BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//AGAH - ECPv5.16.4//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:AGAH
X-ORIGINAL-URL:https://dev.agah.eu
X-WR-CALDESC:Events for AGAH
BEGIN:VTIMEZONE
TZID:Europe/Berlin
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20150329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20151025T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;VALUE=DATE:20150220
DTEND;VALUE=DATE:20150221
DTSTAMP:20260929T023919
CREATED:20190604T211021Z
LAST-MODIFIED:20190624T232418Z
UID:3020-1424390400-1424476799@dev.agah.eu
SUMMARY:Oncological Drugs: Early Development from pre-clinics to phase II
DESCRIPTION:Early clinical trials in oncology are challenging for all parties involved: sponsors\, investigators and patients. After decades of drug development with highly toxic drugs and identification of the maximal tolerated dose as the major objective\, targeted therapies come in the focus redefining benefit/risk ratio in this field. Nevertheless\, an adequate balance between scientific planning\, regulatory requirements\, the need to minimize burden and to maximize benefit for the study participants is difficult to find. \nThe basic principles of course are identical to “classical” drug development\, but all types of early clinical studies i.e. First-into-men\, PK-studies\, bioavailability and bioequivalence trials\, MTD and dose finding studies\, even DDI and QTc trials require a specific knowledge and assessments. From Inclusion-/Exclusion criteria to design development – everything appears to be “somewhat different”. \nThe workshop has been set-up to carve out these specificities. It is intended for participants from industry- and CRO side as well as for regulators and investigators involved in oncological drug development. A group of highly experienced experts will present the relevant aspects to be observed and will share their specific experience with you. \n\n\n\n\n\n\n\n\n\n\n\nInformationen\n\n\nOncological drugs “Early development from pre-clinics to phase II”\n20.02.2015 in Frankfurt/Main\, Germany\n\n\n\n\nIntroduction\n\nRationale for the workshop\nEarly clinical trials in oncology are challenging for all parties involved: sponsors\, investigators and patients. After decades of drug development with highly toxic drugs and identification of the maximal tolerated dose as the major objective\, targeted therapies come in the focus redefining benefit/risk ratio in this field. Nevertheless\, an adequate balance between scientific planning\, regulatory requirements\, the need to minimize burden and to maximise benefit for the study participants is difficult to find. \nThe basic principles of course are identical to “classical” drug development\, but all types of early clinical studies i.e. First-into-men\, PK-studies\, bioavailability and bioequivalence trials\, MTD and dose finding studies\, even DDI and QTc trials require a specific knowledge and assessments. From Inclusion-/Exclusion criteria to design development – everything appears to be “somewhat different”. \nThe workshop has been set-up to carve out these specificities. It is intended for participants from industry- and CRO side as well as for regulators and investigators involved in oncological drug development. A group of highly experienced experts will present the relevant aspects to be observed and will share their specific experience with you. \nChairs:\nDr. Andreas Kovar\, Regent AGAH\, Sanofi-Aventis\, Frankfurt\nDr. Barbara Schug\, President-elect AGAH\, SocraTec R&D\, Oberursel\nDr. Michael Zühlsdorf\, Regent AGAH\, Merck KGaA\, Darmstadt \n\n\n\n\nMorning session: 20.2.2015\n\n\n\n\n08:00\nRegistration\n\n\n08:30\nIntroduction\, Barbara Schug\, Oberursel/Erfurt\n\n\n08:45\nPharmacological aspects of oncology\, Michael Zühlsdorf\, Darmstadt\nRelevance of preclinical models\, xenograft models and biomarkers.\n\n\n09:30\nNon-clinical safety assessments of anti-cancer medication and determination of the first dose for FIM\, an introduction\, Stephanie Plassmann\, Basel \nSpecific aspects of a variety of drug classes with different safety profiles and mechanisms of action and determination of the first dose – from small molecules to biologics and antibody-drug conjugates\, an overview. \n\n\n\n10:30\nDiscussion\n\n\n\n10:45\nBreak\n\n\n\n11:00\nStudy design for FIM: from 3 plus 3 to adaptive designs\, Andreas Kovar\, Frankfurt \nStudy design options including DLT and stopping criteria as well as decision rules for adaptive designs. \n\n\n\n11:45\nTranslational medicines using molecular defined diseases\, Michael Zühlsdorf\, Darmstadt \nPharmacodynamics\, disease segmentation\, alternative endpoints and companion diagnostics. \n\n\n\n12:30\nQuestion and Answer session with the morning speakers.\n\n\n\n13:00\nBreak\n\n\n\n\n\n\n\n\n\nAfternoon session: 20.2.2015\n\n\n\n\n14:00\nImaging in oncology\, Michael Zühlsdorf\, Darmstadt \nImaging tools applied in oncological trials: from functional monitoring of drug response to endpoint assessment. \n\n\n\n14:30\n„Traditional“ clinical-pharmacology package\, Andreas Kovar\, Frankfurt\n \nDDI and QTc-trials\, studies in special populations (hepatic\, renal) and other basic questions also applicable for oncology. \n\n\n\n15:15\nBreak\n\n\n15:30\nEarly development after having passed FIM\, Manfred Klevesath\, Darmstadt \nDevelopment options\, expansion cohorts in Phase I and Phase II. \n\n\n\n16:15\nPractical aspects of early phase oncology trials – the oncologists view\, Salah-Eddin Al-Batran\, Frankfurt \nPatient informed consent procedure\, lack of therapeutic benefit in FIM\, handling of multimorbidities\, meaningful definition of in ex criteria\, organizational and financial aspect. \n\n\n\n17:00\nA patients’ perspective on early clinical trial design\, Bettina Ryll\, Uppsala \nAspects of the study design in early oncological trials which interfere with the patient’s decision to participate. \n\n\n\n17:15 – 17:45\nRound table discussion with all speakers.\n\n\n\n\n\n\n\n\nOrganisation\n\nAttendance Fees\n\n\n\n400€\nNon-Members\n\n\n300€\nMember of AGAH\, DGPharMed or DGKliPha or Junior Scientist up to the age of 30.\n\n\n\nThe participation fee is per person. Please note\, according to  §4 para 22 German turnover tax law\, registration and workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.v. All bookings are subject to change. \n\n\n\n\nContact\n\nAssociation for Applied Human Pharmacology (AGAH) e.V.\nPostfach 10 14 58\nD-41546 Kaarst \nPhone: +49 (0)2131-2018194\nEmail: sekretariat ( a t ) agah-web.de\nWeb: www.agah-web.de or http://www.agah.eu \n\n\n\nAccommodation\n\nThere is a limited number of rooms reserved at Spenerhaus. Reservation can be made in context with your workshop registration. \n\n\n\nProgramme Committee\n\nDr. Andreas Kovar\, \nSanofi-Aventis\, Frankfurt \nDr. Barbara Schug\, \nSocraTec R&D\, Oberursel/Erfurt \nDr. Michael Zühlsdorf\, \nMerck KGaA\, Darmstadt \n\n\n\nWorkshop Venue\n\nDAS SPENERHAUS\nHotel und Tagungszentrum am Dominikanerkloster\nDominikanergasse 5\n60311 Frankfurt am Main\nwww.spenerhaus.de \n\n\n\nRegistration & Organisation\n\nCSi GmbH\nAntje Blömeke | Matthias Runow\nJungfrauenthal 22\, 20149 Hamburg\nTelefon: +49 40 30770300\nTelefax: +49 40 30770301\nE-Mail: agah-veranstaltungen ( a t ) csihamburg.de\nwww.csihamburg.de \n\n\n\n\n\n\n\n\n\n\nDownloads\nPlassmann_non-clinical-safety-assessment-anti-cancer_medications_Fv1_0-for-website \nRyll_a_patients_perspective \nAl-Batran_Practical_aspects
URL:https://dev.agah.eu/event/oncological-drugs-early-development-from-pre-clinics-to-phase-ii-2/
LOCATION:AGAH Workshop\, Frankfurt\, Deutschland
CATEGORIES:Training
END:VEVENT
END:VCALENDAR