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 and qualify nonclinical toxicology contract research organizations (CROs)
• Perform cGLP audits of nonclinical toxicology 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
• Provide on-site or web-based training in preclinical development and regulatory compliance

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
  1. Managed preclinical drug and biologic development programs at TherImmune
  2. Provided nonclinical regulatory support and authored preclinical IND and pre-IND sections
  3. Developed Strategic Development plans for drug and biopharmaceutical products
  4. Identified, qualified and managed nonclinical pharmacology and toxicology laboratories
  5. Outsourced and managed nonclinical safety studies at outside contract service providers
  6. Served as on-site study monitor for client’s crucial IND-enabling GLP toxicology studies
  7. Designed nonclinical pharmacology and toxicology studies
  8. Prepared and reviewed nonclinical study reports, position papers, scientific manuscripts and/or technical reports 
  9. Coordinated the Sr. Scientist Seminar Series for 2003 and arranged for internal and outside speakers

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

• Preclinical Development of Drugs and Biologics – From Concept to Commercialization, Virginia Tech University, Falls Church, VA, October, 2009.
• Nonclinical development of Cell Therapy Products – Reconciling FDA Expectations with Industry Realities, 2009 ISCT Meeting, San Diego CA.
• FDA Requirements for Nonclinical Safety Testing of Cell Therapy Products, 2008 ISCT Meeting, Miami, FL.
• 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: July 23, 2010