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X-WR-CALDESC:Veranstaltungen für AGAH
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DTSTART:20120325T010000
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DTSTART:20121028T010000
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DTSTART;VALUE=DATE:20120229
DTEND;VALUE=DATE:20120303
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SUMMARY:21st AGAH Annual Meeting 2012
DESCRIPTION:The Role of the Patient in Human Pharmacology – A Changing Paradigm? \n\n\n\n	Announcement \n\n\nIt is a common assumption that toxic compounds to be developed\, e.g.\, for oncologic indications should not be investigated in healthy subjects\, hence the phase-I clinical programme is conducted in patients. Beyond that\, discussion is on whether or to what extent investigational compounds can be tested in patients during clinical phase I/IIa in order to streamline the clinical development programme and achieve proof-of-concept at an earlier stage. This is also closely related to the impact of special populations in early clinical development. Important topics in this context are dedicated studies in women\, paediatric populations\, the elderly\, ethnic groups\, but also the choice of suitable patient populations for studies of medical devices and drug/device-combinations. It is widely recognized that the identification of the most suitable population for a clinical trial is an important factor on the way to stratified medicine\, but the discussion about the right target population is also influenced by safety considerations\, the availability of appropriate biomarkers and translational approaches and\, last but not least\, regulatory aspects. \nIn Plenary Sessions and Parallel Workshops the AGAH Annual Meeting 2012 will provide the floor for a com-prehensive exchange of experience and opinion on the future of the healthy subject in clinical trials in times where rapid proof-of-concept is of utmost importance. Full sessions are dedicated to population issues in oncology studies and the best way to get to rapid proof-of-concept. \n \n\n\n\n\n\n\n	Introduction \n\n\n  \n\n\nThere is a common assumption that toxic compounds to be\ndeveloped\, e.g.\, for oncologic indications must not be\ninvestigated in healthy subjects\, and that is why\, in those\ncases\, the phase-I clinical programme is usually conducted in\npatients. But even beyond that\, there has been an evolving\ndiscussion whether\, or to what extent\, suitable investigational\ncompounds can be tested in patients during clinical phase\nI/IIa in order to streamline the clinical development\nprogramme and achieve proof-of-concept data at an early\nstage. This discussion is closely related to the role of special\npopulations in early clinical development. Important topics in\nthis context are dedicated studies in females\, paediatric\npopulations\, elderlies and ethnical aspects. Further special\naspects in this discussion are medical devices and\ndrug/device-combinations. It is recognized that the\nidentification of the most suitable population for clinical study\nis an important factor on the way to stratified medicine\, but the\ndiscussion about the right target population is also influenced\nby safety considerations\, the availability of appropriate\nbiomarkers and translational approaches and\, last but not\nleast\, regulatory aspects.\nIn Plenary Sessions and Parallel Workshops with much room\nfor discussion\, the AGAH Annual Conference 2012 will\nprovide the floor for comprehensive exchange of experience\nand opinion on the future of the healthy subject in clinical trials\n– in times where rapid proof-of-concept is of utmost\nimportance. Discussions about the most suitable populations\nfor particular types of scientific questions and clinical trials as\nwell as the specific challenges of study populations\nconcerning age\, gender and genetic disposition including\noptimised protection of these different kinds of study\nparticipants will be facilitated by this programme. Full\nsessions will be dedicated to population issues in oncology\nstudies and the best way to get to rapid proof-of –concept. \n\n\n\n\n	Day 1\, Wednesday\, 29 February 2012  \n\n18:00  \nGet Together \n\n19:00 \nAGAH General Assembly \n\n\n\n\n	Day 2\, Thursday\, 01 March 2012 \n08:00  \nRegistration \n\n09:00  \nOpening remarks\nIngrid Klingmann\, Brussels  \n\nSession 1 \nChoosing the most appropriate study population in early-phase studies (healthy subjects or patients) \n\nChairs \nAndreas Kovar\, Georg Wensing \n\n09:10  \nIntroduction to session topic by Chair \n\n09:20  \nWhen are early-phase studies in patients mandatory?\nSebastian Harder\, Frankfurt am Main \n\n09:50  \nWhen are early-phase studies more appropriate in patients as compared to healthy subjects?\nBernd Liedert\, Darmstadt \n\n10:20  \nWhen are early-phase studies in patients not useful or even not acceptable?\nWolfgang Timmer\, Mannheim \n\n10:50-11:20 \nBreak \n\nSession 2  \nConsideration of gender in clinical trials  \n\nChairs \nChristine Klipping\, Hildegard Sourgens \n\n11:20  \nDo gender-specific data from early phase clinical trials translate into therapeutic recommendations?\nKerstin Breithaupt-Grögler\, Frankfurt am Main  \n\n11:50  \nPractical aspects and feasibility of studies in females – aspects related to indication\, hormonal status\, pregnancy and lactation\nChristine Klipping\, Groningen\nHildegard Sourgens\, Munich  \n\n12:30 \nDevelopment of “life-style drugs” for men and women\nArmin Schultz\, Mannheim  \n\n13:00-14:30  \nBreak \n\n14:30-16:00  \nParallel Workshops  \n\nWS 1  \nEthical issues in vulnerable populations\nGerhard Fortwengel\, Hannover\nIngrid Klingmann\, Brussels  \n\nWS 2  \nDose selection for special populations\n(children\, elderlies\, renal & hepatic impairment)\nWolfgang Mück\, Wuppertal\nGeorg Wensing\, Wuppertal  \n\nWS 3  \nStudies with medical devices and drug/device-combinations in healthy subjects and patients including in-vitro technology studies (focus on therapeutic area respiratory diseases)\nSabine Häußermann\, Gauting\nDominik Kappeler\, Gauting\nSebastian Klammt\, Rostock  \n\nWS 4 \nWhen is a subject healthy? – Requirements by the German BfArM\nFrank Donath\, Erfurt\nChristoph Clemens Haufe\, Erfurt\nHeidrun Reißenweber\, Gräfelfing/Munich\nHildegard Sourgens\, Munich\nThomas Sudhop\, Bonn  \n\n16:00-16:30 \nBreak \n\nSession 3 \n Various ages:\nchildren – adolescents – elderlies \n\nChairs \n Kerstin Breithaupt-Grögler\, Barbara Schug \n\n16:30  \nLegal requirements to include children in clinical trials as patients\, for diagnostic procedures and to prevent diseases\nAntje Neubert\, Erlangen  \n\n17:00 \nIN/EX criteria in studies with healthy elderlies and special approaches with regard to geriatric patient populations (Pop-PK?) (Should we be using patients instead of healthy elderlies?)\nPetra Thürmann\, Wuppertal \n\n17:30  \nOpen-forum discussion:\n"Similarities and differences in drug development for geriatric and pediatric populations" \n\n18:00 \nEnd of Sessions Day 1 \n\n19:30 \n Conference Dinner \n\n\n\n\n	Day 3\, Friday\, 02 March 2012 \nSession 4 \n Subject stratification in drug development –\ngetting it right? \n\nChairs \nJens Rengelshausen\, Jörg Täubel \n\n09:00  \nChairman’s introduction: Concept and impact of stratified medicine \n\n09:10 \nImplementation of stratification throughout drug development – examples from oncology\nMichael Zühlsdorf\, Darmstadt  \n\n09:30  \nPersonalised medicine: A new challenge for applied human pharmacology?\nJochen Theis\, Bergisch-Gladbach  \n\n09:50 \nRoundtable discussion: When and how shall we use stratification? \n\n10:20 \nChairman`s summary and outlook: The future of stratified medicine \n\n10:30-11:00 \nBreak \n\nSession 5  \nPopulation aspects in oncology studies  \n\nChairs \nAndreas Kovar\, Barbara Schug \n\n11:00 \nBE and ADME studies in oncological patient populations\nBarbara Schug\, Oberursel \n\n11:30  \nDrug-drug-interaction studies in oncology – a regulatory perspective \nJutta Heßling\, Bonn  \n\n12:00  \nClinical relevance of drug-drug interactions in oncology\nSalah-Eddin Al-Batran\, Frankfurt am Main  \n\n12:30-13:30 \n Break  \n\nSession 6  \nProof-of-Mechanism (PoM) / Proof-of-Concept (PoC) package \n\nChairs  \nThomas Sudhop\, Wolfgang Timmer \n\n13:30  \nPractical examples of PoM studies in healthy subjects\nMatthias Grossmann\, Berlin\nKlaus Francke\, London \n\n14:00  \nSuitable patient populations and study designs for rapid PoC\nAnton Drollmann\, Basel  \n\n14:30  \nHow predictive is PoC for therapeutic success of the new drug?\nJoop van Gerven\, Leiden \n\n15:00 \n Closing Remarks  \n\n\n\n\n	Information \n  \nVenue\nPentahotel Leipzig\nGrosser Brockhaus 3\n04103 Leipzig (Germany)\nPhone: +49 (0)341 12920 \nDate\nThursday\, 01 & Friday\, 02 March 2012 \nFees \n\n\n\n\nearly bird\nregular\n\n\n\n\nMember*\n370 EUR\n320 EUR\n\n\nNon-Member\n330 EUR\n380 EUR\n\n\nJunior Scientists\n130 EUR\n230 EUR\n\n\nDay Ticket\n\n200 EUR\n\n\nConference Dinner\n25 EUR\n25 EUR\n\n\n\n*of AGAH\, CPI\, AHPPI\, BAPU \n(Early Bird: before December 31\, 2011) \n  \n\nAGAH e.V.\nhttp://www.agah.info/ \nInquiries\nIntercom Kongresse GmbH\nAntje Blömeke\nEppendorfer Baum 39a\n20249 Hamburg (Germany)\nPhone: +49 (0)40 4806 1061\nFax: +49 (0)40 4806 1066\nEmail abloemeke@intercom.de \nOnline registration and hotel reservation by\nhttp://www.intercom-kongresse.de/agah2012/ \n  \n  \n\n\n\n\n	Downloads \nAl-Batran\, S-E.\nAl-Batran drug interaction final.pdf (1.2 MB) \nClinical relevance of drug-drug interactions in oncology \n\nBreithaupt-Grögler\, K.\nBreithaupt-Groegler gender therapeutic recommendations 01MAR12.pdf (300 kB) \nDo gender-specific data from early phase clinical trials translate into therapeutic recommendations? \n\nDrollmann A.\nDrollmann Suitable Patient Populations and Study Designs for rapid PoC.pdf (668 kB) \nSuitable patient populations and study designs for rapid PoC \n\nGrossmann\, M.\nGrossmann AGAH 2012 Grossmann Francke Final Session 6 01.pdf(1.1 MB) \nPractical examples of PoM studies in healthy Subjects \n\nHarder\, S.\nHarder Frankfurt a M 01.pdf(3.8 MB) \nWhen are early-phase studies in patients mandatory? \n\nHeßling\, J.\nHessling DDI studies 120302 01.pdf(1.2 MB) \nDrug-drug-interaction studies in oncology – a regulatory perspective \n\nKlipping\, Ch.\nKlipping practical aspects and feasibility of studies in females 01.pdf(197 kB) \nPractical aspects and feasibility of studies in females – aspects related to indication\, hormonal status\, pregnancy and lactation \n\nLiedert\, B.\nBernd Liedert 1 March 2012 When are early-phase studies more appropriate in patients as compared to healthy subjects .pdf(1.5 MB) \nWhen are early-phase studies more appropriate in patients as compared to healthy subjects? \n\nNeubert\, A.\nNeubert AGAH Studies in children final 01.pdf(1.6 MB) \nLegal requirements to include children in clinical \n\n\nRengelshausen\, J.\n\nRengelshausen AGAH 2012 Session4 Introduction JR-JT 01.pdf(95 kB) \nSubject stratification in drug development – getting it right? \n\nSchug\, B.\nSchug 120301 Schug Oncology final 01.pdf(351 kB) \nBE and ADME studies in oncological patient populations \n\nSchultz\, A.\nSchultz AGAH-LSD 03.pdf(0.9 MB) \nDevelopment of “life-style drugs” for men and women \n\nSchultz\, A.\nSchultz AGAH-LSD 03.pdf(0.9 MB) \nDevelopment of “life-style drugs” for men and women \n\nSourgens\, H.\nSourgens AGAH-pregnancy 01.pdf(1.6 MB) \nPractical aspects and feasibility of studies in females – aspects related to pregnancy \n\nTheis\, J.\nTheis Personalized Medicine AGAH Leipzig FINAL 01.pdf(1.9 MB) \nPersonalised medicine: A new challenge for applied human pharmacology? \n\nTimmer\, W.\nTimmer Vortrag AGAH 2012 01.pdf(166 kB) \nWhen are early-phase studies in patients not useful or even not acceptable? \n\nThürmann\, P.\nThuermann Geriatric Clinical Trials AGAH20121 01.pdf(1.1 MB) \nIN/EX criteria in studies with healthy elderlies and special approaches with regard to geriatric patient populations (Pop-PK?) (Should we be using patients instead of healthy elderlies?) \n\nvan Gerven\, J.\nvan Gerven How predictive is proof of concept for 01.pdf(1.7 MB) \nHow predictive is PoC for therapeutic success of the new drug? \n\nZühlsdorf\, M.\nZuehlsdorf EGFR CD AHAH JT 2012-03-01 final 01.pdf(0.9 MB) \nImplementation of stratification throughout drug development – examples from oncology \n\nRoundtable discussion\nRoundtable 2 AHAH JT Backups session 4 01.pdf(325 kB) \nWhen and how shall we use stratification?
URL:https://dev.agah.eu/event/22nd-annual-meeting-2012/
LOCATION:Annual Meeting 2012\, Leipzig\, Deutschland
CATEGORIES:Jahrestreffen
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