Drug Metabolism - Pharmacokinetics Expert Specific to Drug Discovery and Early Drug Development

Technical Consultant #2029

ADME, (Absorption, Distribution, Metabolism, and Excretion) and PK (Pharmacokinetics) in drug discovery.
Early drug development.
In vivo and in vitro enzyme induction.
Cytochrome P450 enzyme inhibition and potential for drug-drug interaction.
In vitro and in vivo metabolism and metabolite profiling.
Preclinical studies to evaluate ADME, toxicokinetics, and PK profile of drug candidates.
Due diligence to evaluate DMPK profile of drug candidates for potential purchasing or in-licensing opportunities.
Interaction with CROs for contracting and monitoring ADME and PK studies as well as report generation.
Set-up of high-throughput Caco-2 absorption screening systems.

Expert Witness Experience

Undisclosed Company, Owner and Founder, 2010 - Present

Oversee drug discovery teams, select candidates and manage teams.
Review studies, protocols and reports.
Plan ADME and PK studies.
Review and interpret data for absorption, distribution, metabolism, excretion and pharmacokinetics (ADME and PK) studies; and cytochrome P50 inhibition and induction.
Scientific review of ADME for Investigative Drug Application (IND).
Due Diligence to evaluate a drug candidate for possible licensing or purchasing opportunities.
Interact with contract research organizations (CROs) for planning and follow-up ADME studies.

Schering-Plough Research Institute, (Merck Research Laboratories), Kenilworth, NJ, 1995 - 2010

Distinguished Fellow, Metabolism and Pharmacokinetics Dept. Exploratory Drug, 2005 - 2010

Directed the research activities of 7 scientists including Ph.D. level scientists. Responsibilities included:
Utilizing LC-MS/MS for in vitro DMPK screening assays including Caco-2 cell automated permeability, CYP inhibition, protein binding, isozyme profiling, metabolic stability and hERG mock run samples.
In vivo enzyme induction in rats and in vitro enzyme induction in rat liver slices.
Designing preclinical studies to evaluate absorption, distribution, metabolism, excretion, toxicokinetics, and pharmacokinetics of drug candidates in animals.
Representing the DMPK Department in three drug discovery teams, and overseeing five other drug discovery teams.
Responsibilities included formulating and implementing DMPK strategies, setting priorities, tracking studies and interacting with various discovery and development partners including pharmacology, chemistry, chemical development, drug safety, pharmaceutical sciences, clinical pharmacology and clinical research.
Membership in two Early Drug Development Teams, which manage and oversee the transition of recommended candidates from discovery to the completion of Phase 2 clinical trials.
Representing DMPK in numerous due diligence assignments to evaluate drug candidates for potential purchasing or in-licensing opportunities.

Director, Drug Metabolism and Pharmacokinetics, 2000 - 2005

Directed the research activities of 15 scientists including 3 Ph.D. level scientists with the following responsibilities:
Analytical method development and sample analysis.
In vivo and in vitro enzyme induction.
Caco-2 cell automated permeability screening.
In vitro and in vivo metabolite profiling and isolation.
The performance of preclinical studies to evaluate ADME and PK of drug candidates in animals.
Representing the department in six drug discovery teams.

Director, Drug Safety and Metabolism Fellow, 1995 - 2000

Supervised the activities of 16 scientists including five Ph.Ds.
Analytical method development and validation.
In vivo and in vitro enzyme induction.
Cytochrome P450 enzyme inhibition.
Caco-2 cell and blood / brain barrier permeability screening.
P-Glycoprotein (MDR1) interactions.
In vitro and in vivo metabolism and metabolite profiling.
Preclinical studies to evaluate ADME, toxicokinetics, and PK of drug candidates.
Bioanalytical support for formulation development.
Interacting with contract research organizations to perform bioanalytical and in vitro and in vivo preclinical PK studies.

Languages

Academic and Professional Affiliations

Member, American Society of Pharmacology and Experimental Therapeutics (ASPET)
Member, International Society for the Study of Xenobiotics (ISSX)
Served as the Industry Advisor for a Ph.D. Graduate Student, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey.
Collaborating with fellow colleague of the Department of Chemistry, Kalamazoo College, Preformed studies on CYP2D6 and CYP3A4 mechanism based inhibition.

Awards

Schering-Plough Research Institute (SPRI) President's Award for Discovery (highest award, 3).
SPRI Premier Award for the setting-up and validating a high-throughput cytochrome P450 inhibition screening assay.
Several Impact Awards in drug discovery and development.

Publications and Patents

More than 125 papers have been published in peer-reviewed national-international journals, in addition to 4 review articles and 6 book chapters.
Invited Lecturer in Pharmacokinetics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey.
Numerous national and international patents.