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 (both CHOP-based and external) through these processes.

The Comparative Medicine Services Core is currently developing the capacity for GLP-compliance.  Fully GLP-compliant services are expected to begin in the third quarter of 2021.  However, 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 veterinary, regulatory, and quality assurance 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 Drafting and Management
  • IBC Protocol Drafting and Management
  • SOP Development, Management, and Archiving
  • GLP Training Delivery and Record Keeping
  • Comprehensive Quality Assurance Activities
  • Study Execution and Data Generation
  • Generation and Submission of IND-Enabling Electronic SEND Datasets to the FDA
  • 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 Dr. Smith or Amy Muehlmatt.

Leadership & Staff

Geary "Chip" Smith, DVM, MS | Technical Director
smithgr@chop.edu

Amy Muehlmatt, MLAS, RLATG | Operations Manager
muehlmatta@chop.edu 

Lindsay Clark, RLATG | Senior Animal Research Support Specialist
clarkl2@chop.edu

Robert Kulawiak, RLAT |Senior Animal Research Support Specialist
kulawiakr@chop.edu

Location and hours of operation

Hours Location

M-F 8:00 AM - 5:00 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

Pristima XD - Our nonclinical study data management system

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 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
Geary "Chip" Smith
Technical Director
 
(215) 630-8896
 
smithgr@chop.edu
 
CTRB 6028