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

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

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

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.

Academic and Professional Affiliations

Editorial Board and Reviewer

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.