Oncological Drugs: Early Development from pre-clinics to phase II
AGAH Workshop, Frankfurt
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.
The 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”.
The 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.
Oncological drugs “Early development from pre-clinics to phase II”
20.02.2015 in Frankfurt/Main, Germany
Introduction
Rationale for the workshop
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 maximise benefit for the study participants is difficult to find.
The 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”.
The 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.
Chairs:
Dr. Andreas Kovar, Regent AGAH, Sanofi-Aventis, Frankfurt
Dr. Barbara Schug, President-elect AGAH, SocraTec R&D, Oberursel
Dr. Michael Zühlsdorf, Regent AGAH, Merck KGaA, Darmstadt
Morning session: 20.2.2015
| 08:00 | Registration | |
|---|---|---|
| 08:30 | Introduction, Barbara Schug, Oberursel/Erfurt | |
| 08:45 | Pharmacological aspects of oncology, Michael Zühlsdorf, Darmstadt Relevance of preclinical models, xenograft models and biomarkers. |
|
| 09:30 | Non-clinical safety assessments of anti-cancer medication and determination of the first dose for FIM, an introduction, Stephanie Plassmann, Basel
Specific 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. |
|
| 10:30 | Discussion | |
| 10:45 | Break | |
| 11:00 | Study design for FIM: from 3 plus 3 to adaptive designs, Andreas Kovar, Frankfurt
Study design options including DLT and stopping criteria as well as decision rules for adaptive designs. |
|
| 11:45 | Translational medicines using molecular defined diseases, Michael Zühlsdorf, Darmstadt
Pharmacodynamics, disease segmentation, alternative endpoints and companion diagnostics. |
|
| 12:30 | Question and Answer session with the morning speakers. | |
| 13:00 | Break |
Afternoon session: 20.2.2015
| 14:00 | Imaging in oncology, Michael Zühlsdorf, Darmstadt
Imaging tools applied in oncological trials: from functional monitoring of drug response to endpoint assessment. |
|---|---|
| 14:30 | „Traditional“ clinical-pharmacology package, Andreas Kovar, Frankfurt DDI and QTc-trials, studies in special populations (hepatic, renal) and other basic questions also applicable for oncology. |
| 15:15 | Break |
| 15:30 | Early development after having passed FIM, Manfred Klevesath, Darmstadt
Development options, expansion cohorts in Phase I and Phase II. |
| 16:15 | Practical aspects of early phase oncology trials – the oncologists view, Salah-Eddin Al-Batran, Frankfurt
Patient informed consent procedure, lack of therapeutic benefit in FIM, handling of multimorbidities, meaningful definition of in ex criteria, organizational and financial aspect. |
| 17:00 | A patients‘ perspective on early clinical trial design, Bettina Ryll, Uppsala
Aspects of the study design in early oncological trials which interfere with the patient’s decision to participate. |
| 17:15 – 17:45 | Round table discussion with all speakers. |
Organisation
Attendance Fees
| 400€ | Non-Members |
|---|---|
| 300€ | Member of AGAH, DGPharMed or DGKliPha or Junior Scientist up to the age of 30. |
The 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.
Contact
Association for Applied Human Pharmacology (AGAH) e.V.
Postfach 10 14 58
D-41546 Kaarst
Phone: +49 (0)2131-2018194
Email: sekretariat ( a t ) agah-web.de
Web: www.agah-web.de or http://www.agah.eu
Accommodation
There is a limited number of rooms reserved at Spenerhaus. Reservation can be made in context with your workshop registration.
Programme Committee
Dr. Andreas Kovar,
Sanofi-Aventis, Frankfurt
Dr. Barbara Schug,
SocraTec R&D, Oberursel/Erfurt
Dr. Michael Zühlsdorf,
Merck KGaA, Darmstadt
Workshop Venue
DAS SPENERHAUS
Hotel und Tagungszentrum am Dominikanerkloster
Dominikanergasse 5
60311 Frankfurt am Main
www.spenerhaus.de
Registration & Organisation
CSi GmbH
Antje Blömeke | Matthias Runow
Jungfrauenthal 22, 20149 Hamburg
Telefon: +49 40 30770300
Telefax: +49 40 30770301
E-Mail: agah-veranstaltungen ( a t ) csihamburg.de
www.csihamburg.de
20. Februar 2015
Oncological Drugs: Early Development from pre-clinics to phase II
AGAH Workshop
Frankfurt
Deutschland