New drug research & development process needed
Involvement of all stakeholders in a dedicated and coordinated effort to streamline drug development and approval is needed. Combining genomics with new technologies for predicting and assessing the effect of new drugs may change the drug R&D process for the benefit society.

Recent advances within genome research, pharmacogenetics, metabonomics, in-silico modelling and other new techniques will pave the way towards individualised medication based on far more specific diagnostic systems than those used today.
New Safe Medicines Faster, established in 2000, is a visionary project intended to encourage and stimulate development of new technologies and approaches and to co-ordinate and integrate whenever possible target identification and validation through safety and efficacy tests to market launch, with the purpose to generate a whole new streamlined faster approach to the development of new medicines.

Framework Programme 6 and EUREKA
One of the priorities of the 6th Framework Programme for Research and Technology of the EU (FP6) will contribute to this goal:

“Rational and accelerated development of new, safer, more effective drugs including pharmacogenomics approaches; development of new diagnostics; development of new in vitro tests to replace animal experimentation; development and testing of new preventive and therapeutic tools, such as somatic gene and cell therapies (in particular stem cell therapies, for example those on neurological and neuromuscular disorders) and immunotherapies; innovative research in post-genomics, which has high potential for application”.

EUREKA, European Network for market oriented R&D, collaboration between 34 European countries, aims to facilitate development of industrial competences to support European innovation and competitiveness.

Specialist workshop clarify the need and the concept
These possibilities were discussed at a workshop in Copenhagen 28-29 April 2003 arranged by EUFEPS (European Federation of Pharmaceutical Sciences) with support from the Danish EUREKA Chairmanship. More than 60 representatives from academia, industry and regulators evaluated this concept.
The issues discussed were:

• New technology (needs and options) for drug development
• Modelling and simulation in drug development
• Challenges and issues in shortening clinical drug development including better characterisation of patients for drug development
• Networks, interplays and platforms for future drug R&D

The workshop concluded that streamlining of the drug development and approval process involves 2 separate topics:

• To streamline or reengineer the current drug research & development processes utilising contemporary scientific knowledge by removing bottlenecks and developing new tools (streamlining).
• To re-evaluate the entire process and create a new efficient flow of knowledge generation and management without compromising safety based on the scientific advances within e.g. the genome research (fresh approach).

A precondition for success rests on a close partnership and knowledge sharing between academia, industry, the public health systems, hospitals and regulators and close contacts to other stakeholders such as health care providers.

If successful, it is thought that this will improve public health services as well as enhance European pharmaceutical competitiveness on the world market.

What next?
It was recommended from the workshop that the way forward should be:

• Streamlining: To establish and fund European platforms dealing with new concepts, methodologies, and technologies needed for “rational and accelerated development of new, safer, more effective drugs”.
• Fresh approach: To establish and fund task groups to propose how to organise and develop a new and more efficient process of drug development and approval.

It is expected that both endeavours will develop valuable competences amongst the active partners in the research consortia and the task groups in a share of cost, risk and benefits.

We need your expression of interest
To move forcefully forward while we have the opportunity to communicate with two of the largest public funds in science, we need 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.

To get the public funding money to prepare for such a platform initiative we need expression of interests from as many stakeholders from as many European countries as possible for the New Safe Medicines Faster concept. No obligations are required. If you express your interest we can substantiate the need for funding to start the process. Therefore, please fill in the attached form and we will keep you informed about the progress of the NSMF Concept. Various consortia may then be established to engage in selected projects.

On behalf of the recent New Safe Medicines Faster Workshop Organisers

Ole J. Bjerrum, Professor, EUFEPS President-Elect
Danish University of Pharmaceutical Sciences
Universitetsparken 2
DK-2100 Copenhagen Ø
Denmark
e-mail: ojb@dfh.dk

Jørgen Dirach, MD, MBA, MFPM
Director
Novo Nordisk A/S
Corporate Research Affairs
Novo Allé 1
DK-2880 Bagsvaerd
Denmark
e-mail: jdi@novonordisk.com

J. Gorm Hansen, MSc
National Project Coordinator, Danish EUREKA Chairmanship
Ministry for Science, Technology and Innovation
Bredgade 43
DK-1260 Copenhagen K
Denmark
e-mail: jgh@vtu.dk

Integrating and strengthening the European Research Area’ (2002-2006)”, (2002/834/EC): Research priorities under Advanced genomics and its applications for health www.eureka.be