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Critical Aspects of Integrated Drug Development – Expect the Unexpected!

28. November 2014 - 29. November 2014
Kardinal-Wendel-Haus, München

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.

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?

The audience is invited to discuss these aspects in depth with experts from health authorities, industry and academia presenting at the meeting.

The workshop will be held in the beautiful city of Munich at the beginning of the pre-Christmas period at the

Kardinal-Wendel-Haus Munich
Mandlstrasse 23
D-80802 Munich

Informations

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 https://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