Pharmaceutical R&D overview from a company...

Dr. Matthias Gottwald

VP R&D Policy and Networking at Bayer HealthCare, Global Drug Discovery - Global External Innovation and Alliances

Pharmaceutical R&D – overview from a company perspective

CEMDC – Budapest September 2015

Agenda R&D at Bayer Pharma

The pharmaceutical industry environment – challenges and opportunities

The pharmaceutical Research and Development process and its challenges

The trend to more collaboration

Summary

• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare

Research Sites

Page 2 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare

Hematology

Biologics Research &

Development

Oncology

Gynecological Therapies

Cross Indication Platform

Cardiology / Hematology

Biologics Research &

Development

Ophthalmology

Cross Indication Platform

Animal Health Research

Chemical and Pharmaceutical Development:

Polymer-based Drug Delivery

Systems

Berlin Wuppertal, Cologne, Monheim

Oncology: Thorium

Conjugates Platform

Turku Oslo

BHC Investment in R&D 2014: € 2.30 billion (Pharma: € 1.88 billion)

BHC Investment in R&D of 2014 total net sales: 11.5 % (Pharma: 15.6 %)

BHC R&D Employees 2014: 8.100

San Francisco,

Berkeley

Bayer HealthCare Pharma

Research Focus


Cardiology

Hematology

Oncology

Ophthalmology Gynecology

• Cell Cycle / Survival Signaling

• Immunotherapy / Antibody-

Drug Conjugates

• Tumor Metabolism / Hypoxia

• Chromatin Modulation /

OncoGenomics

• Myeloproliferative neoplasms

• Thorium conjugates

• Endometriosis

• Uterine Fibroids

• Polycystic Ovary

Syndrome (PCOS)

• Heart Failure, Atrial fibrillation

• Ischemic Stroke

• Pulm. (Arterial) Hypertension

• Inflammatory & Fibrotic Lung

Conditions

• Vascular Dysfunction (e.g. rHT)

• Thrombosis, ACS

• Acute CV organ disorders

• Chronic kidney disease

• Hemophilia

• Anemia and other blood

diseases

• Hematopoiesis

• Hemoglobinopathies

• Wet AMD & DME

• Dry AMD &

Stargardt disease

Science For A Better Life

Innovations for our Patients


Combined* Peak Sales Potential > 7.5 bn €

Anticoagulation:

Improving quality of

life for wide range of

patients;

oral, no monitoring,

no dietary

restrictions

Rivaroxaban

2011 2012 2012 2013 2013

Launch in first/main indication

*Combined peak sales potential for Xarelto, Stivarga, Eylea, Xofigo and Adempas assuming approvals and launches planned

Gastrointestinal

stromal tumors:

Highly significant

progression free

survival benefit

Regorafenib

Wet age-related

macular

degeneration:

Maintaining or even

improving visual

acuity

Aflibercept

Bone metastases

in prostate cancer:

Extending survival,

improving quality of

life, being well

tolerated

Radium-223

dichloride

Pulmonary

hypertension:

The first and only

treatment with

sustained clinical

efficacy in two types

of severe pulmonary

hypertension

Riociguat

Case Study – Rivaroxaban

A novel Anticoagulant


Drawbacks of previous anticoagulant therapies:

Vitamin K antagonists (e.g. warfarin)

Narrow therapeutic window

Unpredictable pharmacodynamics

→ Regular laboratory monitoring required

Delayed onset of action and reversal of effect

Multiple drug and food interactions

Low molecular weight heparins (e.g. enoxaparin)

Parenteral administration

Heparin induced thrombocytopenia type II

► High medical need for safe anticoagulation

Discovery of the first oral FXa Inhibitor

Rivaroxaban


HTS

Factor Xa

HTS hit

HTS hit

identified in 1998

IC50 = 20.000 nM

NH

N

O

O

O

S

NS

F

Rivaroxaban

First approval

of Rivaroxaban in 2008

IC50 = 0.7 nM

NH

N

O

O

O

S

NO

ClO





Summary


The challenging environment for R&D


Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006;

Forbes, Matthew Herper, „The Truly Staggering Cost of Inventing New Drugs“, February 10, 2012

Current R&D pathways are expensive and slow

in getting new therapies to patients

Pre

-Cli

nic

al R

es

ea

rch

Clo

se

d &

Op

en

In

no

va

tio

n

3 – 6 years 6 – 7 years

Phase 1 Phase 2 Phase 3

2 – 5 years

EM

A F

iling

EM

A A

pp

rova

l fo

r S

ale

HTA

Ap

pro

va

l

Ne

go

tia

on fo

r R

eim

bu

rsem

ent

in 2

7 m

em

ber

Sta

tes

Drug

Discovery

Pre-Clinical

Testing Clinical Trials Evaluation / Approval

10,000

Compounds

<250

Compounds

5

Therapies

1

Therapy

PhV

Mo

nito

rin

g

Number of Patients / Subjects

20 – 100 100 – 500 1000 – 10,000

Total Cost: $2 – $4 Billion USD

New therapies

don‘t reach patients

until here

Biologically

heterogeneous

patient population

Responders

Non-

responders

Adverse drug events

Trial and error

Responders

Non-

responders

Adverse drug events

Dx

test

A

B

C Measures

biomarker

Informed treatment decision vs

• For targeted drugs, biological variability may (is likely to!) result in

benefit for only a subset of patients

• Biomarker-based prediction of treatment response will allow selection

of patients appropriate for treatment

• Development of a companion diagnostic test necessary to select

patients for treatment with targeted agents

The Principle of “Personalized Medicine”:

Prediction of Treatment Response

The Principle of “Personalized Medicine”:

Prediction of Treatment Response


Graphic adapted from C. Carini, C. Fratazzi,

Eur. Pharm. Rev. 2008, 2, 39-45

Translational Medicine: Linking

Animal Models to Patients


Target Identification

and Validation HTS and Lead

Optimization

Multimorbid Patient Multimorbid Animal

Defined biomarker pattern

applicable to 'translation'

to proof-of-concept in man

Page 10

Macro trends in healthcare prompt

risks & opportunities


Consequences for R&D

Address diseases with

high medical need

Trigger innovation

through increased

external focus (research

collaborations with

academia / biotechs)

Address patient´s

needs in „Emerging

Markets“

State-of-the-Art Technology Platforms are in

Place for small Molecule Drug Discovery…


* highly competitive, high impact

Compound

Collection*

Early

ADME/PK

Pharmacophore

Informatics

Structural Biology

Combinatorial

Chemistry High Throughput

Screening*

Early

Toxicology

Medinical

Chemistry*

Predictive

Pharmacology*

Computational

Chemistry

…but full Integration of the Technology

Platforms is Key to Success...


Output

Copanlisib

Molidustat

Finerenone

Vericiguat

Vilaprisan

Add. 3

Phase II

projects

16 Phase I

projects

Compound

Collection*

Compu-

tational

Chemistry

Early

Toxicology

Structural

Biology

Early

ADME/PK

Pharmaco-

phore

Informatics

High

Throughput

Screening*

Predictive

Pharma-

cology*

Medinical

Chemistry*

Combina-

torial

Chemistry

…and is complemented by external

Contributions


Output

Copanlisib

Molidustat

Finerenone

Vericiguat

Vilaprisan

Add. 3

Phase II

projects

16 Phase I

projects

Compound

Collection*

Compu-

tational

Chemistry

Early

Toxicology

Structural

Biology

Early

ADME/PK

Pharmaco-

phore

Informatics

High

Throughput

Screening*

Predictive

Pharma-

cology*

Medinical

Chemistry*

Combina-

torial

Chemistry

Collaboration

Collaboration

Collaboration

Collaboration





Summary

Page 15 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare

The R&D process


Clear decision points and criteria needed before any new investment is started

Decisions by cross functional management teams

During development (around phase III) increasing involvement of marketing

Preclinical

Development Phase I

Lead

Optimisation

Launch Marketing incl.

Phase IV Submission Target

ID

GPF Lead

Identification

Phase IIb Phase III

Phase IIa/

PoC

Page 16

The Space of Project Ideas and

General Project Frames @ Bayer

Pathways / Mechanisms

Ind

icat

ion

s

Where does it all start ?


The General Project Frame (GPF) is the strategic frame defined by

the Business Unit together with all relevant functions against which all

further projects will be evaluated.

It is the backbone for a Therapeutic Area Strategy and contains all

relevant information from different areas (Research, Medical,

Marketing, etc.) in one document.

Content:

• Definition of Treatment Mechanism

• General Target Profile

• Marketing Opportunity/ Medical Needs

• Generic Product Profile

• Market Access and Sustainability

• Competency Overview / Technical feasibility

Page 18

Start of the development –

Target Product Profile

The Target Product Profile (TPP) defines the product characteristics that

are required to generate a commercially viable product.

It is a description of the target product characteristics (claims)

along the six categories:

• Target population / indication

• Efficacy

• Safety / tolerability

• Dose / administration

• Health economics / outcomes research

• Brand benefit ladder (strategic objectives, marketing claims or other

advantages of the product, which will not be reflected in the labeling)

The information in the TPP should be as specific as possible – depending

on the development phase.

• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare Page 19

In vitro activity (binding, functional, whole cell assays)

Confirmed mechanism of action

Selectivity

In vivo activity in 2 species

PhysChem and crystallinity assessment

Genotoxicity screens

Toxicology in vivo in rodent and non-rodent species

Safety pharmacology

Preliminary PK/PD model

CYP, hERG, in vitro cytotoxicity

Formulation assessment

Cost of goods / CMC assessment (production cell line,

downstream process, etc.)

IP protection

Small molecules

Along the process:

Clear milestone criteria are a must e.g. Optimized lead structure suitable for entry in preclinical development

Biologicals


Significant Effort is Required to

Develop New Drugs


Market Entry

Clinical Development

Phase II: dose, efficacy

Phase III: standard therapy comparison, multi-center


Phase I: safety, pharmaco- kinetics/pharmacodynamics

('proof-of-concept')

Drug Discovery,

Preclinical Development

4-5 years 8-9 years

12-14 years, 1-2 billion EUR, success rate 0.7%

Page 21



A global task

Clinical trials Phase I in dedicated Phase I units

(at company or more and more via CROs)

Phase II and especially phase III trials

always multi-center studies

(the high number of required patients can only be

recruited in time using a global approach and regional requirements have to be

addressed

Global project teams leading the development through to registration / launch

(representatives from all relevant functions, depending on the stage, e.g.

research, preclinical dev., CMC, clinical development, regulatory affairs,

marketing, production)

Marketing more and more involved and leading the way for the definition of the

commercial strategy and the LCM (life cycle management) strategy (Global

Brand Teams)

Page 22

A highly regulated environment


Compliance with regulations worldwide:

EMA

EU Pharmacovigilance system

FDA

SFDA

…

Page 23

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php

http://photoworld.bayerhealthcare.de/start;jsessionid=xysGk4gHNTID9sRjFnXutg**.bcs-app2?method=detailEntry&entryId=38132&listIndex=176



A highly regulated environment


Philosophy in new medicines approval:

Everything is forbidden, as long as it is not explicitly allowed

Prerequisites for drug approval:

Proof of

Quality

Efficacy

Safety

Plus: Proof of “value” / a positive cost – benefit – ratio

Page 24

Benefit-Risk-Assessment

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php

Stock Market

Other key influences


Patients Health Care Providers

Press …

Lawyers (Liability)

http://en.wikipedia.org/wiki/File:NASDAQ.JPG

http://de.wikipedia.org/w/index.php?title=Datei:NYSE_july_2003.jpg&filetimestamp=20051127164751







Summary


Macro trends are driving the evolution of the predominant business models in healthcare

Healthcare is moving from product- to value-

based approach: this opens new space to

innovate.


Health 1.0 Blockbuster Products

Health 2.0 Diversified Portfolios

Health 3.0 Health Value

“How can we

sell more product?”

“How can we

balance operational risk?”

“How can we create

true value in healthcare?”

Guiding Question:

Macro trends 1-4

Adapted from: Ernst & Young, Progressions: Pharma 3.0

Product Mindset

Value Mindset

Partnering to address the

challenges in biomedical R&D


Need

Proof of „true“ innovation with

added value in comparison to

standard of care

Basic understanding of (molecular)

mechanisms of diseases

Predictive models

Biomarker for patient stratification

and treatment monitoring

New regulatory framework

One company only represents a small

portion of the biomedical knowledge

Partnerships with all relevant groups as a key to success

Page 28

Global life

sciences R&D

> 300 Bill €

BHC R&D

~ 2 Bill €

Biomedical R&D spending p.a.

Partnerships deliver essential input for

Bayer’s success


Access to assets complementing internal

research and development

Are key to achieve

Breakthrough Innovation

Help us to increase flexibility and

to de-risk our research

Help to establish networks in core areas

Pa

rtn

ers

hip

s

The subjects of external contribution

change along the value chain


Disease

Hypothesis

Target ID/

Validation Lead ID Preclinic

Phase I-

III

Reg.

Approval

Lead

Optimization

Assets

Idea/ Concepts

Cmpds/ Projects

Academia,

Start-ups

Academic Screening Ctrs,

Academia, SMEs, CROs CROs, Clinics, Biopharma

Value chain

Subject

External

Partners

Products

Added value is generated through

complementary expertise


High innovation expertise

(diverse & complementary to

big pharma)

Culture of risk-taking,

serendipity-driven innovation

hunting and entrepreneurship

Excellent R&D expertise

(lead generation & optimization,

development, regulatory)

Focus on core therapeutic

areas & technologies

Generate added value through

complementary expertise:

Increase diversity of innovation at pharma &

increase the POS* for biotech/academia

Pharma Biotech/Academia

*probability of success

A wide range of (flexible) models

provides the right fit to our partners


Model

■ Strategic

Alliance

■ Consortium

■ Joint lab

■ Crowdsourcing

■ Outsourcing

■ Incubator

■ VC Investment

■ Licensing*

Examples

■ Broad Institute (2013),

OncoMed (2010),

Peking University (2014)

■ Innovative Medicines

Initiative, SGC

■ DKFZ (2008)

■ Grants4Targets (2009),

Grants4Leads (2013)

■ WuXi Apptech

■ CoLaborator

Mission Bay (2012),

Berlin (2014)

■ Versant Ventures

(2013), HTGF (2013)

■ PSMA BiTE, FXIa Ab

Flexibility Criteria

Involvement, Investment/Size, # of Projects,

# of Partners, Duration…

Idea for a Collaboration

Partner

* BD&L is responsible for most licensing projects

Partner

Partnering Models – 1:

Consortia


Pre-competitive Consortia

• Paradigm shift over the last decade with respect to what is regarded as the competitive field of pharmaceutical research

• Formed by parties sharing a common interest in developing general tools and standards in drug discovery and development

Example: Innovative Medicines Initiative (IMI)

• A joint initiative of EU and EFPIA (European Federation of Pharmaceutical Industries and Associations)

• Worldwide largest public-private partnership in healthcare R&D; EUR >5 billion budget

• Addressing major pharma industry and healthcare- related societal needs

• Disease heterogeneity

• Lack of predictive biomarkers for drug efficacy

and safety

• Insufficient pharmacovigilance tools

• Outdated, inflexible clinical designs and tools

• Societal challenges: healthcare costs

• Insufficient incentives to develop drugs for rare or complex diseases

• Poor EU market conditions to create biotech companies

• Lack of training programmes focusing on collaborative approaches

IMI focus – Hurdles to better

Healthcare


IMI – Joining forces from public and

private bodies


The biggest public/private

partnership in Life Science

aiming to:

■ Make drug R&D processes in Europe

more innovative and efficient

■ Enhance Europe’s competitiveness

■ Address key societal challenges

IMI1 and IMI2 ̶ 2008 - 2024

Page 35

Innovative Medicines Initative: Joining Forces in the Healthcare Sector

Specific features of IMI


■ Companies and public partners work together, joint decision making

■ 1:1 funding of public and private partners

Public partners’ (SMEs, academia, patient organisations and

regulatory agencies) costs are reimbursed by EU: grants for

collaborating with industry

Large pharmaceutical industry, represented by EFPIA,

contributes in-kind

■ Industry defines the research agenda and projects

Impact on research, regulatory and medical practice

■ Managed by a neutral broker that facilitates participation of

authorities and patients

Page 36

Working together beyond borders –

Multiple stakeholder teams with critical mass


EFPIA

ACADEMIA

HOSPITALS

PATIENTS’ ORGANISATIO

NS

SMALL AND MEDIUM-

SIZED ENTERPRISES

REGULATORS

Pharma 1

Pharma 2

Pharma 3

Pharma 4

Pharma 5

Pharma 6

A typical IMI consortium,

initiated by a group of

pharma companies

A managable size and professional project management are key for success

IMI – An international, cross-sector

community


Over 7 000 researchers

59 public-private consortia

Regulators on board of 13

projects

Regulatory authorities in

Scientific Advisory Boards of

50% of projects

61% of projects reported

some form of PATIENT

INVOLVEMENT

842 academic

teams

169 SMEs

480 EFPIA teams

26 patient orgs

20 regulators

MARCAR Uni Dundee, UK

EHR4CR The EuroRec Inst, B

SafeSciMET Uni Amsterdam, NL

CHEM21 Uni Manchester, UK

eTRIKS Imperial College

London, UK

EUPATI Eur. Patients Forum, B

ABIRISK INSERM, F

SAFE-T NMI, Tuebingen, D

OncoTrack MPI Molecular Genetics, D

EMTRAIN Medical Uni Vienna, A

PROTECT EMA and Danish

Med. Agency, DK

PREDECT Uni Helsinki, SF

OrBiTo Uni Uppsala, S

K4DD Uni Leiden, NL

eTOX Fundacio IMIM, E

EU2P Uni Bordeaux, F

PharmaTrain Uni Basel, CH

ELF TI Pharma, NL and

Taros Chemicals, D

GetREAL Uni Utrecht, NL

PRECISESADS GENYO, E

Web-RADR MHRA, UK

iPiE Fundacio IMIM, E

CANCER-ID Uni Hamburg, D

Ultra-DD SGC, UK

Page 39

Coordinators of IMI projects

with Bayer participation

Pre-competitive IMI consortia connect Bayer

with excellent partners across Europe


Examples of IMI outputs that support new research paradigms


Clinical trials - improved design and process

Development of biomarkers and tools predictive of clinical outcomes

(efficacy and safety)

Establishment of robust, validated tools for preclinical drug

development

Identification and validation of new drug targets and novel hit and

lead discovery

‘Big data’ solutions to leverage knowledge

Implementation of data standards

Examples from IMI1 –

Improving processes in R&D


Enhancement of the drug discovery process:

Establishment of a comprehensive compound library accessible for private and

public target programmes; Screening Center for identification of ‚qualified hits‘ with

the potential to deliver D2 candidates into our pipeline and option on novel public

targets

Safer and Faster Evidence Based Translation:

Established largest preclinical safety database in its area, using an honest broker

model and 90 predictive in-silico models (currently validated in companies);

close dialogue with regulators initiated

New approaches for data collection and use

in clinical development:

Establish a common understanding on requirements for approval and

reimbursement between academia, pharma, regulatory as well as HTA agencies

(joint guideline on phase III study designs in order to meet the common

requirements)

■ Sustainable business model developed for the use of

electronic health record (EHR) data to enable better clinical

trial protocol development, a faster identification of patients and

trial sites and reduce manual data transcription and overall site

workload

■ Development of a smartphone App for reporting ADRs and

outcomes by patients and healthcare professionals to

collect real life AE data; interaction with and mining of social

media for Pharmacovigilance and Pharmacoepidemiology data

Examples from IMI1 – New Approaches for Data Collection and Use in Clinical Development


• Shared data set of patient-level data from 5 companies

(AZ, Eli Lilly, J&J, Lundbeck, Pfizer) from 34 clinical trials

(11.670 patients) testing second generation antipsychotics

Drug-placebo differences already significant after 4 vs. 6

weeks of observation with 40% less patients

(>2 mio€ savings per trial)

Examples from IMI1 –

Improving processes in R&D

■ Development of the regulatory framework:

Novel framework for PE studies developed, as well as new methods for signal

detection and data collection from consumers and novel databases; PROTECT

ADR database (45298 ADRs for 654 medicines) and Inventory of Drug

Consumption Databases in Europe (17 countries); project coordinated by EMA

■ Better patient involvement in R&D:

Developing training programs for patients on processes of R&D and

guidelines for patient involvement in all phases of medicines R&D; network

with patient organisations across Europe, coordinated by European Patient

Forum


EU LEAD FACTORY –

Sharing Compound Collections and

Target Programmes

Page 44 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare Page 44

■ Creation of a highly diverse Joint European

Compound Collection with ~500.000

compounds from public and private institutions

■ Establishment of a screening platform available

to researchers in universities, SMEs and pharma

industry

■ Total Budget: 196.5 Mio €

By sharing compounds, target programmes and screening capabilities

partners create unrivalled opportunities to generate new drug lead

molecules for the development of innovative novel drugs

Education and Training in IMI –

Joint Extension Project started


Key Deliverables:

■ Joint branding

concept

■ Joint portal

■ Needs assessment

and career dev.

support for IMI/IMI2

projects

■ Globalization of

training standards

and courses

■ Piloting of „Specialist

in Medicines Dev.“

(SMD) degree in Italy

Page 45

PhD

Masters

Modules

Masters

(MDD, MRA)

Modules

CTP, CLIC

Specialist

Masters

Modules

on-course®

PhD framework, workshops, & network

Tools & Methodolog

ies

Modular courses

information tool box

Quality standards, on-course® centre, gap analysis, LifeTrain (CPD)

framework, SME expert panel, communications, globalisation,

competences, networks, e-learning standards, customer focus

Make Drug R&D processes in Europe more efficient and effective and enhance Europe’s competitiveness in the Pharma sector

Idea generation

Primary focus of early IMI calls

2007 SRA

Basic research

and non-clinical

testing

Shift to also addressing challenges in in society and

healthcare 2011 SRA

Human testing Regulatory

Approval

HTA and

Pharmacovigi-

lance

The Journey from IMI1 to IMI2


Daily

Medical

practice

IMI 2 includes real life medical practice

2013 SRA

Page 46

IMI2 – From Science to Patients


Primary focus of early IMI calls:

Safety & Efficacy

Target &

Biomarker

Identification

(safety & efficacy)

Innovative clinical

trial paradigms

Patient tailored

adherence

programmes

Innovative

Medicines

Vision for IMI 2:

The right prevention and treatment for the right patient at the right time Drive change in real life medical practice

Page 47

Source: Lessl et al., 2011, Nature Drug Discovery 10, 241-242

Crowd sourcing as partnering model to

tap into the expertise of a large scientific

community


Challenge* to be solved defined

by seeking institution

1

to address challenges

Solutions/ideas

provided by scientific

community (Internet as

communication platform)

2

Review 3

* such as the search for novel

targets, compounds or

indications for known assets


Crowd Sourcing


Crowd Sourcing

• Using the expertise of a larger scientific community, often using the internet as a platform, instead of a single partner to address an issue

• Success factors include precise definition of the problems, expectations, offerings and IP policy, and low bureaucratic hurdles and short response times

Examples:

• InnoCentive (broad scope across industries)

• PD² (Phenotypic Drug Discovery)

• GSK Innovation (Drug Discovery ideas)

• (Drug Discovery ideas)

• Grants4Targets (Novel target ideas)

BHC Open Innovation Family


Grants4Targets

BHC grants for targets/

biomarkers. Offers

expertise, tools and

technologies to help

develop your ideas.

http://www.grants4targets.

com

Grants4Leads

BHC grants to access

and assess small

molecule leads which

may lead to

collaborations to explore

such leads.

http://www.grants4leads.

com

Grants4Apps

BHC grants for

innovative IT projects

which may lead to new

business models.

http://www.grants4apps.

com

http://www.grants4leads.com/


Incubators


Innovation Incubators

• Promotion of interaction between innovative start-up companies and industry

• Providing rental lab space next door to research and development facilities and assistance with access to funding, and drug discovery technologies

Examples:

• Janssen Labs (e.g. in San Diego)

• Celgene (hosting companies co-funded by Versant Ventures)

• GSK Biotech Park

• CoLaborator

Bayer provides incubator space to interact

with innovative start-up companies


Example: CoLaborator™

• An attractive incubator space for life science start-ups, with ideas related to the Bayer HealthCare R&D strategy

• Provision of lab and office space according to the needs of start-ups

• Options for interactions/collaborations with Bayer HealthCare

• Co-located with Bayer HealthCare sites, currently in the US (San Francisco, CA)

and Europe (Berlin, Germany)

More information @ www.colaborator.bayer.com

Partnership models – 4:

Strategic Alliances


Strategic Alliances

• Long-term-oriented risk-and-reward-sharing agreements; complementary expertise, but common overall goals

• Significant contributions from both partners in terms of content, resources and financials

• Allow to pursue highly complex and innovative projects that the single partners could not have handled on their own

Examples:

• Pfizer with UCSF and Harvard

• Astra Zeneca with Camebridge University

• Sanofi with Charité

• Janssen with Uni Toronto

• Bayer with DKFZ

Balance between central expertise and

being close to the partners


Many major pharmaceutical companies have established global partnering organizations to ensure transparency and consistency of activities and use synergies

While quality and strategic fit are the key drivers for partnering decisions proximity to the partners gives an added value

Cultural differences, language bareers and problems resulting from working in different time zones can better be addresssed by a global organization

Science and Innovation Hubs


Berlin • CoLaborator

Singapore Science Hub Singapore

Region

Integrated Translational

Oncology Network

Beijing • GDD Innovation Center China

• Bayer HealthCare/Peking University

Center of Translational Research for

Drug Discovery

• * Bayer Tsinghua Center for

Innovative Drug Discovery

Osaka • Open Innovation

Center Japan

San Francisco • Science Hub US

• CoLaborator

* Facilitity of collaboration partner

Boston (in preparation)

Concluding remarks


There is a continuous need for innovative medicines

The environment for pharmaceutical industry is changing significantly

towards high value medicine and more targeted approaches,

requiring changes of the companies

R&D in pharmaceutical industry is a global, highly complex, lengthy,

costly and risky process

A better understanding of the molecular mechanisms of complex

diseases is needed together with more robust R&D tools and processes

Partnerships are one key to address these challenges

Further information / literature


• Bayer Pharma Website: Overview movie on pharmaceutical R&D

http://www.bayerpharma.com/html/pdf/forschung_und_entwicklung/110713_BayerPharma_Brosch_en_web.pdf

• Pharmaceutical R&D – The road to positive returns; Nature Reviews Drug Discovery 8, 609-10, 2009:

http://www.nature.com/nrd/journal/v8/n8/full/nrd2948.html

• Forbes:

http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/

• CMR International Pharmaceutical R&D Factbook, Aug-2013 (http://cmr.thomsonreuters.com/cmr/pdf/fb-exec-2013.pdf

• Garrido, M. V.; Gerhardusb, A.; Røttingenc, J.-A.; Bussea, R. Health Policy 2010, 94, 196–202.

• DePalma, A. 'New models for drug discovery and marketing', published on eyeforpharma

(http://social.eyeforpharma.com/marketing/new-models-drug-discovery-and-marketing) on 06-Jun-2011.

• Lessl, M.; Schoepe, S.; Sommer, A.; Schneider, M.; Asadullah, K. Drug Discov Today 2011, 16, 288-292.

• Goldman, M. Clinical Pharmacology and Therapeutics 2012, 91, 418-125.

• Wellenreuther, R.; Keppler, D.; Mumberg, D.; Ziegelbauer, K.; Lessl, M. Drug Discovery Today 2012, 17, 1242–1248.

http://cmr.thomsonreuters.com/cmr/pdf/fb-exec-2013.pdf






Thank you for your attention!

Thank you for your attention!

Forward-Looking Statements


This presentation may contain forward-looking statements based on

current assumptions and forecasts made by Bayer Group or

subgroup management.

Various known and unknown risks, uncertainties and other factors

could lead to material differences between the actual future results,

financial situation, development or performance of the company and

the estimates given here. These factors include those discussed in

Bayer’s public reports which are available on the Bayer website at

www.bayer.com.

The company assumes no liability whatsoever to update these

forward-looking statements or to conform them to future events or

developments.

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