ag fernández collab_innov_140911

Barcelona 14/09/2011

[email protected]

Collaborative InnovationThe role of the Academy and the Pharma Industry

Joining our Efforts, Sharing our Future

Innovation in BiotechnologyBusiness Development & Licensing

International Division

September 14, 2011


[email protected]© Ferrer, 2011

A Global Collaborative Environment

Collaborative Innovation @ Ferrer

Outline



Trends in Biopharma Industry. The future has arrived.

A dramatic lost of efficiency and competitiveness has been experienced by the pharma companies over the last 15 years

A Global Environment

The stocks of some of the industry's biggest players, including Pfizer and Merck,

are down 40% from a decade ago.

The industry has cut 300,000 jobs in the last 10 years.



What to do...


To increase Corporate efficiency:Promote M&A, …

To increase R&D efficiency: Change the research model


To achieve system sustainability: Evolve the regulatory model




And M&A arrived...

PHARMACIA

UPJOHN

PHARMACIA-UPJOHN

PHARMACIA CORP.

MONSANTO

PFIZER

WARNERT-LAMBERT

PFIZER INC.

PFIZER INC.

AMERICAN CYANAMID

WYETH

PFIZER




SANOFI

STERLING W

SANOFI-WINTHROP

SANOFI-SYNTHELABO

SYNTHELABO

HMR

FISONS

RHONE-POULENC R

RHONE-POULENC R

ROUSSEL-UCLAF MARION MERRELL DOW

HOECHST HOECHST-

MARION MERRELL DOW

AVENTISSANOFI-AVENTIS




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




But… are M&A solving the problem? What about the announced synergies?

Consolidationeffects

% world market

Dec-98 Dec-03 Dec-08

PFIZER 9.0 10.1 7.8

SANOFI-AVENTIS 5.8 5.4 5.8

GSK 7.2 6.6 7.0




What to do...









Jürgen DrewsHoffmann-La Roche International

Research Division, Former President

In 1996…




CLIN

DEVELOP

DISCOV

1975

ACAD

201520051985 1995

CLIN

DEVELOP

DISCOV

CLIN

DEVELOP

DISCOV

CLIN

DEVELOP

DISCOV

CLIN

DEVELOP

ACADACAD

BIOTECH

DISCOVERYBIOTECH

DISCOVERY

INDUSTRY

ACADEMIA




CLIN

DEVELOP

DISCOV

1975

ACAD

2015…20051985 1995

CLIN

DEVELOP

DISCOV

CLIN

DEVELOP

DISCOV

CLIN

DEVELOP

DISCOV

CLIN

DEVELOP

ACADACAD

BIOTECH

DISCOVERYBIOTECH

Increasingly fragmented value chain

DISCOVERY

INDUSTRY



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).

What is really happening ...





Paul IsherwoodGlaxoSmithKline

Director of Innovation

In 2011…




0

10

20

30

40

50

60

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Allia

nces

/ yea

rThe number of alliances confirms the new scenario

Merck: More than 300 alliances in 6 years 500% increase in 7 years




020406080

100120140160

Dea

lsThe number of alliances confirms the new scenario

Announced Deals (2005-2009)

Source: Deloitte Recap LLC



58% 52% 52% 46%38%

13% 17% 14% 20%

19%

30% 31% 34% 33%43%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2005 2006 2007 2008 2009

Early Mid Late


Distribution by Stage at Signing for Alliances

Late StageApproved 270Phase III 197Phase II 151

Mid StagePhase I 107Preclinical 191

Early stageLead molec. 76Discovery 832

Source: Deloitte Recap LLC



External origin of R&D projects in a sample of the Top-25 companies

Ranking position (2010)

Company R&D projects(2010)

Projects of External origin

(%)

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...


0%

5%

10%

15%

20%

1900 1920 1940 1960 1980 2000

Golden age of R&D

corporate labs

Source: EIRMA

During the late 19th and the early part

of the 20th, practically all research

had been conducted outsourced




Munos' Laws1. 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.

3. Do what works. Stop trying to manage drug discovery with Six Sigma processes.

4. Lower costs with collaborative research.5. Mitigate risk by developing lots of potential

breakthroughs, not by trying to develop projects that seem low-risk. History says the risk is never low.

6. Don't move anything into human trials unless it is a potential breakthrough.

7. Cut research and development.

Bernard Munos has a radical idea to save the drug industry:

Take bigger risks, do collaborative research and cut R&D..

.

Rallying Pharma's RebelsForbes Magazine August 22, 2011

“Is there a less bureaucratic and cheaper way to invent new medicines? Former Big Pharma bigwigs say… yes!




Mind the gap…

BIOPONTIS (USA)

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.

Bridge companiesNew York University

University of Pennsylvania

University of Florida

Columbia University

Memorial Sloan-Kettering

University of North Carolina

University of Virginia




Novel drugs (excluding me-too) FDA approvals Phase III failures

Biotech 9 42

Biotech-Pharma alliances 5 5

Pharma 16 4

Drug development scorecard: Jan-06 to Dec-07

Source: EA Czerepak & S Ryser (2008). Drug approvals and failures: implications for alliances. Nat Rev Drug Discov 7: 197-8.

Pharma are still necessary…



Market Technology

Business Model

What is needed?

What is possible?

What fits our strategy?

Here is where innovation happens




Market Technology

Business Model

What is needed?

What is possible?

What fits our strategy?

Collaborative Innovation

improves the room and the

likelihood




What to do...








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

The required evolution



Santos Dumont Airplane Airbus A-380





The IUPS Physiome Project is a worldwide effort todefine the physiome through the development ofdatabases and models which will facilitate theunderstanding of the integrative function of cells,organs, and organisms. The project is focused oncompiling and providing a central repository ofdatabases, linking experimental information andcomputational models from many laboratories into asingle, self-consistent framework.

2000-2010





72 M euros del 7PM



http://www.vph-noe.eu/�



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 newapproaches including systems biology, multiscale modeling, and the physiome, will becomepractically possible only when an entirely new framework of methods and technologies has beendeveloped for investigating organisms as single systems. In Europe, this framework has been namedthe Virtual Physiological Human. In the USA, while this particular name is not typically in use, thesame 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 VirtualPhysiological Human (VPH) and the use of such solutions to support the diagnosis and treatment ofrare diseases.





Primary Pharmacol.Wide-ligand profiling

ADME propertiesPharmac. Science

Toxicology

Target ID Design of molecule

Synthesis of

molecule

Hit ID/ screening

of molecule

TestingMolecule

in vitro

Initial testing in

man

TestingMolecule

in vivo

Target ID Design of treatment

Testing of

treatment

Synthesis of

treatment

Initial testing in

man

In silico

Lab

Clinical

The current process

The process after VPH

Source: PWC





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

Source: PWC

First into Man(Adaptive Design) 20-100 patients

Limited Clinical use




Source: PWC

First into Man(Adaptive Design) 20-100 patients

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




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

Source: PWC






Outline



Ferrer

CollaborativeInnovation

Ferrer


Recently, Ferrer has created the

Area of Innovation in Biotechnology

Focused on expanding Collaborative Research.

Identifying, incorporating and (co-)managing

projects originated outside the company.




Ferrer


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




Ferrer


Time

Open Innovation @ Ferrer

Research Development

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…

FERRER

BIOTECH ACADEMY

Collaborative Innovation @ FerrerFerrer




Ferrer


Classical Scouting.

Personal Networking.

Domestic & International events.

Active communication/spreading of our policy/interests

(internal & external).

Routine activities Connect

Collaborative Innovation @ FerrerFerrer




Ferrer


Connect Special initiatives

ATTGCGCCATGCGTGCFINESTCGACGATTAGCCATAGGCTA

FerrerInitiative for

Networking andExcellence in Health

Sciences and Therapeutics




Ferrer


Connect

A network of Excellence (by invitation only):

Composed by emerging and brilliant middle age bioscientists and clinicians.

Extend coverage of translational medicine.

A think tank to help in:

Prospective

Strategy design.

Emerging opportunities.

Avoiding /anticipating pitfalls and no-ways.

A virtual community with an attractive intranet (web based) platform & blog .

Annual Presential Meeting.

Special initiatives

ATTGCGCCATGCGTGCFINESTCGACGATTAGCCATAGGCTA




Ferrer

CollaborativeInnovationWhat do we look for

Projects yielding high added value products

Development Segment Target (Entry Point)

Main Strategic Areas

Preferred Technological Platforms

but, we do also like OPPORTUNITIES

Next slides will define our…

Projects yielding high added value products

Development Segment Target (Entry Point)


Preferred Technological Platforms

but, we do also like OPPORTUNITIES



Ferrer


Why do we need high added valued products?

Which one is the most effective? Which one exhibits the best healtheconomics profile? Which one solves an unmeet medical need?

Compound A is reimbursed ORCompound B is reimbursed

Regulatory agencies

Compound A is safe? Is effective? has it a suitable benefit risk ratio ?

Compound B is safe? Is effective? has it a suitable benefit risk ratio ?

Compound A approvedANDCompound B approved

HTA



Ferrer


Industry averages

Cost * Time** PoS***

D I S COVE RY

D E V E L OPMENT

Target ID

Assay Development

HTS Screening

Lead Optimization

pPoC / Preclinical Dev

Phase I

Phase IIA / cPoC

Phase IIB

Phase III

Registration

Hit To Lead

37

1

2.7 %

37

28

25

19

9

5

3

2

1.5

1.1

0 2 4 6 8 10 12Years

What do we look for

* MUSD** Years*** Probability of SuccessSource: Gaviragui, 2011

ENTRY POINT



Ferrer



Cardiovascular

Dermatology

CNS

Gastrointestinal



Ferrer


Other areas of interest

Oncology

Oncology support

Anti-infectives

Ophtalmology



Ferrer


Technological platforms: their pivotal importance



Ferrer


Regenerative Medicine

Ophtalmology

CNS (stroke…)

Specific opportunities

Technology scouting:

Reprogramming evolution

New biomaterials

What do we look for

Preferred technological platforms



Ferrer


New Drug Therapies: antibodies

New Generation Antibodies

LMW: Nanobodies

Bispecific – Trispecific antibodies

What do we look for




Ferrer


New Drug Therapies: New GPCRs modulators

Deorphanised GPCRs: focus in CNS

“Valued” Oligomeric GPCRs: focus in CNS

PAM, NAM & bitopics discovery technologies

or opportunities

What do we look for


Ferrer




Ferrer


Gene Therapies

Plasmids

Very specific/singular opportunities in:

siRNA

Antisense

Oncolytic viruses

What do we look for


Ferrer




Ferrer



What do we look for Ferrer


Strong IP status

Fast development

Repositioning



Ferrer


New Protein Production or Delivery Technologies applied to

Rare diseases

Protein deficiency

Very specific opportunities in therapeutic

vaccines

Advanced stage of development


What do we look for



Ferrer


New Frontiers in Predictive Medicine

Theranostics

Epigenetics

Metabolomics

Transcriptomics

Non-image based CNS diagnostic tools


What do we look for



Ferrer


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

What do we look for

…and opportunities

Ferrer




Ferrer


Phase 3Phase 2Phase 1

Precl. Dev.Candidate

Hit to LeadDiscovery

What do we look for Ferrer


Pipeline: an idealized 3D representation


“Drawing thefuture

throughCollaborative

Innovation”


Gràcies!

ag fernández collab_innov_140911

Technology

ferrer barcelona

global environmentwhat

global environmentfocus

global environmenttrends

global environmentbut

global environmentand

rd efficiency

president barcelona