Regulatory Affairs

ASVCP Regulatory Affairs Committee

The Regulatory Affair Committee (RAC) of the ASVCP strives to advance toxicologic clinical pathology in industry by educating, promoting communication and publishing contemporary best practices for clinical pathology in industry. Primary RAC activities include sponsorship of resident externships in industry, development and publication of guidelines for veterinary clinical pathology aspects in industry, and fostering of collaboration with ACVP and STP to improve harmonization efforts. The RAC also surveys government regulatory agencies, national and international committees, the pharmaceutical industry, professional organizations, and oral and written communication for current and impending legislation/regulations or publications that may affect the daily business of our membership. The RAC forms consensus opinions and responds appropriately to these agencies on behalf of the ASVCP. Many of our members are employed in the industry (contract research organizations, biotech, pharmaceutical, agrochemical and food industries, and private diagnostic laboratories).

Chair: 

Adam Aulbach, Adam.Aulbach@mpiresearch.com

 

Committee Members:

 

Lila Ramaiah (outgoing chair), lramaiah@mac.com

 

Denise Bounous, denise.bounous@bms.com

 

Allison Vitsky, Allison.vitsky@pfizer.com

 

William Siska, William.Siska@crl.com

 

Aradhana Gupta, Aradhana.Gupta@Merial.com

 

Laura Cregar, Laura.Cregar@mpiresearch.com

 

Niraj Tripathi, Niraj.Tripathi@covance.com

 

Eric Fish, ejf0007@tigermail.auburn.edu

 

Holly Jordan, Holly.Jordan@covance.com

 

Michael Logan, michael.logan@abbvie.com

 

Yemi Adedeji, Adedeji.adeyemi@gene.com

 

Tara Arndt, tara.arndt@covance.com

 

Kate Biddle, Kathleen.Biddle@pfizer.com

 

 
Trainee Information:

ASVCP Scholarship Application for Clinical Pathology Resident Externship Training in Industry

Black LJ, et al. Veterinary clinical pathology trainees benefit from toxicologic externship opportunities in the biopharmaceutical industry. Vet Clin Path 2016:5-6.

Adedeji AO and Huang C-T. Toxicologic and comparative clinical  pathology externship scholarships broaden clinical pathology resident training opportunities. Vet Clin Path 2015:1-2.

 

RAC Endorsed Publications:

Ramaiah L, et al. Principles for assessing adversity in toxicologic clinical pathology. Toxicol Pathol 2017:260-266.

Tomlinson L, et al. STP best practices for evaluating clinical pathology in pharmaceutical recovery studies. Toxicol Pathol 2016:163-72.

Poitout-Belissent F, et al. Reducing blood volume requirements for clinical pathology testing in toxicologic studies—points to consider. Vet Clin Path 2016:534-51.

Tomlinson L, et al. Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries. Vet Clin Path 2013:252-69.

Young JK, et al. Best practices for clinical pathology testing in carcinogenicity studies. Toxicol Pathol 2011:429-34.

Reagan WJ, et al. Best practices for evaluation of bone marrow in nonclinical toxicity studies. Vet Clin Path 2011:119-34.

Also Toxicol Pathol 2011:435-48.

Morton D, et al. Best practices for reporting pathology interpretations within GLP toxicology studies. Toxicol Pathol. 2006:806-9.

Boone L, et al. Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies. Vet Clin Path 2005:182-8.

 

 

Helpful Resources:

Aulbach A, et al. Influence of study design variables on clinical pathology data. Toxicol Pathol 2017:288-295.

  • Podcast on Tox Path

Reagan WJ. The American Society for Veterinary Clinical Pathology Regulatory Affairs Committee’s clinical pathology best practices recommendations will impact the discipline of veterinary toxicologic clinical pathology. Vet Clin Path 2013:247-9.

Burkhardt JE, et al. Recommendations for the evaluation of pathology data in nonclinical safety biomarker qualification studies. Tox Pathol 2011:1129-37.

Schultze AE et al, Veterinary clinical pathologists in the biopharmaceutical industry. Vet Clin Path 2008:146-58.

 

Drug Development Presentation: Introduction to Toxicologic Pathology

 

Links of Interest: Related Society Links

Society of Toxicologic Pathology

European Society of Veterinary Clinical Pathology

International Society for Animal Clinical Pathology

Division of Animal Clinical Chemistry, AACC

European Society of Toxicologic Pathology

British Society of Toxicologic Pathology

Society of Toxicologic Pathology-India

Latin American Society of Toxicologic Pathology

Japanese Society of Toxicologic Pathology

French Society of Toxicologic Pathology

American Society For Veterinary Clinical Pathology
2424 American Lane
Madison, WI 53704


Telephone: +1-608-443-2479
Fax: +1-608-443-2474

Connect With Us
Public Page Members-Only