Senior Consultant, Biologics Consulting Group, Inc., Montgomery Village, MD

• Design preclinical pharmacology and toxicology study protocols and nonclinical programs
  
• Develop and review strategic product development programs
  
• Identify, qualify and audit nonclinical toxicology contract research organizations (CROs)
  
• Source and manage preclinical pharmacology, pharmacokinetic and toxicology studies
  
• Serve as project or program manager, maintain timelines, budgets and milestones
  
• Facilitate communication and liaison between sponsor and nonclinical CROs
  
• Perform on-site study monitoring for pharmacology and toxicology studies
  
• Identify and develop efficacy models, source and manage pharmacology studies
  
• Prepare and review nonclinical regulatory documents including IND, Pre-IND and CTD submissions
  
• Review and revise nonclinical study reports for regulatory submissions
  
• Author, review and revise position papers, scientific manuscripts and technical reports
  

Manager, Preclinical Development, Drug Development Division, TherImmune Research Corporation, A subsidiary of Gene Logic, Inc.

• Served as Toxicologist and Project Manager for Preclinical development programs
  
• Managed preclinical drug and biologic development programs at TherImmune
  
• Provided nonclinical regulatory support and authored preclinical IND and pre-IND sections
  
• Developed Strategic Development plans for drug and biopharmaceutical products
  
• Identified, qualified and managed nonclinical pharmacology and toxicology laboratories
  
• Outsourced and managed nonclinical safety studies at outside contract service providers
  
• Served as on-site study monitor for client's crucial IND-enabling GLP toxicology studies
  
• Designed nonclinical pharmacology and toxicology studies
  
• Prepared and reviewed nonclincial study reports, position papers, scientific manuscripts and/or technical reports.

Manager of Pharmacology/Toxicology, SRA Life Sciences, Falls Church, VA.

• Served as both project manager and a technical manager, providing technical expertise in the areas of pharmacology and toxicology.
  
• Served as client liaison with nonclinical CROs
  
• Designed pre-clinical pharmacology and toxicology studies, and performed on-site study monitoring on behalf of clients
  
• Assisted in the development of strategic product development plans.
  
• Prepared nonclinical pre-IND and IND submissions, and study monitoring reports
  
• Identified nonclinical CROs, sourced and managed nonclinical pharmacology and toxicology studies
  
• Prepared and reviewed study monitoring reports, preclinical assessments and study reports
  
• Authored scientific manuscripts and provided clients with concise information on specific models or scientific paradigms relevant to their product development plans.

Research Scientist, SRA Life Sciences, Rockville, MD.

• Managed a hollow fiber bioreactor research laboratory and performed experiments aimed at studying the in vitro pharmacokinetic profiles of anti-viral compounds.
  
• Primary responsibility of performing contracted studies and basic research in the HIV area.
  
• Maintained lymphocyte and fibroblast cell lines for the study of anti-viral compounds, and followed the kinetics of HIV and CMV infection using hollow-fiber bioreactors as model systems.
  
• Developed and applied GFP reporter gene technology to study infection of CEM cells with recombinant HIV.
  

Research Scientist, Receptor Biology, Inc., Beltsville, MD.

• Developed and tested novel target systems for examining G-protein coupled receptor pharmacology and biology.
  
• Developed transiently-transfected cell lines for functional screening assays.
  
• Served as radiation safety monitor
  

Aug. 1996 - Feb. 1998

• Examined the expression and regulation of RGS proteins (regulators of G-protein signaling) in cultured cell models.
  
• Utilized slot blot analyses and RNAse protection assays to examine the effect of amphetamine on gene expression in the rat brain

Postdoctoral Research Scientist, Pharmacia & Upjohn, Kalamazoo, MI

• Studied the pharmacology and biology of dopamine receptor subtypes in vitro.
  
• Developed an in vitro yeast system to detect proteins interacting with the Dopamine D2L receptor.
  
• Identified a novel cDNA clone for a D2 receptor interacting protein
  
• Developed NT-2 cell models stably expressing specific dopamine receptor isoforms.

Graduate Research Assistant, Dept. of Pharmacology and Toxicology, University of Arizona, Tucson, AZ.

• Developed an in vitro cAMP-responsive reporter gene assay for studying 2 adrenergic receptor pharmacology and function.
  
• Compared the pharmacology and signaling of distinct adrenergic receptor subtypes
  
• Examined the pharmacology of a peripheral-type benzodiazepine receptor in COS-7 cells.

Laboratory Technician, Biochemistry Dept., Michigan State University, East Lansing, MI.

• Responsibilities included large-scale growth and maintenance of mammalian Vero cells, Herpes Simplex Virus (HSV-1) purification, and molecular biological studies of HSV-1

Laboratory Assistant, Biochemistry Department, Michigan State University, East Lansing, MI.

• Purified cGMP phosphodiesterase from retinal ROS using chromatographic and electrophoretic techniques and performed second messenger assays and routine laboratory maintenance

• American College of Toxicology (ACT), 2000-present
• National Capital Area Society of Toxicology, 2000-2001
• Drug Information Association (DIA), 2002-2004

• GLP Compliance Audits: What to look out for at New Nonclinical CROs, Compliance Online Webinar, April, 2008
  
• FDA Expectations for Cell, Tissue and Gene Therapy Products. Compliance Online Webinar, April, 2008
  
• World Vaccine Congress, March, 2007
  
• Chesapeake High School, Baltimore, MD, September, 2007
  
• Villa Julie College, Stevenson, MD, November, 2005
  
• American Chinese Pharmaceutical Assn., 2005 Regional Conference, October, 2005
  
• Immunogenicity Testing for Therapeutics, Barnett International, September, 2005
  
• PERI Biologics Drug Development, April 11-13, 2005, Bethesda, MD
  
• Combination Products, Barnett International, March 25-26, 2004, Philadelphia, PA
  
• Medical Device and Combination Products, March 11-12 2004, Minneapolis, MN
  
• Combination Products, Barnett International, July 30-31, 2003, Washington, DC.
  
• PERI, Biologics Drug Development, March, 2003, Arlington, VA.
  
• Combination Products, Barnett International, November 19, 2002, Philadelphia, PA.
  
• National Institute of Health, 1996.
  
• Berrien County, Michigan Math/Science Center, September, 1995.
  
• Michigan Society for Neuroscience, May 1995, Ann Arbor, Michigan.
  

CONTINUING EDUCATION

BIBLIOGRAPHY

Page Updated: June 16, 2008