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

13.02.2019 – 15.02.2019 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 1, students should be able to demonstrate an understanding / knowledge of the following:  

  • principal steps in drug development – from compound selection to marketing application and beyond
  • pertinent issues involved in the undertaking of early clinical research
  • specific aspects of how to set-up and conduct early phase clinical trials
  • regulation of medicines in Europe
  • development and review of compound-specific information to ensure adherence to scientific, medical, ethical, and legal provisions
  • integration of pertinent available scientific information into an IB and a clinical trial protocol
  • principles of trial design, protocol submission and clinical conduct
  • selection of appropriate trial population
  • most common early phase clinical trials and their specific requirements
  • assessment and evaluation of safety data from clinical trials
  • relevance of formulation properties and in vitro characteristics of the trial medication for design and planning of an early phase clinical trial
  • basics of pharmacokinetics
  • defining pharmacokinetic (PK) endpoints for early phase clinical trials
  • method validation according to good clinical (GCP) and good laboratory (GLP) practise practical aspects of bioequivalence 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 (in 2016/17) was accredited 3 ECTS (Parts I plus II).

Day 1: Wednesday, 13th February 2019

09:00 – 09:30 Introduction of faculty and participants  
09:30 – 10:30

Overview on the drug development process: Nonclinical studies, evaluation of toxicity, pharmacokinetics, pharmacodynamics, First-in-human, Phases I to III, exploratory vs. confirmatory trials, submission and marketing authorisation; Phase IV, non-interventional studies / post-marketing surveillance, epidemiological studies; go/no-go decision making, definition of proof-of-mechanism (PoM), proof-of-concept (PoC)

Georg Wensing 

10:30 – 10:45 Break
10:45 – 12:00

Design elements of human pharmacology trials: Controlled / uncontrolled, placebo / active control, cross-over / parallel-group, single-blind / double-blind, single dose / multiple dose, randomisation procedures, dose-escalation, staggered timing, combined protocols, adaptive elements, microdosing studies

Wolfgang Timmer

12:00 – 12:45

Regulatory and ethical aspects of trial conduct I: Risk-benefit evaluation, GCP, Declaration of Helsinki, EU-Directive and Regulation, ICH-Guidelines

Kerstin Breithaupt-Grögler

12:45 – 13:45 Break
13:45 – 14:30

Regulatory and ethical aspects of trial conduct II: Trial authorisation: ethics committee favourable opinion and competent authority approval

Kerstin Breithaupt-Grögler

14:45 – 15:00 Break
15:00 – 16:30

Most common early phase clinical trials: First-in-human, safety, exploratory PK and PD, drug-drug-interaction, drug-food interaction, bioavailability / bioequivalence, QTc trials, PoC trials

Wolfgang Timmer

16:30 – 17:00

First-in-human trials in patients: most common designs for dose escalation, relevant differences vs trials in healthy subjects

Antje Blank

17:00 – 17:15 Break
17:15 – 18:00

Trial protocol and investigator's brochure: How to integrate information from scientific literature, nonclinical / clinical information and other sources; primary and secondary objectives vs. endpoints, differences between IB and IMPD

Kerstin Breithaupt-Grögler

18:30 – 20:30 Get together: formation of break-out groups

 

Day 2: Thursday, 14th February 2019

08:45 – 10:15

Selection of trial population and definition of inclusion / exclusion criteria in early drug development (including case study): Healthy subjects, symptomatic subjects, patients in early phase, children, elderly, gender, ethnicities, cultural differences

Katharina Erb-Zohar 

10:15 – 10:30 Break
10:30 – 11:00

Conduct of clinical trials: Site selection

Katharina Erb-Zohar

11.00 – 12:15

Conduct of clinical trials (including case study): Practical aspects in planning of early phase trials

Sybille Baumann

12:15 – 13:00 Conduct of clinical trials: Subject / patient informed consent in early phase clinical trials 
Kerstin Breithaupt-Grögler
13:00 – 14:00 Break
14:00 – 15:45 Conduct of clinical trials (including case study): Safety parameters and stopping criteria (AE, SAE, ADR, SUSAR), relationship to trial medication, severity of AE, liver / renal toxicity, general tolerability, local tolerance, monitoring of vital signs
Antje Blank
15:45 – 16:00 Break
16:00 – 16:30 Conduct of clinical trials: Independent data monitoring committee
Katharina Erb-Zohar
16:30 – 18:00 Trial medication: drug substance / product, labelling, stability, drug accountability, code breaking envelopes / emergency unblinding, specific aspects of preparation / administration / storage in Phase I, route of administration, formulations, fasted or fed conditions, blinding, double-dummy, test / reference therapy, challenging substances, IMPD information, non-IMPD medication, release process according to ANNEX 1
Barbara Schug
Evening Please prepare homework for Day 3

Day 3: Friday, 15th February 2019

08:45 – 09:00

Discussion of homework: case studies: AE/SAE documentation, set-up of a FIH / a BE trial

Kerstin Breithaupt-Grögler

09:00 – 10:30

Pharmacokinetics I: ADME, drug-drug interaction, drug-food interaction, bioequivalence / bioavailability, steady state, accumulation factors

Andreas Kovar

10:30 – 10:45 Break
10:45 -13:00

Pharmacokinetics II: pharmacogenetics / polymorphisms, pharmacometrics, PK/PD relationship

Andreas Kovar

13:00 – 13:45 Break
13:45 – 14:45

GCP / GLP – focus on method validation: Bioanalytics, sample collection, sample preparation, quality assurance procedures

Barbara Schug

14:45 – 15.00  Break
15:00 – 16:00

Bioequivalence trials: How to do it right – planning a successful BE trial

Barbara Schug

16:00 – 16.45

Mandatory Test on Part I (50% of questions must be correctly answered to pass test and receive a certificate)                 

Kerstin Breithaupt-Grögler                           

16:45 – 17:00 Feed back and end of Part I

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

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: +49 170 7844438
E-Mail: info ( a t ) agah.eu
Web:   www.agah.eu

This workshop is supported by PreClinical Safety (PCS) Consultants Ltd.