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Hvorfor er der brug for dyrlægernes kompetencer i den biomedicinske forskning på tværs af discipliner og sektorer?

Biopeople har siden 2005 styrket innovation inden for Life Science ved at katalysere samarbejde mellem forskerne i industrien og på universiteterne. Siden vi introducerede “science dating” konceptet i midten af nullerne, hvor deltagerne på tid mødtes to og to og introducerede deres projekter, ideer og sig selv har vi konstant haft fokus på, hvordan vi kunne udvikle mødekoncepter, der tilfredsstiller behovene hos de travle forskere fra universiteterne og virksomhederne.

Erhvervsministeriet og Sundheds- og Ældreministeriet ser Life Science som en vigtig styrkeposition i Danmark, som bidrager væsentligt til det danske velfærdssystem. Den danske Life Science sektor, herunder beskæftigelsen inden for sektoren, har udviklet sig betydeligt i løbet af mange år. Og der synes at være stor enighed om, at Danmark skal hæge om Life Science sektoren for at sikre den fortsatte udvikling.

Øgede forventninger til sundhedsvæsenet i forhold til behandling, information og inddragelse samt en mere proaktiv tilgang til egen sundhed er to centrale forhold for den nye sundhedsforbruger.

Erhvervsministeriet og Sundheds- og Ældreministeriet ser Life Science som en vigtig styrkeposition i Danmark, som bidrager væsentligt til det danske velfærdssystem. Den danske Life Science sektor, herunder beskæftigelsen inden for sektoren, har udviklet sig betydeligt i løbet af mange år. Og der synes at være stor enighed om, at Danmark skal hæge om Life Science sektoren for at sikre den fortsatte udvikling.

Biopeople har siden 2005 styrket innovation inden for Life Science ved at katalysere samarbejde mellem forskerne i industrien og på universiteterne. Siden vi introducerede “science dating” konceptet i midten af nullerne, hvor deltagerne på tid mødtes to og to og introducerede deres projekter, ideer og sig selv har vi konstant haft fokus på, hvordan vi kunne udvikle mødekoncepter, der tilfredsstiller behovene hos de travle forskere fra universiteterne og virksomhederne.

We present a commentary on the international aspects of the evolution of regulatory science as a multidisciplinary, multistakeholder academic discipline of education and applied research emphasizing the need for seamless interaction between stakeholders such as regulatory authorities, the pharmaceutical industry, universities, payers, and patient organizations. Regulatory science is the science of developing new tools, standards, and approaches to evaluate the efficacy, safety, quality, and performance of medical products in order to assess benefit/risk and facilitate a sound and transparent regulatory decision making throughout development and life cycle management.

4. Spindler P (2015) Editorial. The Change Agenda. The Global Forum (Publication of the Drug Information Association, ISSN 1944-1991), 7, 3, 6-7.

To support approval of pharmaceuticals for long term use in humans it is required that product safety is supported by acute and chronic toxicity studies in rodents and non-rodents. The duration of acute toxicity studies (S4A) and chronic rodent studies (S4B) were harmonised between the three ICH regions in 1991; whereas the process of harmonising the duration of non-rodent studies was initiated. The US FDA originally required studies of at least 12 months duration, whereas in Japan and EU studies of 6 months duration were considered acceptable as an ICH objective. In this chapter, the background for the ICH S4B guideline regarding the duration of non-rodent repeated dose toxicity studies is explained and lessons learned are discussed. Since the guideline was issued in 1997 changes occurred in e.g. the language of the European legislation, and the requirements for non-clinical studies to support clinical development has progressed within the ICH (M3): we therefore consider options such as prospective evaluation, biomarker-based mechanistic understanding, toxicokinetics and the use of evidence-based medicine to support further joint activities to harmonise the duration of non-rodent toxicity studies at the global level.

To support approval of pharmaceuticals for long term use in humans it is required that product safety is supported by acute and chronic toxicity studies in rodents and non-rodents. The duration of acute toxicity studies (S4A) and chronic rodent studies (S4B) were harmonised between the three ICH regions in 1991; whereas the process of harmonising the duration of non-rodent studies was initiated. The US FDA originally required studies of at least 12 months duration, whereas in Japan and EU studies of 6 months duration were considered acceptable as an ICH objective. In this chapter, the background for the ICH S4B guideline regarding the duration of non-rodent repeated dose toxicity studies is explained and lessons learned are discussed. Since the guideline was issued in 1997 changes occurred in e.g. the language of the European legislation, and the requirements for non-clinical studies to support clinical development has progressed within the ICH (M3): we therefore consider options such as prospective evaluation, biomarker-based mechanistic understanding, toxicokinetics and the use of evidence-based medicine to support further joint activities to harmonise the duration of non-rodent toxicity studies at the global level.

A Drug Information Association (DIA) workshop was held in May 2001 to discuss the outcome of the International Life Sciences Institute-Health and Environmental Sciences Institute (ILSI-HESI) project on alternative models for carcinogenicity assessment such as the P53(+/-) and XPA(+/-) knockout mouse models, the RasH2 and Tg.AC transgenic mouse models, and the neonatal mouse model. The "ICH Guideline S1B on Testing for Carcinogenicity of Pharmaceuticals" advocates that carcinogenicity testing of pharmaceuticals, when needed, might be carried out choosing one 2-year rodent carcinogenicity study (rat) plus one other study that supplements the 2-year study and providing additional information that is not readily available from the 2-year study: either (1) a short- or medium-term in vivo rodent test system or (2) a 2-year carcinogenicity study in a second rodent species (mouse). Another topic of discussion was pros and cons of the short- and medium-term models being evaluated by the ILSI-HESI project, in particular the usefulness of the models in relation to results of genotoxicity assays. Further discussions were advised following publication of the ILSI-HESI database, which is expected before the end of 2001. The use of the short- and medium-term rodent test systems were not considered appropriate for the assessment of carcinogenic potential of biotechnology-derived medicinal products.

Pharmacology has traditionally been excluded from the mandatory application of good laboratory practice (GLP) principles. Consensus has been reached through the process of the International Conference on Harmonisation (ICH, Topic S7A) with regard to the definitions of the different types of pharmacology studies (ICH S7A): primary pharmacodynamic, secondary pharmacodynamic and safety pharmacology studies, and guidance on the quality standards (expectations for GLP conformity) for these study types have been provided. Primary pharmacodynamic studies are the only study types that are fully exempt from GLP requirements. Secondary pharmacodynamic and safety pharmacology studies are expected to be conducted to GLP quality standards -- preferably to full, formal GLP compliance, when results are used for human safety assessment. At the present time, regulatory authorities will most likely be prepared to exercise flexibility in their requirement for GLP compliance, however, if non-clinical studies used in human safety assessment are not formally in compliance with the principles of GLP, regulatory acceptance may not be guaranteed. Historically, the application of formal GLP standards in safety pharmacology studies appears to vary between test facilities, and a number of study components in safety pharmacology studies, e.g. ECG monitoring, may not always conform to formal GLP standards. Apparently, however, formal GLP standards for these study components can be implemented for a relatively low additional cost. Based on the guidance given in the ICH S7A guideline, it thus appears logical to recommend that test facilities and sponsors consider their organisation of safety pharmacology studies in view of sound study management and formal implementation of GLP, where needed. Organisation of study management should facilitate collaboration across scientific disciplines because a plethora of data, originating from basic pharmacodynamics, toxicology, kinetics, and metabolism, as

Pharmacology has traditionally been excluded from the mandatory application of good laboratory practice (GLP) principles. Consensus has been reached through the process of the International Conference on Harmonisation (ICH, Topic S7A) with regard to the definitions of the different types of pharmacology studies (ICH S7A): primary pharmacodynamic, secondary pharmacodynamic and safety pharmacology studies, and guidance on the quality standards (expectations for GLP conformity) for these study types have been provided. Primary pharmacodynamic studies are the only study types that are fully exempt from GLP requirements. Secondary pharmacodynamic and safety pharmacology studies are expected to be conducted to GLP quality standards -- preferably to full, formal GLP compliance, when results are used for human safety assessment. At the present time, regulatory authorities will most likely be prepared to exercise flexibility in their requirement for GLP compliance, however, if non-clinical studies used in human safety assessment are not formally in compliance with the principles of GLP, regulatory acceptance may not be guaranteed. Historically, the application of formal GLP standards in safety pharmacology studies appears to vary between test facilities, and a number of study components in safety pharmacology studies, e.g. ECG monitoring, may not always conform to formal GLP standards. Apparently, however, formal GLP standards for these study components can be implemented for a relatively low additional cost. Based on the guidance given in the ICH S7A guideline, it thus appears logical to recommend that test facilities and sponsors consider their organisation of safety pharmacology studies in view of sound study management and formal implementation of GLP, where needed. Organisation of study management should facilitate collaboration across scientific disciplines because a plethora of data, originating from basic pharmacodynamics, toxicology, kinetics, and metabolism, as

A Drug Information Association (DIA) workshop was held in May 2001 to discuss the outcome of the International Life Sciences Institute-Health and Environmental Sciences Institute (ILSI-HESI) project on alternative models for carcinogenicity assessment such as the P53(+/-) and XPA(+/-) knockout mouse models, the RasH2 and Tg.AC transgenic mouse models, and the neonatal mouse model. The "ICH Guideline S1B on Testing for Carcinogenicity of Pharmaceuticals" advocates that carcinogenicity testing of pharmaceuticals, when needed, might be carried out choosing one 2-year rodent carcinogenicity study (rat) plus one other study that supplements the 2-year study and providing additional information that is not readily available from the 2-year study: either (1) a short- or medium-term in vivo rodent test system or (2) a 2-year carcinogenicity study in a second rodent species (mouse). Another topic of discussion was pros and cons of the short- and medium-term models being evaluated by the ILSI-HESI project, in particular the usefulness of the models in relation to results of genotoxicity assays. Further discussions were advised following publication of the ILSI-HESI database, which is expected before the end of 2001. The use of the short- and medium-term rodent test systems were not considered appropriate for the assessment of carcinogenic potential of biotechnology-derived medicinal products.

Udgivelsesdato: 2000-null, The safety of a volunteer/patient who participate in the very first human trial relies on data from animal experimentation and on the design of the trial. Recommendations on the type and extent of preclinical safety studies that should be conducted prior to first dose in man have been developed by the International Conference on Harmonisation, and the European Committee for Proprietary Medicinal Products. These recommendations include studies designed to characterise local tolerance and general toxicity of the drug candidate as well as its genotoxic potential and ability to interfere with reproduction. For trials which can be categorised as low dose PK screening trials and trials with products where rodent and non-rodent (primarily dog) models do not show any biological response (e.g. some biotechnology-derived hormones and cytokines) other testing paradigms should be used. The present recommendations for preclinical testing have had an important impact on the documented impressive safety record of phase I clinical trials. In this spirit we extend our warmest and sincerest thanks to Professor Jens S. Schou for his long and deep engagement in European and International harmonisation of preclinical test recommendations. His efforts have had a substantial impact on the present testing recommendations, which are of obvious benefit to the safety of the patient.

Udgivelsesdato: 2000-null, The safety of a volunteer/patient who participate in the very first human trial relies on data from animal experimentation and on the design of the trial. Recommendations on the type and extent of preclinical safety studies that should be conducted prior to first dose in man have been developed by the International Conference on Harmonisation, and the European Committee for Proprietary Medicinal Products. These recommendations include studies designed to characterise local tolerance and general toxicity of the drug candidate as well as its genotoxic potential and ability to interfere with reproduction. For trials which can be categorised as low dose PK screening trials and trials with products where rodent and non-rodent (primarily dog) models do not show any biological response (e.g. some biotechnology-derived hormones and cytokines) other testing paradigms should be used. The present recommendations for preclinical testing have had an important impact on the documented impressive safety record of phase I clinical trials. In this spirit we extend our warmest and sincerest thanks to Professor Jens S. Schou for his long and deep engagement in European and International harmonisation of preclinical test recommendations. His efforts have had a substantial impact on the present testing recommendations, which are of obvious benefit to the safety of the patient.