Drug Research Unit Maastricht

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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

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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) - PowerPoint PPT Presentation

Transcript of Drug Research Unit Maastricht

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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

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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

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• 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

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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

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sponsors

•Pharmaceutical industry (+ nutriceuticals)

•Non for profit organisations

•MUMC

•Other University departments

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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

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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

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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?)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Ready to start!

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Summary

•Centre of Excellence (qualified staff / approval / external audits / ISO 9001:2008)

• short timelines, high flexibility

• takes advantage of university knowledge centre

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YES, we can!