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

02.04. – 05.04.2019 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, 2nd April 2019

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

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, 3rd April 2019

09:00 – 10:45

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

10:45 – 11:00 Break
11:00 – 11:30

The revised EMA guideline on early phase clinical trials – key elements

Kerstin Breithaupt-Grögler

11:30 – 12:45

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

Stephanie Plassmann

12:45-13:45 Break
13:45 – 14:45

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

Stephanie Plassmann

14:45 – 15:00 Break
15:00 – 15:30

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

Kerstin Breithaupt-Grögler

15:30-15:45 Break
15:45 – 17:15

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

Day 3: Thursday, 4th April 2019

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 – 12:15

How to design a first-in-human trial? Development of case study in break-out groups

Karin Göhler

12:15 – 13:15 Break
13:15 – 14:00

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

Karin Göhler

14:00 – 14:15 Break
14:15 – 16:00 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
16:00 – 16:15 Break
16:15 – 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, 5th April 2019

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

Monitoring and Auditing: An essential tool to ensure credibility of data

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

Venue

SocraTec R&D GmbH
Im Setzling 35
61440 Oberursel

Contact and further information

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

phone: +49 40 30772097
e-Mail: info ( a t ) agah.eu
Web:   www.agah.eu