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Oncological Drugs: Early Development from pre-clinics to phase II

20. February 2015
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.

Informationen

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 https://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. February 2015

Oncological Drugs: Early Development from pre-clinics to phase II

AGAH Workshop


Frankfurt
Deutschland