Slide 1

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 Slide 2 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 Slide 3 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 Position in MUMC-holding/valorisation chain Slide 4 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 Slide 5 sponsors Pharmaceutical industry (+ nutriceuticals) Non for profit organisations MUMC Other University departments Slide 6 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 Slide 7 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 Slide 8 Quality quality control first party (internal) audits scheduled on main procedures ad hoc for (near) errors training in SOP (all SOPs 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?) Slide 9 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 Slide 10 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 Slide 11 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 Slide 12 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 14,511 1414.5 From submission EC to first dosing 2324 2218.5 From last monitoring visit to release of study data to monitor 13331 Slide 13 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 Slide 14 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 Slide 15 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 Slide 16 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 Slide 17 facilities 16 beds for clinical research and overnight stay 2 sample handling laboratories (temperature controlled) 1 drug storage room (temperature controlled / alarm) 1 freezer (-18C) + 1 (-70C) temperature controlled / alarm) 2 refrigerators (temperature controlled / alarm) offices, archive, meeting room, reception, kitchen, storage room Slide 18 facilities 16 beds for clinical research and overnight stay 2 sample handling laboratories (temperature controlled) 1 drug storage room (temperature controlled / alarm) 1 freezer (-18C) + 1 (-70C) temperature controlled / alarm) 2 refrigerators (temperature controlled / alarm) offices, archive, meeting room, reception, kitchen, storage room Slide 19 facilities 16 beds for clinical research and overnight stay 2 sample handling laboratories (temperature controlled) 1 drug storage room (temperature controlled / alarm) 1 freezer (-18C) + 1 (-70C) temperature controlled / alarm) 2 refrigerators (temperature controlled / alarm) offices, archive, meeting room, reception, kitchen, storage room Slide 20 Ready to start! Slide 21 Summary Centre of Excellence (qualified staff / approval / external audits / ISO 9001:2008) short timelines, high flexibility takes advantage of university knowledge centre Slide 22 YES, we can!