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 Expert  722626

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


Available for your Consulting and Expert Witness Needs

North Carolina (NC)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

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.

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drug development

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bioassay

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biostatistics

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design of experiments

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statistics

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

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.
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response surface methodology

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.
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statistical simulation


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

Work History:
Years   Employer   Department   Title   Responsibilities

2004 to 2007

 

PharmaLinkFHI

 

Biostatistics

 

Sr. Biostatistician

 

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.

2003 to 2004

 

PPD Development

 

Biostatistics

 

Associate Director, Phase I Biostatistics

 

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.

2002 to 2003

 

LipoScience

 

Research

 

Director Experimental Design,Analysis, and Quality

 

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.

1999 to 2001

 

Pharsight

 

Software

 

Scientific Software Strategist

 

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.

1996 to 1999

 

Chiron

 

Biostatistics

 

Biostatistician III

 

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.

1992 to 1996

 

Syntex/Roche

 

Biostatistics

 

Research Biostatistician

 

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).

1991 to 1992

 

Memphis State University

 

Mathematics and Statistics

 

Visiting Assistant Professor

 

He taught graduate and undergraduate statistics. Classes included probability and inference. He also engaged in statistical research.

1990 to 1991

 

University of Rochester

 

Statistics

 

Visiting Assistant Professor

 

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:
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.

Selected Publications and Publishers  
 - Statistics in Medicine  
 - U.S. Patent and Trademark Office  
 - Communications in Statistics  
 - Biopharmaceutical Section of the American Standards Association  

Consulting Services:
Selected Consulting Examples:
  • 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.
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Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Developed PK/PD basic training for Pharsight. Presented seminars on each of bioassay analysis and assay validation. Taught at the university level for 2 years before entering industry.


 

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