Clinical & Translational Research Center

(CTRC)

Clinical & Translational Science Award (CTSA)

Chemical BiologyIn Translation (CBIT)

Chemical BiologyIn Translation (CBIT)

Clinical and Translational

Research Center(CTRC)

Clinical and Translational

Research Center(CTRC)

Personalized Medicinein Translation (PERMIT)Personalized Medicinein Translation (PERMIT)

Biomedical InformaticsIn Translation (BIIT)

Biomedical InformaticsIn Translation (BIIT)

Translational Biomedical

Imaging Center (TBIT)

Translational Biomedical

Imaging Center (TBIT)

Structure of the Penn CTSA

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

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

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

CTRC administration

Active CTRC protocols

245 234

0

50

100

150

200

250

CHOPPENN

No. of protocols by CHOP division

0 5 10 15 20 25 30 35

Gen PedsGenetics

PharmacologyNursing

PsychiatryICU/anesthesi

PsychologyRehab

AdolescentAllergy/ID

SurgeryCardiologyPulmonary

RheumatologyNeurologyOncology

NeonatologyHematologyNephrology

EndocrinologyGI/Nutrition

No. of protocols by Penn division

0 5 10 15 20 25

Internal MedicinePsychology

NursingNephrology

DermatologyGeriatrics

MonellRheumatology

SurgeryAnesthesia

GIOB/GYN

Radiation OncRadiology

EndocrinologyEpidemiology

CardiologyInfectious

PulmonaryNeurology

NephrologySleep

PsychiatryOncology

Phamacology

Clinical Research Space(CHOP)

Inpatient: 5 West• 4 beds

Outpatient: Main & 3550•4 exam rooms•6 chairs•Consultation rooms•Lab processing

Research Nursing

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

Scatterbed Nurses

• ICUs• OR• ED• Clinics• Sleep lab• etc.

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)

Research nursing (PENN)

• Unit is open 24/7• 16 nurses trained in research nursing• 1 nurse practitioner

CTSA cores

• Equipment

• Personnel

• Scientific and technical oversight

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)

Nutrition Core

Babette Zemel, PhD

Nutrition Laboratory

• Anthropometrics & growth• Body composition (BodPod, DXA)• Resting energy expenditure• Bone density, growth (DXA, pQCT,

knee height)• Muscle strength

Bionutrition Research Unit (Dr. Compher)

• Analyze diet records• Nutrition education / consult• Plan study meals• Design & test recipes• Provide special diets

(metabolic kitchen)

Cardiovascular Core

Emile Mohler, MD & Meryl Cohen, MD

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

Pediatric tests

• Echo (with or without sedation)

• EKG

Pulmonary Core

Hank Mayer, MD

Pulmonary Core

• PFTs: Outpatient & inpatient

• Bronchodilator / metacholine challenges

• Exhaled NO; breath condensates

• Infant PFTs

Behavioral Neuroscience Core

Jerilynn Radcliffe, PhD

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

Sleep Core

Allan Pack, MD PhD, Alex Mason, MD PhD

Sleep Core

• Polysomnography• Multiple sleep latency tests• Actigraphy

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

Informatics Core(E. Escobar)

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

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

Translational Core Laboratory

Charles Stanley MD, Muredoch Reilly MD

TRANSLATIONAL CORE LABORATORIES

Biochemistry CoreMolecular Biology Core Cell Biology Core

Sample Processing

TCL Bioinformatics

Proteomic CoreLipidomic Core

DERC RIA Biomarker CoreLipid/CV Biomarker LabPathology BioResources

Clinical Sites

Sample Collection

Novel Bioassay Development

BIIT

Pre-Clinical Laboratories

Sample Collection

Freezer Storage

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

Translational Core LaboratoryMolecular MarkersMolecular 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 Establishment of EBV transformed cell lines from fresh or frozen PBMCsfresh or frozen PBMCs

How do I apply?

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

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

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

GRANTS

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

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

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

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