Transcript Dia 1 - UGent

Drug Research Unit Maastricht
The Early Phase (0-I-II)
Clinical Drug Research Unit
of
Maastricht University Medical Center (MUMC)
prof dr L. Van Bortel
Mission Statement
To contribute to the development
of new drugs
by conducting early phase clinical trials (phase 0-I-II)
in compliance with (inter)national legislation
and quality standards
Position in MUMC-holding/valorisation chain
• essential part in chain of drug development
preclinical → early phase → phase 3&4
• by filling the gap in the drug research chain
• facilitates translational research
Strategic alliance
Close collaboration with
Drug Research Unit Ghent (DRUG):
1 CEO for 2 units
• ↑ possibilities of conducting larger trials or trials with
difficult recruitment
• DRUM can take advantage of the elaborated quality
management system and training at DRUG
• Joint PR for internal and external sponsors
• Cross-fertilisation of know-how/methods …
sponsors
•Pharmaceutical industry (+ nutriceuticals)
•Non for profit organisations
•MUMC
•Other University departments
What can DRUM offer sponsors
State of the art conduct of
early phase clinical studies
•
•
•
•
•
High quality
Large expertise
Short timelines
High flexibility
Fair cost
What can DRUM offer sponsors
State of the art conduct of
early phase clinical studies
•
•
•
•
•
High quality
Large expertise
Short timelines
High flexibility
Fair cost
Quality
quality control
–
–
–
first party (internal) audits
• scheduled on main procedures
• ad hoc for (near) errors
training in SOP (all SOP’s revised within 2 yrs)
close feedback on the spot / approval system
quality assurance
–
–
1 GCP-ICH third party audit/yr
ISO 9001:2008 → 1 ISO audit/yr (within 1 year?)
What can DRUM offer sponsors
State of the art conduct of
early phase clinical studies
•
•
•
•
•
High quality
Large expertise
Short timelines
High flexibility
Fair cost
Large expertise
takes advantage of experts in 2
knowledge centers: MUMC - U(Z)Gent
→ many therapeutic areas
→ high tec investigations
experience in early phase clinical drug
research
– principal investigator: 24 years
– investigator: 4 years
What can DRUM offer sponsors
State of the art conduct of
early phase clinical studies
•
•
•
•
•
High quality
Large expertise
Short timelines
High flexibility
Fair cost
Timelines (cfr DRUG)
Number of working days
From submission EC to final
answer EC
Median
2005
Median Median Median Median
2006
2007
2008
2009
14,5
11
11
14
14.5
From submission EC to first
dosing
23
24
24
22
18.5
From last monitoring visit to
release of study data to monitor
1
3
3
3
1
EC: Ethics Committee
www.drug-uzgent.be
What can DRUM offer sponsors
State of the art conduct of
early phase clinical studies
•
•
•
•
•
High quality
Large expertise
Short timelines
High flexibility
Fair cost
High flexibility
•Dose adjustments
•Pharmacy with GMPz
•Pharmacell bv with full GMP
•Additional safety measures
•Puts pressure on working
hours/social environment of staff,
particularly in the early years
What can DRUM offer the MUMC
• Service center for early phase drug
investigations
• Take advantage of knowledge center
(experts in MUMC)
• Facilitates education (training) in Medicine/
Health Sciences/clinical pharmacologist
staff
•Principal investigator - investigator - quality coordinator managing coordinator - clinical research coordinator - trial nurse office manager
•investigator/principal investigator experienced in early phase
studies
•All are well-trained
training at DRUG
•Highly motivated
•Bank personnel: trial nurses / co-investigators
facilities
• 16 beds for clinical research and overnight stay
• 2 sample handling laboratories (temperature controlled)
• 1 drug storage room (temperature controlled / alarm)
• 1 freezer (-18°C) + 1 (-70°C) temperature controlled /
alarm)
• 2 refrigerators (temperature controlled / alarm)
• offices, archive, meeting room, reception, kitchen, storage
room
facilities
• 16 beds for clinical research and overnight stay
• 2 sample handling laboratories (temperature controlled)
• 1 drug storage room (temperature controlled / alarm)
• 1 freezer (-18°C) + 1 (-70°C) temperature controlled /
alarm)
• 2 refrigerators (temperature controlled / alarm)
• offices, archive, meeting room, reception, kitchen, storage
room
facilities
• 16 beds for clinical research and overnight stay
• 2 sample handling laboratories (temperature controlled)
• 1 drug storage room (temperature controlled / alarm)
• 1 freezer (-18°C) + 1 (-70°C) temperature controlled /
alarm)
• 2 refrigerators (temperature controlled / alarm)
• offices, archive, meeting room, reception, kitchen, storage
room
Ready to start!
Summary
•Centre of Excellence
(qualified staff / approval / external audits /
ISO 9001:2008)
• short timelines, high flexibility
• takes advantage of university knowledge centre
YES, we can!