Introductory Course in Exploratory Medicines Development – Part II
AGAH Workshop, Oberursel
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of 2.5 days each 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.
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 – 12:45 | Stop 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 – 14:30 | Break |
| 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 – 16:30 | Mandatory Test on Part I (50% of questions must be correctly answered to pass test and receive a certificate) |
| 16:30 – 17:00 | Feed 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 40 30772097
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
1. February 2017 - 3. February 2017
Introductory Course in Exploratory Medicines Development – Part II
AGAH Workshop
Oberursel
Deutschland