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SUMMARY:19th AGAH Annual Meeting 2010
DESCRIPTION:20 Years of Applied Human Pharmacology in Clinical Drug Development – \nLessons Learned and Translation to Future Needs \n\n\n\n	Announcement \n\n\n21 – 23 February 2010\, Hamburg\, Germany  \nTo foster the creation of an association for applied human pharmacology\, a group of human pharmacology experts working in Phase 1 Units in Industry and CROs organised a first conference in 1990 to exchange information and experience on how to perform human pharmacology trials according to the then newly established GCP principles and to enable faster drug development. This led to the foundation of AGAH (Association For Applied Human Pharmacology) which became incorporated in 1991\, creating a lot of enthusiasm resulting every year in an interesting programme for the annual meetings. Thus\, 2010 has marked the 20th AGAH Annual Meeting. \nThis was an excellent opportunity to critically review the progress made since\, the lessons learned\, as well as the potential to translate this knowledge into strategies and tools to successfully manage the forthcoming challenges in human pharmacology: drugs with new mechanisms of action\, personalised therapies\, higher pressure to achieve better predictability of a molecule’s suitability for further development\, shorter development times and globalization of trial performance. \nThis conference gave the opportunity to critically review current and past approaches to drug development\, learn about experiences and practical aspects of human pharmacology\, discuss strategies and up-to-date tools for further improvement of clinical development in special populations\, difficult pharmacokinetic conditions and an ever-changing regulatory environment. \n\n\n\n\n\n\n	Introduction \n\n\nTWENTY YEARS OF APPLIED HUMAN PHARMACOLOGY IN CLINICAL DRUG DEVELOPMENT – LESSONS\nLEARNED AND TRANSLATION TO FUTURE NEEDS\nTo foster the creation of an association for applied human pharmacology\, a group of human pharmacology\nexperts working in Phase 1 Units in Industry and CROs\norganised a first conference in 1990 to exchange information and experience on how to perform human\npharmacology trials according to the then newly established GCP principles and to enable faster drug development. This led to the foundation of AGAH (Association For Applied Human Pharmacology) which became\nincorporated in 1991\, creating a lot of enthusiasm resulting every year in an interesting programme for the\nannual meetings. Thus\, 2010 will mark the 20th AGAH\nAnnual Meeting.\nThis is an excellent opportunity to critically review the\nprogress made since\, the lessons learned\, as well as\nthe potential to translate this knowledge into strategies\nand tools to successfully manage the forthcoming challenges in human pharmacology: drugs with new mechanisms of action\, personalised therapies\, higher\npressure to achieve better predictability of a molecule’s\nsuitability for further development\, shorter development\ntimes and globalisation of trial performance.\nThis conference will give you the opportunity to critically\nreview current and past approaches to drug development\, learn about experiences and practical aspects of\nhuman pharmacology\, to discuss strategies and up-todate tools for further improvement of clinical development in special populations\, difficult pharmacokinetic\nconditions and an ever-changing regulatory environment. \n\n\n\n\n\n\n	Day 1\, Sunday\, 21 February 2010  \n\n15:00 – 18:00  \nTRAINING SESSION (in German)\n“Zielstellungen und Studienkonzepte in der klinischen Entwicklung (Wolfgang Timmer\, Mannheim)\nÜbersicht über Studienarten\, Studiendesigns\, Zielkriterien\, Mechanismen der Risikosteuerung und Elemente\neines effizienten Projektmanagements“\nVeranstaltungsort: Hotel Empire Riverside\nUnkostenbeitrag: € 40\,00 für Nichtmitglieder. \n\n19:00  \nAGAH General Assembly \n\n\n\n\n	Day 2\, Monday\, 22 February 2010 \n08:30  \nRegistration \n\n09:00  \nOpening remarks\nIngrid Klingmann\, Brussels \n\nSession 1:  \nPAST AND FUTURE CHALLENGES FOR APPLIED HUMAN PHARMACOLOGY \n\nChair \nKerstin Breithaupt-Grögler\,\nJens Rengelshausen \n\n9:10  \nSolved Problems and Unsolved Challenges in Applied Human Pharmacology\nHildegard Sourgens\, Munich \n\n9:40  \nThe Changing Regulatory Requirements for Applied Human Pharmacology\nThomas Sudhop\, Bonn \n\n10:10  \nApplied Ethics and Societal Aspects in Applied Human Pharmacology\nDavid Haerry\, Bern \n\n10:40  \nHealth Economics in Early Clinical Drug Development\nClemens Troche\, Schwäbisch Hall \n\n11:10 – 11:40  \nCoffee Break \n\nSession 2: \nPOX: POM\, POP OR POC?  \n\nChair: \n Thomas Gramatté\, Wolfgang Timmer \n\n11:40  \nFrom PD Models to PoX: Changing Terms or Mindset?\nMichael Zühlsdorf\, Darmstadt \n\n12:10 \nLessons Learned (practical example)\nPierre Laurent-Puig\, Paris \n\n12:40  \nPhase I\, Ib\, IIa\, IIb\, etc. - Is this way of thinking still appropriate?\nRobert Hermann\, Radolfzell \n\n13:10 – 14:30  \nLunch \n\n14:30 – 16:00  \nPARALLEL WORKSHOPS \n\nWS 1 \nCultural differences in GCP perception\nIlufredo (Fred) Tantoy\, San Francisco  \n\nWS 2 \nModern Strategies for the Development of Generic Drugs:\na) Locally Acting / Locally Applied Drug Products: A Playing Field for Human Pharmacologists?\nBarbara Schug\, Oberursel \n\nWS 3  \nModern Strategies for the Development of Generic Drugs:\nb) Highly Variable Drugs: Sources of High Variability and Solutions to Overcome Problems in Bioequivalence Assessment“\nHenning Blume\, Oberursel/Germany\,\nJan Welink\, The Hague/The Netherlands \n\n16:00 – 16:30  \nCoffee Break \n\nSession 3:  \nFAST TRACK DEVELOPMENT –\nHAS THE CONCEPT WORKED\, AND WHEN\nIS IT REALLY FEASIBLE? \n\nChair \nUlrich Feifel\, Thomas Sudhop \n\n16:30  \nThe Regulatory Perspective:\nWhat has Worked?\nBirka Lehmann\, Bonn \n\n17:00  \nThe Clinical Perspective:\nExperiences and Tools for Fast Track Developments\nFritz Bühler\, Basel \n  \n\n17:30  \nEnd of Sessions on Day 1 \n  \n\n19:30  \nConference Dinner \n\n\n\n\n	Day 3\, Tuesday\, 23 February 2010 \nSession 4:  \nSCIENCE-DRIVEN REGULATION VERSUS TICKBOX APPROACH:\nAPPLIED HUMAN PHARMACOLOGY IN SPECIAL POPULATIONS \n\nChair \nBarbara Schug\, Christian Hinze \n\n9:00  \nIntroductory Remarks from the Chair \n\n9:15  \nApplied Human Pharmacology in Children:\nFrom Past to Present\nMatthias Schwab\, Stuttgart \n\n9:45  \nPaediatric Investigational Plan (PiP):\nClinical Impact vs. Effort?\nAngelika Joos\, Brussels \n\n10:15  \nRenal Impairment: From Dettli to Guideline:\nWhat Can We Learn?\nMeinolf Wonnemann\, Erfurt \n\n10:45 - 11:15 \nCoffee Break \n\nSession 5:  \nTOOLBOX IN CLINICAL PHARMACOLOGY – PAST\, PRESENT AND FUTURE \n\nChair \nTorben Thomsen\, Michael Zühlsdorf \n\n11:15 \nToday’s Value of Population Pharmacokinetics\nHans-Günter Schäfer\, Biberach \n\n11:45  \nBiomarker: Clinical Validation for Intended Use\nJoop van Gerven\, Leiden \n\n12:15  \nThe Value of Pharmacodynamic Models and Go / No Go Criteria During Clinical Drug Development\nGeorg Wensing\, Wuppertal \n\n12:45 – 13:45  \nLunch Break \n\nSession 6:  \nSTRATEGIES FOR CLINICAL DRUG DEVELOPMENT IN THE FUTURE - APPLIED HUMAN PHARMACOLOGY 2.0  \n\nChair \n Fritz Bühler\, Matthias Schwab\n \n\n13:45 \nKey-note Speech\nAdam Cohen\, Leiden\nPanel Discussion\nF. Bühler\, A. Cohen\, M. Schwab\, T. Sudhop\,\nJ. van Gerven\, G. Wensing  \n\n14:45 \nClosing Remarks\nTorben Thomsen\, Andernach \n\n\n\n\n	Information \n  \nVenue\nHotel Hafen Hamburg\nSeewartenstrasse 9\, D-20459 Hamburg\nPhone: +49 (40) 311130 \nDate\nSunday\, 21 Feb to Tuesday\, 23 Feb 2010 \nFees \n\n\n\nMembers of AGAH\, CPI\, AHPPI\, BAPU\n340 EUR\n\n\nNon-members\n400 EUR\n\n\nJunior scientists\n250 EUR\n\n\nDay ticket\n200 EUR\n\n\n\n  \n\nOnline registration and hotel reservation:\nhttp://www.intercom-dresden.de/agah2010/ \n  \n\n\n\n\n	Downloads \nBlume\, H.\nBlume H BE-HVD AGAH 2010 Einleitung1.pdf(100 kB) \nHighly variable drugs: reasons for high variability and solutions to overcome BE problems \n\nBühler\, F. R.\nBuehler F.R. HH 2010.pdf(696 kB) \nFast Track Drug Development – The Clinical (Caleidoscopic) Perspective \n\nGerven\, J. v.\nGerven J. v. HH 2010 01.pdf(1.4 MB) \nBiomarker: Clinical Validation for Intended Use \n\nHaerry\, D. H.-U.\nHaerry D. H.-U. HH 2010 01.pdf(0.9 MB) \nApplied Ethics and Societal Aspects in Applied Human Pharmacology \n\nSourgens\, H.\nSourgens H. HH 2010 01.pdf(3.2 MB) \nSolved Problems and Unsolved Challenges in Applied Human Pharmacology \n\n\nSudhop\, T.\n\nSudhop T. HH 2010 01.pdf(268 kB)\nThe Changing Regulatory Requirements for Applied Human Pharmacology \n\nTantoy\, I.\nTantoy I. HH 2010 01.pdf(240 kB) \nCultural differences in GCP perception \n\nTimmer\, W.\nTimmer W. HH 2010 01.pdf(830 kB) \nZielstellungen und Studienkonzepte früher Entwicklungsphasen \n\nWonnemann\, M.\nWonnemann M. HH 2010 01.pdf(1.1 MB) \nRenal Impairment – From Dettli to Guideline: What can we learn? \n\n 
URL:https://dev.agah.eu/event/19th-agah-annual-meeting-2010/
LOCATION:Annual Meeting 2010\, Hamburg\, Deutschland
CATEGORIES:Annual Meetings
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