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.

 

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18:00 – 19:00

Get Together / Meet the Board

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19:30

General Assembly

08:00

Registration

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08:45

Opening remarks
K. Breithaupt-Grögler, Frankfurt

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09:00 - 09:30

Attrition in clinical development: the earlier, the better? – an introduction into the conference -
A. Kovar, Darmstadt

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Risks identified from nonclinical development
Chairs: S. Plassmann, Muttenz; G. Wensing, Wuppertal

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09:30

Early nonclinical characterisation of drugs in development
W. Muster, Basel 

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10:00

Predictivity of toxicological findings for first-in-man safety
S. Plassmann, Muttenz

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10:30

Early safety assessment of biologicals
J. Sims, Basel

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11:00

Break

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Risks arising from pharmacokinetics / biopharmaceutics
Chairs: B. Schug, Oberursel; A. Kovar, Darmstadt

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11:30

Drug-drug interactions that really matter – focus on transporters
J. Rengelshausen, Aachen

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12:00

How to increase “drugability” by use of specific formulations – locally acting, locally applied
B. Schug, Oberursel

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12:30

How relevant are drug-food interactions
H. Blume, Oberursel

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13:00 – 14:15

Lunch Break

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Workshops

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14:15 – 15:45

 

1. 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
2. New guidelines on drug-drug interaction
   U. Fuhr, Köln; S. Oswald, Greifswald
3. How to decrease risks in early development of oncological drugs
   H. Oberwittler, Paris; G. Mikus, Heidelberg
4. Phase I risk mitigation in high risk compounds
   T. van Iersel, Groningen 

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15:45 – 16:15

Break

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Risks related to safety and tolerability
Chairs: T. Sudhop, Bonn; K. Erb-Zohar, Hanau

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16:15

When is a subject healthy? – results of two AGAH workshops
K. Breithaupt-Grögler, Frankfurt; H. Sourgens, München

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16:45

QT assessment in a first-in-man trial – is the earlier really the better?
J. Täubel, London

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17:15

Ethnic differences which may affect safety/tolerability
K. Diefenbach

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17:45

End of Sessions on Day 1

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19:30

Conference Dinner

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Risks arising from lack of efficacy
Chairs: J. Rengelshausen, Aachen; Ingrid Klingmann, Brüssel

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09:00

Biomarkers for new anticoagulants – vice and virtue
D. Kubitza, Wuppertal

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09:30

Predictivity of pain models
K.-H. Konopka, Leiden

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10:00

In cooperation with BioM, München: Early response monitoring in molecular oncologic treatment regimens by non-invasive imaging techniques?
C. Cyran, München

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10:30 

Break

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Workshops

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11:00 – 12:30

1. 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

2. New guidelines on drug-drug interaction

   U. Fuhr, Köln; S. Oswald, Greifswald

3. How to decrease risk in early development of oncological drugs

   H. Oberwittler, Paris; G. Mikus, Heidelberg

4. Phase I risk mitigation in high risk compounds

   T. van Iersel, Groningen

5. Decreasing risk by investigator training: European training concepts: EMTRAIN, On-course, AGAH human pharmacology training course
   I. Klingmann, Brüssel

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12:30 – 13:45

Lunch Break

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Mitigating risks – pitfalls and perspectives
Chairs: U. Feifel, Ingelheim; H. Sourgens, München

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13:45

False positive and false negative biomarkers
S. Jurcevic, London

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14:15

Risk/benefit assessment for new forms of clinical research in the era of molecular biology
S. Burock, Brussels

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14:45

Open-forum discussion with all speakers and chairs 

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15:15

Closing remarks

H. Sourgens, München

 

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