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Toxicology Expert Focusing on Inhalation, Tobacco, Cancer Cell Biology, In-Vitro, Preclinical, and Medical Device Biocompatibility (EU MDR)

Technical Consultant #2042


Expertise

  • Preclinical toxicology of consumer products.
  • Design and manage external toxicity studies and summarize study reports.
  • Research on natural compounds and cancer reversion, and toxin induced pathways involved in disease.
  • Inhalation, reproductive, and in vitro toxicology.
  • High content screening assays and new in vitro toxicology assay development.
  • Proof-of-concept for new products, and regulatory toxicology (FDA) and EU.
  • Design and manage cancer research, nutrition and toxicology studies.
  • Mechanistic toxicology.
  • Medical device biocompatibility (EU MDR).

Experience

Independent Consultant, Greensboro, NC, 2013 - Present

  • Toxicologist responding to inquiries regarding additives to consumer products including tobacco,food and cosmetics.
  • Evaluate and explain in vitro toxicology assays and utility to organizations for meeting regulatory requirements.
  • Risk assessment of products including CA Prop65.
  • Toxicology Safety Assessment Peer Review International Expert Panel Member. Evaluate data for consumer products.
  • Assess toxicity data and manuscripts.

Alcon (A Novartis Division-Regulator), Toxicologist and Preclinical Safety Consultant, 2018 - 2019

  • European Medical Device Regulation (EU MDR) Subject Matter Expert.
  • Toxicology and biocompatibility risk assessment for CE Marked Medical Devices including gap assessment
  • Author Summary Technical Documentation (STeD) for medical devices (Class II) for regulatory submissions including ISO (10993), EU (2017/745) and FDA standards.

Apex Life Sciences, Regulatory Toxicologist, 2017 - 2018

Medical Writer Non-Clinical (Altria Contractor)

  • Contribute to Premarket Tobacco Application (PMTA ) for FDA.
  • Review ingredient literature, study reports and, data. Develop documents on various scientific, risk assessment, and regulatory topics, including toxicological data summaries.
  • Prepare and or review materials supporting regulatory submissions.

Lorillard Tobacco Company, Greensboro, NC, Sr. Toxicologist, 2006 - 2012

  • Research, product development, evaluation and regulatory.
  • Design and direct multiple projects leading to increased understanding of mechanisms of air-borne toxicant-induced disease and establish new in vitro toxicology assays to screen new consumer products.
  • Reveal biomarkers of smoke exposure and disease from "hits" in in vitro and in vivo models as Study Director of in vivo proteomic studies, and Team Leader of HCS projects.
  • Design and manage toxicity studies performed externally at CRO's and summarize study reports.
  • Publish peer-reviewed publications and present posters at key scientific meetings.
  • Contribute to regulatory response documents to FDA on modified risk tobacco products.
  • Support product development, litigation, product stewardship, risk assessment and quality control.
  • Consumer ingredient toxicity studies.

The Rogosin Institute, Xenia, OH, Cancer Res. Labs, Director, 2005 - 2006

  • Supervise manufacturing of biologicals in cGMP/cGLP laboratory for Phase I clinical trials.
  • Direct the manufacturing and research operations including supervision of 7 direct reports.
  • Troubleshoot processes and establish state of the art protocols for scale-up.
  • Detailed review of submitted IND's for process development and improvement.

BelumedX, LLC, Little Rock, AR, Research Director, 2002 - 2005

  • Direct and perform wound healing studies to evaluate new wound healing platelet rich plasma products in a large animal wound model including publications and presentations at national meetings and presentations to DVM's and other product end users.
  • Provide proof-of-concept and post-product launch support for biological therapeutic products.
  • Prepare scientific and technical disclosures for potential investors.

University of Arkansas at Little Rock, Little Rock, AR, Visiting Assistant Professor, 1995 - 2000

  • Teach Histology lectures and labs.

Medical Sciences, Assistant Professor

  • PI of a research laboratory evaluating the effects of retinoids on reversing endometrial cancer.
  • Discovered novel cell signaling pathways through which retinoids act.
  • Supervise 4-6 assistants.

Director of Confocal Laser Scanning Microscopy Facility in Arkansas Cancer Research Center

  • Evaluate phytoestrogen effects on mammary cancer in a rat model.
  • Immunostaining and evaluation of cervical cancer tissues.

Hendrix College, Conway, AR, Visiting Assistant Professor, 2001

  • Teach Developmental Biology and Biology of the Human Body.

Additional Areas of Professional Experience

  • Extensive scientific research and teaching experience in industry, government and academics.
  • Study Director of projects including budgeting, experimental design, data analysis and publication.
  • Follow projects from cradle to grave. Manage multiple in-house and external toxicology studies at CRO's.
  • Cell signaling pathways in disease and nutritional disease modulation.
  • Direct studies in cGLP laboratories.
  • Toxicology and alternative models.
  • Tissue regeneration research.
  • High content screening and confocal microscopy.
  • Regulatory interactions.
  • Cancer cell biology.
  • Product Development.
  • Project design and management.

Honors & Publications


Academic and Professional Affiliations

  • American Association for Cancer Research
  • American College of Toxicology
  • American Society for Cell Biology
  • Microscopy Society of America
  • Society of Toxicology
  • Sigma Xi

Editorial Board and Reviewer

  • International J. of Toxicology.
  • Ad Hoc Reviewer for numerous Scientific Journals including:
  • Breast Cancer Research and Treatment
  • Current Drug Targets
  • Food and Chemical Toxicology
  • Inhalation Toxicology
  • International Journal of Cancer
  • Pathobiology
  • Toxicology
  • Toxicological Science
  • Toxicology & Applied Pharm. (TAAP)

Publications and Patents

  • Author and Co-Author of Numerous seminars, publications and abstracts.
  • Over 30 peer-reviewed scientific publications, 59 abstracts, Federal and local grant writing.
  • 60 poster and platform presentations at national scientific meetings.
  • U.S. Patent Submitted for invention " CAC-1 Cells.

Education

  • Ph.D. Zoology, Clemson University, Clemson, SC.
  • M.A. Biology, Appalachian State University, Boone, NC.
  • B.S. Biology, Mars Hill College, Mars Hill, NC.
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