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