Clinical and Translational Research Institute. February 2012
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1 Clinical and Translational Research Institute February 2012
2 What is Translational Medicine? Divided into three general categories: T1 Understanding disease pathogenesis/etiology and developing new methods of treatment, diagnosis, and prevention T2 Translation of clinical research results into clinical practice T3 Comparative effectiveness of new treatments
3 Clinical and Translational Research Institute Mission: To translate innovative science into improved health Organized Research Unit (ORU) at UCSD Funding sources include: Institutional funds Clinical and Translational Science Award Recharges for CTRI services Grants and service agreements Pfizer CTI awards UCOP BRAID funding
4 Clinical and Translational Research Institute Affiliated institutions LIAI, Salk, Sanford-Burnham, Ventor, SDSU, Palomar-Pomerado health, Rady Children s hospital Rady School of Management MBA program, new Project Management curriculum Moores Cancer Center School of Engineering translational partner, affiliated with Von Liebig Center >600 members About 30% of UCSD Health Sciences Faculty Members at affiliated institutions
5 General organization of the CTRI Six divisions Center for Clinical Research Biomedical Informatics Translational Research Technology Translational Research Alliance Education and Training Community Engagement
6 Idea to Innovation: CTRI Advancing Healthcare Idea Funding & Education Continuum Early Development Pre-Clinical Clinical Library Seed Grants Screening Biomarker Clinical Pilot Project Grants Community Community Funded Education/Training (KL2, TL1, K30, Symposia) Industry Funding/Express License/Business Plans Omics Consultation & Analysis Data management & Analysis Services & Infrastructure Biostatistics Clinical Data Warehouse Mining Clinical Trial Software/Database Management Biomarker Analysis & Mass Spec Biorepositories & Sample Annotation IND/DSMP/DSMB/IRB Inpatient/Outpatient/Phase I Facility Clinical Cores/Subject Recruitment/fMRI Ethics Consultation & Support
7 CTRI supplements and support
8 General organization of the CTRI Center for Clinical Research Services Personnel Clinical Coordinators and Nurses Rady Children s Hospital Other services (phlebotomy, skin biopsy, DEXA, exercise physiology, etc.) Biostatistics no pre-award cost Design, Ethics, and Safety Review Space for research Hillcrest (inpatient) La Jolla (outpatient and overnight stays)
9 General organization of the CTRI Biomedical Informatics BioComputational Center Consultation and data analysis Next Generation Sequencing Epigenetics Plans (proteomics, metabolomics) Medical Informatics Clinical Data Warehouse for Research Clinical Trial Management Software (Velos) REDCap CRIQueT
10 Biomedical Informatics CRIQueT Searchable database in CDWR De-identified IRB approval not needed Examples Parkinsons 1200 patients Alzheimers 1200 patients (750 females, 450 males) SLE 1000 patients (240 with C4 <12 mg/dl) CHF 4600 patients (300 with creat >2.0 mg/d in last 5 months) Identify patients with IRB approval In progress Linking 5 UCs via UC ReX
11 Translational Research Technology Biosample repository Sample collection, processing and tracking Biomarker Laboratory CTRI-run facilities (Luminex, Mesoscale, Nanopro) Consortium of technologies fmri CTRI matching funds for pilot projects Mass Spec Seed grant program Tissue imaging core Web-based imaging purchased by CTRI High throughput screening Seed grant program Genomics Core (Sanford Consortium) Funding project scientist
12 KL2 program Institutional K award Roadmap TL1 Education Equivalent to T32 Pharmacy and Medical Student research experience K30 CREST program Individual modules Master s degree and certificate programs Symposia and other programs Rady Health Sciences MBA Project management course
13 Community Alliance Community Advisory Board Assistance with design of community-based projects Pilot project grants for community-based projects Research Match Link researchers to participants Science Fair, Facebook, Twitter, Public forums
14 Translational Research Alliance Translational Alliance Salk Institute Sanford-Burnham La Jolla Inst Allergy and Immunology J Craig Ventor Institute Institute of Engineering in Medicine Biological sample transfer, technology transfer Pilot project grants Industry collaborations (Pfizer, Roche, GSK, Takeda, Bayer, etc) Industry Advisory Council
15 Translational Research Alliance Pilot Projects Clinical Research Translational Research (including preclinical) Innovative Technology Seed grants $2-8 K for CTRI services to support grant submission 1-4 week turnaround Over $1 M in funding to date
16 Clinical and Translational Research Institute 7 funded KL2 junior faculty Medicine, Biostatistics, Neuroscience, Surgery, Rad Oncology 63 TL1 Medical/Pharmacy students 37 short term; 26 long term 96 K30/CREST enrollees 16 Master s degrees in clinical research
17 Clinical and Translational Research Institute 82 active clinical research protocols 202 total protocols since letters of support for grants 39 publications 96 grants/clinical trials supported Supported $134 M in research grants in faculty using ResearchMatch
18 Clinical and Translational Research Institute 62 biostatistics consults 52 BioComputational Center consults Biomarker lab 12,733 assays 234 fluid and 84 tissue samples collected 6 biorepositories managed Approx 100 skin biopsies for ips 59 CRIQueT users REDCap 84 projects 199 users
19 Clinical and Translational Research Institute 33 pilot projects funded ($1 M) 29 traditional pilot projects; 4 community projects 7 papers, 7 abstracts published 4 new grants (RO1, K23, foundation grants) Pediatrics, Surgery, Medicine, Bioengineering, Psych, SPPS, Radiology 12 seed grants 4 Mass Spec mini grants High Throughput mini grants RFA 2 CTSA supplements ($1 M)
20 CTRI: Pilot project examples Innovative targeting of melanoma with allosteric RAF inhibitors Neurocognitive effects of nicotine use in schizophrenia: parallel human and animal studies Pharmacogenetics in treatment refractory depression Premature infant nutrition post-discharge collaborative project Targeted nanosomal delivery of Imatinib to ameliorate renal damage from cis-platinum therapy for cervical cancer The role of type 1 interferon in allogeneic stem cell transplant Real-time wireless blood pressure monitoring for kidney disease Quantitative magnetic resonance assessment of secretions in cystic fibrosis airways Neurobiology of pain processing in children with gastrointestinal disorders
21 CTRI innovations Harmonization of IRBs among UC sites UC-wide Stem Cell Research Oversight Committee Master clinical trial agreements Rapid review IRB approvals Seven-year IRB renewal Express license for start up companies Shared cores (mass spec, muscle imaging, fmri) New biospecimen policy and governance for UCSD Implementation of UBMTA Adoption of ResearchMatch
22 CTRI Website: ctri.ucsd.edu
23 CTRI Website: ctri.ucsd.edu
24 CTRI online service request form
25 CTRI online Letter of Support request
26 UC CTSA Consortium $5 M for UC ReX funded by UCOP for systemwide CDWR Planned funding for multi-center trials, coordinating UC cores, drug development
27 CTRI Space
28 CTRI facility East Campus
29 CTRI space East Campus Office Building Clinical Research Space Staff hotel Informatics, statistics OCTA HRPP
30 Altman CTRI Building
31 Altman CTRI Building
32 CTRI Building Clinical research floor
33 CTRI Building Wet and Dry Lab Space
34 CTRI Building Dry lab floor
35 Shiley Eye Center Jacobs Retina Center Hamilton Glaucoma Center Moores Cancer Center Perlman Medical Offices Thornton Hospital Ratner Children s Eye Center Medical Plaza Sulpizio Cardiovascular Center Parking Structure
36 Shiley Eye Center Jacobs Retina Center Hamilton Glaucoma Center Moores Cancer Center Perlman Medical Offices Thornton Hospital Jacobs Medical Center Ratner Children s Eye Center Medical Plaza Sulpizio Cardiovascular Center Parking Structure Altman Clinical and Translational Research Institute
37 Future plans Expand current services and increase utilization BioComp Center Tissue Acquisition Informatics tools, e.g., Velos Improved web interface Greater involvement of TRA partners Integrate new biomarker and imaging technologies Communication strategy to increase awareness Improved metrics and tracking
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