PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com Abstract is available at http://www.pharmaconnectme.com

1. European Federation for
Pharmaceutical Sciences
Advances Pharmaceutical Sciences
Represents Pharmaceutical Scientists
Hans H. Linden
May 24, 2007
Dubrovnik, Croatia
Established in 1991
1
Hans H. Linden

2. The Mission of EUFEPS
“The mission of the European Federation for
Pharmaceutical Sciences (EUFEPS) is to
serve and advance excellence in the pharmaceutical
sciences and innovative drug research in Europe,
including in training and education, and to
represent the interests of scientists engaged in
drug research and development, drug regulation,
drug utilisation, and drug policy making.”
Strategic Plan 2006-2010
2
Hans H. Linden

3. EUFEPS’ Italy
Current Netherlands Individual Members
600+ currently
Norway
Member Poland
Sphere Networks of Expertise
Societies in Portugal 8 (member + organisation)
Austria Romania
Switzerland EU RTD FP6 Consortia
Belgium
BioSim; InnoMed;
Denmark Slovakia
EuMapp; IMI
Croatia Slovenia
Czech Republic Spain
Liaisons and Observers
Finland Sweden
20+ incl. Student Assoc.
France Turkey
Germany United Kingdom
Greece 24 countries; 16000 “scientific” members
Hungary
Israel (Asia) Member Institutions
10 currently
HUB:
Executive Committee
Central Office – 2 fulltime
Branch Offices
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Hans H. Linden

4. Current Operations
Organisational development and service
(membership, committees, networks)
Research policy initiatives and coordination
(including special workshops)
Congresses, conferences and other meetings
(from A-Z)
Research training and education
(courses, database, programmes)
Publications (e.g. Eur J Pharm Sci)
Transformation of local/national
events into European ones (e.g. courses)
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Hans H. Linden

5. EUFEPS Committees
Advisory Committees
– Academic Research Relations (CARR)
– Industrial Research Relations (CIRR)
– Training and Education (CTE)
– Awards and Prizes (CAP
Programme Committees
5
Hans H. Linden

6. More EUFEPS Committees
Steering Committees
– In-silico Systems and Learning (SC:ISL)
– Meetings and Events (SC:ME)
– Membership Development (SC:ME)
– Research and Policy (SC:RP)
– Training and Education (SC:TE)
Executive Committee
Supported by …
“Branch Offices” and “Central Office”
6
Hans H. Linden

7. Relevant Science Communities
Academic
Industrial
Regulatory
Health care settings
(asked for)
7
Hans H. Linden

8. The Mission of EUFEPS
Instrument – General
Bring people together (in small and big groups)
around specific or focussed topics, visit with them
and arrive at outcomes recommendation reports…
8
Hans H. Linden

9. EUFEPS Meetings
9
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10. EUFEPS Meetings
10
Hans H. Linden

11. EUFEPS Meetings
EUFEPS
Co-sponsor/Organiser of
Pre-Satellite
PhD Students/PostDocs
Main Programme
Afternoon Sessions
PSWC/PharmSciFair
Exhibition
Post-Satellite
Monoclonal Antibodies
Post-Satellite
Microdialysis 11
Hans H. Linden

12. EUFEPS Meetings
BBBB =
Balaton
Baltic
Bled
Bosporus
12
Hans H. Linden

13. EUFEPS
Meetings
Scientific Progress Underpinning
Process Analytical Technology (PAT)
November 21-22 • 2006 • Göteborg SE
& 13
Hans H. Linden

14. www.pharmscifair.org 14
Hans H. Linden

15. Pharmaceutical Sciences Fair &
Exhibition – The PharmSciFair
First one ever – June 12-17, 2005, Nice FR
Opening Session and 60 more sessions
provided by 26 PharmSciFair Partners
(13 of them Member Societies of EUFEPS),
in 5 days of 5-7 parallel sessions each
EUFEPS coordinator of this new European
meetings platform and providing 6 sessions
(4 “compound profiling” + 2 “biomarkers”)
1255 delegates; 694 scientific contributions
(371 posters) and 66 exhibitors (52 commercial)
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Hans H. Linden

16. PharmSci
Fair
&
Exhibition
2009
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17. EUFEPS Training and Education
Identification of research training needs
Courses together with Institutional Partners
– E.g. on High-throughput Drug Metabolism
Selection of courses for co-sponsorship
– E.g. on Quality in Pharma and Biotech
Database on Training and Education Courses
– for the membership (to be launched)
Investigating specialist training programmes
– E.g. in Drug Development
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Hans H. Linden

18. EUFEPS Publications
European Journal of Pharmaceutical
Sciences (Eur J Pharm Sci)
EUFEPS NewsLetter
EUFEPS Online (www.eufeps.org)
EUFEPS Flash
EUFEPS Membership Bulletin
EUFEPS Workshop Reports
18
Hans H. Linden

19. European Federation for
Pharmaceutical Sciences
Advances Pharmaceutical Sciences
Represents Pharmaceutical Scientists
Established in 1991
19
Hans H. Linden

20. EUFEPS & New Safe
Medicines Faster (NSMF)… 1
1998: First initiative in EUFEPS CIRR
2000: Exploratory Workshop and Report
2001: Substantial impact on the EU RTD FP6
2002: Focus in EUFEPS 2002 Congress
Expression of Interests for calls collected
2003: Workshop and Report on EUREKA-EU
Interest to join projects explored
EUFEPS engaging as consortium
member in several EU applications
20
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21. EUFEPS & New Safe
Medicines Faster (NSMF) … 2
2003/ EUFEPS present in
2004: high-level strategy meetings
2004: Brainstorm Workshop on
Safety Sciences and Report
2005: Workshop on How to Establish a new
European Technology Platform for
Innovative Medicines & SRA for FP7
2005/ “Ambassadorship” for follow-up and
2006/ additional input for FP7, plus work in
2007: BioSim, InnoMed; EuMapp consortia
21
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22. New Safe Medicines Faster From Ole J. Bjerrum, December 2006
– Learned Society initiative Innovative SRA European
Medicines EFPIA Technology
New for Europe
Platform (JTI)
accelerated BIOSIM
development
Commission FP6 Ambassadorships
of medicines EUMAPP
GALENOS
etc.
Position Workshop Workshop Workshop Workshop Workshop Workshop
paper
1999 2000 2001 2002 2003 2004 2005 2006 2007
Conferences optimizing drug development Conferences optimizing drug development
DRUG 2000 GENAU National European
EUREKA
FIN AUS Platforms Pharma Sciences
Network Safety
DRA FIGON ES Leadership Forum
Science
EFP
DK NL DK/S
Network
Medicines University
AU
Section Membership
IR
Critical PAT Top Pharma
F
Path FDA Network
Institute NL
22
US
Hans H. Linden

23. IMI
Innovative
Medicines
Initiative
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24. BioSim
Network of Excellence
Modern biosimulation techniques
Consortium of 40 partners (incl. EUFEPS)
3+ years from December 1, 2004
Developing in silico simulation models of cellular,
physiological and pharmacological processes
to better understand
Basis for a disease-driven drug development process
that can lead to biologically designed medicines
Integrated with systems approaches and modelling in
EUFEPS conferences • Communication with public
Training and Education • Information Dissemination 24
Hans H. Linden

25. InnoMed
Integrated Project
Innovative medicines for Europe
Consortium of 44 partners (incl. EUFEPS)
44 months from October 1, 2005
Strategic Research Agenda (SRA)
Discovery of new markers for Alzheimer’s
Correlation of ‘omics technology results with
conventional toxicity data (liver & kidney)
25
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26. EuMapp
Specific Targeted Research Project
EU Microdose AMS Partnership Programme
Consortium of 10 partners (incl. EUFEPS)
30 months from November 1, 2005
Human microdosing to predict drugs PK
Body of knowledge of science driven approach
Ultra-sensitive accelerator mass spectrometry (AMS)
In silico modelling applications
•Results dissemination • Standardisation • Legislation
Volunteer patient concerns and needs • Ethics
26
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27. IMI JU
Innovative Medicines Initiative Joint Undertaking
Challenge to impact on drug discovery and
development – for 7 years
Unique pan-European public and private sector
collaboration in biopharmaceutical research
First big pre-competitive collaboration effort
Cancer, inflammatory disease, brain disorders,
metabolic disease, and infectious disease
Commission final decision in mid May 2007
Forwarded to Council and Parliament for approval
27
Hans H. Linden

28. The Innovative Medicines Initiative
Strategic Research Agenda focus on the “pre-
competitive” bottlenecks in the R&D Process
Discovery Preclinical Translational Clinical Pharmaco-
research develop. medicine develop. vigilance
Knowledge Management
Education & Training
Benefit/Risk
Predictive Predictive Identification Patient Validation of
assessment
pharmacology toxicology of biomarkers recruitment biomarkers
with regulatory
authorities
Efficacy Safety
4
•From Ian Ragan, December 2006
28
Hans H. Linden

29. EU FP RTD 7
“Tomorrow’s answers start today”
Pooling and leveraging resources
Fostering human capacity and excellence in
science and technology
Better integration of European research and
development
European Union’s main instrument for funding
research in Europe in 2007 through 2013
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Hans H. Linden

30. Global recognition of the problem
Innovative Medicines Initiative (EU)
Medicamentos Innovadores (Spain)
Top Institute Pharma (Netherlands)
ECRIN (France)
Safety Biomakers (UK)
FDA Critical Path Initiative (NIH)
Safe and Innovative Medicines (PhRMA)
Biomarker Initiative (PhRMA)
Critical Path Institute (University of Arizona)
Center for Biomedical Innovation (MIT)
Toxicogenomics Project (JPMA)
Proteome Factory Consortium (JPMA)
Large-scale Clinical Trial Network
7
•From Ian Ragan, December 2006
30
Hans H. Linden

31. European Federation for
Pharmaceutical Sciences
Advances Pharmaceutical Sciences
Represents Pharmaceutical Scientists
Established in 1991
31
Hans H. Linden

32. New Focus Areas
and Membership Networks
Safety Sciences
– Since 2004
PAT (Process Analytical Technology) Sciences
– Since 2004
Bioavailability & Biopharmaceutics
– Since 2006
PharmacoGenetics/PharmacoGenomics
incl. Personalised Medicines
– Since 2006
32
Hans H. Linden

33. Focus Area and Network:
Safety Sciences (2004)
Follow-up
Workshop
July 2-3, 2007
April Vienna AT
2004
33
Hans H. Linden

34. Focus Area and Network:
Process Analytical Technology
(PAT) Sciences (2004)
“Manufacturing Science”
EuPAT1 – November 2006, Göteborg SE
EuPAT2 – November 2007, Copenhagen DK
EuPAT3 – November 2008 (?), (?)
PharmSciFair Session – June 2009, Nice FR
EUFEPS-ISPE “Quality by Design” (QbD)
Education and Training for Regulatory Agencies
on two levels being explored
34
Hans H. Linden

35. Focus Area and Network:
Bioavailability &
Biopharmaceutics (2006)
Discussion Papers, Concept Papers,
Conferences and Projects
Sample topics:
– Links between in vitro and in vivo variability
– Limitations of the BE concept
– Impact of different salts on BE assessment
– Highly variable drugs
– Fixed combination bioequivalence
Afternoon Session at PSWC2007 35
Hans H. Linden

36. Focus Area and Network:
PharmacoGenetics
& PharmacoGenomics (2006)
incl. Personalised Medicines
Raise (European) funding
Improve such research in Europe
Contribute to better health (in Europe)
through better individualised drug therapy
Establish a European Reference Sample
for genetic testing
Afternoon Session at the PSWC2007 36
Hans H. Linden

37. European Federation for
Pharmaceutical Sciences
Advances Pharmaceutical Sciences
Represents Pharmaceutical Scientists
Established in 1991
37
Hans H. Linden

38. European Drug Research and
Research Policy Stakeholder
Spheres
REGULATORY
CLINICAL
HUB:
RESEARCH EMEA
HUB: FUNDING
INDUSTRY ?
HUB:
?
HUB:
QUALITY &
EFPIA LEARNED
REFERENCES
SOCIETIES
& NETWORKS
HUB:
PATIENTS
HUB: EDQM
ACADEMIA EUFEPS
HUB:
HUB:
EPF
?
38
Hans H. Linden

39. Towards a European
Supra Sphere LEARNED
SOCIETIES &
NETWORKS
Strong REGULATORY
QUALITY &
Strategic REFERENCES
and
Coordinating CLINICAL
Role ? INDUSTRY
ACADEMIA
PATIENTS
RESEARCH
FUNDING
39
Hans H. Linden

40. Priority Spheres
LEARNED
SOCIETIES &
NETWORKS
REGULATORY
QUALITY &
REFERENCES
CLINICAL
RESEARCH
INDUSTRY
HUB/Task:
Co-ordination
ACDEMIA
PATIENTS
RESEARCH
FUNDING
40
Hans H. Linden

41. Executive Committee
1 OJ Bjerrum 5 DJA Crommelin 8 B Aksu
2 H Köszegi-Szalai 6 T Dingermann 9 C Doherty
3 P From 7 CR Noe (Chair) 10 P Vuorela
4 HH Linden
41
Hans H. Linden

42. Structural Approaches & Tasks
European European European European European European
Pharm Sci Pharm Sci Pharm Sci Pharm Sci Pharm Sci Pharm Sci
Academy Forum Train / Ed Fair Workshops Funding
refine engage identify gather initiate identify
integrate organise define submit outline map
position stimulate integrate present produce utilise
expand represent meet expose publish develop
sciences sci assoc needs results pos papers resources
Intellectual Influential Individual Scientific Policy- Enabling
authority body careers progress making instrument
• Deliverables?
• What in what years?
• Budgets?
42
Hans H. Linden

43. Structural Approaches & Tasks
European European European European European European
PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci
Academy Forum Train / Ed Fair Workshops Funding
refine engage identify gather initiate identify
integrate organise define submit outline map
position stimulate integrate present produce utilise
expand represent meet expose publish develop
sciences sci assoc needs results pos papers resources
Intellectual Influential Individual Scientific Policy- Enabling
authority body careers progress making instrument
• Senate
• Senators
• 50-100 43
Hans H. Linden
As of May 2007

44. Structural Approaches & Tasks
European European European European European European
PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci
Academy Forum Train / Ed Fair Workshops Funding
refine engage identify gather initiate identify
integrate organise define submit outline map
position stimulate integrate present produce utilise
expand represent meet expose publish develop
sciences sci assoc needs results pos papers resources
Intellectual Influential Individual Scientific Policy- Enabling
authority body careers progress making instrument
• Senate • Leadership Forum
• Senators • Presidents
• 50-100 • Currently 10 44
Hans H. Linden
As of May 2007

45. Forum Initiative & Invitation
Meeting in Vienna AT
– June 11, 2006: Agreement to go
Meeting in Leiden NL
– October 1, 2006: Letter of Intent drafted
Meeting in Amsterdam NL
– April 23, 2007: Presentation and discussion
45
Hans H. Linden

46. European Pharma Sciences
Leadership Forum - EuPSLF
EACPT European Association of Clinical Pharmacology and
Therapeutics
EAPB European Association of Pharma Biotechnology
ECRIN European Clinical Research Infrastructures Network
EFB European Federation of Biotechnology
EFMC European Federation of Medicinal Chemistry
ELSO European Life Science Organisation
EPHAR Federation of European Pharmacological Societies
ESCP European Society of Clinical Pharmacy
ESF/EMRC European Science Foundation/European Medicines
Research Councils (?)
EUFEPS European Federation for Pharmaceutical Sciences
EUROTOX European Federation of Toxicologists & European
Societies of Toxicology
FEBS Federation of European Biochemical Societies
GA Society for Medicinal Plant Research
46
Hans H. Linden

47. European Federation for
Pharmaceutical Sciences
www.eufeps.org
secretariat@eufeps.org
Hans H. Linden, EUFEPS
PO Box 1136
SE-111 81 Stockholm, Sweden
Tel +46 8 7235025; +46 708 799813
hans.linden@eufeps.org
Established in 1991
47
Hans H. Linden

48. Structural Approaches & Tasks
European European European European European European
PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci
Academy Forum Train / Ed Fair Workshops Funding
refine engage identify gather initiate identify
integrate organise define submit outline map
position stimulate integrate present produce utilise
expand represent meet expose publish develop
sciences sci assoc needs results pos papers resources
Intellectual Influential Individual Scientific Policy- Enabling
authority body careers progress making instrument
• Senate • Leadership Forum • Meetings & Events SC
• 2nd 2009 with Partners
• Senators • Presidents
• 50-100 • Currently 10 • EUFEPS Committee/s 48
Hans H. Linden
As of May 2007

49. Structural Approaches & Tasks
European European European European European European
PharmSci PharmSci PharmSci PharmSci PharmSci PharmSci
Academy Forum Train / Ed Fair Workshops Funding
refine engage identify gather initiate identify
integrate organise define submit outline map
position stimulate integrate present produce utilise
expand represent meet expose publish develop
sciences sci assoc needs results pos papers resources
Intellectual Influential Individual Scientific Policy- Enabling
authority body careers progress making instrument
• Will follow…
• Senate • Leadership Forum • Meetings & Events SC
• 2nd 2009 with Partners
• Senators • Presidents
• 50-100 • Currently 10 • EUFEPS Committee/s 49
Hans H. Linden
As of May 2007

50. “Networking is imperative!” 1
EUFEPS Networks of Individual Members
EUFEPS Network of Member Societies
EUFEPS Network of Member Institutions
European Forum of Presidents of Scientific
Communities – Relevant for Drug Discovery,
Development and Utilisation (EuPSLF)
European Senate of Distinguished Scientists in
Pharmaceutical Sciences (to be established)
FIP Board of Pharmaceutical Sciences
50
Hans H. Linden

51. “Networking is imperative!” 2
EU FP RTD Consortia
– InnoMed
– BioSim
– EuMapp
BBBB Conference Series Leading Group
PharmSciFair Programme Providing Partners
& Clusters & Planning Team
World Events Organising Committees
51
Hans H. Linden

52. Current Strategic Focal Points*
Focus on Innovation
– NSMF; IMI; PharmSciFair; new networks/platforms
Focus on Quality
– Pharmaceutically okay (wherever produced)
– Therapeutically meaningful (for desired outcome)
– Rationally manufactured (efficient processes)
Focus on Responsibility
– Improved competence and professionalism (personal)
– Local, regional and global collaboration (political)
– Medicines “for Europe and the World” (industrial)
* EUFEPS Strategic Plan 2006-2010
52
Hans H. Linden

53. Current Finance and Funding 2007
Membership Dues
Royalty of Eur J Pharm Sci (EJPS)
Support by SAPS, TI Pharma and
University of Vienna, respectively
Conference and Course Income
EU Project Funding
Sponsorship by companies
A “EUFEPS Fund” (being established)
53
Hans H. Linden

54. Why invest more in EUFEPS?
To underpin the only pan-European body for
pharmaceutical/drug scientists (whatever origin,
domain or discipline)
To proactively support systems approaches
in European collaboration, co-operation and
co-ordination for better drug research and
development
To further strengthen the European voice and
platform for needs and progress communication
along with beneficial networking
Efficient organisation 54
Hans H. Linden

55. European Federation for
Pharmaceutical Sciences
www.eufeps.org
secretariat@eufeps.org
Hans H. Linden, EUFEPS
PO Box 1136
SE-111 81 Stockholm, Sweden
Tel +46 8 7235025; +46 708 799813
hans.linden@eufeps.org
Established in 1991
55
Hans H. Linden