On how to rethink and accelerate drug development
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.
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.
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.
"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.
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.
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.
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.
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.
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).
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.
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
Workshop II Report June 15 2003 - Appendix 4
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
Workshop III Report September 9 2005
Final Outcomes Report: How to Establish a European Technology Platform for Innovative Medicines.