clinical & translational research center (ctrc)

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  • Slide 1
  • Clinical & Translational Research Center (CTRC)
  • Slide 2
  • Slide 3
  • Clinical & Translational Science Award (CTSA)
  • Slide 4
  • Chemical Biology In Translation (CBIT) Chemical Biology In Translation (CBIT) Clinical and Translational Research Center (CTRC) Clinical and Translational Research Center (CTRC) Personalized Medicine in Translation (PERMIT) Personalized Medicine in Translation (PERMIT) Biomedical Informatics In Translation (BIIT) Biomedical Informatics In Translation (BIIT) Translational Biomedical Imaging Center (TBIT) Translational Biomedical Imaging Center (TBIT) Structure of the Penn CTSA
  • Slide 5
  • Transcendant themes of the Penn CTSA Translational therapeutics Promote and facilitate translation of preclinical studies into proof of concept and mechanistic studies in humans Bridging the pediatrics / adult divide Education and investment in human capital
  • Slide 6
  • CTRC Formed in 2006 Joining of 2 previous GCRCs (PENN 1965, CHOP 1962) Expanded services, functions and clinical cores Competitive renewal phase to start this July
  • Slide 7
  • CTSA Clinical & Translational Research Center Inpatient & outpatient research beds Clinical cores Nutrition, Neurobehavioral, Sleep, Cardiovascular, Pulmonary Translational core lab Informatics support Biostatistical support Junior and senior investigator grants
  • Slide 8
  • CTRC administration
  • Slide 9
  • Active CTRC protocols CHOPPENN
  • Slide 10
  • No. of protocols by CHOP division
  • Slide 11
  • No. of protocols by Penn division
  • Slide 12
  • Clinical Research Space (CHOP) Inpatient: 5 West 4 beds Outpatient: Main & 3550 4 exam rooms 6 chairs Consultation rooms Lab processing
  • Slide 13
  • Research Nursing
  • Slide 14
  • Research Nursing (CHOP) (Dr. Medoff-Cooper) Nursing services: Phlebotomy / IV infusions Medication administration Vital signs Patient monitoring Study specific requirements, e.g. ECGs Basic laboratory processing / shipping Space for consenting of study participants, physical exams, questionnaire administration Limited Saturday hours offered
  • Slide 15
  • Scatterbed Nurses ICUs OR ED Clinics Sleep lab etc.
  • Slide 16
  • Clinical research space (PENN) HUP (1 Dulles) Dedicated 8 bed inpatient unit Outpatient units (5 single rooms; one large room with 5 chairs) 2 consultation rooms Penn Presbyterian Hospital (Mutch) Dedicated outpatient unit (2 beds, 4 chairs)
  • Slide 17
  • Research nursing (PENN) Unit is open 24/7 16 nurses trained in research nursing 1 nurse practitioner
  • Slide 18
  • CTSA cores Equipment Personnel Scientific and technical oversight
  • Slide 19
  • Core design Medical and technical directorship Combined adult / pediatric components Research quality control Charge-back mechanism with low rates (need to budget into new grant proposals)
  • Slide 20
  • Nutrition Core Babette Zemel, PhD
  • Slide 21
  • Nutrition Laboratory Anthropometrics & growth Body composition (BodPod, DXA) Resting energy expenditure Bone density, growth (DXA, pQCT, knee height) Muscle strength
  • Slide 22
  • Bionutrition Research Unit (Dr. Compher) Analyze diet records Nutrition education / consult Plan study meals Design & test recipes Provide special diets (metabolic kitchen)
  • Slide 23
  • Cardiovascular Core Emile Mohler, MD & Meryl Cohen, MD
  • Slide 24
  • Vascular studies Brachial artery reactivity testing Carotid intimal medial thickness testing Arterial duplex ultrasound Venous duplex ultrasound Ankle-brachial index Pulse wave velocity NIRS of skeletal muscle
  • Slide 25
  • Pediatric tests Echo (with or without sedation) EKG
  • Slide 26
  • Pulmonary Core Hank Mayer, MD
  • Slide 27
  • Pulmonary Core PFTs: Outpatient & inpatient Bronchodilator / metacholine challenges Exhaled NO; breath condensates Infant PFTs
  • Slide 28
  • Behavioral Neuroscience Core Jerilynn Radcliffe, PhD
  • Slide 29
  • Behavioral Neuroscience Core Neuropsychological testing (infancy through adulthood) Training and supervision for research assistants to conduct neuropsychological testing Consultation on study design, test interpretation, manuscript preparation
  • Slide 30
  • Sleep Core Allan Pack, MD PhD, Alex Mason, MD PhD
  • Slide 31
  • Sleep Core Polysomnography Multiple sleep latency tests Actigraphy
  • Slide 32
  • Investigational Drug Service K. Rockwell Procurement / storage / dispensing study drugs Randomization Placebos Maintains study randomization schedule to allow for unblinding in case of emergency, 24/7
  • Slide 33
  • Informatics Core (E. Escobar)
  • Slide 34
  • Informatics Core Case report forms (CRF) development Development and maintenance of databases Storage of study databases on a secured server Assistance with proprietary software New initiatives in conjunction with CTSA BIIT
  • Slide 35
  • Biostatistics Core Assist with statistical analysis plans Power calculations Help revise protocols after Council reviews Data analysis for K23 & JIPGP recipients, pilot studies Drs. Cucchiari, Gallagher & Shults
  • Slide 36
  • Translational Core Laboratory Charles Stanley MD, Muredoch Reilly MD
  • Slide 37
  • TRANSLATIONAL CORE LABORATORIES Biochemistry CoreMolecular Biology CoreCell Biology Core Sample Processing TCL Bioinformatics Proteomic Core Lipidomic Core DERC RIA Biomarker Core Lipid/CV Biomarker Lab Pathology BioResources Clinical Sites Sample Collection Novel Bioassay Development BIIT Pre-Clinical Laboratories Sample Collection Freezer Storage
  • Slide 38
  • Biochemistry services ELISA, RIA, spectrophotometry, SPE, TLC, HPLC, platelet aggregation and function studies 69 types of ELISA, enzymatic and RIA assays Collection, processing, shipping, storage
  • Slide 39
  • Translational Core Laboratory Molecular Markers DNA sequencing/Re-sequencing/Mutation detectionDNA sequencing/Re-sequencing/Mutation detection Sequencing prep Data analysisSequencing prep Data analysis TaqMan SNP genotypingTaqMan SNP genotyping Microsatellite marker/LOH analysis/Fragment analysisMicrosatellite marker/LOH analysis/Fragment analysis Real-time TaqMan PCR Gene Expression AnalysisReal-time TaqMan PCR Gene Expression Analysis PCR/Gel Analysis/Primer DesignPCR/Gel Analysis/Primer Design Establishment of EBV transformed cell lines from fresh or frozen PBMCs
  • Slide 40
  • How do I apply?
  • Slide 41
  • Application process (1) Joint IRB/CTRC reviews via eIRB Answer Yes to question asking if you will use the CTRC links to eCTRC module Reciprocity with Penn Annual reviews concurrent with IRB reviews
  • Slide 42
  • Application process (2) Resources committee meets monthly Rapid feedback May be asked to present to CTRC Council or Staff meeting You MUST acknowledge the CTSA in your publications
  • Slide 43
  • Charge-back mechanism Minimal charges to cover actual costs of the study Discuss with CTRC before submitting grants CTRC provides blurbs to include in your grant budget justifications Charges may go up soon
  • Slide 44
  • Slide 45
  • GRANTS
  • Slide 46
  • Junior Investigator Pilot Grants Junior investigators (rank < associate professor) Patient oriented research Primarily pilot studies for generation of preliminary data for grants Use of CTRC resources $20,000 / yr for 1-2 years
  • Slide 47
  • JIPGP recipients 2010 Michelle Denburg, MD,MSCE, Nephrology, Pediatrics Vitamin D Status in the Setting of Nephrotic-Range Proteinuria Sara DeMauro, MD,MSCE, Neonatal-Perinatal, Pediatrics The Role of Serial Echocardiography to Detect an Asymptomatic Patent Ductus Arteriosus (PDA) in Very Low Birth Weight (VLBW) Infants: A Pilot Randomized Controlled Trial Kimberly Lin, MD, Cardiology, Pediatrics Cardiac biomarkers during anthracycline therapy and the risk of cardiotoxicity Frances Balamuth, MD, PhD, Emergency Medicine, Pediatrics Characterization of Inflammatory Biosignatures in Adolescent Females with Abdominal Pain Andrew Calabria, MD, Endocrinology, Pediatrics Adjunctive Measures of Glycemic Control in Children with Post-prandial Hypoglycemia after Fundoplication Michael Grandner, PhD, Center for Sleep and Respiratory Neurobiology, Medicine Health and Performance Outcomes Associated with Short Sleep Duration James Lee, MD, Pulmonary, Allergy, and Critical Care, Medicine Dietary Antioxidant Therapy for the Prevention of Primary Graft Dysfunction in Lung Transplantation
  • Slide 48
  • CTSA grants JIPGP ($20-40,000) TAPITMAT ($150,000) Transdisciplinary awards program in translational medicine and therapeutics ) TBIC ($25-50,000) Translational Biomedical Imaging Center) CBIT ($15,000) Chemical Biology in Translation) K12
  • Slide 49
  • http://www.itmat.u

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