Clinical & Translational Research Center (CTRC)

1. Clinical & Translational Research Center (CTRC)

3. Clinical & Translational Science Award (CTSA)

4. Structure of the Penn CTSA Translational BiomedicalImaging Center (TBIT) Biomedical Informatics In Translation (BIIT) Clinical and Translational Research Center (CTRC) Personalized Medicine in Translation (PERMIT) Chemical Biology In Translation (CBIT)

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

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

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

8. CTRC administration

9. Active CTRC protocols PENN CHOP

10. No. of protocols by CHOP division

11. No. of protocols by Penn division

12. Clinical Research Space(CHOP) • Inpatient: 5 West • 4 beds • Outpatient: Main & 3550 • 4 exam rooms • 6 chairs • Consultation rooms • Lab processing

13. Research Nursing

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

15. Scatterbed Nurses • ICUs • OR • ED • Clinics • Sleep lab • etc.

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)

17. Research nursing (PENN) • Unit is open 24/7 • 16 nurses trained in research nursing • 1 nurse practitioner

18. CTSA cores • Equipment • Personnel • Scientific and technical oversight

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)

20. Nutrition Core Babette Zemel, PhD

21. Nutrition Laboratory • Anthropometrics & growth • Body composition (BodPod, DXA) • Resting energy expenditure • Bone density, growth (DXA, pQCT, knee height) • Muscle strength

22. Bionutrition Research Unit(Dr. Compher) • Analyze diet records • Nutrition education / consult • Plan study meals • Design & test recipes • Provide special diets (metabolic kitchen)

23. Cardiovascular Core Emile Mohler, MD & Meryl Cohen, MD

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

25. Pediatric tests • Echo (with or without sedation) • EKG

26. Pulmonary Core Hank Mayer, MD

27. Pulmonary Core PFTs: Outpatient & inpatient Bronchodilator / metacholine challenges Exhaled NO; breath condensates Infant PFTs

28. Behavioral Neuroscience Core Jerilynn Radcliffe, PhD

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

30. Sleep Core Allan Pack, MD PhD, Alex Mason, MD PhD

31. Sleep Core • Polysomnography • Multiple sleep latency tests • Actigraphy

32. Investigational Drug ServiceK. Rockwell • Procurement / storage / dispensing study drugs • Randomization • Placebos • Maintains study randomization schedule to allow for unblinding in case of emergency, 24/7

33. Informatics Core(E. Escobar)

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

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

36. Translational Core Laboratory Charles Stanley MD, Muredoch Reilly MD

37. BIIT TRANSLATIONAL CORE LABORATORIES Pre-Clinical Laboratories Sample Collection Clinical Sites Sample Collection Sample Processing TCL Bioinformatics Freezer Storage Molecular Biology Core Biochemistry Core Cell Biology Core Novel Bioassay Development Proteomic Core Lipidomic Core DERC RIA Biomarker Core Lipid/CV Biomarker Lab Pathology BioResources

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

39. Translational Core Laboratory • Molecular Markers • DNA sequencing/Re-sequencing/Mutation detection • Sequencing prep Data analysis • TaqMan SNP genotyping • Microsatellite marker/LOH analysis/Fragment analysis • Real-time TaqMan PCR Gene Expression Analysis • PCR/Gel Analysis/Primer Design • Establishment of EBV transformed cell lines from • fresh or frozen PBMCs

40. How do I apply?

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

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

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 

45. GRANTS

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

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

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

49. http://www.itmat.upenn.edu/ctrc/index.shtml