Date post: | 19-Feb-2017 |
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Health & Medicine |
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Founded in 1710
Largest university hospital in Germany
17 centres with over 100 clinics
CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
CHARITÉ RESEARCH ORGANISATION CHARITÉ OWNED - OPERATIONALLY INDEPENDENT – FOR PROFIT
Phase I/II unit with 30+ beds, 500sqm out-patient facility and a dedicated team
Facilitate a single centre solution for early clinical studies in HVs and patients whenever possible
Deliver Proof of Concept faster via more effective use of university hospital resources
267 FTIH- POC PROJECTS TO DATEFROM MORE THAN 50 INDUSTRY SPONSORS
Projects By Primary Area, March 2016
Cardiolo
gy
Clinica
l Pha
rmac
ology
Consu
ltanc
y
Dermato
logy
Endoc
rinolo
gy
Gastro
enter
ology
Immun
ology
Infec
tiolog
y
Nephro
logy
Neurol
ogy
Nutritio
n
Oncolo
gy
Psych
iatry
Pulmon
ology
Rheum
atolog
y
Urolog
yOthe
r0
2
4
6
8
10
12
14
16
18
20
22
24
26
28
30
Completed In Progress In Preparation
CRO SERVICES
Internalised Partnered
Scientific & Regulatory Consultancy
Project Management
Protocol Development
Ethical & Regulatory Submissions
Clinical Conduct
Medical Writing
Routine Laboratory Analysis
Biomarker Validation & Analysis
GMP Pharmacy
Monitoring
Data Management
Statistical Analysis
CRO’s CENTRES OF EXCELLENCE APPROACH
Independent Phase I/II unit
and team
Methodological and scientific support from therapeutic
area experts
Access to key technologies such
as MRI
Access to specialist biomarker research and laboratory capabilities
Patient recruitment via dedicated team using database and advertising
Clinicians share expertise Clinics provide access
Scientists utilise
research
IMAGING CENTRE OF EXCELLENCE
MRI with central scoring services, PD Dr. med. Kay-Geert Hermann
Ultrasound expertise via Prof. Dr. med. Marina Backhaus, developed US 7 score
Leading the way in use of Florescence Optical Imaging in rheumatology
BIOMARKER CENTRE OF EXCELLENCE
Prof. Hans-Dieter VolkScientific Director
PD Dr. Gerlald GrützHead of Laboratory
Immunological Study Laboratory (ISL)
10 colour flow cytometer
Hematology analyzer
Multiplex ECL
Multi-analyte ELISA
Multiplex Luminex
ELISA-Reader
Off the shelf assays
Transfer and validation of sponsor assays
Research laboratory
DIN EN ISO 15189
DIN EN ISO/IEC 17025
EXCELLENCE IN ALL PARTNERSHIPS
Accredited laboratory providing routine and advanced analysis capabilities, serving the
pharma and CRO industries for more than 15 years
Pharmacy with GMP license and dedicated clinical trials support, serving the pharma
and CRO industries for more than 20 years, providing on-site pharmacist support and
manufacturing capabilities
Patients Enrolled Per Site 0 - 5
% of Sites Contributing Zero
Patients20-30%
CHALLENGING THE CONVENTIONAL PATIENT STUDY APPROACH
It’s expensive to set-up and quite ineffective
Would be much better if you could bring (most of) the patients to a single central unit…
DOES A PHASE III-STYLE APPROACH WORK IN EARLY DEVELOPMENT?
Tends to limit what you can do in a study – lowest common denominator, logistics issues
CRO RECRUITMENT APPROACH
Appeal directly to the patient
Financially compensate the patient properly+
Have the resources to treat the patient with utmost respect
+
SINGLE CENTRE PHASE IIa SJÖGREN’S STUDY – GERMAN WIDE RECRUITMENT
Work with KOL’s for indication expertise
German wide recruitment using FB and Google
Allowed 1 site solution instead of 17 site solution
All patients received financial compensation
n=27 patients enrolled, 11 from Berlin, 16 from German wide recruitment
FTIH-POC STUDY EXAMPLES
Indication Key Criteria Phase Type Design Enrolled n= Screened n=Avg. Enrolment Rate / Month
Key Methods
RA DAS28 ≥ 3.2 FTIH Single-CentreSAD i.v., SAD s.c., MAD s.c.
92 134 8
DAS28, MRI, ultrasound, PD markers, local RO assessments
SLE
SELENA-SLEDAI 2-9, autoantibody positive
Phase I Multi-CentreMAD s.c., SD s.c.
21 56 3
SLELENA-SLEDAI, BILAG, Lupus-QoL, PD markers
Sjögren's
ESSDAI ≥ 6, elevated serum titers, antibody positive
Phase IIa Single-Centre SAD i.v. 27 55 3
ESSDAI, PD markers, salivary flow, salivary gland biopsy
RA & Psoriasis
RA: diagnosis > 3 months, on MTXPsoriasis: Diagnosis > 6 months, stable, no MTX
Phase I Single-CentreMAD i.v., MAD s.c.
RA: 24Psoriasis: 60
RA: 48Psoriasis: 156
RA: 8Psoriasis: 8
PASI, target lesion score, PD markers
HV & Crohn's
HV: restricted lab rangesCrohn's: remission with CDAI ≤ 150
FTIH Single-CentreSAD i.v., SAD s.c.
HV: 64Crohn's: 24
HV: 184Crohn's: 37
HV: 8Crohn's: 6
CDAI, PD markers
FTIH-POC STUDY EXAMPLES
Indication Key Criteria Phase Type Design Enrolled n= Screened n=Avg. Enrolment Rate / Month
Key Methods
HV & Asthma
HV: restricted lab & ECG rangesAsthma: FEV1 ≥ 70% pedicted with ≥ 12% reversibility
FTIH Single-Centre MAD oralHV: 80Asthma: 54
HV: 235Asthma: 98 (pre-screening study 244)
HV: 80Asthma: 27
Spirometry, PD markers
MS (Progressive)
Diagnosis of primary forms of MS
FTIH Single-CentreSAD i.v., SAD s.c.
44 87 4EDSS, MRI, PD markers
HIVHIV-1 Clade B, C
Phase IIa Multi-Centre MAD. Oral 91 150 8Long in-house stays (30 days), viral load, CD4+
HCV HCV GT1, GT3 Phase I Single-Centre MAD Oral 54 102 3 Viral load
HV & T2D
HV: restricted lab & ECG rangesT2D: overweight, metformin
Phase I Single-Centre MAD s.c.HV: 40T2D: 36
HV: 129T2D: 116
HV: 16T2D: 6
Long in-house stays (21 days), PD markers, holters
INNOVATION – PRE-SCREENING STUDIES
n=244 asthma patients identified and pre-screened against key study inc/exc. criteria before
and during conduct of HV part
n=108 considered to be “probably” eligible for main study
n=98 entered into main study screening
n=54 enrolled in just over 2 months in 2 parallel
cohorts of 27
Pre-screening study approved by local ethics
Core block of patients identified to push to main
study
Ultimately n=98 retained for main study screening
n=54 enrolled
INNOVATION – WORLD FIRSTS
World’s first clinical trial (CV area) conducted under micro-gravity conditions somewhere over the Atlantic Ocean