Introductory Course in Early Medicines Development
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.
Introductory Course in Early Medicines Development
22. – 24.04.2015 in Oberursel bei Frankfurt
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
- method validation according to good clinical (GCP) and good laboratory (GLP) practise
- planning and management of a first-in-man trial
- practical aspects of bioequivalence trials
- 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, 22 April 2015
| 12:00 – 12:15 | Introduction of faculty and participants
All |
|---|---|
| 12:15 – 12:30 | Overview on Part II training course
All |
| 12:30 – 14:00 | Molecular basis of drug action (receptor pharmacology, agonists, antagonists, second messengers, enzymes, regulatory proteins, transcription factors, cellular site of drug action
Martin Coenen |
| 14:00 – 14:15 | Break |
| 14:15 – 16:15 | Pharmacodynamic endpoints and biomarkers (cardiovascular, CNS, diabetes, immunology, challenging substances, stress tests, cardiac safety / QTc trial), proof of concept (POM, POC) Jens Rengelshausen |
| 16:15 – 16:30 | Break |
| 16:30 – 18:30 | Nonclinical development: compound selection (in silico, in vitro assays, early in vivo studies incl. primary and secondary pharmacodynamics and kinetics); safety pharmacology, general toxicology in various species [rodents, non-rodents] incl. NOEL/NOAEL and MTD
Stephanie Plassmann, Hildegard Sourgens |
Day 2: Thursday, 23 April 2015
| 08:45 – 09:45 | GCP / GLP – focus on method validation: bioanalytics, sample collection, sample preparation, quality assurance procedures
Barbara Schug |
|---|---|
| 09:45 – 10:45 | Bioequivalence trials: Design development and realization –practical examples. Specific aspects besides the classical standard design Barbara Schug |
| 10:45 – 11:15 | Break |
| 11:15- 13:15 | Nonclinical development: genetic toxicology, immunotoxicology, local tolerance, phototoxicity, reproductive toxicity Stephanie Plassmann, Hildegard Sourgens |
| 13:15 – 14:15 | Break |
| 14:15 – 15:30 | Pharmacokinetics: allometric scaling, 14C-studies, absorption half-life, flip-flop kinetics, protein binding, PK linearity / non-linearity, dose proportionality assessments, biopharmaceutics classification system
Andreas Kovar |
| 15:30 – 15:45 | Break |
| 15:45 – 17:00 | Key safety parameters to characterise and determination of a safe starting dose for FIM – case studies
Stephanie Plassmann |
| 17:00 – 17:15 | Break |
| 17:15 – 18:15 | Case study: stop dose escalation or continue dosing? Katharina Erb-Zohar |
| 19:30 | Dinner Meeting |
Day 3: Friday, 24 April 2015
| 08:45 – 09:15 |
Data management
Manfred Wargenau |
|---|---|
| 09:15 – 09:45 |
Flow of information / reporting and publication
Kerstin Breithaupt-Grögler |
| 09:45 – 10:15 |
Break |
| 10:15 – 13:00 |
Principles of medical statistics: differences between treatments regarding biomarkers, pharmacodynamic effects, and safety, e.g., t-tests, repeated measures ANOVA, parametric vs. non-parametric analysis, Chi-square, Fisher’s exact
Manfred Wargenau |
| 13:00 – 14:00 |
Break |
| 14:00 – 15:45 |
Introduction to biologicals and biosimilars Hildegard Sourgens |
| 15:45 – 16:30 |
Test on Part II contents of Human Pharmacology Training;
participation in test is mandatory to receive the certificate of attendance! All |
| 16:30 – 17:00 |
Feed back
All |
| 17:00 | End of Part II |
Attendance Fees
| 1.100 € 1.450 € |
Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha Non-Members |
|---|
Special fees for students are available on request.
This meeting will be accredited by the Landesärztekammer, participants will be awarded ”Fortbildungspunkte”. More information will be provided in due time.
Contact
Registration | Workshop Office:
CSi Hamburg GmbH
Jungfrauenthal 22
D-20149 Hamburg
Phone: +49 40 307720 97
Telefax: +49 40 846097 60
E-Mail: agah-veranstaltungen ( a t ) csihamburg.de
Venue
SocraTec R&D GmbH
Im Setzling 35
61440 Oberursel
22. April 2015 - 24. April 2015
Introductory Course in Early Medicines Development
AGAH Workshop
Oberursel
Deutschland