Kardinal-Wendel-Haus, München
AGAH-Workshop “Critical aspects of integrated drug development – expect the unexpected!”
28.11.2014 – 29.11.2014 in Munich
Introduction
Drug development presents the experts in all disciplines involved with unexpected challenges during the complex process it takes to bring new medicines in a variety of indications to the market. These challenges require integration into what proves to be a demanding journey through often unknown territories which need to be explored as the route unfolds itself on the way.
What do we understand at a specific moment in time when we are facing an issue? Will this issue be a “show stopper” or only make us take a more complicated but still potentially successful route? How can we mitigate potential risks in humans? How reliably can we translate data from animals or clinical studies to the patient target population? How can we responsibly balance potential risks against essential benefits? How certain can we be as to whether we have asked the right questions along the way? Are we sure that we do really understand the answers we get?
Expect the unexpected – this AGAH workshop provides practical insight into critical situations arising during successful drug development with a focus on non-clinical and clinical development of biologics and anti-cancer drugs. Moreover, specific aspects regarding reproductive and juvenile toxicity and drug development for the paediatric patient population will be addressed.
Day 1: 28.11.2014
| Time | Content |
|---|---|
| 09:00 | Registration |
| 10:00 | Welcome and Introduction
S. Plassmann, Munich |
| 10:15 | The realms of drug development – how can we achieve better?
A. Kovar, Darmstadt |
Session 1: “Biologics” – a challenging and diverse field in drug development
| Chairs: H. Sourgens and B. Ziegele | |
| 10:45 | What are we talking about? An overview on biologics: a regulatory perspective
B. Ziegele, Langen Questions, Answers and Discussion |
| 11:30 | Critical aspects of the clinical development of biologics
D. Seimetz, Munich Questions, Answers and Discussion |
| 12:15 | Break |
| 13:15 | CMC and immunogenicity aspects of the development of biosimilars
P. Chamberlain, Munich Questions, Answers and Discussion |
| 14:00 | PK/PD and safety assessment of biologics to support early clinical development
J. Sims, Basel Questions, Answers and Discussion |
| 14:45 | Round table discussion
“The Good, the Bad and the Ugly” and how to deal with them All Workshop participants |
| 15:15 | Break |
Session 2: Oncology – surprises guaranteed!
| Chairs: B. Schug and S. Leclair | |
| 15:45 | Non-clinical development of anti-cancer medications
E. Koch, Denver Questions, Answers and Discussion |
| 16:30 | How to bring targeted anti-cancer agents to the market today: an industry perspective
A-R. Hanauske, Bad Homburg Questions, Answers and Discussion |
| 17:15 | Round table discussion
“A high unmet medical need and the specific challenges of fighting cancer” |
| 17:45 | End of Day 1 |
| 19:00 | Get-together in Munich City |
Day 2: 29.11.2014
Session 3: Reproductive and juvenile toxicity and paediatric drug development – “Everything you always wanted to know but were too afraid to ask”
| Chair: L. Wiesner and G. Bailey | |
| 09:00 | Introduction
S. Plassmann, Munich |
| 09:15 | The applicability of animal reproductive data in human drug safety
S. Plassmann, Munich Questions, Answers and Discussion |
| 10:00 | From clinical data to new therapeutic concepts for paediatric patients
C. Mallard, Gothenburg Questions, Answers and Discussion |
| 10:45 | Break |
| 11:15 | Juvenile animal studies for new chemical entities: PIPs, pups and problems
G. Bailey, Beerse Questions, Answers and Discussion |
| 12:00 | Juvenile toxicity studies with biopharmaceuticals: considerations and current practices
S. Maguire, Cambridge Questions, Answers and Discussion |
| 12:45 | Paediatric trials – daily challenges in clinical practice
V. Klingmann, Düsseldorf Questions, Answers and Discussion |
| 13:30 | Round table discussion
“How to protect the young, the very young and those not even born: take the challenge and expect the unexpected” All Workshop participants |
| 14:00 | Closing remarks
S. Plassmann, Munich |
| 14:10 | Farewell |
Speakers and Chairs
- Graham Bailey, Johnson & Johnson, Beerse (Belgium)
- Paul Chamberlain, Biopharma Excellence, Munich (Germany)
- Axel-Rainer Hanauske, Lilly Deutschland GmbH, Bad Homburg (Germany)
- Viviane Klingmann, Universitätsklinikum Düsseldorf, Düsseldorf (Germany)
- Elisabeth Koch, PreClinical Safety Consultants Ltd., Denver (USA)
- Andreas Kovar, Consultant, Darmstadt (Germany)
- Stéphane Leclair, Roche Diagnostics GmbH, Penzberg (Germany)
- Shaun Maguire, Medimmune (AZ Biologics), Cambridge (UK)
- Carina Mallard, University of Gothenburg, Gothenburg (Sweden)
- Stephanie Plassmann, PreClinical Safety Consultants Ltd., Basel (Switzerland)
- Barbara Schug, Socratec R&D GmbH, Oberursel (Germany)
- Diane Seimetz, Biopharma Excellence, Munich (Germany)
- Jennifer Sims, Integrated Biologix GmbH, Basel (Switzerland)
- Hildegard Sourgens, Consultant, Munich (Germany)
- Lutz Wiesner, Bundesamt für Arzneimittel und Medizinprodukte, Bonn (Germany)
- Bettina Ziegele, Paul-Ehrlich-Institut, Langen (Germany)
Organisation
Attendance Fees
| 450€ | Non-Members |
|---|---|
| 300€ | for Members of AGAH, DGPharMed, DGKliPha, BAPU, Club Phase I and AHHPI as well as for young scientists up to the age of 30. |
The participation fee is per person. Please note, according to § 4, para. 22, German Turnover-Tax Law work-shop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.V. (PO Box 10 14 58, 41546 Kaarst, VAT No: 122/5786/2578). All bookings are subject to change.
Accommodation at the conference venue can be booked separately at registration.
On-site registration is possible!
Registration
CSi Hamburg GmbH
Jungfrauenthal 22
20149 Hamburg
Germany
Tel.: +49 40 30770300
Fax: +49 40 30770301
E-Mail: agah-veranstaltungen ( a t ) csihamburg.de
May we please ask you to use the registration form.
Workshop Venue
Kardinal-Wendel-Haus Munich
Katholische Akademie in Bayern
Mandlstraße 23
80802 Munich
Contact and further information
Association for Applied Human Pharmacology (AGAH) e.V.
Postfach 10 14 58
D-41546 Kaarst
Germany
Phone: +49 (0)2131-2018194
Email: sekretariat ( a t ) agah-web.de
Web: www.agah-web.de or http://www.agah.eu
This workshop is supported by PreClinical Safety (PCS) Consultants Ltd.
28. November 2014 - 29. November 2014
Critical Aspects of Integrated Drug Development – Expect the Unexpected!
Kardinal-Wendel-Haus
München
Deutschland