
23rd AGAH Annual Meeting 2014
Annual Meeting 2014, München
Mitigating risks in early medicines development
Kardinal Wendel Haus
Katholische Akademie in Bayern
Mandlstraße 23, D-80802 München
Phone: 0 89 / 38 10 2-0
Wednesday, 12 Mar 2014 (General Assembly)
Thursday, 13 Mar 2014
Friday, 14 Mar 2014
CSi Hamburg GmbH
Falkenried 88, 20251 Hamburg
Phone: +49 40 307720 97
Fax: +49 40 846097 60
E-Mail: info@csihamburg.de
(early bird until January 15, 2014)
early bird | regular | |
Member | 300 EUR | 350 EUR |
Non-Member | 380 EUR | 450 EUR |
Junior Scientists | 150 EUR | 250 EUR |
Day Ticket (on special request only) | 250 EUR | |
Conference Dinner | 50 EUR | 50 EUR |
Risk mitigation in early medicines development is the focus of the 2014 Annual Meeting in Munich. Whereas recent meetings mainly addressed aspects of early clinical utility assessment and exploratory development of modern therapies, there is need for an overall evaluation of risks and in consequence for the advancement of mitigation strategies.
A broad range of approaches is offered such as the impact of nonclinical findings, biopharmaceutics, personalised medicine approaches, updates on safety/tolerability from a clinical pharmacology perspective, as well as early investigation of lack of efficacy. Risk mitigation is increasingly important in early medicines development not only to allow early attrition but also to improve the chances of early drug development.
In Plenary Sessions and Parallel Workshops with much room for discussion the AGAH Annual Meeting 2014 will provide a floor for comprehensive exchange on these topics. As the conference is located in Munich the AGAH has taken the initiative to cooperate with BioM (Biotech Cluster Development GmbH, a nonprofit organisation) in preparing the conference and thereby involve speakers from Munich's biotechnology sector.
Dr. Kerstin Breithaupt-Grögler
President AGAH e.V.
Prof. Dr. Hildegard Sourgens
President Elect AGAH e.V.
18:00 – 19:00
Get Together / Meet the Board
19:30
General Assembly
08:00
Registration
08:45
Opening remarks
K. Breithaupt-Grögler, Frankfurt
09:00 - 09:30
Attrition in clinical development: the earlier, the better? – an introduction into the conference -
A. Kovar, Darmstadt
Risks identified from nonclinical development
Chairs: S. Plassmann, Muttenz; G. Wensing, Wuppertal
09:30
Early nonclinical characterisation of drugs in development
W. Muster, Basel
10:00
Predictivity of toxicological findings for first-in-man safety
S. Plassmann, Muttenz
10:30
Early safety assessment of biologicals
J. Sims, Basel
11:00
Break
Risks arising from pharmacokinetics / biopharmaceutics
Chairs: B. Schug, Oberursel; A. Kovar, Darmstadt
11:30
Drug-drug interactions that really matter – focus on transporters
J. Rengelshausen, Aachen
12:00
How to increase “drugability” by use of specific formulations – locally acting, locally applied
B. Schug, Oberursel
12:30
How relevant are drug-food interactions
H. Blume, Oberursel
13:00 – 14:15
Lunch Break
Workshops
14:15 – 15:45
- In cooperation with BioM, München: Personalized medicine – approaches for enhanced drug safety: MetaHeps® – a novel approach to causality assessment in drug-induced liver injury.
A. Benesic, München; J. Rengelshausen, Aachen - New guidelines on drug-drug interaction
U. Fuhr, Köln; S. Oswald, Greifswald - How to decrease risks in early development of oncological drugs
H. Oberwittler, Paris; G. Mikus, Heidelberg - Phase I risk mitigation in high risk compounds
T. van Iersel, Groningen
15:45 – 16:15
Break
Risks related to safety and tolerability
Chairs: T. Sudhop, Bonn; K. Erb-Zohar, Hanau
16:15
When is a subject healthy? – results of two AGAH workshops
K. Breithaupt-Grögler, Frankfurt; H. Sourgens, München
16:45
QT assessment in a first-in-man trial – is the earlier really the better?
J. Täubel, London
17:15
Ethnic differences which may affect safety/tolerability
K. Diefenbach
17:45
End of Sessions on Day 1
19:30
Conference Dinner
Risks arising from lack of efficacy
Chairs: J. Rengelshausen, Aachen; Ingrid Klingmann, Brüssel
09:00
Biomarkers for new anticoagulants – vice and virtue
D. Kubitza, Wuppertal
09:30
Predictivity of pain models
K.-H. Konopka, Leiden
10:00
In cooperation with BioM, München: Early response monitoring in molecular oncologic treatment regimens by non-invasive imaging techniques?
C. Cyran, München
10:30
Break
Workshops
11:00 – 12:30
- In cooperation with BioM, München: Personalized medicine – approaches for enhanced drug safety: Biomarker-based personalized medicine in cardiac arrhythmia
S. Kääb, München; J. Rengelshausen, Aachen
- New guidelines on drug-drug interaction
U. Fuhr, Köln; S. Oswald, Greifswald
- How to decrease risk in early development of oncological drugs
H. Oberwittler, Paris; G. Mikus, Heidelberg
- Phase I risk mitigation in high risk compounds
T. van Iersel, Groningen
- Decreasing risk by investigator training: European training concepts: EMTRAIN, On-course, AGAH human pharmacology training course
I. Klingmann, Brüssel
12:30 – 13:45
Lunch Break
Mitigating risks – pitfalls and perspectives
Chairs: U. Feifel, Ingelheim; H. Sourgens, München
13:45
False positive and false negative biomarkers
S. Jurcevic, London
14:15
Risk/benefit assessment for new forms of clinical research in the era of molecular biology
S. Burock, Brussels
14:45
Open-forum discussion with all speakers and chairs
15:15
Closing remarks
H. Sourgens, München