Drug Research Unit Maastricht
description
Transcript of 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
Drug Research Unit Maastricht
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
• essential part in chain of drug developmentpreclinical → early phase → phase 3&4
• by filling the gap in the drug research chain • facilitates translational research
Position in MUMC-holding/valorisation chain
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 …
Strategic alliance
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)
EC: Ethics Committee www.drug-uzgent.be
Number of working days Median 2005
Median 2006
Median 2007
Median 2008
Median 2009
From submission EC to final answer EC
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
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!