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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
Page 1
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
Page 3 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 4 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 5 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 6 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 7
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
The challenging environment for R&D
Page 8 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 9 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
Graphic adapted from C. Carini, C. Fratazzi,
Eur. Pharm. Rev. 2008, 2, 39-45
Translational Medicine: Linking
Animal Models to Patients
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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…
Page 12 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
* 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...
Page 13 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 14 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
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
Page 15 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
The R&D process
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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 ?
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare Page 20
Significant Effort is Required to
Develop New Drugs
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
Market Entry
Clinical Development
Phase II: dose, efficacy
Phase III: standard therapy comparison, multi-center
Clinical Development
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
Clinical Development
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
Compliance with regulations worldwide:
EMA
EU Pharmacovigilance system
FDA
SFDA
…
Page 23
A highly regulated environment
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Stock Market
Other key influences
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare Page 25
Patients Health Care Providers
Press …
Lawyers (Liability)
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
Page 26 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
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.
Page 27 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 28 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
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
Page 29 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 30 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 31 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 32 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 33 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 34 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
IMI – Joining forces from public and
private bodies
Page 35 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 36 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
■ 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
Page 37 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 38 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 39 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
Examples of IMI outputs that support new research paradigms
Page 40 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 41 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 42 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
• 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
Page 43 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 45 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
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
Page 46 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
Daily
Medical
practice
IMI 2 includes real life medical practice
2013 SRA
Page 46
IMI2 – From Science to Patients
Page 47 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
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
Page 48 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
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
Partnering Models – 2:
Crowd Sourcing
Page 49 • PME Study Unit 2 • 13.06.2015 • Matthias Gottwald - Bayer HealthCare
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
Page 50 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Partnering Models – 3:
Incubators
Page 51 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 52 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 53 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 54 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 55 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 56 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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
Page 57 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
• 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.
Page 58 • CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
Thank you for your attention!
Thank you for your attention!
Forward-Looking Statements
• CEMDC 2015 • Budapest • Matthias Gottwald - Bayer HealthCare
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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