Annual Meeting 2014 “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

Conference office

CSi Hamburg GmbH
Falkenried 88, 20251 Hamburg

Phone: +49 40 307720 97
Fax: +49 40 846097 60
E-Mail: info ( a t )

Fees (early bird until January 15, 2014)

early birdregular
Member 300 EUR350 EUR
Non-Member380 EUR450 EUR
Junior Scientists150 EUR250 EUR
Day Ticket (on special request only)250 EUR
Conference Dinner 50 EUR50 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.

Day 1: Wednesday, 12 Mar 2014

18:00 – 19:00Get Together / Meet the Board
19:30General Assembly

Day 2: Thursday, 13 Mar 2014

08:45Opening remarks
K. Breithaupt-Grögler, Frankfurt
09:00 – 9:30Attrition 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


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


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

10:30 Early safety assessment of biologicals
J. Sims, Basel 

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


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


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


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

13:00 – 14:15 Lunch break


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  
15:45 – 16:15Break

 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
17:45End of Sessions on Day 1
19:30Conference Dinner

Day 3: Friday, 14 Mar 2014

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


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


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
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
12:30 – 13:45Lunch break

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


False positive and false negative biomarkers
S. Jurcevic, London


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


Open-forum discussion with all speakers and chairs 

15:15 Closing remarks
H. Sourgens, München