setting the scene : the context module 1 2018-2019/m1/… · director drug discovery, ogeda,...
TRANSCRIPT
Module 1 24- 25 January 2018
For more information please contact :
Mrs Bahija JELLOULI
PHARMED – ULB CP611Route de Lennik, 808
1070 Bruxelles-BELGIUM
E-mail: [email protected] - Phone : 32 2 555 62 29
The courses take place in Brussels, at
IBIS BRUSSELS ERASMUS HOTEL Route de Lennik 790 – 1070 Brussels
Phone : 32-02/523 62 82
Introduction to
medicines
development
Setting the scene : the context
of drug development
An overview of drug
development
High throughput screening
using recombinant receptors
Planning the development of
new medicinal products : a
recent case in the field of
biologics
The invention, optimization
and clinical development of
fezolinetant: an NK3
antagonist for the treatment of
hormone-dependent
pathologies.
http://www.ulb.ac.be/medecine/pharmed
SETTING THE SCENE: THE CONTEXT OF DRUG DEVELOPMENT Marc CZARKA This introductory course will present an overview of pharmaceutical innovation. It will show how social needs and wealth creation both drive innovation. The specificities of the pharmaceutical market and the changes in the healthcare environment will be analyzed. An overview of the pharma life cycle, from discovery to marketing, will be presented. Finally a case study in pharmaceutical R&D strategy will be presented. AN OVERVIEW OF DRUG DEVELOPMENT Jean-Marie BOEYNAEMS This course will present an overview of the
process of drug development, from drug
discovery to market access. The following topics
will be presented and discussed :timeline and
cost of R&D, evolution of R&D productivity,
examples of failure, evolution from blockbuster
to precision medicine and rising importance of
orphan medicinal products.
HIGH THROUGHPUT SCREENING USING RECOMBINANT RECEPTORS Vincent Dupriez The course will show how the methods used for drug screening have evolved with time, moving from whole animals to isolated organs, radioligand binding to membranes and finally to systems expressing recombinant proteins. This has resulted in a major increase in throughput. The various steps involved in setting-up new functional assays will be described. The robustness, throughput and quality of various assays will be discussed. Examples will be presented: aequorin (cytosolic calcium), time-resolved fluorescence (cAMP), AlphaScreen SureFire (kinases), IonWorks Quattro (automated patch clamp)… PLANNING THE DEVELOPMENT OF NEW MEDICINAL PRODUCTS : A RECENT CASE IN THE FIELD OF BIOLOGICS Marc de LONGUEVILLE This course provides an overview of the integrated development of a new medicine at a corporate and international level, with emphasis on the clinical aspects of a development plan. Specific emphasis will be given on key specificities of the development plan for a biologic, covering both pre-clinical and clinical aspects, and also the post- registration commitments including Risk Management Plan… This will be illustrated by a real life example. THE INVENTION, OPTIMIZATION AND CLINICAL DEVELOPMENT OF FEZOLINETANT: AN NK3 ANTAGONIST FOR THE TREATMENT OF HORMONE-
DEPENDENT PATHOLOGIES.Graeme FRASER The invention and optimization of our NK3 antagonist molecule fezolinetant will be described with emphasis on receptor pharmacology and pharmacokinetics in various animal models. These results aim to provide further insight into the role of NK3 in the modulation of the hypothalamic-pituitary-gonadal axis. The rationale used to select the compound to be advanced into clinical development will be discussed. The clinical pharmacology of fezolinetant will be presented including the results of Phase 2a clinical proof-of-concept studies. Thus, this course aims to describe the evolution of fezolinetant from initial concept through to its current status as the leading non-hormonal therapy in development for the treatment of menopausal hot flashes.
Marc CZARKA M.D., MBCPM, Member of the board
of BeAPP, Managing Partner HM3A
(Market Access Associates)
Jean-Marie BOEYNAEMS MD, PhD, ULB, Professor at ULB,
Chairman of the Ethics Committee
Erasme-ULB, Brussels, Belgium
Vincent Dupriez Ph.D. in agronomical sciences, UCL,
Senior scientist, Global Product
Leader / European Scientific
Application Leader at PerkinElmer,
Zaventem, Belgium
Marc de LONGUEVILLE
MD, PhD, FFPM, MBPCM, Sr Medical
Director Immunology Safety and
registries, UCB BioPharma SPRL
Graeme FRASER
PhD in pharmacology & therapeutics,
McGill University, Montreal, Canada,
Director Drug Discovery, Ogeda,
Gosselies, Belgium
WEDNESDAY 24 January 2018
Welcoming participants 9.30-10.00
etting Setting the scene : the context of
drug development Marc CZARKA 10.00-13.00
e ene : the context of drug Setting the scene : the context of
drug development Marc CZARKA 14.00-15.00
An overview of drug development
Jean-Marie BOEYNAEMS 15.00–15.50
Coffee break
15.50 – 16.10
An overview of drug development
Jean-Marie BOEYNAEMS 16.10–18.00
THURSDAY 25 January 2018
High-throughput screening
Vincent DUPRIEZ 09.00–10.50
Coffee break 10.50–11.10
High-throughput screening
Vincent DUPRIEZ 11.10–12.00
Planning the development of new
medicinal product Marc de LONGUEVILLE
12.00–13.00
Lunch
13.00–14.30
Planning the development of new
medicinal product
Marc de LONGUEVILLE
14.30–16.00
ng the Coffee break
16.00–16.15
Planning the
The invention,optimization and
clinical development of fezolinetant Graeme FRASER
16.15–18.15