28.08.2013 09:00 Predictive Pharmacogenetics

In current clinical practice, the majority of drugs are given at a standardized dose that is sometimes followed by individual titration according to the physician’s experience and to the patient’s related disease conditions, co-morbidities and co-medications. The knowledge of genetic modulation of therapeutic targets and of metabolism and transport of drugs has increased over the last decade so that individualized therapy adjusted to the patient’s genetic background has moved closer to reality. This session will be devoted to examine, with two outstanding experts, the validity of this issue in psychiatric and cardiovascular diseases, two main therapeutic challenges of the forthcoming century.

Chairs: Prof Jules Desmeules, Prof Ingolf Cascorbi

Genetics of treatment response in depression	Antonio Drago			Wednesday 28. August 2013	09:00
Pharmacogenetics and other factors in individualization of oral anti-vitamine k anti-coagulants	Philippe Beaune Paris France			Wednesday 28. August 2013	09:30
A promising predictor for heart diseases and diuretic drug therapy in the aldosterone receptor gene	Nawar Dalila			Wednesday 28. August 2013	10:00
CYP2R1 genetic polymorphisms are associated with lower 25-hydroxy vitamin D levels in Lebanese subjects	Nathalie Zgheib			Wednesday 28. August 2013	10:15

28.08.2013 11:00 Special populations: prenatal pharmacology

This session is devoted to two very special and fragile populations: pregnant women (and their baby to be born) and neonates. The study of drugs in these populations faces major issues from both a practical and ethical point of view. There is consequently a lack of good quality information for prescription of drugs in neonates and pregnant women even though these two groups do receive treatments either during their pregnancy or in their first day of life. The need for high-quality studies is therefore vital. With the expertise in this field of our two speakers, we will understand during this session how to deal with these challenges.

Chairs: Dr Victoria Rollason, Prof Gerard Rongen

TINN (Treat Infections In Neonates) : an FP7 project	Evelyne Jacqz-Aigrain Paris France			Wednesday 28. August 2013	11:00
Studying teratogenic effects of medication use during pregnancy: challenges and pitfalls	Marleen van Gelder Nijmegen The Netherlands			Wednesday 28. August 2013	11:30
Pregnancy outcome following maternal exposure to mirtazapine: preliminary results of a collaborative entis study	Ursula Winterfeld			Wednesday 28. August 2013	12:00
Fetal exposure to nonsteroidal antiinflammatory drugs and spontaneous abortions	Sharon Daniel			Wednesday 28. August 2013	12:15

28.08.2013 13:30 Training tomorrow's prescribers

There is growing evidence that prescribing errors are common and cause avoidable ineffective treatments, adverse drug reactions, hospital admissions, and discomfort to patients. It is also recognized that not enough time is devoted to undergraduate and postgraduate teaching in CPT, which is unfortunate because it is difficult to correct bad prescribing habits once they have been developed.

In order to ‘immunize’ future prescribers against making these errors, this symposium addresses two key issues: clinical workplace learning and assessment. First, undergraduate and postgraduate students should be trained in therapeutics and prescribing in a structured manner during their clinical clerkships and residency. This so-called clinical workplace learning is essential, because during this period students acquire prescribing skills and habits. Secondly, the prescribing skills and performance of students should be assessed throughout the undergraduate and postgraduate teaching period in order to establish a positive learning curve.

Chairs: Prof Maxwell, Prof Theo de Vries

The relevance of clinical workplace learning and assessment in CP&T	Tim Dornan Maastricht The Netherlands			Wednesday 28. August 2013	13:30
A systematic follow-up of student-prescribers (track): therapeutic knowledge, skills/competencies and attitude	David Brinkman Amsterdam The Netherlands			Wednesday 28. August 2013	14:00
Assessment of clinical pharmacology skills as part of the new integrated final exam for medical students at Karolinska Institutet	Marie-Louise Ovesjo			Wednesday 28. August 2013	14:30
The effect of a structured medical record on the recording of therapeutic information and communication between doctors	Robert Van Unen			Wednesday 28. August 2013	14:45

28.08.2013 15:30 Assessing and supporting tomorrow's prescribers (sponsored by BPS)

Prescribing is core business for most healthcare organisation and the major tool used to influence the course of their patients' illness as well as prevent future disease. Much of the workload is undertaken by relatively junior doctors and there is accumulating evidence that avoidable adverse drug reactions and prescribing errors are common. This symposium will address several issues that are relevant to this problem. First, it will examine the development of assessments that might predict poor prescribing performance and the need for further training. Second, it will highlight how prescribing education might be improved. Third, it will look at the potential for electronic prescribing solutions to improve quality. Finally, the impact of implementing standardised prescribing documentation will be discussed.

Chairs: Prof David Webb, Prof Phil Routledge

Development of a UK national Prescribing Skills Assessment	Simon Maxwell Edinburgh UK			Wednesday 28. August 2013	15:30
Undergraduate training for medical students in CPT and prescribing	Sarah Ross Aberdeen UK			Wednesday 28. August 2013	16:00
Electronic solutions to safer hospital prescribing	Jamie Coleman Birmingham UK			Wednesday 28. August 2013	16:20
Developing a standardised prescription chart to reduce error	Phil Routledge Cardiff UK			Wednesday 28. August 2013	16:40

29.08.2013 09:00 Personalizing cancer therapy

Interindividual differences in patient responses to cancer therapies are consistently observed. Personalizing cancer therapy refers to the individualized cancer patient management driven by host and tumor characteristics. Both organ dysfonction and genetic alterations in drug disposition and targets may result in suboptimal treatment or excessive toxicity. Therefore, personalized cancer therapy ultimately aims at selecting the right drug and dose for the right patient. The genetic characteristics of a tumor may also guide the treatment and molecular targeted therapies have indeed been a major breakthrough in oncology.

In this session co-organized by the American Society of Clinical Pharmacology and Therapeutics (ASCPT), three world-reknowned experts will examine the latest developments in tailoring cancer therapies, with a focus on individualizing therapies in special populations, hematological malignancies and breast cancer.

Chairs: Dr Caroline Samer, Prof Matthias Schwab

The individualisation of cancer therapy in organ dysfunction	Michelle Rudek Baltimore USA			Thursday 29. August 2013	09:00
Targeted therapies in hematological malignancies	Raymond Hohl Iowa USA			Thursday 29. August 2013	09:30
Personalized therapy in breast cancer	Matthias Schwab Stuttgart Germany			Thursday 29. August 2013	10:00

29.08.2013 13:30 Inflammatory disease and Biotherapeutics

The development of biotherapeutics has considerably expanded during the last decade with the formidable improvement of biotechnological tools and a better validation of targets. Inflammatory disorders represent indications of choice for the development of biotherapeutics where an intense competition takes place currently to find new treatments for disorders against which the therapeutic armamentarium had remained limited for a long time. This session will focus on the latest therapeutic developments in the field of neurological and rheumatologic inflammatory disorders and discuss the promises but also the limitations of these new approaches.

Chairs: Dr François Curtin, Prof Edoardo Spina

New targets in the treatment of rheumatoid arthritis	Zoltán Szekanecz Debrecen Hungary			Thursday 29. August 2013	13:30
Multiple Sclerosis - New chances ?	François Curtin Geneva Switzerland			Thursday 29. August 2013	14:00
Up-titration study with ponesimod, a selective s1p1 receptor modulator, to assess its maximum tolerated dose in healthy subjects	Matthias Hoch			Thursday 29. August 2013	14:30
Off-label use and adverse events of biologic agents in paediatric patients with juvenile idiopathic arthritis	Julie Broe			Thursday 29. August 2013	14:45

29.08.2013 15:30 Frontiers in Pharmacology (sponsored by BPS)

Always more sophisticated understanding of pathogenesis coincides with a decline in licensing of new medicines for hypertension. The strategies allowing reductions in the risks and costs of clinical development and making available affordable new generations of molecules will be discussed. Drug-induced liver injury (DILI) represents a significant cause of patient morbidity and mortality and a major contributor to attrition in drug development. The advantage of the new markers of DILI compared to the traditional marker of cell death and hepatic function will be discussed and the challenges associated with their clinical qualification be addressed. Since there is a pressing need for faster and more efficient evaluation of new cancer agents to improve outcomes, a new approach to trial design which links novel treatment evaluation with the concurrent evaluation of a biomarker within a confirmatory phase II-III trial setting will be presented.

Chairs: Prof Mounir Pirmohamed, Prof Mark Caulfield

Novel clinical trial designs for assessing the efficacy of drugs	Max Parmar London UK			Thursday 29. August 2013	15:30
Novel biomarkers of drug-induced liver injury	Kevin Park Liverpool UK			Thursday 29. August 2013	16:00
Advances in genomics of blood pressure - time for translation	Mark Caulfield London UK			Thursday 29. August 2013	16:30

30.08.2013 09:00 PK/PD modelling

Population pharmacokinetic and pharmacodynamic modeling is used for exploratory analyses in the clinical development of new drugs or during post-marketing studies.  The advantages of such an approach are the collection of data in the target population, the assessment of the variability within this population and, hopefully, the discovery of factors that control this variability. The present and future developments of this discipline will be outlined in the view of regulatory acceptance, extension to mechanistic-based and disease progression modeling, and application to treatment optimization, exemplified by a panel of illustrative studies.

Chairs: Prof Chantal Csjaska, Prof Kim Broesen

The role of modelling and simulation in clinical pharmacology	Kayode Ogungbenro			Friday 30 August 2013	09:00
Quantifying the impact of nevirapine-based prophylaxis strategies to prevent mother-to-child transmission of HIV-1 using the population approach	Charlotte Kloft Halle Germany			Friday 30 August 2013	09:30
Intrapulmonary pharmacokinetics and the intracellular disposition to support the long-lasting efficacy after an inhaled administration of its prodrug laninamivir octanoate	Kaoru Toyama			Friday 30 August 2013	10:00
Optimal sampling strategy for busulfan in stem cell transplantation patients	Francine Castro			Friday 30 August 2013	10:15

30.08.2013 13:30 Special cardiovascular pharmacology

Chairs: Prof Jean-Luc Reny, Prof Tabassome Simon

Clinical drug developpement of new anticoagulants : a lesson of modern clinical pharmacology	Patrick Mismetti Saint-Etienne France			Friday 30 August 2013	13:30
Novel approaches in the treatment of dyslipidemia	Anton F Stalenhoef			Friday 30 August 2013	14:00
Reversal strategy in antagonizing the P2Y12-inhibitor ticagrelor	Eva-Luise Hobl			Friday 30 August 2013	14:30
Impact of circulating levels of interleukin-17 and cardiovascular outcomes in patients with acute myocardial infarction	Tabassome Simon			Friday 30 August 2013	14:45

30.08.2013 15:30 New targets for pain treatment

Chronic pain and neuropathic pain in particular are a medical challenge as they are poorly responsive to classical peripheral anti-inflammatory or powerful, centrally-acting analgesics.

Since our understanding of the mechanisms generating pain has noticeably increased, the idea of targeting key molecules has emerged and a mechanism-based approach to treatment has been advocated. This concept will be discussed in this session, from a basic science point of view as well as with the clinical example of HIV neuropathy.

Oral short communications will be selected abstracts are most welcome!

Chairs: Prof Jules Desmeules, Prof Dinko Vitezic

Targets for drug development in HIV neuropathy	Andrew Rice London UK			Friday 30 August 2013	15:30
Transient receptor potential channels as novel drug targets	Pierangelo Geppetti Florence Italy			Friday 30 August 2013	16:00
Dual reuptake inhibitor milnacipran and spinal pain pathways in fibromyalgia patients: a randomized double-blind placebo-controlled trial	Alain Matthey			Friday 30 August 2013	16:30
A new pharmaceutical form of paracetamol : efficacy of transmucous buccal paracetamol in acute pain patients	Gisele Pickering			Friday 30 August 2013	16:45

31.08.2013 09:00 Doping: Sports and Pharmacologists

Chairs: Dr Mitsuko Kondo, Dr Martial Saugy

Development of partnerships between the biopharmaceutical industry and the World Anti-Doping Agency	Olivier Rabin Montreal Canada			Saturday 31 August 2013	09:00
Doping in sport: The biomarkers  are the best tools to measure its prevalence and to establish the individual monitoring of the athletes	Martial Saugy Lausanne Switzerland			Saturday 31 August 2013	09:30
The makings of the world-class athlete: physiologic, genetic, psychosocial and economic determinants	Yannis Pitsiladis Glasgow UK			Saturday 31 August 2013	10:00

end faq

28.08.2013 09:00 How to become a self-empowered patient

An empowered patient is defined as an individual being an active member of his/her disease management team and being able to make decisions consistent with his/her values. Thus conceived, the concept of empowerment is a real paradigm shift for patients and for health professionals. The relation between the physician and the patient is moving from a “the powered physician to the self-powered patient” and the fast growing access to Internet is accelerating the shift. This session will discuss how this new form of “Doctor-patient relationship” may impact on drug therapy and compliance as well as on clinical research.

Chairs: Dr Christine Cedraschi, Prof Donald Singer

Collection and impact of patient reported outcomes	Anne Viola			Wednesday 28. August 2013	09:00
Medication use: from leaflet to e-learning	Valérie Piguet Geneva Switzerland			Wednesday 28. August 2013	09:30
How to govern a self-powered patient: privacy and biopower	Sami Coll Geneva Switzerland			Wednesday 28. August 2013	10:00

28.08.2013 11:00 Clinical trials methodologies

Clinical investigations in human pharmacology, such as typically the Phase I trials, aim to assess the pharmacokinetic, pharmacodynamic and safety profiles of medicinal drugs. Unlike trials focused on therapeutic effectiveness (Phase III), these early clinical trials do not benefit from reporting guidelines giving directions for their publication. This session will first address the need of best reporting practice guidelines for clinical pharmacology trials. The second presentation will envisage recent and future developments in data modeling and simulation approaches during drug development, which are to represent true challenges for authors, editors and readers of Clinical Pharmacology literature.

Chairs: Prof Thierry Buclin, Dr Ylva Böttiger

Towards best reporting practices for clinical pharmacology trials	Doug Altman Oxford UK			Wednesday 28 August 2013	11:00
The future of modeling and simulation approaches in drug development	Marc Pfister USA			Wednesday 28 August 2013	11:30
Biases on the administered parenteral doses of an experimental drug during phase I clinical trials	Nicolas Widmer			Wednesday 28 August 2013	12:00
Critical review of the validation process of six predictive biomarkers: how good is the quality and quantity of the evidence?	Joaquin Saez Penataro			Wednesday 28 August 2013	12:15

28.08.2013 13:30 Health therapies assessment

The UK’s National Institute of Health and Clinical Excellence (NICE) has led the way internationally in development of Health Technology Assessment (HTA), setting thresholds for acceptable cost-effectiveness, identifying factors that may modify this threshold (e.g. orphan drugs). NICE focused on disease-area treatment with multiple technology appraisals but has subsequently developed more rapid single-technology appraisal to provide authoritative clinical guidelines, quality standards, and implementation tools. Other European HTA agencies are based on relative effectiveness assessment of listed pharmaceuticals (REAL) and provide additional approaches in evaluating drug utility.

Chairs: Dr François Girardin, Prof David Webb

The role of the clinical pharmacologist in pharmacoeconomics /health economics	Michael Rawlins Newcastle-Upon-Tyne UK			Wednesday 28 August 2013	13:30
The Scottish model: Scottish Medicines Consortium (SMC)	David Webb Edinburgh UK			Wednesday 28 August 2013	14:00
An assessment of the accuracy of horizon scanning predictions of medicine use in the scottish national health service	Sharon Hems			Wednesday 28 August 2013	14:30
Dabigatran - demonstrates the need for comprehensive approaches to optimise the use of new drugs	Brian Godman			Wednesday 28 August 2013	14:45

28.08.2013 15:30 Health economic assessment

Personalised medicine and pharmacogenetic testing add new insights in drug development. From 2014, all new branded medicines and diagnostic tools in some European countries will be priced according to their therapeutic value and wider benefits they may deliver. Under this value-based pricing (VBP) system, it is proposed that explicit weightings be attached to the health benefits (e.g. QALY gains) provided by medicines to reflect a broader range of relevant criteria. There is controversy as to which forms of benefits are to be weighted, and by how much. The transferability issues from a country to another one will be discussed.

Chairs: Dr François Girardin, Prof Michael Rawlins

The economics of personalised medecine and pharmacogenetic testing	Dyfrig Hughes Bangor UK			Wednesday 28 August 2013	15:30
Value Based Pricing to ensure cost effective drugs for the UK NHS: will it work?	Mark Sculpher York UK			Wednesday 28 August 2013	16:00
Patented drug extension strategies on healthcare spending: a cost-evaluation analysis	Nathalie Vernaz			Wednesday 28 August 2013	16:30
Pharmacoeconomic drivers in pharmacogenomics	Stijn Vandekerckhove			Wednesday 28 August 2013	16:45

28.08.2013 17:30 What's new in malaria therapeutics (sponsored by WHO)

Chairs: Dr Lembit Rägo, Dr Andrea Bosman

Update on the status of artemisinin resistance	Pascal Ringwald (WHO Switzerland)		Wednesday 28 August 2013	17:30
New medicines for control and elimination of malaria	Timothy Wells (Geneva Switzerland)		Wednesday 28 August 2013	18:00

29.08.2013 09:00 New developments in TDM

The development and implementation of rational, evidence-based approaches for the monitoring of medicinal therapies belong to the agenda of Clinical Pharmacology. The principles and challenges of therapeutic monitoring in the broad sense will first be reviewed during this session. Further emphasis will be put on the monitoring of circulating drug concentrations, illustrated with the particular case of novel anticancer agents among other candidates to target concentration interventions. Recent developments will be presented and discussed in view of current needs for patients to benefit from the best possible dosage adjustment for such drug agents.

Chairs: Prof Thierry Buclin, Dr Ylva Böttiger

Monitoring drug therapy: TDM-te deum or tedium?	Jeffrey Aronson Oxford UK			Thursday 29 August 2013	09:00
Strategies for the development of TDM for targeted anticancer agents	Thierry Buclin Lausanne Switzerland			Thursday 29 August 2013	09:30
A simplified method for busulfan therapeutic drug monitoring using dried blood spot sampling in pediatric patient undergoing stem cell transplantation	Chakradhara Rao Uppugunduri			Thursday 29 August 2013	10:00
Clinical usefulness of therapeutic concentration monitoring for imatinib dosage individualization: results from the randomized controlled i-come trial	Verena Gotta			Thursday 29 August 2013	10:15

29.08.2013 13:30 Clinical trials regulation, control, benefits

In July 2012, the European Commission adopted a proposal for a Regulation on Clinical Trials. This is now under discussion by the European Parliament and the Council. Input from affected stakeholders is deemed also critical to end up in an optimised legislative framework for clinical trials in Europe. During next year the discussion process should be reaching its end. This session will be a unique opportunity to share and discuss first hand opinions from two key stakeholders intervening in clinical trials, regulatory bodies and academia, and discuss together benefits and risks associated to the legislative proposal.

Chairs: Dr Emilie Alirol, Prof Gonzalo Calvo

Introductory remarks to the revision of the EU Clinical Trials regulation	Gonzalo Calvo			Thursday 29 August 2013	13:30
The clinical researcher view: Ideas for improvement	Cristina Avendaño Madrid Spain			Thursday 29 August 2013	13:45
Clinical and non-interventional trials assessment in Croatia	Dinko Vitezic			Thursday 29 August 2013	14:30
The number of included older people in recent pre-autorisation trials	Erna Beers			Thursday 29 August 2013	14:45

29.08.2013 15:30 Ocular Pharmacology

In recent years, much scientific progresses has been achieved in the field of ophthalmology to improve treatment options. In particular, treatment of age-related macular degeneration (AMD) with anti-VEGF antibodies and/or VEGF- trap, (aflibercept), has changed the quality of life of many patients. Moreover, inflammatory disorders are better controlled with new molecules such as anti-TNF agents (inlfiximab, adalimumab)  and new immune suppressive drugs such as mabthera. DNA polymerase testing of ocular fluids begins to be useful for diagnosis of ocular infections and holds great promise for the future.

Chairs: Dr Edoardo Baglivo, Prof Zoltan Szekanecz

Anti-TNF in ocular diseases	Ildiko Süveges Hungary			Thursday 29 August 2013	15:30
Non infectiousintermediate and posterior uveitis: treatement and place of local corticosteroids	Massimo Accorinti Rome Italy			Thursday 29 August 2013	15:50
Interferon alpha and posterior uveitis	Christine Fardeau Paris France			Thursday 29 August 2013	16:10
Sjögren ocular disease treatment	László Modis Debrecen Hungary			Thursday 29 August 2013	16:30

29.08.2013 17:30 Pharmacology of Chocolate

Chocolate consumption is highly associated with pleasure but recent research has focused on its flavonoids content and their potential to promote health and/or reduce risk factors for various diseases. Chemical compounds found in cocoa are fragile and the art of the chocolate maker is to protect the cocoa values during the chocolate production. This session will describe chocolate properties and its link to heath and diseases and highlight in an interactive way what an artisanal process brings to chocolate quality.
Switzerland produces one of the most famous chocolates in the world, don’t miss the chocolate tasting after the symposium. 

Chairs: Prof Jules Desmeules

Chocolate: Pleasure for health	Claude Pichard Geneva Switzerland			Thursday 29 August 2013	17:30
Chocolate: Pleasure for health	Jeremy Ramsauer Switzerland			Thursday 29 August 2013	17:30

30.08.2013 09:00 Who should initiate drug development ?

Chairs: Prof Oliver Hartley, Prof Adam Vas

Industry is more fit for clinical trials than academy	Adam Vas Budapest Hungary			Friday 30 August 2013	09:00
Academia isn’t so bad either	Nicholas Moore Bordeaux France			Friday 30 August 2013	09:30
Clinical trials registry and good clinical practice: an indian scenario	Bikash Medhi			Friday 30 August 2013	10:00
Interchangeability of gabapentin generic formulations in the netherlands: a comparative bioavailability study	Marc Maliepaard			Friday 30 August 2013	10:15

30.08.2013 13:30 Ethics

Chairs: Prof Ingolf Cascorbi

Ethics and Privacy of Biobanks	Berenice Elger Basel Switzerland			Friday 30 August 2013	13:30
Public health genomics and personalized healthcare	Angela Brand Maastricht Germany			Friday 30 August 2013	14:15

30.08.2013 15:30 Advances in the treatment of rare diseases. Expectations on advanced therapies

Inborn errors of metabolism represent a relatively new and rapidly expanding class of genetic diseases. Signs and symptoms can affect all organs and may start at any age, from infancy to old age. Tremendous advances in laboratory techniques have led the way to the identification of hundreds of different diseases, requiring development of very diverse new therapeutic approaches, such as enzyme replacement or pharmacological chaperone therapies.
Inborn errors of metabolism offer not only new niches for orphan drug developers, but also models to get a better understanding of physiological pathways that play a role in many more common diseases.

Chairs: Dr Ilse Kern, Prof Gonzalo Calvo

New developments in the treatment of Inborn Errors of Metabolism	Matthias Baumgartner Zurich Switzerland			Friday 30 August 2013	15:30
Treating rare inborn errors of metabolism: from theory to practice	Matthias Gautschi Bern Switzerland			Friday 30 August 2013	16:00
Gene therapy approval process at EMA	Sol Ruiz Madrid Spain			Friday 30 August 2013	16:30

30.08.2013 17:30 Future Challenges for Clinical Pharmacology in Health Care

The new manifesto on clinical pharmacology, to follow the original document produced by the World Health Organisation (WHO) in 1970, was published in late 2012 jointly by the WHO, the Council for International Organizations of Medical Sciences (CIOMS) and the International Union of Basic and Clinical Pharmacology (IUPHAR). This document entitled “Clinical Pharmacology in Health Care, Teaching and Research” puts particular emphasis on the importance of Clinical Pharmacology in the delivery of Health Care. It is clear from a recent survey that in many European countries Clinical Pharmacology has not had the impact in health care that had been hoped for originally ( Orme and Sjoqvist E.J. Clin. Pharmacol. in press). In this session one of the editors of the new manifesto (Michael Orme UK) will describe the background in the development of the new manifesto and will, in particular, stress the important role that clinical pharmacologists can have in the delivery of health care. After this setting of the scene two younger speakers from the Russian Federation ( Ksenia Zagorodnikova ) and Croatia (Vera Vlahovic-Palcevski) will separately describe how clinical pharmacology is closely involved in health care in their countries. In addition they will assess critically the statements in the manifesto that are relevant to health care, to show how the discipline of clinical pharmacology can be more involved in the delivery of health care. The aim of this session is to involve clinical pharmacologists from other European countries in the discussion and facilitate making their discipline an integral part of health care. This process should inevitably mean that more clinical pharmacologist posts are funded by organisations involved in health care regulation and provision, and not only by academia.

Chairs: Prof Michael Orme, Prof Folke Sjöqvist

The background to the new WHO/IUPHAR/CIOMS manifesto entitled “Clinical Pharmacology in Health Care, Teaching and Research” and the importance of the focus on health care	Folke Sjöqvist			Friday 30 August 2013	17:00
Historical development and current state of Clinical Pharmacology in Russia	Ksenia Zagorodnikova Russia			Friday 30 August 2013	17:30
Clinical Pharmacology in Healthcare in Croatia	Vera Vlahovic-Palcevski Croatia			Friday 30 August 2013	18:00

31.08.2013 09:00 Best posters oral communications

Chairs: Prof Pierre Dayer, Prof Gonzalo Calvo

Generic substitution of antiepileptic drug (AED) and loss of seizure control: a population-based case-crossover study	Elisabeth Polard			Saturday 31 August 2013	09:00
Parenteral Busulfan in Myeloablative conditioning regimens for hematopoietic stem-cell transplantation (HSCT) in children	Daniela Janeckova			Saturday 31 August 2013	09:15
Cedia assays for buprenorphine, methadone and EDDP in urine – simple methods, but sufficient for the purpose?	Jon Berg			Saturday 31 August 2013	09:30
Target gene evaluation of two miRNAs differently expressed in focal and non-focal brain tissue of therapy resistant epilepsy patients	Sierk Haenisch			Saturday 31 August 2013	09:45
Self-empowering patients – a promising example in oral anticoagulation	Stefan Vormfelde			Saturday 31 August 2013	10:00
Impact of CYP2C9 polymorphisms on the vulnerability to pharmacokinetic drug-drug interactions during acenocoumarol treatment	Victoria Rollason			Saturday 31 August 2013	10:15

end faq

28.08.2013 09:00 Updates in clinical toxicology

New medicines, new therapeutic principles, development of new chemical substances, new illicit drugs are all challenges for poisons centres and clinical toxicologists in Europe and elsewhere. All these represent new risks for accidental, intentional, occupational, and abusive exposures to an ever increasing number of agents. Research in clinical toxicology leads to new antidotal treatments and insights in toxic mechanisms. As large studies are often difficult to perform in human toxicty, careful diagnostic workup of individual cases will sometimes reveal surprising results, even in long known substances such as dioxin or paracetamol.

Chairs: Dr Hugo Kupferschmidt, Prof Gerald Rongen

Lipid emulsion as a new antidote - current use, extension from lipophilic local anesthetics to other drugs, and state of the art	Theodore Bania New York USA			Wednesday 28 August 2013	09:00
Challenges in paracetamol poisoning	Nicholas Bateman Edinburgh UK			Wednesday 28 August 2013	09:30
New insights into the mechanisms of dioxin toxicity in humans	Jean-Hilaire Saurat Geneva Switzerland			Wednesday 28 August 2013	10:00

28.08.2013 11:00 Networking in Clinical toxicology

Various fields in the area of clinical toxicology exist, covering topics such as emergency medicine, intensive care, analytical and forensic toxicology, teratology, occupational and environmental medicine, prevention, and regulatory toxicology. Poisons Centres which serve as national telephone hotlines in toxic emergencies, keep contacts and collaborate closely with experts of all these areas of clinical toxicology, in order to be able to give expert advice to members of the general public and medical professionals, for questions of clinical management, diagnostic and therapeutic procedures, antidote provision and use, prognosis in acute poisoning, toxicoepidemiology and toxicovigilance.

Chairs: Dr Hugo Kupferschmidt, Prof Gonzalo Calvo

The poisons centres networks - toxicosurveillance	Herbet Desel Goettingen Germany			Wednesday 28 August 2013	11:00
Networking for regulatory toxicology	Martin Wilks Basel Switzerland			Wednesday 28 August 2013	11:30
The Swiss model of comprehensive antidote provision	Hugo Kupferschmidt Zurich Switzerland			Wednesday 28 August 2013	12:00

28.08.2013 13:30 The use of molecular imaging biomarkers in drug development (sponsored by the European Association of Nuclear Medicine) 

The European Association for Nuclear Medicine (EANM) is the largest professional medical association in Europe in the respective field, comprising 39 national societies and over 3,200 individual members. EANM has several Taskgroups and Committees, among which the Drug Development Committee (EANM-DDC) aims at promoting the proper use of molecular imaging in the drug research and development process. The workshop, organized by the EANM-DDC, will focus on the use of molecular imaging biomarkers in drug development and speakers from both the academia and the pharma industry will share their views and experiences on the topic with the audience.

Chairs: Prof Christer Halldin, Prof Adam Vas

Translational PET in Neuroscience and Drug Development	Christer Halldin Stockholm Sweden			Wednesday 28 August 2013	13:30
The academia's view on collaboration with industry	Antony Gee London UK			Wednesday 28 August 2013	13:50
Opportunities and challenges of molecular imaging collaboration in pharmaceutical development	Paul Maguire			Wednesday 28 August 2013	14:10
Interaction between industry and academia: Developing PET imaging tracer for Novel Targets	Gilles Tamagnan Boston USA			Wednesday 28 August 2013	14:30

28.08.2013 15:30 Health issues and communication

Strategic dissemination and critical evaluation of relevant and understandable scientific health information plays a critical role in public health promotion and protection. The reach and impact of health and risk communication have never been greater. Dr Irène Frachon, who revealed the danger and extent of the damage caused by the amphetamine-derived benfluorex (Mediator®) initially marketed for use in diabetes and hypertriglyceridaemia, but also widely prescribed to healthy patients as an appetite suppressant, will dissect the so-called Mediator® scandal. Professor Michel Lièvre will discuss the necessity of a constant reevaluation of the fluctuating risk–benefit relationship in drug development and post-marketing analysis, and the possible consequences on the fate of a drug. Risk perceptions among health care professionals and the public also vary significantly, and Dr Jan Schjott will describe the Norvegian experience from regional medicines information and pharmacovigilance centres.

Chairs: Prof Pierre Dayer, Prof Donald Singer

Mediator (Benfluorex), a French and worldwide public health disaster	Irène Frachon Brest France			Wednesday 28 August 2013	15:30
Risk perception among healthcare professionals and the public: experience from regional medicines information and pharmacovigilance centres in Norway	Jan Schjott Bergen Norway			Wednesday 28 August 2013	16:00
the risk–benefit relationship as a moral compass	Michel Lievre Lyon France			Wednesday 28 August 2013	16:30

28.08.2013 17:30 Current trends in Global Pharmacovigilance (sponsored by WHO)

Chairs: Dr Lembit Rägo

Safety Information today and how can we improve patient safety tomorrow?	Andrzej Czarnecki			Wednesday 28 August 2013	17:30
Population pharmacogenetics and its impact for pharmacovigilance	Adrian Llerena			Wednesday 28 August 2013	18:00

29.08.2013 09:00 Pharmacovigilance networks (sponsored by WHO)

Chairs: Dr Lembit Rägo, Dr Shanthi Pal

ENCEPP: Strengthening methodology, transparency and independence	Henry Fitt			Thursday 29 August 2013	09:00
WHO Programme for International Drug Monitoring	Shanthi Pal WHO Geneva Switzerland			Thursday 29 August 2013	09:30
What is the additional value of electronic medical records for drug safety signal detection? The experience of EU-ADR project	Gianluca Trifiro Messina Italy			Thursday 29 August 2013	10:00

29.08.2013 12:00 Innovative medicine initiative 

With its €2 billion budget, the Innovative Medicines Initiative (IMI,www.imi.europa.eu)is the world’s largest public-private partnership in health research and development (R&D). IMI is a joint undertaking between the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The EU contributes €1 billion in cash through its Seventh Framework Programme (FP7/2007-2013). EFPIA companies contribute €1 billion in kind to the IMI projects. Forty projects have now been launched and some are already generating significant results, in areas such as schizophrenia, asthma, cancer, diabetes, chronic pain, lung disease and drug safety.

Chairs: Dr Elisabetta Vaudano, Prof Adam Vas

IMI: A Public Private Partnership approach to the boosting of pharmaceutical R&D	Elisabetta Vaudano		Thursday 29 August 2013	12:00 - 12:15
Creating new models for R&D in areas of unmet clinical need:  Autism Spectrum Disorder	Will Spooren , Roche		Thursday 29 August 2013	12:15 - 12:40
Addressing the challenges of diabetes and its complication: The IMI Diabetes Platform	Bernd Jablonka, Sanofi		Thursday 29 August 2013	12:40 - 13:05
A PPP approach to boost antimicrobial resistance R&D: the ND4BB IMI platform	Seamus O’Brien, Astra Zeneca		Thursday 29 August 2013	13:05 - 13:30

29.08.2013 13:30 Drug Safety: from clinical trials to clinical practice (sponsored by WHO)

The session will discuss pharmacovigilance as a continuous and evolving process that monitors the safety and safe use of medicinal products. Delegates will hear about global standards for comparable efforts in the benefit harm assessment of medicines, how adverse reaction databases can help identify inappropriate clinical practices, how evolving evidence must inform and update regulatory decisions on medians, and how all of this can help close the ‘know-do’ gap in practice.

Chairs: Dr Lembit Rägo, Dr Shanthi Pal

CIOMS-From clinical trials to clinical practice-recent development	Gunilla Sjölin-Forsberg  WHO Geneva Switzerland			Thursday 29 August 2013	13:30
The New Zealand centre for adverse drug reactions monitoring: a source of practice-based evidence	Ruth Savage Dunedin New Zealand			Thursday 29 August 2013	14:00
Regulatory decisions and drug safety – views from an agency outside EU	Rudolf Stoller			Thursday 29 August 2013	14:30

29.08.2013 15:30 Drug Safety in emerging countries (sponsored by WHO)

Pharmacovigilance, as a discipline, has seen tremendous growth these last few years but in response to different needs and priorities in the various parts of the world. While ‘high-burden diseases’ have been the focus in some settings, the demand for transparency and access to information has driven this growth elsewhere. This session will trace the growth of PV these last forty years in low and middle income countries. Speakers will present the drivers for this growth and how some countries have leveraged international interest in medicines safety to develop pharmacovigilance systems while addressing most urgent PV priorities in their settings.

Chairs: Dr Lembit Rägo, Dr Shanthi Pal

Drug safety in emerging countries - a perspective from Nigeria	Ambrose Isah Benin Benin			Thursday 29 August 2013	15:30
Latin-American pharmacovigilance update report: a quick overview	Mariano Madurga Sanz			Thursday 29 August 2013	16:00
Overview of pharmacovigilance in resource limited settings: challenges and opportunities	Sten Olsson			Thursday 29 August 2013	16:30

29.08.2013 17:30 The dopamine D3 receptor as a potential target for psychiatric diseases (sponsored by Gedeon Richter)

Peculiar cerebral distribution of the dopamine D3 receptor predisposes it to be an attractive  drug target in psychiatric diseases. Preclinical results highlighting the function of the D3 receptor in cognition, mood and motor function are promising, yet only few drugs with prominent D3 receptor action have reached the clinic so far. This is in sharp contrast to the case of the dopamine D2 receptor, its closest relative, whose ligands are widely used in various CNS disorders. The symposium provides an overview - along with a comparison with the D2 receptor – on the characteristics of the D3 receptor, compounds acting at this receptor and their pharmacology and therapeutic potential.

Chairs: Dr Gerhard Gründer, Prof Adam Vas

Antagonists and partial agonists at D2 and D3 dopamine receptors in psychiatric disorders: the spectrum of therapeutic options	Gerhard Gründer			Thursday 29 August 2013	17:30
The functional role of D2 versus D3 dopamine receptors in health and disease	Peter Gmeiner			Thursday 29 August 2013	18:00
Imaging the dopamine D2 and dopamine D3 receptors in the living brain	Ilan Rabiner			Thursday 29 August 2013	18:30
A D3/D2 partial agonist antipsychotic with preferential D3 binding on the horizon	István Laszlovszky			Thursday 29 August 2013	19:00
Concluding remarks	Gerhard Gründer			Thursday 29 August 2013	19:25

30.08.2013 09:00 Diabetes

Diabetes is a major matter of public health in Europe since more than 8% of the European adult population is affected and since global diabetes prevalence is still growing. During the past few years, several new classes of antidiabetic drugs have appeared on the market and while these drugs have mostly very attractive modes of action, their use in clinical practice is often limited by side effects and unbearable cost. This session will discuss the need and the rationale of using an individualized approach in antidiabetic therapy.
The second topic will rely on a recent new epidemiological aspect of diabetes, which is its potential association with an increased risk of breast cancer.  

Chairs: Dr Markus Hodel, Prof Matthias Schwab

Novel antidiabetics: should they be used at all - and in whom?	Christoph Meier Zurich Switzerland			Friday 30 August 2013	9:00
Diabetes, diabetes risk factors and treatments, and breast cancer	Peter Boyle France			Friday 30 August 2013	9:30
Do treatment quality indicators predict cardiovascular outcomes in patients with diabetes?	Grigory Sidorenko			Friday 30 August 2013	10:00
Addressing the challenges of diabetes and its complication: the IMI diabetes platform	Bernd Jablonka			Friday 30 August 2013	10:15

30.08.2013 13:30 Special liver pharmacology

Drug-induced liver injury (DILI) is a rare but clinically important problem. Many different drugs can cause DILI, with the pattern of injury varying between drugs. A better understanding of the genetic and environmental factors that are associated with DILI will allow the development strategies to identify susceptible individuals prior to prescription. Current detection methods do not provide insight into injury mechanisms and do not allow prediction of clinical outcome of liver injury. This session will focus on the molecular mechanisms that cause DILI, novel biomarkers for the diagnosis of DILI and current approaches towards classifying DILI within clinical studies.

Chairs: Prof Gerd Kullak, Prof Kari Kivisto

Immunological aspects of drug hypersensitivity – from molecule to man	Kevin Park Liverpool UK			Friday 30 August 2013	13:30
Acetaminophen-induced liver injury in experimental animals and humans	Hartmut Jaeschke Kansas City USA			Friday 30 August 2013	14:00
Assessment of drug-induced liver injury from clinical trial data	Michael Merz Basel Switzerland			Friday 30 August 2013	14:30

30.08.2013 15:30 Drug-drug interactions

Drug-drug interaction is one of themajor problems in therapeutics associated with the use of drugs. Given the aging of the population, polymedication and the continuous development of new drugs, the occurrence of clinically significant drug-drug interactions will dramatically increase. Metabolic enzymes as well as drug transporters are frequently involved in DDI. In vitro-in vivo extrapolation (IVIVE) methodology is widely used in drug discovery and huge effort in both academia and industry has focused on developing reliable methods to predict DDI. During this session, you will have the opportunity to discuss with international experts in the field the state of the art in predicting the magnitude of DDI at the individual level, the clinical pertinence and the roleof transporters in drug interactions. 

Chairs: Dr Youssef Daali, Prof Kim Broesen

Complexity of predicting the magnitude of drug-drug interactions in an individual patient: this cannot fit to a pocket guide; ipad may be!	Amin Rostami-Hodjegan Manchester UK			Friday 30 August 2013	15:30
Role of membrane transporters in drug interactions	Mikko Niemi Helsinki Finland			Friday 30 August 2013	16:00
Interaction between mycophenolate mophetil and tacrolimus in kidney graft recipients	Jan Strojil			Friday 30 August 2013	16:30
Gemfibrozil impairs imatinib absorption and inhibits the CYP2C8-mediated formation of its main metabolite in healthy volunteers	Anne M Filppula			Friday 30 August 2013	16:45

30.08.2013 17:30 Methodological issues in clinical trials with CNS drugs (sponsored by the Italian Society of Clinical Pharmacology)

Clinical trials provide the basis for the acquisition of the critical information that physicians need for rational prescribing. Therefore, clinical trials should be designed and conducted utilizing clinically meaningful procedures and endpoints and potential bias should be minimized. Methodological issues in clinical trials of central nervous system (CNS) drugs include aspects related to study design, procedures of randomization, inclusion and exclusion criteria, treatment outcome measures, sample size, statistical power and ethical considerations. In this respect, the use of placebo arms in randomized controlled trials remains a very controversial problem when evaluating the efficacy and safety of medications used to treat neurological or psychiatric disorders. This symposium focuses mainly on the shortcomings of clinical trials in epilepsy, neuropathic pain and schizophrenia.

Chairs: Prof Pier Luigi Canonica, Prof Edoardo Spina

Clinical trials in epilepsy	Emilio Perucca Pavia Italy			Friday 30 August 2013	17:30
Clinical trials in neuropathic pain	Soren Sindrup Odense Denmark			Friday 30 August 2013	18:30
Clinical trials in schizophrenia	Wolfgang Fleischacker Innsbruk Austria			Friday 30 August 2013	19:00

31.08.2013 09:00 Neuro-Psychopharmacology: filling the gaps

The exact neurobiological mechanisms involved in the therapeutic action of antidepressant are not clearly understood and better knowledge may help to identify new therapeutic targets and to overcome the limitations such as poor efficacy and slowness of action. Moreover most of the psychotropic drugs may be considered as “dirty drugs” as they bind to many different molecular targets in the body, and therefore tend to have a wide range of effects and side effects. This session will discuss the neurobiology of depression as well as the prediction of the pharmacological effects of CNS-active agents in human so as to fill the gap between basic science and potential clinical effectiveness.

Oral short communications will be selected abstracts are most welcome!

Chairs: Dr Marie Besson, Prof Edoardo Spina

Prediction of pharmacological effects of CNS-active agents during early phases of drug development	Joop Van Gerven			Saturday 31 August 2013	9:00
New strategies in the treatment of major depression	Francesco Artigas Barcelona Spain			Saturday 31 August 2013	9:30
Sleep quality of chronic benzodiazepine users in nursing homes: a comparative study with non-users.	Jolyce Bourgeois			Saturday 31 August 2013	10:00
Indications and dosages of atypical antipsychotics in Belgian nursing homes	Majda Azermai			Saturday 31 August 2013	10:15

end faq