Jef Tavernier,
Minister of Public Health, inaugurates
the new wing.
Merksem, May 14 – Jef Tavernier,
Minister of Public Health, today officially
opened a new wing at Jan Palfijn Hospital.
This Clinical Pharmacology Unit is
a collaborative initiative between
Johnson & Johnson Pharmaceutical
Research & Development and Jan
Palfijn Hospital.
In his address, Minister Tavernier
stressed that the European Directive
on clinical research would shortly
be incorporated into Belgian law.
It is the explicit aim of the Minister
and his administration to ensure that
clinical research can continue to
be carried out in Belgium.
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To make this possible, a fast and flexible procedure
is needed. It is a tenet of the pharmaceutical
industry that speed and efficiency are decisive
factors in the choice by pharmaceutical companies
of countries in which to invest in clinical research.
The Clinical Pharmacology Unit meets the most
stringent requirements for conducting early-phase
drug research in healthy volunteers. This research
aims primarily at testing product safety. New
drugs from Johnson & Johnson will be tested
there, including those from Janssen Pharmaceutica.
A joint investment of 3 million euros has been
made in research equipment and new buildings with
a total floor area of 945 m². The facilities
of the Clinical Pharmacology Unit include a test
room for specialized research techniques, a laboratory,
an administrative area and extensive hotel accommodations
for study volunteers. The capacity of the unit
has increased three-fold since 2000, with 16 state-of-the-art
research beds. The customized unit is being put
at the firm’s disposal on a long-term lease.
A total of 12 highly qualified research staff
work in the Clinical Pharmacology Unit. The medical
team is supported by the hospital and a team of
experienced nurses, so that staffing is available
on a 24/7 basis.
The presence of the Clinical Pharmacology Unit
at Jan Palfijn General Hospital in Merksem constitutes
a real boost to discovery and clinical drug research
in Belgium and in Antwerp in particular. The close
cooperation between Jan Palfijn Hospital and one
of the largest pharmaceutical R&D organizations
in the world offers research, physicians, and
above all patients, substantial added value.
The collaboration between the company and the
hospital stems from an initiative by Dr. Herman
Verhaegen and Dr. Paul Janssen, and is based on
the concept of partnership between the public
and private sectors, which they proposed before
the term was even coined.
On the occasion of the inauguration, Johnson
& Johnson presented the hospital with a sculpture
by Bart Decq, which is on display in the garden.
Johnson & Johnson Pharmaceutical Research
& Development (J&JPRD) is the new name
of the departments of Johnson & Johnson concerned
with pharmaceutical research. The entity came
about as a result of a merger between Janssen
Research Foundation and the Pharmaceutical Research
Institute of Johnson & Johnson. The organization
has more than 1,300 staff in Belgium.
Jan Palfijn Hospital is one of the three hospitals
affiliated with the Antwerp Public Center for
Social Welfare. It admits more than 12,000 people
annually, and it urgently needs to expand in order
to meet the needs of the North Antwerp area. A
total of 1,100 people now work at the Merksem
and Deurne sites.
BACKGROUND INFORMATION
Pharmaceutical research proceeds through various
phases.
The first phase of clinical research consists
in testing the potential drug in healthy volunteers.
The safety of the product and how it is metabolized
in the body are looked at in particular. All this
activity is carried out in a strictly regulated
environment and in accordance with national and
international legislation, medical and ethical
standards and Good Clinical Practice. Volunteers
for Phase 1 research are thoroughly screened before
they are allowed to take part in an investigation.
The length of stay at the unit varies with the
nature of the research, from one day to as long
as several weeks.
In Phase 2, the test substance is investigated
in a limited group of patients. If it is found
to be medicinally active, it is tested on a large
scale for efficacy and safety in Phase 3 in thousands
of patients. The studies are carried out by doctors
and in compliance with formal protocols.
The process is documented at each step and forms
the basis for registration of the drug by the
regulatory authorities. Previously the totality
of these documents was so voluminous that they
filled a van. Nowadays data are increasingly stored
electronically on a CD-ROM. It takes years to
complete the process. Only one in twenty of the
drugs tested in Phase 1 makes it to the market.
The average cost price of developing a single
new medicine today is around 850 million euros,
an investment that has to be financed entirely
by drug sales. The time from the initial discovery
of a molecule to its release onto the market is
about 12 years.
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