Comparative Medicine Services Core

CMSC LogoOverview of Services

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:

  • Grant Preparation
  • Budget Preparation
  • Facilitating Type A, B, & C meetings with the FDA
  • Experimental Design
  • Study Protocol Drafting and Management
  • IACUC protocol advice
  • SOP Development, Management, and Archiving
  • GLP Training Delivery and Record Keeping
  • Comprehensive Quality Assurance Activities
  • Study Execution and Data Generation
  • Archiving of Study Materials and Data

The Comparative Medicine Services Core specializes in, but is not limited to, the following types of studies:

  • Pharmacokinetic Studies
  • Biodistribution Studies
  • Toxicology and Reproductive Toxicology Studies
  • Medical Device Testing
  • Surgical Model Development

To request services, please e-mail or call Melanie McFadden

Leadership & Staff

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

 

Location and hours of operation

Hours Location

M-F 8:00 AM - 4:00 PM

CTRB 6028

Links and Resources

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)

Center for Devices and Radiological Health (CDRH)

Templates for Nonclinical Studies

Contacts

Name Role Phone Email Location
Melanie McFadden
Technical Director
 

 
mcfaddenmc@chop.edu