Toxicology Expert Focusing on Inhalation, Tobacco, Cancer Cell Biology, In-Vitro, Preclinical, and Medical Device Biocompatibility (EU MDR)
Technical Consultant #2042
- 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).
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
- 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.
- Ph.D. Zoology, Clemson University, Clemson, SC.
- M.A. Biology, Appalachian State University, Boone, NC.
- B.S. Biology, Mars Hill College, Mars Hill, NC.