2011 Anniversary Yearbook - EUFEPS today and history

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paradigm shift regarding the quality of internal productivity, which undoubtedly will drive the mature portfolio in the 6 to 10 years to come. We often hear that the remedy for the present situation is seen in a decrease of the attrition of early candidates. This is the wrong direction! Before candidate selection and prior to entering clinical development, the attrition should be very high. Thereafter of course, it must be low or as close to zero as possible. If one would follow logic then early attempts to screen out molecules should focus on the main causes of failure that we can influence – if the principal stakeholders accept a paradigm shift through very early partnership. This partnership is still far from optimal in most companies despite the fact that safety issues are – after lack of efficacy – the most important reason for attrition. Knowing that pre-clinical safety plays today a subordinate role in the selection process of a drug candidate and that Discovery’s efficacy models make often a rather questionable prediction of the desired efficacy in the human target (disease) population, one cannot be surprised about the result, i.e. high attrition during those drug development phases that start being very expensive, due to lack of both safety and efficacy. Hence, there is real urgency to partner between Discovery and the scientists involved in pre-clinical Drug Safety to improve safety-related attrition at least. Our industry cannot afford any longer to start with safety evaluation only once the candidates are selected, knowing that many of them will fail rather quickly thereafter due to safety issues. Many of these compound deficiencies could have been discovered prior to candidate selection if enough API (Active Pharmaceutical Ingredient) had been available for a base set of experiments looking at more than just acute toxicity, genotoxicity and QT interval prolongation. Examples include: photo-toxicity, phospholipidosis, a reasonably short in vivo study in a suitable rodent or small non-rodent, the use of geneexpression and metabonomics data as well as any other pro-active data gathering that is tailored to the needs of candidate selection and to the development path of the future drug, taking into account the indication, target patient population with possible specific hazards, etc. Most importantly, experienced multi-disciplinary safety experts will have to be an integral and creative part of the project teams during pre-candidate selection. Unfortunately, preclinical safety people have in the past not been viewed as creative contributors to drug discovery. They rather have the image of obstacles to productivity. As a consequence, companies prefer investing in increasing the number of discovery scientists and new technologies promising to fulfil the (short term) productivity goals. This strategy has been in place now for over ten years and companies get what they reward for, i.e. high numbers of drug candidates whereas overall productivity in terms of successfully launched innovative drugs still drops. So, in order to progress logically one should strive for a high safety-related attrition (of the right molecules!) through a much earlier (target identification!) more intense and integrated partnership between Discovery and preclinical as well as clinical safety scientists (safety pharmacology, DMPK, toxicology, clinical) with the goal to increase the confidence in the safety of a molecule, at the latest when it is selected as a drug candidate. The solution cannot be to simply shift the conventional safety studies necessary for Phase I into the precandidate selection phase. The solution should rather be to use our grey matter before we test the white powder in order to come to a tailor made safety strategy for every new molecule! The future: Today the profile of a pre-clinical safety scientist has to go significantly beyond the one of a traditional toxicologist. The future safety scientist has to integrate knowledge accumulated in all safety relevant disciplines (primary & secondary pharmacology, functional genomics, safety pharmacology, ADME, physicochemistry, clinical and toxicology with all its special branches) to excel in modern risk assessment and risk management. In order to succeed in this ambitious endeavour, there is an urgent need for improved, XXXIV enhanced and adapted academic training in safety sciences, aiming at closing the gap perceived in industry and regulatory sciences. This gap becomes evident if one tries to hire an experienced safety scientist. Several university courses such as veterinary medicine, pharmacy, medicine and biology should provide its students from the beginning with a transparent avenue towards a future career in multi-disciplinary ‘Safety Sciences’. The latter must therefore become a visible and attractive area of specialization. How to proceed: A rational approach for enhanced training in safety sciences with a potential midterm impact would be to seek input from the interested parties (Academia, Industry and Regulatory Agencies), during a workshop focusing through case studies on training needs in our university education system. Such a gap analysis could then serve to draft a post-graduate curriculum for a safety scientist, identify already existing elements for a tailored training program and draft a staged approach to meet the evident additional needs. An increase in the quality of existing postgraduate training and education could have an impact relatively quickly, while a real mid- to long-term improvement can probably only be achieved, if the support of European partners in the education of future safety scientists can be gained through the realization that there is a true chance for a scientific career. This career will have broad benefit not only for the pharmaceutical industry, the related regulatory agencies and eventually the patient, but also for food, chemical and cosmetic industries and agencies protecting the environment from toxins, to name the most obvious ones. Last but not least a strong science driven safety evaluation will serve the 3 R’s (Refinement, Reduction and Replacement of animals). If this rule is applied strictly then molecules that do not merit development from a safety point of view should not go beyond initial pre-selection stages and will thus not enter costly development phases that require preparation by safety studies using dogs and/or non-human primates.
EUFEPS Newsletter, 2003, vol. 12, issue 2 Pharmaceutical Sciences Fair Dominique Duchêne, Professor EUFEPS President Professor Dominique Duchêne introduces a new EUFEPS initiative. What is it? This is a completely new concept launched by EUFEPS: to gather together the European Pharmaceutical Sciences societies, associations and federations, for the joint organization of a world event in pharmaceutical sciences. One year ago, the EUFEPS member societies, as well as the major European federations and organisations involved in the promotion of specific pharmaceutical sciences, were invited by EUFEPS to cooperate in the organisation of a Fair of Pharmaceutical Sciences. These societies will be invited to organise or co-organise scientific events. There will be congresses with parallel sessions for several days and symposia on well defined topics for one or two days, combining invited prestigious speakers with scientific contributions (oral or posters). The partner societies will be responsible for the scientific content of their respective events. EUFEPS will set up the platform and co-ordinate the different activities. This proposal was enthusiastically received by many of our member societies and other European scientific organisations. Who will participate? On what topics? Up to now, more than 50% of our member societies (Austria, Belgium, Denmark, Finland, France, Great Britain, Hungary, Italy, Slovenia, Spain, Sweden, Switzerland, The Netherlands, Turkey) indicated their willingness to participate actively, as well as ISSX, PEFRAS, IPEC, EFB/EAPB, EPSA and the European Pharmacopoeia. The different events, congresses or symposia, will deal with: Pharmaceutical Technology/Pharmaceutics, Excipients, Drug Disposition/Metabolism/Safety, Biotechnology, Proteomics, Biomarkers, Bioanalysis, Medicinal Plants/Natural Products, Regulatory Aspects of Pharmaceutical Sciences. All this will fill 5 days and 6 parallel sessions, to which a prestigious half-day opening session will be added. Beside this purely scientific aspect, all our member societies and the European pharmaceutical sciences organisations are invited to introduce their society, their members, their major objectives and their activities through a stand. Last but not least, an exhibition will take place, open to all the partner companies of drug research and development activities: raw materials, apparatus for physico-chemical evaluation, production equipment, animal technologies, startup companies, etc. About 100 to 150 exhibitors are expected. Different social events will take place, either global events for the whole Fair or separate events for the partner societies which are encouraged to organise cocktail parties, in the same place on the same evening. Where and when will the Fair take place? For such an event a very attractive, wellequipped, conference centre is essential. This is the reason why the Nice Acropolis Conference Centre was chosen for the first Pharmaceutical Sciences Fair. The Fair will take place in 2005, and more precisely from June 12–17, which normally corresponds to very pleasant weather on the French Côte d’Azur. We intend that the next Fair would be held in 2008, in Vienna, and then regularly every two years in different European cities. XXXV Up to now, what has been done? The partner societies are known. The scientific programme is being set up. The conference centre is already reserved with rooms adapted to the different events. A preliminary budget has been established. The share of risk and benefit has been defined. The Pharmaceutical Sciences Fair has been definitively chosen as the name of this event, with the abbreviation of PharmSciFair. The leading team has been nominated. Currently, it consists of Dominique Duchêne (EUFEPS, Chair), Hans H. Lindén (EUFEPS), Bill Dawson (GB), Elias Fattal/Philippe Arnaud (FR), Carlo Fornara (IT), Véronique Préat (BE), Bernard Rentier (EFB), Tom Sam (NL), Nico Vermeulen (ISSX) and Pia Vuorela (FIN). Three plenary meetings of the partners were already held (Nice, Brussels, Paris) as well as three meetings of the leading team (Brussels, Paris, Amsterdam). This leading article constitutes the official public launching of the Fair. The first PharmSciFair circular will be mailed by November 2003.
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EUFEPS Yearbook 2011 20 th Annivers
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Pharma Ingredients & Services Custo
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The Gamlen Tablet Press The world
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Sustainable sponsorship of EUFEPS g
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2. PRESIDENT’S INTRODUCTION Democ
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4. Member Societies Academy of Phar
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Croatian Pharmaceutical Society - C
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Hellenic Society of Medicinal Chemi
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Romanian Society of Pharmaceutical
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Swedish Swedish Academy Academy of
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5. Individual Memberships Represent
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B. The membership terminates: • i
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K. The Executive Director shall •
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7. Executive Committee 2010-2011 EU
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