Toxicologic and comparative clinical pathology externship scholarships broaden clinical pathology resident training opportunities

The ASVCP Regulatory Affairs Committee (RAC) serves to provide recommendations for best practices in clinical pathology for drug development and drug safety assessment in pharmaceutical industries. The committee currently consists of members primarily from pharmaceutical, Ag‐Chem and food industries, and private diagnostic laboratories. One of the goals of the RAC is to create opportunities for clinical pathology residents to experience toxicologic and laboratory animal clinical pathology as externs in an industrial environment. To accomplish this aim, the RAC secures funding from ASVCP to support interested clinical pathology residents for such externships. The 1^st set of beneficiaries of this initiative included 2 clinical pathology residents from the United States.

One of the participants, Dr. Adeyemi Adedeji, is a 3^rd year clinical pathology resident at University of California–Davis. For Dr. Adedeji, this was a welcome opportunity, especially given his background in small molecule drug discovery for coronaviruses based on his PhD. Dr. Adedeji spent 4 weeks at MPI Research, a contract research organization (CRO) located in Michigan, under the mentorship of the MPI Research clinical pathologists Drs. Aulbach and Cregar. Dr. Chien‐Tsun (June) Huang, who is also a 3^rd year clinical pathology resident at the University of Georgia, was the 2^nd beneficiary of this initiative. For Dr. Huang, this was also an exceptional opportunity to explore industrial clinical pathology, especially given her extensive interest and experience with laboratory animals (rodents and dogs) during her PhD program. Dr. Huang spent 2 weeks at non‐GLP and GLP facilities at Pfizer, a multinational pharmaceutical corporation, under the guidance of the Pfizer's clinical pathologists, Drs. Lindsay Tomlinson, Bill Reagan, and Shashi Ramaiah.

Both participants received insights into toxicologic study design, analysis, and reporting. They also gained valuable experience in clinical pathology data interpretation and its correlation with histopathologic findings, biomarker development under GLP laboratory operations, assay validations/quality controls, in vitro hemolysis and platelet function tests, and received exposure to anatomic and clinical pathology of laboratory animals. Overall, this opportunity exposed them to the diverse roles of clinical pathologists in the pharmaceutical industries.

For Dr. Adedeji, specific aspects of his training at MPI Research included:

• 1Toxicologic clinical pathology report write‐ups and review rounds.
• 2Participation in several integration meetings involving the clinical and anatomic pathologists with other contributing scientists on different studies.
• 3A seminar on Guidance on scientific report writing for regulatory bodies with focus on FDA requirements.
• 4Several Journal Club discussions on the following topics:

  1. Factors that affect interpretation of clinical pathology parameters in lab animal species (rats, mice, monkeys, and dogs), with a special focus on food consumption and procedure‐related effects.

  2. Biologic variations in lab animal species (rats, mice, monkeys, and dogs).

  3. Biomarker developments with specific focus on immunotoxicology biomarkers (blood cytokines) and renal biomarkers (KIM‐1, CLUSTERIN, Cystatin C, TFF3, etc).

• 5Assay validations with MSD‐based assays.
• 6Indications for bone marrow evaluation in industry including the 19‐part differentials.
• 7Weekly toxicologic pathology rounds.

For Dr. Huang, specific aspects of her training included:

• 1Gaining diverse experience through discussions and participations in multiple meetings/seminars with industrial clinical, anatomic pathologists, toxicologists, and scientists.
• 2Non‐GLP and GLP clinical pathology laboratories:

  1. Assay validations/quality controls for hematology, chemistry, and urinalysis analyzers.

  2. ADVIA scatterplot interpretation for lab animal species.

  3. Lab animal blood smear and urine microscopy review.

• 3Toxicologic pathology discussions on the following topics:

  1. Interpretation of clinical pathology variables of lab animal species (rats, mice, monkeys, and dogs), and determination of drug‐related changes.

  2. Biomarker research and development with special focus on cytokines (IL‐10, MCP‐1), and cardiac (troponin) and renal biomarkers (KIM‐1, Cystatin C, NAG).

  3. Histologic bone marrow interpretation in rodents.

Due to the success of these externships, the RAC has been able to secure funding for the 2^nd consecutive year from ASCVP to support toxicologic and comparative clinical pathology externships for interested clinical pathology residents. These externships allow residents to experience the diverse roles of clinical pathologists in industry.

Residents who apply for these awards must first arrange specific dates and times for individualized externship opportunities with the organization they plan to visit and with their residency program coordinator. A partial list of organizations interested in supporting resident externships is posted at http://www.asvcp.org/stures/ExternshipContacts.cfm. The application for this funding can be accessed at http://www.asvcp.org/stures/RACScholarship.cfm.

Overall, this was a wonderful experience for both trainees, and both participants have expressed their strong interests in having a career in industry, as a result of these externships.