Round Table of Toxicology Consultants

Name and Educational Degree:

Rodgers, Kathleen, Ph.D.

Certifications

DABT

Education

University of California at Irvine, Irvine, California; BA; 1980; Biology

University of California at Riverside, Riverside, CA; PhD ;1984; Molecular/Cellular Biology

University of California at Riverside, Riverside, CA; Post Doctoral; 1986; Immunology

Business Address:

1321 N Mission Road
Room 110
Los Angeles, CA 90033-1020
USA

Contact Information:

Telephone:	323-222-0089
Mobile Number:
Email Address:	krodgers@usc.edu
Web Site URL:	http://www.kathyrodgers.com

Specialties

Device Safety and Efficacy Drug Efficacy & Pharmacology General Toxicology Immunotoxicology Preparation and Support of IDE/IND Applications Drug Development Environmental Toxicology

Experience

My research areas have included the evaluation of the immunotoxicity of organophosphate pesticides, development of an immunoassay for gynecological cancers and an understanding of the process of peritoneal healing and the formation of intraperitoneal adhesions and identification of therapeutics to modify these processes. The current focus of my basic science research is the cellular and molecular mechanisms by which angiotensin peptides accelerated tissue regeneration. As my focus has been to provide translational assistance from the bench to the patient, I have spent a considerable amount of my time consulting for companies interested in developing products within my areas of expertise. I have consulted for industry in preclinical product development (12 of which are currently in clinical trials or marketed). For many of these studies, my technical staff has conducted the preclinical studies and prepared the technical reports that were submitted to the FDA. Further, I have developed recommended panels of safety studies to allow conduct of clinical trials under FDA and EU supervision. I have further overseen the contracting and conduct of the safety studies both within contract facilities (standardized studies) and academic laboratories, including my own (specialized safety studies). In addition, I have meet with the FDA on behalf of clients at various levels, from preIND meetings to panel meetings when seeking regulatory approval to market. I have also prepared regulatory documents for FDA submission and white papers summarizing available toxicological data from the literature, technical reports and clinical trial data. I have also provided litigation support for a number of cases including environmental exposures and medical devices.

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