New Approaches to Metabolomics Research Institute for Clinical and Translational Research And Translational Laboratory Cores Craig Hendrix, MD, ICTR/CFAR Lab Core Director chendrix@jhmi.edu, 410-955-9707 Curt Reynolds, MAS, ICTR/CFAR Lab Core Project Manager cjreyn@jhmi.edu, 443-287-3060

What can ICTR do for you? http://ictr.johnshopkins.edu/ Organized into 6 Cores Translational Laboratory Core (TLC) Human Subjects Research Core Quantitative Methodologies Core Informatics Core Research Participant and Community Partnership Core Education, Training and Career Development Core …and 2 stand-alone programs The Studio/Navigation Program Translational Research Communities

Pilot Funding http://ictr.johnshopkins.edu/ Objective: Targeted Funding & Engaged Management to Advance Translational Research Accelerated Translational Incubator Program (ATIP) Funding requests one to two times per year. Approximately 5-10 awards made per year. Awards up to $100,000 in direct costs (no salary support) 12-month accelerated funding period Nexus Awards Gap targeted RFA from each Research community Biomarker and Diagnostic Testing Drugs/Biologics/Vaccines/Devices Behavioral, Social, and Systems Science Funding/timing similar to ATIP

Pilot Funding http://ictr.johnshopkins.edu/ Doris Duke Early Clinical Investigator Award 1 – 2 years of funding of $30,000 – 40,000 per year to fund salary or other research support needs Comprehensive support program that integrates supplemental financial resources with guidance for career development services, and ongoing mentoring. Support may include: Salary support for research coordinator, biostatistician, data base specialist, help with access to clinical data, writer; Salary support to allow more research time (e.g., reduce clinical obligations) SOM Discovery Fund For Synergy and Innovation Award Provide grant awards to cross-divisional teams, comprised of faculty and/or non-faculty members from at least two schools or affiliates of the university, who are poised to arrive at important discoveries or creative works. The expectation is that these awards will spark new, synergistic interactions between investigators across the institution and lead to work of the highest quality and impact.

Translational Laboratory Core (TLC) Provide state-of-the-art conceptual and technical laboratory support Deliver services to translational scientists Priority to ATIP developmental grants, junior, and new translational scientists 11 service core laboratories provide: Consultation Assay development Sample analysis Coordination with ICTR Clinical Services, Studios, Communities Costs subsidized; depend on investigator funding

TLC Laboratories Drug Development Resources & Services Drug Analysis Units Assay development, sample analysis, pharmacokinetics, pre-clinic study design Oncology Michelle Rudek , (mrudek2@jhmi.edu, 443-287-6476) Clinical Pharmacology Analytical Lab (CPAL) Mark Marzinke (mmarzin1@jhmi.edu, 410-502-7691) Medicinal Chemistry Unit David Meyers (dmeyers7@jhmi.edu , 410-502-4804) Small molecule synthesis, supports structure-activity relationship studies Drug Screening Library Unit Jun Liu (joliu@jhu.edu, 410-955-4619) FDA approved drug library; repurposing licensed drugs

TLC Laboratories Drug Development Resources & Services (Continued) Johns Hopkins Drug Discovery Research Consultancy and Services Barbara Slusher (bslusher@jhmi.edu, 410-614-0662) Offers consultants based on 18 years of Pharma industry experience. The program has interactions and connections with the pharma, biotech and venture community. Medicinal Chemistry Unit: Takashi Tsukamoto Assay development Unit: Camilo Rojas Drug Metabolism & Pharmacokinetics Unit: Rana Rais In vivo Pharmacology Unit: Krystyna Wozniak Drug Development Unit Craig Hendrix (chendrix@jhmi.edu, 410-955-9707) Consultative support for early clinical drug development Protocol design, data analysis, clinical study support

TLC Laboratories Biologics Vic Lemas, Ruth Karron (mvlemas@jhmi.edu , 410-614-5411, rkarron1@jhu.edu, 410-614-0319) Biologic product development/testing, GMP cell lines, gene vectors, antibodies, peptides Proteomics Robert Cole (rcole@jhmi.edu, 410-614-6968) Profiling for small molecules, biomarker development, protein analysis Metabolomics Anne Le (annele@jhmi.edu, 410-955-9297) Analysis of endogenous small molecules, targeted mass spec-based metabolomics Genetics Garry Cutting (gcutting@jhmi.edu, 410-955-1773) Genetic based sequencing and diagnostic assays, Clinical assay development Imaging Kasia Macura (kmacura@jhmi.edu, 410-955-6500) Facilitates integrated use of imaging resources, image data file storage, & distribution CRU Core Laboratory Neal Fedarko (ndarko@jhmi.edu, 410-550-2632) Kit-based assays validated, applied to support clinical studies

On The Web - Information http://ictr.johnshopkins.edu Click on Laboratory Services