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 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.
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 (Parts I plus II) was accredited 3 ECTS.
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
08:45 – 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 – 16:15
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
16:15-16:30
Break
16:30 – 17:00
Quiz on essential terms: questions and answers provided by the audience
Kerstin Breithaupt-Grögler
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
16:15 – 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
2. April 2019 - 5. April 2019
Introductory Course in Exploratory Medicines Development – Part II
AGAH Workshop
Oberursel
Deutschland