START-UP

Scientific and technological issues in alternatives research in drug development and Union politics

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 Obiettivo del progetto (Objective)

'Scientific and technological issues in alternatives research in drug development and Union politics START-UP The START-UP project concerns the identification and proposals to abolish bottlenecks in the 3Rs approach in pharmaceutical discovery and development. The goal of the project is organising 3 Workshops to determine the state of the art of each of the 3Rs in the EU, assess European strength and gaps in 3Rs and identify rate limiting steps on a scientific and technological level, resulting in a Consensus Paper containing concepts and suggestions for a Road Map for future research. Stakeholders (among them European Pharmaceutical Industries) have identified bottlenecks in drug development and in the integration of in vitro methods. Early identification of wrong candidates for further development and avoiding efforts for under-performing candidates are essential for the competitiveness of European Industry. Identification of bottlenecks in the implementation of the 3Rs in drug R&D should help identifying the best in vitro and in vivo systems, and to speed up the drug development process. Existing hurdles in the scientific, technological, ethical, regulatory and political level, play a substantial role and are rate-limiting in developing new drugs, including biological entities. The project is structured around 3 Workshops, preceded by 2 Expert Meetings redefining and prioritising current bottlenecks in 3Rs methodology, drug discovery and development. The limitations and gaps of each phase will be addressed, e.g. many cell systems do not have the required stability for genomics, proteomics or metabonomics ; many current cell systems lack crucial bioactivation capability. Thus, the status of satisfactory “predictive” pharmacology and toxicology in vitro has not yet been reached. The final goal is a Consensus Document .Thereupon, a Road Map to implement the strategy for a better integration of 3Rs in the EU drug discovery and development strategy will be proposed.'

Introduzione (Teaser)

Science may have benefited from live animal testing over the years, but there are better, safer and less harmful ways to undertake research that would alleviate their suffering.

Descrizione progetto (Article)

Animal testing has played an important part in scientific advancement over the last century or so. However, many authorities question the ethical implications of animal laboratory tests and their reliability, considering the often unnecessary suffering involved for the animals.

In the context of pharmaceutical research and development, the EU-funded Start-Up project is exploring issues related to the 3Rs of animal testing: reduce, replace, refine. The three topics were analysed in three expert meetings and open workshops with industry, academia and regulatory authorities.

Among other things the workshops and meetings concluded that while animal experiments may still be needed, live testing (in vivo) and laboratory research (in vitro) should support each other. Alternatives must be explored, and more emphasis should be put on in-vitro testing. The project highlighted the need to deal with embryo toxicity (embryo poisoning), teratogenicity (abnormal development) and carcinogenicity (cancer-causing issues) in animals.

Data sharing and reporting of negative results would also reduce replication of tests and minimise duplication of results in live testing. In parallel, data quality control, protocol standardisation and protection of intellectual property should be adopted by establishing a non-biased pan European entity.

Start-Up also addressed lab animal husbandry and best practice for lab animal keeping. Better training of personnel and positive animal welfare were emphasised, while central breeding with strict quality controls were stressed for primates and transgenic animals.

In addition, the project recommended the use of combined non-invasive (molecular) imaging techniques that allow diagnosis and long-term monitoring of treatment and offer in vitro innovation. The need for proper and tested vaccines for animals was also emphasised - Start-Up called for the setting up of national animal welfare and ethics committees to address this.

Communication across sectors and with participation of regulatory authorities should be enhanced to address these issues, while animal welfare in the different Member States should be harmonised.