| Background
Traditionally, pharmaceutical companies headquartered in Europe
have played a leading role in developing new drugs. However, there
is evidence that this may no longer be true. Accordingly, initiatives
will be needed to reverse this trend.
Development of new medicines represents a process which has all
the features of integrated research projects: research interface
to many disciplines; identified bottlenecks of the process to be
addressed; need of pan-European collaboration; well defined deliverables
to the citizens; job generation potential; and room for start-up
companies, including small and medium size enterprises (SME). For
these reasons, good input to the EU RTD Framework Programme is essential.
First
Intiative
To get started, EUFEPS, in 1999, produced a Position Paper entitled
"New safe medicines faster". This document was enthusiastically
received by scientists, industrialists and regulators, including
the European Federation of Pharmaceutical Industries and Associations
(EFPIA); the European Federation of Biotechnology (EFB); the Danish
Medicines Agency; the schools of pharmacy in Amsterdam (NL), Copenhagen
(DK), Leiden (NL), London (UK), Paris (FR), Saarbrücken (DE)
and Uppsala (SE); the national industry associations in Denmark
(LIF) and Italy (Farmindustria); and the medical research group
of the European Co-operation in the Field of Scientific and Technical
Research (COST).
In 2000, EUFEPS established the New Safe Medicines Faster Project,
the ultimate goal of which would be to contribute to effective development
of medicines for the benefit of the European citizens. In a Workshop,
held on March 15-16, 2000, in Brussels, ideas and suggestions for
research topics, methodologies, techniques and other means of promoting
the drug development process were identified, put together and published
in the Workshop I Report. In the future, it was suggested,
- identifying new technologies,
capable of more effective selection, development and approval
of new, innovative and safe drugs;
- using such technologies
to increase the capacity and speed of the pharmaceutical development
process; and
- cultivating a pan-European
interdisciplinary network to bridge the existing gap between industry,
academia, health care and regulatory authorities;
would to be of paramount
importance. The
Workshop I Report was presented to the European Commission, in July
2000. Studying
the new EU RTD Framework Work Programme, launched in the fall 2002
(FP6), EUFEPS concluded that nearly all EUFEPS activities and initiatives
would meet the criteria of these measures.
Clinical
Research
In 2001, representatives of EUFEPS, EACPT (European Association
for Clinical Pharmacology and Therapeutics), EORTC (European Organisation
for Research and Treatment of Cancer) and Novo Nordisk Denmark met
to explore interest in and options for a joint EU RTD FP6 Accompanying
Measure application on optimisation of clinical research in general
and for the drug development process in particular, also referring
to the "article 169" initiative by the European Commission.
By the end of October 2001, there might be a chance to apply for
funding which would enable effective and efficient preparation of
such an Accompanying Measure application, e.g. by organising an
additional successful workshop for useful input and by engaging
a part-time person for the job to be done.
The 2001 meeting resulted in a Draft Proposal on Research on and
Optimisation of Clinical Trials in Europe (June 26, 2001), but due
to limited capacity on all hands, it did not result in any EU RTD
FP6 Accompanying Measure application.
EUFEPS
2002
"New Safe Medicines Faster" was selected overall theme
for the EUFEPS 2002, i.e. the 7th European Congress of Pharmaceutical
Sciences, held on October 20-23, 2002, in Stockholm, Sweden. At
this integrated congress, a series of "afternoon special sessions"
and "forum events", funded by the European Commission,
were set up on industrial collaboration, ethics, training and education,
job search and recruitment, entrepreneurship and start-ups finance
and funding etc., all to support drug development sciences in the
creation of a European Research Area (ERA).
An Outcomes and Progress Report (of December 30, 2002) was produced
and presented to the European Commission as stipulated in the contract
with the Commission. Conclusions included that all beginnings are
difficult, but the para-scientific events, in addition to the conventional
programme of the EUFEPS Congress, represented valuable add-on activities,
which caught the interest of the scientific community. Although
positive outcome, further refinement, marketing and sponsoring would,
would be needed, before such initiatives would be self-sustained.
EUREKA
Collaboration
In the beginning of 2003, the Danish Chair of the EUREKA (European
Research Coordination Agency) approached EUFEPS, looking for synergies
with its own programme and ambitions and those of the FP6. The New
Safe Medicines Faster approach might be useful, and EUFEPS was asked
to arrange for a second Workshop, to be funded by EUREKA Denmark.
EUFEPS agreed, and this Workshop was held on April 28-29, 2003 -
on how to rethink and accelerate drug development. Objectives of
it included:
- To arrive at and recommend
urgent research projects, which would pave the way for faster
drug development and approval.
- To propose prioritised
topics for dedicated calls by FP6 and EUREKA.
- To clarify possibilities
for joint project funding from EUREKA and FP6 of strategic projects.
- To propose organisational
initiatives to secure progress of this initiative.
The outcome of it was
put together in a Workshop II Report, presented to the EUREKA, in
June 2003, and to the European Commission, in July 2003. In addition,
EUFEPS and EUREKA agreed to issue a call for "expressions of
interest" to identify active stakeholders from all the European
players involved in discovery, development and approval representing
industry (big and small pharma companies, producers and technology
companies), academia, hospitals, regulators and health care providers.
As of the end of August 2003, 225 "stakeholders", in 23
European countries, reported their interest. More were welcome,
of course, and more joined, later.
Safety
Sciences Brainstorm
A growing number of new and unexplored drug targets had been said
not to be well accompanied by increasing knowledge of the safety
aspects of the corresponding potential medicines. This, together
with introduction of high throughput early assessment of safety
aspects of leads for drug candidates, would lead to an increased
and unmet demand for safety scientists in the pharmaceutical industry.
To address such issues, the EUFEPS Committee on Industrial Relations
(CIR), supported by the EUFEPS Committee on Training and Education
(CTE), suggested that EUFEPS set up a Brainstorm Workshop on Safety
Sciences. Objectives of it would include:
- To define the ideal
safety scientist profile in industry, in regulatory agencies and
in academia.
- To describe current
and new options as to sciences education and training, including
funding aspects.
- To recommend concerted
and other actions to meet short and long range needs in Europe.
The Brainstorm Workshop
on Safety Sciences was held on April 2-3, 2004, in Brussels, Belgium.
It was funded by EUFEPS itself and a small grant from Pfizer France.
The report of the outcomes of it became a compilation of the bottom-up
input received. It was presented to the European Commission, as
input for the 4th Call of the FP6 as well as for the forthcoming
7th Framework Programme (FP7). For a pdf of the Brainstorm Workshop
Report (June 2004), consult the EUFEPS Network
on Safety Sciences, which is also on outcome of this Brainstorm
Workshop (the delegates of it agreed to constitute the first membership).
The complexity, however, of safety sciences in the drug development
process is too demanding to be covered by a single workshop or one
other initiative. The results obtained from the four sessions of
the Brainstorm Workshop suggested that an EU supported effort by
industry, academia and regulatory authorities would be the most
appropriate means of setting new European standards in this important
aspect of drug development.
New
Technology Platform
Towards the end of 2004, the European Commission and a consortium,
comprising EUFEPS, ECRIN, EFMC, EFPIA, EUROTOX, and the University
of Cyprus, signed a contract on how to arrive at recommendations
on how to establish a technology platform for drug development in
Europe. There were two parts of it, one of which including a third
Workshop with a substantial number of stakeholder representatives,
and the other a follow-up promoting period of several months. In
parallel, there were initiatives by the Commission and the European
pharmaceutical industry association (EFPIA) on how to strengthen
European research on innovative medicines, including a “strategic
research agenda” as input for the 7th Framework Programme
(FP7).
Combining these initiatives, it was agreed, in February 2005, that
this new Workshop should address: How to Establish a European Technology
Platform for Innovative Medicines, on April 21-22, 2005, in Barcelona,
Spain. It was held in conjunction with the 3rd World Conference
on Drug Absorption, Transport and Delivery, organised by EUFEPS.
A Summary Outcomes Report of this Workshop, as well as a SWOT analysis
in an appendix, was completed by the end of May 2005. The full Workshop
Report on How to Establish a European Technology Platform for Innovative
Medicines is available since September 2005.
Innovative
Medicines Initiative (IMI)
One of the major objectives of the European Union (EU) is to build
the most competitive and dynamic knowledge-based economy in the
world by 2010, a key element of which is said to be to strengthen
the science base in Europe. The above April 2005 Workshop in Barcelona
was in turn a key event towards the Strategic Research Agenda (SRA),
which is the key stone of the today's Innovative Medicines Initiative
(IMI). In this, bottlenecks in the biomedical R&D process have
been identified and recommendations on how to address these bottlenecks
have been developed using a pre-competitive approach, it is reported.
The recommendations are organised around four main topics: prediction
of safety, early indication of efficacy, knowledge management and
education and training to develop the talent base needed for the
EU biomedical environment of the future.
For current status and plans, consult the
Innovative Medicines Initiative (IMI), section of the European
Commission website on Life Sciences, Genomics and Biotechnology
for Health, and the i.e. IMI
- The Innovative Medicines Initiative Online
Other
Consortia including EUFEPS
In addition to the above, EUFEPS actively engaged in three additional
and ongoing (FP6) consortia, including:
BioSim
- which is a newly established network on biosimulation (FP6 Network
of Excellence - NoE), with 40 partners, on how to use modern simulation
techniques for more rational drug development, including reduction
of animal experiments.
EUMAPP
- which is the European Microdose AMS Partnership Programme (FP6
Specific Targeted Research Project - STREP), with 10 partners, on
how to use the microdosing approach and meet analytical requirements
in microdosing studies.
InnoMed - which is the Innovative Medicines for
Europe joint research project (FP6 Integrated Project - IP), with
44 partners, on how to resolve complex issues associated with the
future of biomedical research.
Support
and Engage
EUFEPS encourages all to continue to support the future development
of the New Safe Medicines Faster and Innovative Medicines initiatives.
» Back to Index
Pertinent PDF documents for downloading
New Safe Medicines Faster: A Proposal for a Key
Action within the EU’s 6th Research Framework Programme Position
Paper - August 10 1999.
Health
and Wealth in the EU: How to improve the conditions for research
and faster development of New Safe Medicines Faster in Europe.
Workshop
I Report July 1 2000
New Safe Medicines Faster: Proposals for research topics, methodologies,
techniques and other means of promoting the drug development process
to the benefit of European citizens.
Workshop
I Report I July 1 2000
- Appendix
1 and 2
Workshop Programme o Abstracts of Introductory Lectures o List of
Participants.
Workshop
I Report July 1 2000 - Appendix 3
Conference Report (Lawrence J. Lesko; Malcolm Rowland; Carl Peck;
Terrence F. Blaschke): Optimizing the science of drug development:
opportunities for better candidate selection and accelerated evaluation
in humans. Published in the European Journal of Pharmaceutical Sciences
10 (2000) iv-xiv (Introduction; Advances and improvements needed,
organized by development phase; Conclusions; Acknowledgements; References).
Draft
Proposal on Clinical Trials Research June 26 2001
EUFEPS
2002 New Safe Medicines Faster - An Integrated Congress Report December
30 2002
EUFEPS
2002 New Safe Medicines Faster - An Integrated Congress Report December
30 2002 - Appendix 3
Call
for Expressions of Interest May 2003
New opportunities for co-funding of research and development
of drug development. An invitation to public-private partnership:
Collaboration between academia, industry and regulators across Europe
for future safe and better medicines.
Call
for Expressions of Interest May 2003 - Form
Please fill in the Form, and you will be informed about the
progress of the NSMF concept.
Workshop
II Report June 15 2003
New Safe Medicines Faster: How to rethink and accelerate the
development and approval of innovative, new medicines for faster
patient relief.
Workshop
II Report June 15 2003 - Appendix 1
Proposals from four workshop sessions on research and technology
projects.
Workshop
II Report June 15 2003 - Appendix 2
List of Participants.
Workshop
II Report June 15 2003 - Appendix 3
Final Programme.
Workshop
II Report June 15 2003 - Appendix 4
Backgrounder.
Workshop
III Report May 27 2005
Summary Outcomes Report: Workshop on How to Establish a European
Technology Platform for Innovative Medicines.
Workshop
III Report May 27 2005 – Appendix 1
SWOT Analysis.
Workshop
III Report September 9 2005
Final Outcomes Report: How to Establish a European Technology
Platform for Innovative Medicines.
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