ICTR Drug Discovery and Development Core

Directed by Dr. Alexander MacKerell, the UMB Computer-Aided Drug Design (CADD) Center provides custom services in the areas of rational drug discovery and optimization and macromolecular modeling, including proteins, DNA, RNA, carbohydrates, and lipids. Specific capabilities include in silico database screening, lead compound optimization and rational formulation of biologics using the site-identification by ligand saturation (SILCS) approach. Macromolecular modeling capabilities include homology modeling and molecular dynamic simulations including enhanced sampling technologies. The CADD center services are eligible for up to $5000 in UMB ICTR Voucher support. See "How to Apply..." below.

Directed by Dr. Joga Gobburu, the Center for Translational Medicine (CTM) offers clinical pharmacology and pharmacometrics services to support drug development and regulatory submissions. 

Pharmacokinetic (PK) Analysis and Reporting

• Non-compartmental PK data analysis for single-, multiple-ascending dose, drug-drug interaction, food effect, bioequivalence, bioavailability, Physiologically based pharmacokinetic (PBPK) modeling and special population studies

Population Pharmacokinetic-pharmacodynamic (PK/PD) & Exposure-Response Analyses and Reporting

• Population pharmacokinetic-pharmacody­namic (PK/PD) analysis, exposure-response model­ing, and simulation for effectiveness and safety endpoint
• Special expertise in pediatric and QT trial design and analysis

Disease Modeling and Trial Design

• Quantitative disease-drug-trial models to support internal company and regulatory decisions
• Comparative effectiveness, clinical trial simulations, projecting net drug effect, un­derstanding trial failures, and asset valua­tion, design and analysis of adaptive, en­richment, and dose-response trials

CTM center services are eligible for up to $5000 in UMB ICTR Voucher support. See "How to Apply..." below.

Directed by Dr. Maureen Kane, the Mass Spectrometry Center (MSC) provides state of the art analysis in various advanced protein analysis techniques including comparative proteomic expression analysis, post-translational modification analysis, protein interaction (interactome) analysis as well as a number of other custom proteomic analysis capabilities. The MSC also provides a host of other mass spectrometry-based techniques including quantitative LC-MS/MS, targeted metabolomics, lipidomics, and mass spectrometry imaging. 

MSC services are eligible for up to $5000 in UMB ICTR Voucher support. See "How to Apply..." below.

 The MSC offers expertise and applications in the following research areas: 

• Metabolomics

• Lipidomics

• Proteomics

• Quantitative Analysis of Metal Ions in Biological Systems and Materials; Metallomics

• LC-MS/MS assay development

• Drug analysis and PK/PD

• GLP regulated bioanalysis for clinical studies

• Chemical compound identification and structure elucidation

• Biomarker identification and characterization

• Mass Spectrometry Imaging (MSI)

• Hydrogen Deuterium Exchange Mass Spectrometry (HDX)

• Fast Photochemical Oxidation of Proteins (FPOP)

• Bioinformatics and Cheminformatics

Directed by Dr. Stephen Hoag, the Drug Formulation Laboratory - also known as the Applied Pharmaceutics Laboratory (APhL) - has fully-equipped modern research laboratories for pre-formulation and formulation production. The APhL can develop custom dosage forms and matching placebos for research, animal testing and human clinical trials: Dosage forms can be immediate, enteric and controlled release. The APhL also conducts studies needed for the Chemistry, Manufacturing and Control (CMC) section of an Investigational New Drug (IND) application and helps prepare regulatory filings to the U.S. Food and Drug Administration (FDA). Drug Formulation Laboratory services are eligible for up to $5000 in UMB ICTR Voucher support. See "How to Apply..." below.