impact of pharmaceutical sciences · hendrik de jong fip secrétaire scientifique, correspondant...
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Impact of the Pharmaceutical Sciences
Hendrik de Jong
FIP secrétaire scientifique,
Correspondant Européen
Académie Nationale de
Pharmacie
FIP
* La Federation Internationale Pharmaceutique,
fondée à La Haye, Pays-Bas en 1912, compte en
2012: 127 associations membres de 87 pays
representant plus de 3 millions de pharmaciens et de
scientifiques
• Les activités de la FIP sont orientés vers:
La profession (BPP)
Les sciences (BPS)
L’enseignement (FIPEd)
2012 Congrès des 100 ans
La branche scientifique a préparé une enquête
auprès des personnalités dans le domaine
pharmaceutique, sur les éléments qui ont le plus
marqués l’avancement des sciences du
médicament et son impact sur la santé publique.
Les domaines
*La Découverte
*Pharmacocinétique et pharmacodynamique
*la Galénique
*la Réglementation
*l’Utilisation des médicaments
The Survey
• The survey began in March 2010.
• Five groups and associated co-ordinators were identified:
• Drug Discovery (Prof. Christian Noe)
• Pharmacokinetics and Pharmacodynamics (Prof. Geoffrey
Tucker)
• Formulation Sciences (Prof. Daan Crommelin)
• Drug Regulation (Dr Carl Peck)
• Drug Utilisation (Dr Mario Rocci)
• Each coordinator invited leading ‘pharmaceutical scientists’ in
their field to identify “The 5 most influential
ideas/concepts/developments introduced by ‘pharmaceutical
scientists’ (in their field) over the last 50 years?”
• The survey was closed on 24 August 2010; 52 responses were
received from the 75 individuals who were canvassed.
Expected outcomes
Two publications with different targets:
• Fellow scientists and decision-makers
• A wider audience - to increase public awareness of the role
that the pharmaceutical sciences play in healthcare, and to
stimulate interest in the pharmaceutical sciences as a career
choice
Drug discovery
Prof. Christian Noe
Coordinator of this group
Key influential ideas/concepts/ developments [...] in Drug Discovery
1. Molecular drug targets – Classification of pharmacological receptors including
their subtypes for better insight into drug-target
interaction of increasingly complex systems
2. Computation in drug design – Calculation of physical-chemical parameters (QSAR),
pharmacophore modelling and high throughput docking
3. Molecular Biology – Tools and Drugs – Biopharmaceuticals, new tools in discovery and
development, new imaging techniques, stratification of
patients (trials and therapy)
Key influential ideas/concepts/ developments [...] in Drug Discovery
4. Automated screening – Increased efficiency in hit identification
5. Biochemistry, signalling pathways and
metabolic networks – Better mapping of disease biology and design of new
drugs with “individualised” therapeutic properties
Pharmacokinetics & Pharmacodynamics
Prof. Geoffrey Tucker
Coordinator
Key influential ideas/concepts/ developments [...] in PK/PD
1. The linkage of PK and PD in combined models – Enhanced interpretation of drug response and the
design of optimal dosage regimens
2. The Clearance concept – Allowed understanding of the impact of physiological and
pathological changes on the elimination of drugs from
the body
3. Whole Body Physiologically-Based PK
modelling – Improved prediction of human (and animal) PK and
drug-drug interactions, and associated variability
Key influential ideas/concepts/ developments [...] in PK/PD
4. The concepts of Bioavailability /
Bioequivalence – Provided a scientific basis for improved design of oral
(and other) drug products and evaluation of the
therapeutic equivalence of innovator and generic
products
5. Nonlinear Mixed Effect modelling (“Population
PK”) – Improved insight into population variability in response to
drugs (both PK and PD) based on sparse data from
individuals.
Formulation Sciences
Prof. Daan Crommelin
Coordinator of this group
Key influential ideas/concepts/ developments [...] in Formulation Sci.
1. Development and implementation of more and
more advanced equipment for the production
of high quality “classical” pharmaceutical
formulations
2. Computational pharmaceutics – Improved process design and development (QbD,
PAT...)
3. Bioavailability concept – Translated into the concept of Biowaivers /
BioClassification System (BCS)
Key influential ideas/concepts/ developments [...] in Formulation Sci.
4. Modified release dosage forms (oral and
parenteral delivery) – Improved PK characteristics of medicines and new
relevant excipients
5. Drug targeting concept with carrier systems – Temporal and spatial release of medicines targeted
actions of medicines (efficacy, toxicity...)
6. New routes of administration apart from oral
and parenteral routes – Improved bioavailability features for transdermal and
pulmonary (systemic) delivery
Drug Regulation
Dr. Carl Peck
Coordinator of this group
Key influential ideas/concepts/ developments [...] in Drug Regulation
1. ADME/PK-PD modeling concepts,
pharmacometric analyses, and simulation
techniques, leading to: – Regulatory guidance/ standards for safer, more effective
individualized dosing regimens
– Facilitated development and regulatory decisions
2. BioAvailability / BioEquivalence – Efficient bridging of candidate drug formulations and
abbreviated regulatory pathway for generic products
Key influential ideas/concepts/ developments [...] in Drug Regulation
3. Pharmacogenomics – Regulatory acceptance of genetic biomarkers associated
with PK-PD variability and disease states
4. Risk-benefit evaluation methods – PKPD, drug metabolism and simulation methods for
identification, evaluation and guidance on drug-related
risks
5. Formulation optimization / drug delivery
systems – Reduction of regulatory burden via regulatory guidance
and evaluation of drug products, including the
Biopharmaceutical Classification System (BCS)
Drug Utilisation
Dr Mario Rocci,
Coordinator of this group
Key influential ideas/concepts/ developments [...] in Drug Utilisation
1. Generic Drug Products – Effective treatment of diseases at a greatly reduced cost
– Strong stimulus for the continual innovation that brings
new drugs to market
2. Drug Utilization Reviews – Maximizing the therapeutic benefit while minimizing
adverse effects at the lowest overall cost
3. Biotechnology
– In its infancy
– New way of treating diseases through complex molecules
(vaccines, antibodies, therapeutic proteins, gene therapy)
Key influential ideas/concepts/ developments [...] in Drug Utilisation
4. Novel Dosage Forms – Improve patient’s adherence and effectiveness of drug
therapy; reduce the frequency of adverse effects
5. Personalized Medicine – Disease are heterogeneous in nature
– Highly target approach to the development of drugs
based on patient attributes
– In its infancy
– Will happen – strong societal and scientific forces at play
Conclusions and acknowledgements
Conclusions
• Along with scientists from other fields,
‘pharmaceutical scientists’ have contributed
significantly to the discovery and development of
new drugs and drug preparations, and to improving
the efficacy and safety of existing drugs and drug
preparations.
• In particular, pharmaceutical scientists have been
key players in facilitating the translation of these
discoveries and developments into better
healthcare
Thanks to all those who responded to the survey:
•Greg Amidon (USA)
• Larry Augsburger (USA)
•Klaus Peter Bogeso
(Denmark),
•Alasdair Breckenridge (UK),
•Douwe Breimer
(Netherlands),
•Bill Charman (Australia),
•Patrick Couvreur (France),
•Daan Crommelin
(Netherlands),
•Hendrik De Jong
(Netherlands),
•Hartmut Derendorf (USA),
•Jürgen Engel (Germany),
•Alexander Florence (UK),
•Leung Fung (USA)
•Johan Gabriellson (Sweden),
•Giovanni Gaviraghi (Italy),
•Anders Grahnen (Sweden),
•Theo Guentert (Switzerland),
•Richard Guy (UK),
•Hideoyshi Harashima
(Japan),
•Mitsuru Hashida (Japan),
•Keith Jones (UK),
•Bill Jusko (USA),
•Thomas Kissel (Germany),
•Axel Kleemann (Germany),
•Larry Lesko (USA)
•Panos Macheras (Greece)
Thanks to all those who responded to the survey:
•Henri Manasse Jr. (USA),
•Kamal K. Midha (Canada),
•Peter Milligan (UK),
•Klaus Mueller (Switzerland),
•Ernst Mutschler (Germany),
•Tsuneji Nagai (Japan),
•Christian Noe (Austria),
•Sandy Pang (Canada),
•Carl Peck (USA),
•Roberto Pelliciari (Italy),
•Malcolm Rowland (UK),
•Tomas Salmonson (Sweden),
•Shigeki Sasaki (Japan),
•Hitoshi Sasaki (Japan),
•Walter Schunack (Germany),
•Vinod Shah (USA),
•Chang-Koo Shim (South
Korea),
•Juergen Siepmann (France),
•Phil Smith (USA),
•Don Stanski (Switzerland),
•Kjell Strandberg (Sweden),
•Yusuke Tanigawara (Japan),
•Henk Timmermann
(Netherlands),
•Vladimir Torchilin (USA),
•Geoffrey Tucker (UK),
•Mitsuru Uchiyama (Japan),
•Albert Wertheimer (USA)
www.fip.org
Publications
Et
J.Pharm Sci 2012 Aug 21
Le rapport complet