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

1. – 3.2.2017 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

Day 1: Wednesday, 01 February 2017

Time Content
09:00 – 09:15

Introduction of faculty and participants 

09:15 – 09:30

Overview on Part II training course

09:30 – 11:00

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

Dr. M. Coenen

11:00 – 11:15 Break
11:15 – 13:00 Pharmacodynamic endpoints and biomarker: Cardiovascular, CNS, diabetes, immunology, challenging substances, stress tests, cardiac safety / QTc, how to assess proof of concept (PoM, PoC)
Dr. J. Rengelshausen or Dr. M. Zühlsdorf
13:00 – 14:00 Break
14:00 – 17:30 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, toxicokinetics, genotoxicity, immunotoxicity, local tolerance, phototoxicity
Dr. S. Plassmann or Prof. Dr. H. Sourgens
17:30 – 17:45 Break
17:45 – 18:45

How to determine a safe starting dose for first-in-human? Key safety parameters, presentation of case studies

Dr. S. Plassmann

Day 2: Thursday, 02 February 2017

08:45 – 09:45

How to determine a safe starting dose for first-in-human? Key safety parameters, presentation of case studies
Dr. S. Plassmann

09:45 – 10:00

Break

10:00 – 12:00

Pharmacokinetics III: PK linearity / non-linearity, dose proportionality assessments, allometric scaling, 14C-studies, absorption half-life, flip-flop kinetics, protein binding, biopharmaceutics classification system
Dr. A. Kovar

12:00 – 12:45Stop dose escalation or continue dosing?
Case study developed in break-out groups
Dr. K. Erb-Zohar

12:45 – 13:30

Break

13:30 – 14:15

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

Dr. K. Erb-Zohar

14:15 – 14:30Break

14:30 – 18:00

How to design an early clinical pharmacology development program? Basic concepts of FIM trial and early clinical pharmacology trials supporting early clinical development and decision making. Case study developed in break-out groups

Dr. K. Göhler

Day 3: Friday, 03 February 2017

08:45 – 09:15

Data management: Principles, electronic / paper CRFs, queries, data cleaning, data base closure
Dr. M. Wargenau

09:15 – 09:45

Reporting and publication: Flow of information, types of reports, guidelines, abstracts and full papers
Dr. K. Breithaupt-Grögler 

09:45 – 10:00

Break

10:00 – 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
Dr. M. Wargenau

12:45 – 13:45

Break

13:45 – 15:45

Introduction to biologicals and biosimilars
Prof. Dr. H. Sourgens
15:45 – 16:30Mandatory Test on Part I
(50% of questions must be correctly answered to pass test and receive a certificate)     
16:30 – 17:00Feed back and end of Part II

Attendance Fees

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

2.500 €

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

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

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.