Since its inception, the CHOP Research Institute has held a “bench to bedside” philosophy that emphasizes bringing basic research ideas to the clinic so that they may improve the lives of our patients and their families. Completion of nonclinical investigations and submission of an Investigational New Drug (IND) application or a Premarket Approval (PMA) application to the FDA for the approval of first-in-human clinical trials are essential steps toward enacting this philosophy. The mission of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics Comparative Medicine Services Core (CMSC) is to partner with and guide investigators through these processes.
The Comparative Medicine Services Core is currently developing the capacity for GLP-compliance. All nonclinical programs require in-depth planning and discussions. Therefore, we encourage you to contact us as soon as you believe you have a drug or device that will eventually require human clinical trials prior to use in patients. The Comparative Medicine Services Core is composed of highly-trained professionals capable of completing and overseeing a variety of animal studies. We adhere to the highest standards of animal welfare, procedure reproducibility and validation, and customer service.
The Comparative Medicine Services Core staff can assist you with all stages of your nonclinical study program, including:
The Comparative Medicine Services Core specializes in, but is not limited to, the following types of studies:
To request services, please e-mail or call Melanie McFadden
Melanie McFadden, DVM, MLAS | Technical Director
mcfaddenmc@chop.edu
Lexi Mackiewicz, DVM, DACLAM | Senior Non-clinical Research Veterinarian
mackiewica@chop.edu
Lindsay Clark, LATG | Research Lab Manager
clarkl2@chop.edu
Robert Kulawiak, LAT | Senior Animal Research Support Specialist
kulawiakr@chop.edu
Tailyn Lyghts | Animal Research Support Specialist
lyghtst@chop.edu
Hours | Location |
M-F 8:00 AM - 4:00 PM |
CTRB 6028 |
CHOP Institutional Animal Care and Use Committee (IACUC) - Must be connected to CHOP network
CHOP Institutional Biosafety Committee (IBC) - Must be connected to CHOP network
CHOP Clinical Vector Core (CVC) - Provides cGMP-compliant viral vector manufacturing services for nonclinical studies
CHOP Research Vector Core (RVC) - Provides viral vector manufacuring services for discovery and developmental studies
CHOP Translational Core Laboratory (TCL) - Provides clinical pathology services
CHOP Large Animal Imaging Facility Core - MRI services and study support
CHOP Biorepository Resource Center (BioRC) - Provides sample archiving services
University of Pennsylvania School of Veterinary Medicine Comparative Pathology Core (CPC) - Provides histopathology slide reading services
CHOP Pathology Core - Provides histopathology slide preparation and staining services
CHOP Small Animal Imaging FacilityCore (SAIF) - Provides MRI, PET/CT, Optical Imaging, and Ultrasound services for rodent and other small animal model systems
University of Pennsylvania Large Animal Imaging Facility (LAIF) - Provides MRI imaging services for large animal model systems
CHOP Transgenic Core - Provides novel mouse and rat genetically engineered model development, cryopreservation, and cryorecovery services
CHOP Bioanalytical Core - Provides quantitative bioanalytical services
Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT)
University of Pennsylvania Institute for Translational Medicine and Therapeutics (ITMAT)
21 CFR Part 58 - Good Laboratory Practice for Nonclinical Studies
Investigational New Drug (IND) Application
Premarket Approval (PMA) Application
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Name | Role | Phone | Location | |
---|---|---|---|---|
Melanie McFadden |
Technical Director
|
mcfaddenmc@chop.edu
|