AGAH-Workshop “Introductory Course in Exploratory Medicines Development – Part II”
AGAH Workshop, 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).
| 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 |
| 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 |
| 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 |
| 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 |
| 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
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.
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.
30. Januar 2018 - 2. Februar 2018
AGAH-Workshop “Introductory Course in Exploratory Medicines Development – Part II”
AGAH Workshop
Oberursel
Deutschland