A collaboration between Johns Hopkins University and the University of Maryland Baltimore ICTR (UMB ICTR).
Discovery & Early Development
Reference compound synthesis to synthesize commercially unavailable compounds of key biological and pharmacological interest to core users as reference and/or tool compounds.
Contact:
Takashi Tsukamoto, PhD., 443-629-7984, ttsukamoto@jhmi.edu
David Meyers, PhD., 410-502-4804, dmeyers7@jhmi.edu
Biochemical and assay development support will assist biochemical assays development for putative therapeutic targets along with Cell-based assay development support that will facilitate development of cell-based drug screening assays. The Drug Screening Library maintains, distributes, and screens drug library (FDA approved) compounds. This library is ideal for re-purposing licensed drugs by screening activity against new targets.
Contact:
Jack Wei, hwei11@jhmi.edu. (Screening Unit)
Jun Liu, PhD., 410-955-4619, joliu@jhmi.edu (Drug Library)
In silico compound databases of commercially available compounds. Virtual lead identification using target-based and ligand-based database screening methods will be available to core users.
Contact:
Alex MacKerell, PhD. (UMB), (410) 706-7442, amackere@rx.umaryland.edu
In vitro metabolic stability assessment will help users predict drug metabolism by measuring in vitro stability in plasma, liver microsomes, S9, and hepatocytes from various species (mouse, rat, dog, monkey, human).
Contact:
Rana Rais, PhD., (410) 614-1906, rrais2@jhmi.edu
Pharmaceutics & Regulatory
Non-sterile formulation (e.g. oral such as film strips, sustained release and colon-targeted tablets, transdermal/topical, inhalation, tobacco modification, nasal, double-blinding and custom matching placebos). Optimized drug formulation to maximize on target and minimize off target effects.
Contact:
James Polli, PhD., (UMB), (410) 706-8292, jpolli@rx.umaryland.edu
Stephen Hoag, PhD., (UMB), (410) 706-6865, shoag@umaryland.edu
Offers a host of techniques for characterization of sequence variants and posttranslational modifications (PTMs) for therapeutic proteins, antibody (Mab) products and antibody-drug conjugates (ADC).
Contact:
Maureen Kane, PhD., (UMB), mkane@rx.umaryland.edu
Lisa Jones, PhD., (UMB), (410) 706-3380, ljones@rx.umaryland.edu
Patrick Wintrode, PhD., (UMB), http://wintrode.openwetware.org
Bruce Yu, PhD. (UMB) byu@rx.umaryland.edu
Consultative support for biologic product development; biologic product development and testing of cell lines, gene vectors, peptides; GMP facility in industry-standard “clean room” environment under current Good Manufacturing. Practices (cGMPs).
Contact:
- Victor Lemas, PhD., 410-614-5411, mvlemas@jhmi.edu
Ruth Karron, MD., 410-614-0319 | rkarron1@jhmi.edu
Clinical Development
Provides extensive early clinical drug development design experience [REF] to support: i) design of first-in-human through phase 2 proof-of-concept trials; ii) planning biological sample and data collection, data management, data analysis; iii) study execution or coordination with ICTR Clinical Research Unit; iv) support of pre-IND, IND, and IRB application.
Contact:
Craig Hendrix, MD., (410) 955-9707, chendrix@jhmi.edu
Provides expertise in quantitative disease, drug, and trial modeling to inform early clinical drug development to inform future pivotal clinical trials through the UMB Center for Translational Medicine.
Contact:
Jogarao Gobburu, PhD, MBA (UMB), (410) 706-5907, jgobburu@rx.umaryland.edu
Supporting Units
In vivo pharmacokinetic studies can be performed in mice, rats, swine, and primates. Test drugs can be administered by various routes of administration including i.v., p.o., i.p., s.c., i.m., intrarectal, or intranasal routes in preclinical vehicles/formulations for intended route.
Contact:
Rana Rais, PhD., (410) 614-1906, rrais2@jhmi.edu
Michelle Rudek, PhD., Pharm.D., (443) 287-6476, mrudek2@jhmi.edu
- protein biomarker development, verification, validation, and qualification
- technology to maximize coverage of key proteomes required for drug discovery
- quantitative mass spectrometry;
Contact:
Robert Cole, PhD., 410-614-6968, rcole@jhmi.edu
Facilitates integrated use of in vitro, pre-clinical, and clinical imaging resources.
Contact:
Drs. Kasia Macura, MD., PhD. (JHU) (410) 955-6500, kmacura@jhmi.edu
Maureen Kane, PhD., (UMB), mkane@rx.umaryland.edu
Offers 87 distinct assays of clinical chemical endpoints and biomarkers to support ICTR research protocols and is designed to serve investigators at all clinical research. Laboratory provides standardized sample handling that upholds high quality control by, for example, minimizing freeze/thaw cycles.
Contact:
Neal Fedarko, PhD., 410-550-2632, nfedark1@jhmi.edu
