Drug Discovery Development Core

“A collaboration between Johns Hopkins University and University of Maryland”

Contacts

Barbara Slusher
Co-Director
bslusher@jhmi.edu

James Polli
Co-Director
jpolli@rx.umaryland.edu

Craig Hendrix
Co-Director
chendrix@jhmi.edu

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:

Camilo Rojas, PhD., (410) 614-0870, crojas2@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:

  1. 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

Customized metabolic approaches ranging from simple assays to high-throughput approaches such as global metabolic profiling and stable isotope-13C and/or 15N-labeled. Lipidomics analysis support by Dr. Maureen Kane (UMB) based on MS-based biomarker discovery experiments, high-resolution metabolite and lipid structural identification to validate biomarker candidates and pharmacodynamic biomarkers of drug efficacy and defining biomarker-clinical endpoint relationships.

Contact:

Dr. Anne Le, MD., HDR., 410-955-9297 annele@jhmi.edu

  1. protein biomarker development, verification, validation, and qualification
  2. technology to maximize coverage of key proteomes required for drug discovery
  3. 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