes, design and analysis of guardband studies, process validation and assay validation, and assay and bioassay development.
Years: 1992 to 1996 Employer: Syntex/Roche Title: Research Biostatistician Department: Biostatistics Responsibilities: His responsibilities included assay development and validation, process development, implementing experimental design methodology (DOE) within the development organization, preclinical studies, stability studies, consulting on clinical trial design and analysis issues. With Mike Hale, he designed the first successful randomized concentration-controlled trial, and initiated the field of computer aided trial design (CATD).
Years: 1991 to 1992 Employer: Memphis State University Title: Visiting Assistant Professor Department: Mathematics and Statistics Responsibilities: He taught graduate and undergraduate statistics. Classes included probability and inference. He also engaged in statistical research.
Years: 1990 to 1991 Employer: University of Rochester Title: Visiting Assistant Professor Department: Statistics Responsibilities: He taught graduate and undergraduate statistics. Classes included probability and inference. He also engaged in statistical research.

Career Accomplishments

Associations / Societies
Sigma Xi research society
Mu Sigma Rho, and president of Virginia Alpha chapter 1988-1989
Awards / Recognition
Invited to participate in NSF-sponsored Statistics Industry/Academia Collaboration Project
Publications and Patents Summary
He has a patent on a metabolomic approach to characterizing lipids in plasma, as well as publications on topics such as bioequivalence, assay validation and development, bioassay analysis, trial aided design, randomization concentration controlled trials, and use of genetic data in trial design and simulation. He is also writing a book on PK/PD biostatistics.

Fields of Expertise

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