Download Pfizer Clinical Research Unit – Brussels

Pfizer Clinical Research Unit –
Brussels
Pfizer Confidential │ 1
Erasme Hospital One–day Clinic
Since 2005
The unit is located in the two upper floors (3 & 4)
of the one-day clinic
Pfizer Confidential │ 2
DRUG DEVELOPMENT –
VALUE OF PHASE I
RESEARCH
Who are we?
• Dedicated group of very experienced staff
– Most experienced phase 1 nursing staff in the industry
– 4 full time MDs
– Never a major medical event
– Never a major quality issue that has forfeited study
• Seen as « Benchmark » by competent authorities (FAHMP)
and other phase one units in Belgium
Pfizer Confidential │ 4
Drug Discovery
Pfizer Confidential │ 5
Cost of a drug
Pfizer Confidential │ 6
Early Development Research
• Healthy volunteers
• Pharmacokinetics
• Pharmacodynamics
• …… ?
Pfizer Confidential │ 7
Early Development Research
• Healthy volunteers
• Pharmacokinetics
• Pharmacodynamics
• …… ?
Pfizer Confidential │ 8
Who are these volunteers?
• The majority (+ 49%) is employed (nurse, police,
military, firemen, independent workers)
– Very little (less than 20%) unemployed
• Reliable and trustworthy!
• Are reimbursed for their time and uncomfortable
nature of study (not for risk!!!)
– i.e. several blood samples, number of nights in the unit
etc
– Average per 24hrs = 110 euro
Pfizer Confidential │ 9
Healthy volunteers
What is “Healthy”?
• No disease
• No modification of drug absorption or elimination (kidney, liver,
gut etc)
• No concomitant medication
• Conclusion: No confounding factors!!!
Pfizer Confidential │ 10
Volunteer types
Volunteering types in the PCRU-BR:
• Healthy Subjects
• Patients
• Specific populations
Pfizer Confidential │ 11
Specific populations
Not « Healthy » but no « Patient »
Characteristics - according to study protocol:
• Elderly
• Lactating women
• Overweight
• Elevated LDL
• ...
Pfizer Confidential │ 12
Patients
• PCRU-BR has experience in studies with patients since 2004
– Phase1/methodology studies in patients
• Characteristics; according to the study protocol
• Since 2011 patient studies are specifically run to assess an
early sign of efficacy => avoid needless (later-phase) studies
Pfizer Confidential │ 13
Recruitment Methods
Are chosen upon protocol requirements
Newspaper Advertisements
PfizerPro Newsmail
(Patient) Associations (e.g. La
Third Party Vendors (Clariness,
leche league)
BBK Worldwide)
Student Associations
Pfizer Corporate Social Media
Accounts (Blog, Facebook, Twitter)
Pharmacies (e.g. Multipharma)
PCRU Newsmail
GP/SP (Close collaboration)
Word of Mouth
Pfizer Confidential │ 14
Recruitment Methods
Recruitment Methods
7%
9%
6%
34%
15%
29%
Word of mouth
Pfizer Website
Banner/Clariness
Medical Referral
Metro
Other
Pfizer Confidential │ 15
Recruitment Process
First Contact
Call Center
First Panel Visit
Selection (Query)
Proposition of a Study
Inscription in a Study
Study Specific Screening
Pfizer Confidential │ 16
What are our « safety nets » ?
MEDICAL
REGULATORY / ETHICS
• 1st contact: Telephone call
• FAMHP
• First visit/screen phone
(general)
• Ethics Committee approval
• AAHRPP Accreditation
• Screening visit (study)
• Admission (just prior to 1st
drug dosing)
Pfizer Confidential │ 17
What happens to the volunteers in the unit?
• Admission: (Day 0) afternoon before dosing
– Drug test; lab safety : BS, urine; physical exam
– Explanation of the « schedule »
– Overnight stay
• Next day (Day 1)
– ECG, BP, BS (PK), Empty bladder, No breakfast unless food interaction studied
– Dosing
– No toilet or water 1 hour after dosing
– Stay in room for first 4 hours, semi-recumbent
– Up to 5 ECG, BP, BS (PK), other tests
– Cardiac Monitoring in case of FIH
– Urine collection
– …………….
• Day 2 In house (idem day 1) ECG, BP, BS (PK), lab safety : BS, urine
• Day 3 ECG, BP, BS (PK), lab safety : BS, urine, physical exam and discharge
Pfizer Confidential │ 18
S
A
F
E
T
Y
What happens to the volunteers in the unit?
Pfizer Confidential │ 19
Adverse Events on 400 Phase 1 protocols:
20 most frequent AE’s
11%
20%
1-6%
Pfizer Confidential │ 20
SAEs in Belgian Phase I Units
Overview period 2009 - 2012
2009
2010
2011
2012
Healthy volunteers (male & female):
3138
3695
2507
2457
Special populations/patients:
92
197
165
250
•
Renal
10
24
10
12
•
Hepatic
15
32
44
15
•
Hypertensive
17
24
39
69
•
Migraine
7
0
4
44
•
Overweight & obese
16
52
0
0
•
Diabetics
0
4
22
5
•
CHF
11
15
0
0
•
COPD
0
14
0
32
•
Schizophrenic
16
32
32
0
•
Asthmatic
0
0
14
0
•
Depression
0
0
0
13
•
Ligated males
0
0
0
11
•
Menopausal women
0
0
0
8
•
Cystic fibrosis
0
0
0
3
•
Gastroparesis
0
0
0
5
•
Osteoarthritis
0
0
0
30
•
Hemophilia
0
0
0
2
•
Ulcero-hemorrhagic rectolitis
0
0
0
2
Grand total of all subjects:
3230
3892
2672
2707
SAEs or SUSAR:
7
12
12
14
•
Related
0
2(0,05%)
0
0
•
Not related
7
10
12
14
•
Fatalities
0
0
0
0
0,22%
0,31%
0,45%
0,52%
% SAEs relative to grand total :
Pfizer Confidential │ 21
SAE in GENERAL POPULATION
vs Phase 1 population
• 3% of all deaths in the general population due to fatal adverse
drug reaction (Br J Clin Pharmacol 2008 April)
• 0.3% of phase 1 population suffer from serious adverse event
• 0.05% of phase 1 population suffer from DRUG RELATED
serious adverse event
Pfizer Confidential │ 22
Early Development Research
• Healthy volunteers
• Pharmacokinetics
• Pharmacodynamics
• …… ?
Pfizer Confidential │ 23
Pharmacokinetics
MTD
Therap.
Pfizer Confidential │ 24
Pharmacokinetics – controlled release
Pfizer Confidential │ 25
Early Development Research
• Healthy volunteers
• Pharmacokinetics
• Pharmacodynamics
• …… ?
Pfizer Confidential │ 26
Pharmacodynamics
• BP
• Temperature
• ECG – QT interval
Pfizer Confidential │ 27
PCRUS :
PFIZER’S INTERNAL UNITS
Pfizer’s 2 Clinical Research Units
act as « 1 Unit »
State of the art internal facilities to conduct Early Development
Clinical Trials
New Haven
Pfizer
Clinical
Research
Units
Brussels
Pfizer has over 20 years of experience with internal CRUs
Pfizer Confidential │ 29
Pfizer’s Clinical Research Units (PCRUs)
New Haven CRU (CRU-NH)
Established 2005; 52 beds
64,000 Sq ft; Adjacent to Yale Medical Center
Brussels CRU (CRU-BR)
Established 1992; 60 beds
32,000 Sq ft; Located in ULB Erasme Hospital
Pfizer Confidential │ 30
Competitive Advantage in Quality
• AAHRPP Accredited since 2009
– Pfizer as a company is AAHRPP accredited for all clinical trials
Phase I-IV since 2013
• State-of-the-art facilities with global span that provide
exceptional data quality as evidenced by 24 hour database
release
• Highly experienced clinical research staff partner with study
teams in high risk/complex studies
• Two locations working to common SOPs and standards
Pfizer Confidential │ 31
31
Competitive Advantage in Speed
 CRU studies are 35% faster than competition
 Pfizer Clinical Study Report delivery is Industry Best-In-Class
100
2009 Cycle Time Metrics
Calendar Days
80
60
CRU
External
40
20
57
88
44
72
0
FAP-FSD*
LSLV-DBR**
* Final Approved Protocol to First Subject Dosed
** Last Subject Last Visit to Database Release
Pfizer Confidential │ 32
Phase I Management System (PIMS)
PIMS is not only an EDC tool!!
PIMS is designed to:
•
•
•
•
Assist CRU staff in review of safety data
Assure quality data collection
Comply with regulatory authorities
Includes subject (volunteer) database & sample management
Pfizer Confidential │ 33
Inside PCRU Brussels
Pfizer Confidential │ 34
Inside PCRU Brussels
Pfizer Confidential │ 35
Conclusion
Speed – Cost – Quality triangle optimal used
Quick timelines for Ethics and Regulatory
Quick database creation and lock
Ability to recruit quickly and with high quality: database, including
patients
Reliable subject population, low drop out
Physicians with significant experience, including specialised
experience in dermatology
Experienced staff over all
25 Years experience in conducting early development trials in
Brussels / Belgium
Pfizer Confidential │ 36