Mais conteúdo relacionado Semelhante a Ag fernández collab_innov_140911 (20) Ag fernández collab_innov_1409111. Collaborative Innovation
The role of the Academy and the Pharma Industry
Joining our Efforts, Sharing our Future
Innovation in Biotechnology
Business Development & Licensing
International Division
Barcelona 14/09/2011
CONFIDENTIAL September 14, 2011
agfernandez@ferrergrupo.com
2. Outline
A Global Collaborative
Environment
Collaborative Innovation @
Ferrer
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
3. A Global Environment
Trends in Biopharma Industry. The future has arrived.
The stocks of some of the industry's
biggest players, including Pfizer and Merck,
are down 40% from a decade ago.
A dramatic lost of efficiency and
competitiveness has been
experienced by the pharma
companies over the last 15 years
The industry has cut 300,000
jobs in the last 10 years.
Barcelona 14/09/2011
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4. A Global Environment
What to do...
To increase Corporate efficiency:
Promote M&A, …
A dramatic lost of efficiency and
competitiveness has been To increase R&D efficiency:
experienced by the pharma Change the research model
companies over the last 15 years
To achieve system sustainability:
Evolve the regulatory model
Barcelona 14/09/2011
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5. A Global Environment
And M&A arrived...
PHARMACIA
PFIZER INC.
UPJOHN
WARNERT-LAMBERT
PHARMACIA-UPJOHN
AMERICAN CYANAMID
MONSANTO
PFIZER INC.
WYETH
PHARMACIA CORP.
PFIZER PFIZER
Barcelona 14/09/2011
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6. A Global Environment
SANOFI
RHONE-POULENC R
STERLING W
FISONS
SANOFI-WINTHROP
RHONE-POULENC R
SYNTHELABO
SANOFI-SYNTHELABO SANOFI-AVENTIS AVENTIS
HOECHST-
HOECHST HMR
MARION MERRELL DOW
MARION MERRELL DOW ROUSSEL-UCLAF
Barcelona 14/09/2011
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7. A Global Environment
Focus on reducing generic-induced erosion of revenues...
Barcelona 14/09/2011
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8. A Global Environment
But… are M&A solving the problem?
What about the announced synergies?
% world market
Consolidation
effects
Dec-98 Dec-03 Dec-08
PFIZER 9.0 10.1 7.8
SANOFI-
5.8 5.4 5.8
AVENTIS
GSK 7.2 6.6 7.0
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
9. A Global Environment
What to do...
To increase Corporate efficiency:
Promote M&A, …
A dramatic lost of efficiency and
competitiveness has been To increase R&D efficiency:
experienced by the pharma Change the research model
companies over the last 15 years
To achieve system sustainability:
Evolve the regulatory model
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
10. A Global Collaborative Environment
In 1996…
Jürgen Drews
Hoffmann-La Roche International
Research Division, Former President
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
11. A Global Collaborative Environment
1975 1985 1995 2005 2015
CLIN CLIN CLIN CLIN CLIN
DEVELOP
DEVELOP
DEVELOP DEVELOP DEVELOP
DISCOV
DISCOV DISCOV DISCOV
DISCOVERY
BIOTECH INDUSTRY
BIOTECH DISCOVERY
ACADEMIA ACAD ACAD
ACAD
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
12. A Global Collaborative Environment
1975 1985 1995 2005 2015…
CLIN CLIN CLIN CLIN CLIN
DEVELOP
DEVELOP
DEVELOP DEVELOP
Increasingly fragmented value chain DEVELOP
DISCOV
DISCOV DISCOV DISCOV
DISCOVERY
BIOTECH INDUSTRY
BIOTECH DISCOVERY
ACAD ACAD
ACAD
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
13. A Global Collaborative Environment
What is really happening ...
Ocho años en espiral
Pfizer despide a 800 investigadores y cierra 6 centros de I+D de un total
de 20 (2009).
J&J anuncia disminución inversión en Discovery (2008).
Procter & Gamble anuncia el cierre de sus centros dedicados al
Discovery farmacéutico (2006).
Wyeth congela sus inversiones en Discovery (2005).
GSK declara que el 50 % de su pipeline clínico se ha obtenido mediante
licensing in (2004).
> 60% del pipeline de Novartis ha sido descubierto extramuros (2003).
Barcelona 14/09/2011
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14. A Global Collaborative Environment
In 2011…
Paul Isherwood
GlaxoSmithKline
Director of Innovation
Barcelona 14/09/2011
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15. A Global Collaborative Environment
The number of alliances confirms the new scenario
Merck: More than 300 alliances in 6 years
500% increase in 7 years
60
Alliances / year
50
40
30
20
10
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
16. A Global Collaborative Environment
The number of alliances confirms the new scenario
Announced Deals (2005-2009)
160
140
Deals
120
100
80
60
40
20
0
Source: Deloitte Recap LLC
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
17. A Global Collaborative Environment
Distribution by Stage at Signing for Alliances
Early Mid Late
100%
Late Stage 90%
30% 31% 33%
Approved 270 80%
34%
43%
Phase III 197
70%
Phase II 151 13%
60% 17% 14% 20%
Mid Stage 50% 19%
Phase I 107 40%
Preclinical 191
30% 58%
52% 52%
46%
Early stage 20% 38%
Lead molec. 76 10%
Discovery 832
0%
2005 2006 2007 2008 2009
Source: Deloitte Recap LLC
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
18. A Global Collaborative Environment
External origin of R&D projects in a sample of the Top-25 companies
Ranking Projects of
R&D projects
position Company External origin
(2010)
(2010) (%)
1 Pfizer 304 26
3 Merck & Co 249 41
7 Sanofi-Aventis 137 46
12 Takeda 90 50
18 Boehringer Ing 53 38
19 Merck KGaA 53 64
21 Kyowa Hakko 52 52
Barcelona 14/09/2011
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19. A Global Collaborative Environment
Collaborative R&D: not a brand new concept...
20%
During the late 19th and the early part
of the 20th, practically all research
15% had been conducted outsourced
10%
5%
Golden age of R&D
corporate labs
0%
1900 1920 1940 1960 1980 2000
Source: EIRMA
Barcelona 14/09/2011
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20. A Global Collaborative Environment
.
Forbes Magazine August 22, 2011 Rallying Pharma's Rebels
Munos' Laws
1. Regain the trust of physicians, regulators and payers.
2. Stop chasing blockbusters, which help lots of people a
little bit, and start chasing breakthroughs, which help
patients a lot.
Bernard Munos has a 3. Do what works. Stop trying to manage drug discovery
radical idea to save the with Six Sigma processes.
drug industry: 4. Lower costs with collaborative research.
5. Mitigate risk by developing lots of potential
Take bigger risks, do breakthroughs, not by trying to develop projects that
collaborative research seem low-risk. History says the risk is never low.
and cut R&D.. 6. Don't move anything into human trials unless it is a
potential breakthrough.
7. Cut research and development.
“Is there a less bureaucratic and cheaper way to invent new medicines?
Former Big Pharma bigwigs say… yes!
Barcelona 14/09/2011
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21. A Global Collaborative Environment
Mind the gap… Bridge companies
New York University
University of Pennsylvania
University of Florida
Columbia University
Memorial Sloan-Kettering
BIOPONTIS (USA)
University of North Carolina
University of Virginia
A brand new company covering 7 prestigious east-
coast institutions & recruiting pharma companies.
JANUS Developments (EU)
A 2-years operating company mainly covering the
Spanish public institutions.
Barcelona 14/09/2011
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22. A Global Collaborative Environment
Drug development scorecard: Jan-06 to Dec-07
Pharma are still necessary…
Novel drugs (excluding me-too) FDA approvals Phase III failures
Biotech 9 42
Biotech-Pharma alliances 5 5
Pharma 16 4
Source: EA Czerepak & S Ryser (2008). Drug approvals and failures: implications for alliances.
Nat Rev Drug Discov 7: 197-8.
Barcelona 14/09/2011
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23. A Global Collaborative Environment
Market Technology
What is What is
needed? possible?
Here is where
innovation
What fits our
strategy? happens
Business Model
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
24. A Global Collaborative Environment
Market Technology
What is What is
needed? possible?
Collaborative
Innovation
What fits our
strategy? improves the
room and the
likelihood
Business Model
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
25. A Global Environment
What to do...
To increase Corporate efficiency:
Promote M&A, …
A dramatic lost of efficiency and
competitiveness has been To increase R&D efficiency:
experienced by the pharma Change the research model
companies over the last 15 years
To achieve system sustainability:
Evolve the regulatory model
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
26. The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
27. The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human
Santos Dumont Airplane Airbus A-380
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
28. The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human
2000-2010
The IUPS Physiome Project is a worldwide effort to
define the physiome through the development of
databases and models which will facilitate the
understanding of the integrative function of cells,
organs, and organisms. The project is focused on
compiling and providing a central repository of
databases, linking experimental information and
computational models from many laboratories into a
single, self-consistent framework.
Barcelona 14/09/2011
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29. The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human
72 M euros del 7PM
Barcelona 14/09/2011
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30. The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human
La apuesta americana
Barcelona 14/09/2011
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31. The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human
ARGOS: La integración
ARGOS Position paper on VPH Research
The vision of integrative biomedical science, shared by a number of distinctly innovative new
approaches including systems biology, multiscale modeling, and the physiome, will become
practically possible only when an entirely new framework of methods and technologies has been
developed for investigating organisms as single systems. In Europe, this framework has been named
the Virtual Physiological Human. In the USA, while this particular name is not typically in use, the
same concept has been expressed repeatedly in a variety of publications and venues.
Modeling and simulation of human physiology and diseases with a focus on the Virtual
Physiological Human (VPH) and the use of such solutions to support the diagnosis and treatment of
rare diseases.
Barcelona 14/09/2011
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32. The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human
The current process
Hit ID/
Synthesis Testing Testing Initial
Design of screening
Target ID molecule
of
of
Molecule Molecule testing in
molecule in vitro in vivo man
molecule
In silico
Lab
Clinical
The process after VPH
Testing Synthesis Initial
Design of
Target ID treatment
of of testing in
treatment treatment man
Primary Pharmacol.
Wide-ligand profiling
ADME properties
Pharmac. Science
Source: PWC Toxicology
Barcelona 14/09/2011
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33. The required evolution
The Drug Develepment Process can dramatically change in 2020...
First into Man Limited
(Adaptive Design) 20-100 patients Clinical use
Source: PWC
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
34. The required evolution
The Drug Develepment Process can dramatically change in 2020...
First into Man
(Adaptive Design)
20-100 patients
Source: PWC
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
35. The required evolution
The goal is to re-shape the curve investment/return...
Source: PWC
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
36. Outline
A Global Collaborative
Environment
Collaborative Innovation @
Ferrer
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
37. Ferrer
Collaborative Innovation @ Ferrer Collaborative
Innovation
Recently, Ferrer has created the
Area of Innovation in Biotechnology
Ferrer Focused on expanding Collaborative Research.
Identifying, incorporating and (co-)managing
Collaborative
projects originated outside the company.
Innovation
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
38. Ferrer
Collaborative Innovation @ Ferrer Collaborative
Innovation
We like to consider the world as our lab, and therefore…
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
39. Ferrer
Collaborative Innovation @ Ferrer Collaborative
Innovation
We like to promote ALLIANCES… as a way of achieving critical mass…
as a way of optimizing resources…
as a way of lowering risk…
as part of our own culture…
Open Innovation @ Ferrer
Research Development
FERRER
BIOTECH ACADEMY
Time
Barcelona 14/09/2011
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40. Ferrer
Collaborative Innovation @ Ferrer Collaborative
Innovation
Connect Routine activities
Classical Scouting.
Personal Networking.
Domestic & International events.
Active communication/spreading of our policy/interests
(internal & external).
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
41. Ferrer
Collaborative Innovation @ Ferrer Collaborative
Innovation
Connect Special initiatives
Ferrer
ATTGCGCCATGCGT Initiative for
GCFINESTCGACGA Networking and
TTAGCCATAGGCTA Excellence in Health
Sciences and
Therapeutics
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
42. Ferrer
Collaborative Innovation @ Ferrer Collaborative
Innovation
Connect Special initiatives
A network of Excellence (by invitation only):
Composed by emerging and brilliant middle age bioscientists and
clinicians.
ATTGCGCCATGCGT Extend coverage of translational medicine.
GCFINESTCGACGA A think tank to help in:
Prospective
TTAGCCATAGGCTA Strategy design.
Emerging opportunities.
Avoiding /anticipating pitfalls and no-ways.
A virtual community with an attractive intranet (web based) platform & blog .
Annual Presential Meeting.
Barcelona 14/09/2011
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43. Ferrer
What do we look for Collaborative
Innovation
Projects yielding high added value products
Next slides will define our…
Development Segment Target (Entry Point)
Main Strategic Areas
Preferred Technological Platforms
but, we do also like OPPORTUNITIES
Barcelona 14/09/2011
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44. Ferrer
What do we look for Collaborative
Innovation
Why do we need high added valued products?
Regulatory agencies HTA
Compound A is safe? Is effective? Which one is the most effective?
has it a suitable benefit risk ratio ? Which one exhibits the best
healtheconomics profile? Which one
Compound B is safe? Is effective? solves an unmeet medical need?
has it a suitable benefit risk ratio ?
Compound A approved Compound A is reimbursed
AND OR
Compound B approved Compound B is reimbursed
Barcelona 14/09/2011
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45. Ferrer
What do we look for Collaborative
Innovation
ENTRY POINT Years Industry averages
0 2 4 6 8 10 12 Cost * Time** PoS***
37
D Target ID 37
I
S Assay Development 28
C
O HTS Screening 25
2.7
V %
Hit To Lead 19
E
R Lead Optimization 9
Y
pPoC / Preclinical Dev 5
D
E Phase I 3
V
E Phase IIA / cPoC 2
L
O Phase IIB 1.5
P
M Phase III 1.1
E
N Registration
1
T
* MUSD
** Years
Source: Gaviragui, 2011 *** Probability of Success
Barcelona 14/09/2011
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46. Ferrer
What do we look for Collaborative
Innovation
Main Strategic Areas
Cardiovascular CNS
Gastrointestinal Dermatology
Barcelona 14/09/2011
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47. Ferrer
What do we look for Collaborative
Innovation
Other areas of interest
Oncology
Ophtalmology
Oncology support
Anti-infectives
Barcelona 14/09/2011
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48. Ferrer
What do we look for Collaborative
Innovation
Technological platforms: their pivotal importance
Barcelona 14/09/2011
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49. Ferrer
What do we look for Collaborative
Innovation
Preferred technological platforms
Regenerative Medicine
Ophtalmology
CNS (stroke…)
Specific opportunities
Technology scouting:
Reprogramming evolution
New biomaterials
Barcelona 14/09/2011
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50. Ferrer
What do we look for Collaborative
Innovation
Preferred technological platforms
New Drug Therapies: antibodies
New Generation Antibodies
LMW: Nanobodies
Bispecific – Trispecific antibodies
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
51. Ferrer
What do we look for Collaborative
Innovation
Preferred technological platforms
New Drug Therapies: New GPCRs modulators
Deorphanised GPCRs: focus in CNS
“Valued” Oligomeric GPCRs: focus in CNS
PAM, NAM & bitopics discovery technologies
or opportunities
Barcelona 14/09/2011
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52. Ferrer
What do we look for Collaborative
Innovation
Preferred technological platforms
Gene Therapies
Plasmids
Very specific/singular opportunities in:
siRNA
Antisense
Oncolytic viruses
Barcelona 14/09/2011
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53. Ferrer
What do we look for Collaborative
Innovation
Preferred technological platforms
Repositioning
Strong IP status
Fast development
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
54. Ferrer
What do we look for Collaborative
Innovation
Preferred technological platforms
New Protein Production or Delivery Technologies applied to
Rare diseases
Protein deficiency
Very specific opportunities in therapeutic
vaccines
Advanced stage of development
Barcelona 14/09/2011
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55. Ferrer
What do we look for Collaborative
Innovation
Preferred technological platforms
New Frontiers in Predictive Medicine
Theranostics
Epigenetics
Metabolomics
Transcriptomics
Non-image based CNS diagnostic tools
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
56. Ferrer
What do we look for Collaborative
Innovation
Theranos/
Reg Med New Drug Gene Th. Reprof. T. Vacc. Diagnos.
…and opportunities
Barcelona 14/09/2011
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57. Ferrer
What do we look for Collaborative
Innovation
Theranos/
Reg Med New Drug Gene Th. Reprof. T. Vacc. Diagnos.
…and opportunities
Barcelona 14/09/2011
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58. Ferrer
What do we look for Collaborative
Innovation
Pipeline: an idealized 3D representation
Phase 3
Phase 2
Phase 1
Precl. Dev.
Candidate
Hit to Lead
Discovery
Barcelona 14/09/2011
© Ferrer, 2011 agfernandez@ferrergrupo.com
59. “Drawing the
future
through
Collaborative
Innovation”
Barcelona 14/09/2011