AGAH-Workshop “Introductory Course in Exploratory Medicines Development – Part II”

30.01. – 02.02.2018 in Oberursel

Introduction and Learning Outcomes

This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of several days provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials.

Learning Outcomes

On successful completion of Part II, students should be able to demonstrate an understanding / knowledge of the following:  

  • nonclinical pharmacology and toxicology
  • molecular basis of drug actions
  • allometric scaling and dose proportionality assessments based on characteristic PK data
  • defining pharmacodynamic (PD) endpoints and biomarkers
  • differentiating between primary and secondary PK and PD endpoints
  • How to design an early clinical pharmacology developmant plan
  • planning and management of a first-in-man trial
  • principles of data management and information flow
  • principles of reporting and publication
  • principles of medical statistics
  • characteristic issues involved in the development of biologicals and biosimilars

This AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (in 2016/17) was accredited 3 ECTS (Parts I plus II).

Day 1: Tuesday, 30 January 2018

10:00 – 10:15 Introduction of faculty and participants  
10:15 – 10:30 Overview on Part II training course
10:30 – 12:00

Molecular basis of drug action: Receptor pharmacology, agonists, antagonists, second messengers, enzymes, regulatory proteins, transcription factors, cellular sites of drug actions

Martin Coenen

12:00 – 13:00 Break
13.15 – 14:45

Pharmacodynamic endpoints and biomarker: Biomarkers for stratified medicine, companion diagnostics and proof of concept; biomarkers and PD endpoints in oncology, diabetes, car diovascular diseases, cardiac safety and in pain

Jens Rengelshausen or Michael Zühlsdorf

14:45 – 15:00 Break
15:00 – 18:30

Assessment of non-clinical data and risk as prerequisites before administration to man: Compound selection, early in vivo studies including primary and secondary pharmacodynamics and -kinetics, safety pharmacology, general toxicology in various species (rodents, non-rodents) including NOEL/NOAEL and MTD, safety ratio, toxicokinetics, genotoxicity, immunotoxicity, local tolerance, phototoxicity

Stephanie Plassmann

18:30 – 20:30 Get together and formation of break-out groups

Day 2: Wednesday, 31 January 2018

09:00 – 11:00

Assessment of non-clinical data and risk as prerequisites before administration to man: Compound selection, early in vivo studies including primary and secondary pharmacodynamics and -kinetics, safety pharmacology, general toxicology in various species (rodents, non-rodents) including NOEL/NOAEL and MTD, toxicokinetics, genotoxicity, immunotoxicity, local tolerance, phototoxicity

Stephanie Plassmann

11:00 – 11:15 Break
11:15 – 12:30

How to determine a safe starting dose for first-in-human? Key safety parameters, case study developed in break-out groups

Stephanie Plassmann

12:30 – 13:30 Break
13:30 – 14:30

How to determine a safe starting dose for first-in-human? Presentations of case study

Stephanie Plassmann

14:30 – 14:45 Break
14:45 – 16:45

Pharmacokinetics III: PK linearity / non-linearity / dose proportionality assessments, biopharmaceutics classification system (BCS), absorption half-life, flip-flop kinetics, protein binding, 14C-studies (mass balance studies), allometric scaling

Andreas Kovar

16:45 – 17:15

Quiz on essential terms: questions and answers provided by the audience

Kerstin Breithaupt-Grögler and Hildegard Sourgens 

Day 3: Thursday, 01 February 2018

09:00 – 10:00

Stop dose escalation or continue dosing? Case study developed in break-out groups 

Katharina Erb-Zohar

10:00 – 10:15 Break
10:15 – 11:00

Stop dose escalation or continue dosing? Presentation of case studies 

Katharina Erb-Zohar

11:00 – 12:30

How to design a first-in-human trial? Basic concepts of FIH trial and development of case study in break-out groups.  

Karin Göhler

12:30 – 13:30 Break
13:30 – 14:15

How to design a first-in-human trial? Presentations of case study

Karin Göhler

14:15 – 14:30 Break
14:30 – 16:15 How to proceed from single ascending dose to multiple ascending dose? Assessment and evaluation of SAD safety and PK data, integrated protocols versus consecutive trials
Karin Göhler
16:15 – 16:30 Break
16:30 – 18:00

How to design an early clinical pharmacology development program? Basic concepts of early phase trials supporting early clinical development and decision making

Karin Göhler

Day 4: Friday, 02 February 2018

08:45 – 09:15

Flow of information and reporting of trial data

Kerstin Breithaupt-Grögler

09:15 – 09:45

Data management: Principles, electronic / paper CRFs, queries, data cleaning, data base closure

Manfred Wargenau

09:45 – 10:00 Break
10:00 – 10:45

Monitorin and Auditing: An essential tool to ensure credibility of datas

Christian Hinze

10:45 – 11:00 Break
11:00 – 12:45

Analysis of early exploratory development studies – principles of medical statistics: Differences between treatments regarding biomarkers, pharmacokinetic / -dynamic effects, safety, parametric vs. non-parametric analysis, t-tests, repeated measures ANOVA, parametric vs. non-parametric analysis, Chi-square, Fisher's exact

Manfred Wargenau

12:45 – 13:30 Break
13:30 – 14:15 Analysis of early exploratory development studies - principles of medical statistics (continued)
14:15 – 16:00

Introduction to biologicals and biosimilars 

Hildegard Sourgens

16:00 – 16:15 Break
16:00 – 16:45 Mandatory Test on Part II (50% of questions must be correctly answered to pass test and receive a certificate)                                             
16:45 – 17:00 Feed back and end of Part II

Attendance Fees

1.100 €
1.450 €
Members of the AGAH, AHPPI, BAPU, Club Phase I, EUFEMED
Non-Members 
1.900 €

2.500 €

Part I plus II  
for Members of the AGAH, AHPPI, BAPU, Club Phase I, EUFEMED

Part I plus II for Non-Members

Special fees for students are available on request

This course will be accredited by the Landesärztekammer, participants will be awarded ”Fortbildungspunkte”.
More information will be given in due time

Contact and further information

Association for Applied Human Pharmacology (AGAH) e.V. 
office: Goernestraße 30
20249 Hamburg

phone: +49 170 7844438
e-Mail: info ( a t ) agah.eu
Web:   www.agah.eu

This workshop is supported by PreClinical Safety (PCS) Consultants Ltd.

Registration and Programme Download

CSi Hamburg GmbH
Conferences | Symposia | Incentives
Goernestraße 30
20249 Hamburg
Germany

phone: +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.