Ag fernández collab_innov_140911

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

Outline

A Global Collaborative
Environment

Collaborative Innovation @
Ferrer


© Ferrer, 2011 agfernandez@ferrergrupo.com

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.




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


And M&A arrived...

PHARMACIA
PFIZER INC.
UPJOHN
WARNERT-LAMBERT
PHARMACIA-UPJOHN
AMERICAN CYANAMID
MONSANTO
PFIZER INC.
WYETH
PHARMACIA CORP.

PFIZER PFIZER


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


Focus on reducing generic-induced erosion of revenues...



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



A Global Collaborative Environment

In 1996…

Jürgen Drews
Hoffmann-La Roche International
Research Division, Former President


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


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


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).



In 2011…

Paul Isherwood
GlaxoSmithKline
Director of Innovation


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


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



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



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


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


.

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!




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.



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.




Market Technology

What is What is
needed? possible?

Here is where
innovation
What fits our
strategy? happens

Business Model




Market Technology

What is What is
needed? possible?

Collaborative
Innovation
What fits our
strategy? improves the
room and the
likelihood
Business Model



The required evolution
The regulatory (r)evolution: towards the Virtual Physiological Human




Santos Dumont Airplane Airbus A-380




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.




72 M euros del 7PM




La apuesta americana




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.


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


The Drug Develepment Process can dramatically change in 2020...

First into Man Limited
(Adaptive Design) 20-100 patients Clinical use

Source: PWC



The Drug Develepment Process can dramatically change in 2020...

First into Man
(Adaptive Design)
20-100 patients

Source: PWC



The goal is to re-shape the curve investment/return...

Source: PWC



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



Ferrer

Innovation

We like to consider the world as our lab, and therefore…



Ferrer

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


Ferrer

Innovation

Connect Routine activities

 Classical Scouting.

 Personal Networking.

 Domestic & International events.

 Active communication/spreading of our policy/interests
(internal & external).



Ferrer

Innovation

Connect Special initiatives

Ferrer
ATTGCGCCATGCGT Initiative for
GCFINESTCGACGA Networking and
TTAGCCATAGGCTA Excellence in Health
Sciences and
Therapeutics



Ferrer

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.



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



Ferrer

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



Ferrer

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


Ferrer

Innovation

Main Strategic Areas

Cardiovascular CNS

Gastrointestinal Dermatology



Ferrer

Innovation

Other areas of interest

Oncology
Ophtalmology
Oncology support

Anti-infectives



Ferrer

Innovation

Technological platforms: their pivotal importance



Ferrer

Innovation

Preferred technological platforms

Regenerative Medicine

 Ophtalmology

 CNS (stroke…)

 Specific opportunities

 Technology scouting:

 Reprogramming evolution

 New biomaterials



Ferrer

Innovation


New Drug Therapies: antibodies

 New Generation Antibodies

 LMW: Nanobodies

 Bispecific – Trispecific antibodies



Ferrer

Innovation


New Drug Therapies: New GPCRs modulators

 Deorphanised GPCRs: focus in CNS

 “Valued” Oligomeric GPCRs: focus in CNS

 PAM, NAM & bitopics discovery technologies

or opportunities



Ferrer

Innovation


Gene Therapies

 Plasmids

 Very specific/singular opportunities in:

 siRNA

 Antisense

 Oncolytic viruses



Ferrer

Innovation


Repositioning

 Strong IP status

 Fast development



Ferrer

Innovation


New Protein Production or Delivery Technologies applied to

 Rare diseases

 Protein deficiency

 Very specific opportunities in therapeutic
vaccines

 Advanced stage of development



Ferrer

Innovation


New Frontiers in Predictive Medicine

 Theranostics

 Epigenetics

 Metabolomics

 Transcriptomics

 Non-image based CNS diagnostic tools



Ferrer

Innovation

Theranos/
Reg Med New Drug Gene Th. Reprof. T. Vacc. Diagnos.

…and opportunities


Ferrer

Innovation

Pipeline: an idealized 3D representation

Phase 3
Phase 2
Phase 1
Precl. Dev.
Candidate
Hit to Lead
Discovery



“Drawing the
future
through
Collaborative
Innovation”


Gràcies!


Ag fernández collab_innov_140911

Recomendados

Recomendados

Más contenido relacionado

Destacado

Destacado (11)

Similar a Ag fernández collab_innov_140911

Similar a Ag fernández collab_innov_140911 (20)

Más de bcntalks

Más de bcntalks (8)

Último

Último (20)

Ag fernández collab_innov_140911