Technology scouting at Bayer Healthcare

Workshop Czech Republic
Pharma TechTransfer
11th of October 2012

TECHNOLOGY SCOUTING (TS) –
we serve your needs

Dr. Jörg Knäblein
TECHNOLOGY SCOUTING
Bayer HealthCare Pharmaceuticals; Berlin, S107, 01, 117
Phone: +49 30 468-1 6852; Fax: +49 30 468-9 6852
Mobile: +49 160 972 06850
E-mail: joerg.knaeblein@bayer.com
Web: http://www.bayer.com

TS – we serve your
needs

TECHNOLOGY SCOUTING (TS) – we serve your needs
Topics and keywords for external search performed by TECHNOLOGY SCOUTING
for focused search in academia:

ANIMAL MODELS
●Preamble
●Search criteria
BIOBANKING and BIOMARKER
●Preamble
●Search criteria
TRG CARDIOLOGY
●Acute Care Research (ACS, PAOD, Ischemic Stroke, DIC, ALI/ARDS)
●Heart Diseases (Heart Failure, Atrial Fibrillation, Cardioprotection)
●Kidney Diseases (Diabetic Nephropathy, CKD, Acute Renal Insufficiency)
●Vascular Disease (Pulmonary Hypertension)
●Hemoglobinopathies (Sickle Cell Disease, Beta-Thalassemia, Hemophilia A and B)
TRG ONCOLOGY / GYNOGOLOGICAL THERAPIES
●Cell cycle / Survival Signaling (Cell cycle inhibition, Induction of apoptosis)
●Chromatin Modulation and OncoGenomics (Transcription and chromatin modulators)
●Tumor Metabolism (Inhibition of tumor metabolism and Selective targeting)
●Cancer Immune Therapy and Antibody Drug Conjugates (neutralize immunosuppression, selective killing)
●Hyper-proliferative Diseases (Uterine fibroids, and Endometriosis / adenomyosis uteri)
CORPORATE INFORMATION
●Reasons to Partner with Bayer
●Overview: Bayer HealthCare

Dr. Jörg Knäblein TECHNOLOGY SCOUTING (TS), GDD Global Innovation Sourcing
#* +49 30 468 1 6852, joerg.knaeblein@bayer.com

needs

Animal Models


TS – we serve your 1
needs /2
Animal models (transgenic, syngeneic, knock-out, knock-in, xenografts,
orthotrop)
As a research-based pharmaceutical company, Bayer Healthcare Pharmaceuticals is aware of the
ethical issues inherent to research with animal models. All experiments performed at Bayer Healthcare
Pharmaceuticals are in accordance with guidelines of the German and European codes for animal
experiments. We are collaborating with providers and scientific institutes who are key opinion leaders
in their field and employing best practice to establish animal models characterized by minimal burden,
high predictability and a high level of feasibility.
External search: in-licensing/scientific collaborations on disease-relevant & predictive animal models
for

☑ TRG ONCOLOGY / GYNECOLOGICAL THERAPIES (updated 06-2012)

● Models of the following indications: gastric, prostate, head & neck, melanoma, colon, bladder, ovarian,
triple-negative breast (TNB) cancer, including the aspects of metastasis, e.g. models of brain/bone
metastasis due to lung, breast and prostate tumors
● Models refractory to clinically approved therapies (e.g. Tarceva-resistant lung CA, Herceptin-resistant
mamma CA, Avastin-resistant/insensitive tumors, Taxane-resistant tumor models)
● Models addressing the topics “tumor metabolism” and “anti-tumor immune responses”
● 3D-in-vitro technologies, Cell/cell & Cell/ECM interactions, “sprouting” or “microenvironment” for tumor
growth studies
● Gynecological Indications: uterine fibroids, endometriosis / adenomyosis uteri; dysfunctional uterine
bleeding
● Animal models for GT (rat, mouse, primate): uterine fibroids, endometriosis / adenomyosis, human
xenografts for uterine fibroids & endometriosis, pain in endometriosis, dysmenorrhea, dysfunctional
bleeding
● GT Mechanisms: transgenic & K.O. animals targeting proteins related to proliferative, extra cellular matrix,
angiogenic, inflammatory/painful or menorrhagic events in endometriosis or uterine fibroids


TS – we serve your 2
needs /2
Animal models (transgenic, syngeneic, knock-out, knock-in, xenografts, orthotrop)
As a research-based pharmaceutical company, Bayer Healthcare Pharmaceuticals is aware of the
ethical issues inherent to research with animal models. All experiments performed at Bayer Healthcare
Pharmaceuticals are in accordance with guidelines of the German and European codes for animal
experiments. We are collaborating with providers and scientific institutes who are key opinion leaders
in their field and employing best practice to establish animal models characterized by minimal burden,
high predictability and a high level of feasibility.
External search: in-licensing/scientific collaborations on disease-relevant & predictive animal models
for

☑ TRG CARDIOLOGY (updated 06-2012)
●Short-term animal models e.g. innovative imaging techniques for PAOD and ischemic stroke
●Animal models with respect to development state for thrombotic disorders mimicking high risk patients
●Animal models with underlying cause Acute Lung Injury (ALI) / Acute Respiratory Distress Syndrome (ARDS)
●Animal models mirroring sec. pulmonary Hypertension (e.g. PH/COPD)
●Animal models for on-line tracking of Heart Failure development and therapy success
●Animal models mirroring Atrial Fibrillation (AF)
●Animal models of acute and chronic kidney injury, diabetic nephropathy
●Ischemic stroke (prevention) models
●Bleeding models


needs

Biobanking and Biomarker


needs
Human specimen-based Research (Oncology / Gynecological Therapies,
☑
Cardiovascular)
Two lines of pharmaceutical research build upon access to human specimens, target identification and validation, and
biomarker validation and qualification. E. g. in oncology, comparing the expression profile of a diseased tissue with that
of a normal adjacent sample might lead to novel ideas for a targeted therapy. Comparing the protein content of a tissue
sample with a peripheral blood sample in ELISA measurements might lead to less invasive diagnostic possibilities, i. e.
biomarker validation (there is much lower interest in techniques for identifying biomarkers).
As a research-based pharmaceutical company, Bayer Healthcare Pharmaceuticals is aware of the ethical issues inherent
to this kind of research and is collaborating with clinicians who are key opinion leaders in their field employing best
practice (e. g., asking for IRB vote and patients' informed consent). A win-win situation exists where we are accepted as
scientific research partner, e. g. offering access to analytical measurements for joint, peer-reviewed publications.
Focus of external search is on scientific collaborations for

☑ Oncology/Gynecological Therapies (updated 06-2012)
●the big five indications breast, colon, lung, ovarian, prostate (in particular the process of metastasis), as well as gastric,
head & neck, melanoma, bladder, and triple-negative breast (TNB) cancer
●refractory to targeted therapy (e. g. Tarceva-resistant lung CA, Herceptin-resistant mamma CA, Avastin-
resistent/insensitive tumors, Taxane-resistant tumor models)
●Tissue from endometriosis / adenomyosis uteri patients and respective biomarkers

☑ Cardiovascular (updated 06-2012)
●Pulmonary Arterial Hypertension, Chronic Obstructive Pulmonary Disease (PAH, COPD), ACS,
Kidney Failure, Peripheral Arterial Occlusion Disease (PAOD, different stages), ALI, ARDS, AKI
●Heart (cardiomyopathy of different NYHA classes); Atrial Fibrillation (AF)
●Thrombotic disorders, Acute Lung Injury, ARDS, Acute Kidney Injury


needs

Cardiology (updated 06-2012)


needs
CARDIOLOGY –
☑
Acute Care Research (ACS, PAOD, Ischemic Stroke, DIC, ALI/ARDS)
Bayer Healthcare Pharmaceuticals’ goal with its Cardiology business is to sustainable protect people‘s heart and
bloodstream, because Cardiovascular Diseases have become a severe problem in our society. Early diagnosis and
therapy of cardiovascular diseases plays a significant role – this is why our research concentrates on innovative
approaches for several heart and vascular diseases as well as anti-coagulants.
As a research-based pharmaceutical company, Bayer Healthcare Pharmaceuticals continues to prevent occlusion of
blood vessels (thrombosis), thromboembolism (e.g. lung embolism) or dissolving clots (peripheral arterial occlusion)
thereby focusing on novel treatment approaches with a balanced risk-benefit profile. Moreover, novel approaches in
cardiovascular specialty indications (acute and intensive care) are of high interest to reduce the high unmet need in
emergency rooms or intensive care units.
Focus of external search is on proprietary (small and biological) molecules (e.g. inhibitors), innovative approaches,
new mechanism-of-action, state-of-the-art in-vitro, in-vivo and ex-vivo pharmacology models, and biomarkers for

Acute Coronary Syndromes (ACS) anticoagulation, antiplatelets
●Chronic treatment, high risk patients
●No acute therapy
●New biomarkers

Peripheral Arterial Occlusive Disease (PAOD), Ischemic Stroke (IS)
prevention, and Critical Limb Ischemia (CLI)
●Novel therapeutic approaches
●Predictive animal models e.g. innovative imaging techniques
●New biomarkers

Acute/Intensive Care e.g. Acute Lung Injury (ALI) / Acute Respiratory
Distress Syndrome (ARDS), Acute Kidney Injury (AKI), Disseminated
Intravascular Coagulation (DIC)
●Predictive animal models with respect to development state
●Identifying disease-stage specific biomarkers


needs
CARDIOLOGY –
☑
Heart Diseases (Heart Failure, Atrial Fibrillation, Cardioprotection)
Bayer Healthcare Pharmaceuticals’ goal with its Cardiology business is to sustainably protect people‘s heart and
As a research-based pharmaceutical company, Bayer Healthcare Pharmaceuticals continues to improve and protect
heart function in patients with heart failure and other heart diseases as well as secondary forms of pulmonary
hypertension.

Heart Failure
(HF)
●Novel therapeutic approaches for anti-remodeling, function improvement
and diastolic HF
●Predictive animal models for remodeling processes and diastolic HF
●Sex and gender-specific models for heart diseases
●New biomarkers monitoring therapeutic success

AFib
Atrial Fibrillation (AF)

●Novel therapeutic approaches for rate and rhythm control AFi
●Predictive animal models
Sinus rhythm
b
Sinus
rhyth
Cardioprotection (ischemia/reperfusion) m

●Novel therapeutic approaches for prophylaxis of cardiac injuries
●Predictive animal models for prim. and sec. prophylaxis
●New biomarkers (patient risk stratification for MACE)


needs
CARDIOLOGY –
☑
Kidney Diseases (Diabetic Nephropathy, CKD, Acute Renal Insufficiency)
Bayer Healthcare Pharmaceuticals’ goal with its Cardiology business is to sustainably protect people‘s heart and
As a research-based pharmaceutical company, Bayer Healthcare Pharmaceuticals continues to improve and protect
renal function in patients with acute and chronic kidney dysfunction and insufficiency.
Diabetic Nephropathy (DN)
●Novel therapeutic approaches to protect diabetic patients from
developing and worsening of DN
●Biomarkers for early monitoring of therapeutic success

Chronic Kidney Disease (CKD) progression

Ischemia- or hypertension- induced CKD AFib

●Predictive animal models Sinus rhythm

Cardiovascular Diseases associated with CKD
Novel therapeutic approaches
●
Predictive animal models and biomarkers
●

Acute Renal Insufficiency


needs
CARDIOLOGY –
☑
Vascular Disease (Pulmonary Hypertension)
Bayer Healthcare Pharmaceuticals’ goal with its Cardiology business is to sustainably protect people‘s heart, lungs and
bloodstream, because Cardiovascular Diseases have become a severe problem in our society. Early diagnosis and therapy of
cardiovascular diseases plays a significant role – this is why our research concentrates on innovative approaches for several
heart, lung and vascular diseases as well as anti-coagulants.
As a research-based pharmaceutical company, Bayer Healthcare Pharmaceuticals continues to improve and protect heart
function in patients with heart failure and other heart diseases as well as primary & secondary forms of pulmonary hypertension.
Focus of external search is on proprietary (small and biological) molecules (e.g. inhibitors), innovative approaches, new
mechanism-of-action, state-of-the-art in-vitro, in-vivo and ex-vivo pharmacology models, and biomarkers for

Pulmonary Arterial Hypertension (PAH)
PAH despite recent therapeutic advances remains a deadly disease
●
NO-deficiency can underlie treatment failure of PDE5-inh.
●
●New therapeutic approaches are of interest (target ideas)
●New biomarkers

Secondary Pulmonary Hypertension (e.g. assoc. with lung diseases)
●Novel therapeutic approaches for sec. PH AFib
●Focus on the interaction of PH and underlying (lung) disease
●Predictive animal models for sec. PH
●Relevance of PH for underlying disease Sinus rhythm
●Subgroup analysis of pat. with secondary PH-forms incl. underlying diseases

Arterial Hypertension
●Current Bayer portfolio offers upside potential towards art. hypertension
●Current focus: resistant art. Hypertension (rHT)
●Stratification of patients with rHT

Chronic forms of peripheral vascular
diseases
●Predictive animal models e.g. innovative imaging techniques
●New biomarkers


needs
CARDIOLOGY –
☑
Hemoglobinopathies (Sickle Cell Disease, Beta-Thalassemia, Hemophilia A and B)
Bayer Healthcare Pharmaceuticals’ goal with its Cardiology business is to sustainably protect people‘s heart, lungs and
bloodstream, because Cardiovascular Diseases have become a severe problem in our society. Early diagnosis and therapy of
cardiovascular diseases plays a significant role – this is why our research concentrates on innovative approaches for several
heart, lung and vascular diseases as well as anti-coagulants.
Leverage hematology / cardiology expertise, particularly in disease complication modeling, with hemophilia core knowledge to
enter new indications in hemoglobinopathies.
Focus of external search is on proprietary (small and biological) molecules (e.g. inhibitors), innovative approaches, new
mechanism-of-action, state-of-the-art in-vitro, in-vivo and ex-vivo pharmacology models, and biomarkers for

Bayer’s cardiology compounds in development
●Novel antithrombotics in thrombosis indications e.g. anticoagulant rivaroxaban (Xarelto®)
●sGC – modulator franchise: frontrunner riociguat in phase III studies in pulmonary hypertension

Bayer seeks to pursue hemoglobinopathies through collaborative partnerships leveraging partner’
s scientific know-how and Bayer’s expertise.

needs

Oncology (updated 06-2012)


needs
☑ ONCOLOGY / GYNECOLOGICAL THERAPIES (innovative therapies for solid tumors)
The vision of the oncology research at Bayer Healthcare Pharmaceuticals is to improve the lives of patients affected by
cancer. Our pipeline offers therapies for both solid tumors (e.g. prostate, liver, colon, breast, kidney, lung, gastric and
pancreatic cancer) and benign hyper-proliferative diseases (e.g. uterine fibroids, endometriosis). It includes innovative
therapeutic strategies for the inhibition of tumor growth and cell proliferation using small molecule compounds (e.g. kinase
inhibitors) and biological compounds (e.g. antibody drug conjugates (ADC), and function blocking antibodies.
Beyond our own research efforts, we cooperate in multiple partnerships with health care professionals, universities,
academic research centers, other pharmaceutical companies, and innovative biotechnology organizations. Our solid
relationships with the scientific community foster an open exchange of ideas and information and help to expand our vision of
treatment.
Focus of external search is on proprietary new targets and tools, small molecules (e.g. kinase inhibitors), proteins (e.g.
antibodies), plasmids and cell lines, in-vitro technologies for functional analyses and animal models in the fields of
Cell cycle / Survival Signaling
● Cell cycle inhibition
● Tumor cell selective induction of apoptosis or other forms of cell death
Disease-relevant & predictive
Chromatin Modulation and OncoGenomics animal models for
Transcription and chromatin modulators
● ● all types of cancer
Specific antagonism/suppression of steroid receptors
●
● tumor metabolism
● triggering immune responses
Tumor Metabolism
● Inhibition of tumor metabolism 3D-in-vitro technologies
● Selective targeting of tumor-specific metabolic dependencies
● Cell/cell and Cell/ECM interactions

Cancer Immune Therapy and Antibody Drug Conjugates (ADCs)
●by counteracting immunosuppressive activities (e.g. immune checkpoint inhibition)
●by actively triggering immune response (e.g. BiTE)
●by selective killing of tumor cells using antibody drug conjugates (ADCs)

Hyper-proliferative Diseases
● Uterine fibroids
● Endometriosis / adenomyosis uteri

needs
☑ ONCOLOGY / GYNECOLOGICAL THERAPIES (innovative therapies for solid tumors)

Bayer Oncology Research Areas

Tumor Cell Cycle & Chromatin Cancer Stem
Metabolism & Survival Signaling Modulation Cells
Hypoxia
Antibody-Drug Cancer
Conjugates Immuno-
therapy

Cancer Genomics


Bayer HealthCare Pharmaceuticals Dr. Jörg Knäblein
Research Focus TECHNOLOGY SCOUTING
Bayer Healthcare Pharmaceuticals
TECHNOLOGY SCOUTING (TS) Phone: +49 30 4681 6852
Mobile: +49 160 972 06850
– presentation available upon request E-mail: joerg.knaeblein@bayer.com

Cardiology Oncology
Pulmonary Hypertension /
● Cell Cycle / Survival Signaling
●

Heart Failure ●Immunotherapy / Antibody-

●Thrombosis / Acute Coronary Drug Conjugates
Syndrome ●Tumor Metabolism / Hypoxia

●Cardiorenal Syndrome (CRS) ●Chromatin Modulation /
OncoGenomics

Hematology Gynecological Therapy
●Anemia and other blood diseases ● Endometriosis
●LCM long acting factor VIII - Uterine Fibroids

Common Mechanism Research & Other Areas
●Leveraging the full potential of development compounds
●Ophthalmology
●Inflammation
●LCM Fertility Control / Menopause-Management
●Magnetic Resonance and Computed Tomography Contrast Media Research

Page * Global Innovation Sourcing • – February 2012

needs

Reasons to Partner with Bayer


BHC Global Innovation Sourcing

We Talk Understand and Live
Science Business Partnerships
, , !

Page * • Global Innovation Sourcing • – February 2012

Our Strengths
Proven track record in identifying and optimizing innovative SMOL
●
leads
●One of the world‘s largest compound library (∼ 3 million cpds)
●Ultra-high-throughput compound screening platform in 1536-well
format
●HT protein optimization platform
●Human antibody / antibody-drug conjugate technology
●Protein analytics and clinical manufacturing
●Excellent cardiology pharmacology with long experience
●Strong oncology expertise with focus on `first in class´ molecules
●Well established oncology network

We want to share our experience with external innovative partners

Page * • Global Innovation Sourcing – February 2012

Reasons to partner with Bayer
●We want to add real value to the compound or therapeutic area
●We are flexible regarding collaboration terms and models
●We leave our partners room to develop and prosper
●We put emphasis on strong alliance management
●We have excellent research and manufacturing capabilities
●We are responsive and committed during the entire partnering
●We compensate adequately

Bayer HealthCare has a proven track record of successful partnerships


Bayer – Already A Selected
Partner of Choice For Many

Development/
Distribution

Discovery/
Technologies

You are welcome to join us!

Bayer Pharma‘s „From Targets To Novel Drugs“ Initiative

needs

Overview: Bayer HealthCare


Bayer HealthCare’s Top-Selling Products
of Today
Sales FY2010, currency-adjusted, €
mio.


Bayer: Science For A Better Life
Sales 2010

Bayer MaterialScience Bayer HealthCare (BHC)
€10.1 billion €17 billion
28.9% 54.2%

Bayer CropScience
19.5%
€6.8 billion


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.

Page * Bayer HealthCare Overview – February 2012

TECHNOLOGY SCOUTING (TS) –
we serve your needs

Dr. Jörg Knäblein
TECHNOLOGY SCOUTING, Global Innovation Sourcing
Bayer HealthCare Pharmaceuticals; Berlin, S107, 01, 117
Phone: +49 30 468-1 6852; Fax: +49 30 468-9 6852
Mobile: +49 160 972 06850
E-mail: joerg.knaeblein@bayer.com
Web: http://www.bayerpharma.de


TS knows internal needs due to close interaction with BHC
community – utilized sources come from personal contacts

TS is complementary to other Innovation Sourcing activities → value add is focus
on “terra incognita” (unpublished)
Scope:
Source, identify & evaluate valuable Tech
Offers / ASSETS (compounds, biomarker, TS addresses “Innovation Gap”:
animal models, cells, biospecimens, maturity, communication,
technologies, co-operations, projects) from and confidence
academic groups world wide
TS
●Conferences / Active Role
Clients: ●Networking / Personal Contacts
●Reach Out / Efficient Trips
Internal customers are from all indications & ●Educational Advertising /
all sites: GTR, LGO, ER groups, BUs, but Trustful Scientist
also GD; plus special requests from GPTs ●Leverage Internal Resources
asking for specific (external) support

Source:
External key sources are academic research
institutes, universities, TTOs, bioregions,
databases, newsletters, publications,
meetings, site-visits, conferences and –
personal communication


Unique Selling Proposition of TS is access to ASSETS not
yet published – enabled by global network of personal
contacts

Trust & scientific acceptance → ASSETS from invisible “terra incognita”
ASSETS Evolution of scouting
strategy

passi acti proactiv focuse
ve
ve e d
receiving screen ask specific request
offers databases TTOs directly @experts
visibl invisible “terra t
e incognita”
Focused Scouting: specific requests at personal contacts yield maximum ASSETS
Focused search in continuously extended network.
Ask for specific technologies at appropriate partners.
Follow-up with experts for other possible sources.


TS communication / interfaces essential to get ASSETS:
“Tell sources what BHC needs – and BHC what sources have”

Sources/Offer BHC Needs
s
●Research institutes pus pus ●ER groups, BUs
●Universities / TTOs ●GPTs,
h h
individuals
pull pull
GDD
Technology
Scouting
External: Internal:
TS Team Rooms
presentationwhat BHC
●Summary of (PIx)
●“Target-specific”
needs repositories

Baye BHC
what‘s r
USA BD&L “identifier
needed ”
“multiplier“ CANADA DDI what‘s needed &
JAPAN NBV what we have

… ROW … BUs

TS uses precise, continuously updated, and very tight
selection criteria to identify ASSETS: all indications, all
categories, all sites

Rigorous filtering (e.g. 98% attrition @Filter One) yields in valuable Tech Offers →
ASSETS
Filter Filter Filter
One: &
precise Two:
selected by Three:
acceptable
tight criteria BU/Functions conditions
(e.g.
resources)
& sponsor
> 10.000 Tech

in-house
@Bayer
Offers

Team Rooms ASSETS WIP
(PIx)

ONC WH DI CV
Animal Models
Biomarker/ -
Banks
Cell Lines
Compounds
Projects
Technologies

Bayer HealthCare Pharmaceuticals - Dr. Jörg Knäblein
TECHNOLOGY SCOUTING
Research Focus Bayer Healthcare Pharmaceuticals
TECHNOLOGY SCOUTING (TS) Phone: +49 30 4681 6852
Mobile: +49 160 972 06850
– presentation available upon request E-mail: joerg.knaeblein@bayer.com

Cardiology Oncology
Pulmonary Hypertension /
● Cell Cycle / Survival Signaling
●

Heart Failure ●Immunotherapy / Antibody-

●Thrombosis / Acute Coronary Drug Conjugates
Syndrome ●Tumor Metabolism / Hypoxia

●Cardiorenal Syndrome (CRS) ●Chromatin Modulation /
OncoGenomics

Hematology Gynecological Therapy
●Anemia and other blood diseases ● Endometriosis
●LCM long acting factor VIII - Uterine Fibroids

Common Mechanism Research & Other Areas
●Leveraging the full potential of development compounds
●Ophthalmology
●Inflammation
●LCM Fertility Control / Menopause-Management
●Magnetic Resonance and Computed Tomography Contrast Media Research


TechTransfer Initiative


TECHNOLOGYSCOUTING (TS) – Meeting in Berlin in upon request
TECHNOLOGY TRANSFER – presentation available August 2011

Pharma perspective on TechTransfer in Germany
Attendies
●Manfred Horst (MSD)
●Jörg Knäblein (Bayer)
●Marcus Kostka (Boehringer Ingelheim)
●Ralph Kray (Johns Hopkins Business School)
●Lucks (Novartis)
●Hüls (MerckSerono)
●Burkhard Fugmann (BIG)

Best practice sharing - TTO and Pharma
Common understanding of optimization potential
●No harmonized clear dataset for technology offers – highly diverse
●Technology transfer professional: skills, edjucational background, motivation
and overview on research activities
●No existing central portal to access all existing technology offers
●PVA´s not acting as central business partner for Pharma
●Optimization of training for TTO professionals (Curriculum)


TECHNOLOGY TRANSFER – proposal for standardized
TechOffers SCOUTING (TS) – presentation available upon request
TECHNOLOGY

Standardization of TechOffers (content / data / info / format)

Prerequisite – all data and information non-confidential
1. Summary of mode of action, target or new pathway/mechanism in the
context of relevant indication
2. Summary of the most important biology/pharmacology data including
the status of the in vivo efficacy profile
3. Information about type of opportunity – NCE/NBE vs method/assay vs
technology (drug delivery, formulation etc)
4. If NCE/NBE overview on compound profiling status (DMPK, CMC, Tox,
Gen Pharm)
5. IP – status and owner of patent applications
6. Further information – citation of relevant publications, patents, or links


TECHNOLOGY TRANSFER – proposal for standardized
TechOffers SCOUTING (TS) – presentation available upon request
TECHNOLOGY

Standardization of TechOffers (content / data / info / format)
Additional points to consider for TechTransfer – at a later stage
1. Business model
a) License model for Foreground IP (created during collaboration):
university to own with NERF (non-exclusive royalty free) license to
sponsor + option for exclusivity to sponsor OR all to sponsor with license?
b) License model for Background IP: milestones, option for exclusivity?
2. Payment for development activities: effort (man hours, consumables etc)
or fixed package? Milestone based?
3. Insight into cost structure (separating actual cost from overhead)

Points for discussion:
1. Proposal of technology transfer portal (communication platform) with
standardized and up to date opportunities
2. Proposal on harmonizing technology transfer by using the existing
PVA´s per state with respective professional skills and education
3. Improvement of skills by continues training of technology transfer
professions at academia and institutes
4. Start dialogue with academic partners on TT optimization on both ends


TECHNOLOGY TRANSFER – additional thoughts from
pharma colleagues
TECHNOLOGY SCOUTING (TS) – presentation available upon request

Standardization of TechTransfer (content / data / info / format)

Create market place
the place to look to get away from “accidental” identification of opportunities
Harmonization is also
the “management of expectations” at both ends

Skill set
Besides the “jack of all trades device” for BAT IIa we wish the following:

Non dogmatic, pragmatic personality (tough to train, but very important)

Excellent negotiation skills (Harvard Business School training or equivalent)
●Sound understanding of pharmaceutical development processes
●Understanding of work in a highly regulated environment (GLP, GMP, GCP etc.)
●Sound understanding of IP principles including “Employee Inventions Act”
●Basics of “Contracting” & Legal language


TECHNOLOGY TRANSFER – current status

Meeting held with TT managers from academia 21st Sep 2011

These "areas of improvement„ (worked out from a pharma perspective) were
presented at a meeting with academic patent commercialization agencies
(4. Treffen der Arbeitsgruppe Technologietransfer) on Wednesday, 21st of
September 2011 in Mannheim.
This initiative to improve Tech Transfer between academia and industry was very
much appreciated by all participants.

Joint meeting with managers from academia and industry 17th of Nov 2011

Due to the success of the Mannheim meeting and the importance of this topic,
attendees asked to organize another exchange forum for academia and industry to
intensify and improve Tech Transfer .
This meeting was held on the 17th of at Bayer in Düsseldorf. Besides colleagues from
Bayer, BI, Merck, and Novartis, essentially ALL German patent commercialization
agencies attended. This was judged as indicator for the importance of tis initiative.

TECHNOLOGY TRANSFER – next steps


Next meeting with EuKTS planned for 7th Mar 2012 in Mnunich

As an important next step we have planned discussions with BMBF (Federal
Ministry of Education and Research) to ensure a specific pharma TechTransfer
curriculum and its region wide establishment.

Also it is planned to closely interact with the European Knowledge Society (EuKTS)
to harmonize all efforts and bring the TechTransfer initiative on a European level.

A meeting with industry representatives from the TechTransfer initiative and
academic representatives from the German patent commercialization agencies will
be held on 7th of March in Munich. Here we will discuss a joint strategy with
representatives from EuKTS.


TECHNOLOGY TRANSFER – presentation available upon request
TECHNOLOGY SCOUTING (TS) – proposal for TT Curriculum (1/2)

TT Curriculum for TT offices and companies
A. Innovation
1. Discovery and invention process kindly provided by
2. Product design and innovation Johns Hopkins
3. Managing the innovation process in a company

B. Intellectual Property
1. Concept of intellectual property and different type of IP
2. Patenting, what constitutes something that can be patented
3. Patent landscaping
4. Patent claims and patenting strategy

C. Market Research
1. Market research (purpose and types)
2. Most common techniques of market research (focus groups, user
surveys, conjoint analysis, potential customer surveys)
3. Estimating market size and market growth

TECHNOLOGY TRANSFER – presentation available upon request
TECHNOLOGY SCOUTING (TS) – proposal for TT Curriculum (2/2)

TT Curriculum for TT offices and companies

D. Go-to-Market Strategies
1. Types of go to market strategies (start up, merger/acquisition, license)
2. Valuation of the IP
3. Financing the go-to-market strategy (sources of financing and costs)

E. Business Planning
1. Concept of the business model
2. Writing the business plan: key elements
3. The Elevator Pitch
4. Governance and ownership structure of the company


Global Innovation Sourcing
Partnering Activities @ Global Drug
Discovery


Bayer HealthCare
Divisions


Bayer HealthCare
Research at a Glance

Berli Wuppertal / Cologne Berkeley / Beijin
n / San g
Monheim Francisco
Oncology
● Cardiology
● ●Hematology ●GDD Innovation
Women’s
● Oncology
● ●Biologics Research & Center China
Healthcare ●Biologics Research & Development ●Bayer Tsinghua
●Diagnostic Imaging Development ●Science Hub US Center for Innovative
●Animal Health Research Drug Discovery

Investment in R&D 2010: € 1.8 billion
●
●Investment in R&D of 2010 total net sales:
16.1%
●R&D Employees: 6,200 (2010)


Our R&D Pipeline Provides a Balanced
Mix of NME and LCM Opportunities
Phase I (10) Phase II (11) Phase III (19)
Cancer CHF Ovarian/Peritoneal Cancer CRVO VTE Treatment
PI3K Inhibitor (BAY 80-6946) BAY 94-8862 (MR Sorafenib VEGF Trap-Eye Rivaroxaban
Cancer Antagonist) Additional Indications Myopic CNV ACS
CDK-Inhibitor (BAY 1000394) Pulmonary Hypertension Sorafenib VEGF Trap-Eye Rivaroxaban
Cancer Riociguat (sGC Stimulator) Lung Infection DME NSCLC
HIF1a – Inhibitor (BAY 97- Cancer Cipro inhale VEGF Trap-Eye Sorafenib
2243) Regorafenib Gram-negative PAH Thyroid Cancer
Cancer Cancer Pneumonia Riociguat (sGC Sorafenib
BAY 94-9343 (Mesothelin-ADC) BAY 86-9766 (MEK-Inhibitor) Amikacin inhale Stimulator) Breast Cancer
Anemia Bone Mets Breast Cancer CTEPH Sorafenib
BAY 85-3934 (HIF-PH) Alpharadin Riociguat (sGC Multiple
Sympt. Uterine Fibroids Atopic Dermatitis Stimulator) Sclerosis
BAY 1002670 (S-PRAnt) Mapracorat (SEGRA) CRC Alemtuzumab
Diagnostic Imaging ED Regorafenib Contraception
PET-Tracer BAY 60-4552/Vardenafil GIST LCS (ULD LNG)
MCI Regorafenib Contraception
BAY 94-9172 (Florbetaben) Alzheimer PET Imaging FC Patch Low
Hemophilia BAY 94-9172 (Florbetaben) MRI LCM
BAY 94-9027 (peg rFVIII) Submental fat removal Gadovist
Hemophilia ATX-101 VV Atrophy
BAY 86-6150 (rFVIIa) Vaginorm

New
Molecular
Entities (NME)
Life Cycle
Status as of October 2011 Management
Table provides a selection of major pipeline projects of Bayer HealthCare (LCM)
Page * Global Innovation Sourcing – February 2012

Strong BHC Clinical Pipeline
Cancer / PI3K Inhibitor Cancer / Regorafenib NSCLC / Sorafenib
Cancer / CDK Inhibitor Cancer / MEK-Inhibitor Thyroid Cancer / Sorafenib
Cancer / HIF1a Inhibitor Bone Mets Breast Cancer / Alpharadin Breast Cancer / Sorafenib
Anemia / HIF-PH Ovarian / Peritoneal Cancer / Sorafenib CRC / Regorafenib
Hemophilia / BAY 94-9027 CRC / Sorafenib GIST / Regorafenib
Hemophilia / BAY 86-6150 Additional Indications / Sorafenib VTE Treatment / Rivaroxaban
Sympt. Uterine Fibroids / S- CHF / MR Antagonist ACS / Rivaroxaban
PRAnt PH / Riociguat (sGC Stimulator) PAH / Riociguat (sGC Stimulator)
MCI / Florbetaben ED / BAY 60-4552/Vardenafil CTEPH / Riociguat (sGC
Diagnostic Imaging / PET-Tracer Atopic Dermatitis / Mapracorat (SEGRA) Stimulator)
Lung Infection / Cipro DPI Myopic CNV / VEGF Trap-Eye
Gram-negative Pneumonia / Amikacin DME / VEGF Trap-Eye
inhale CRVO / VEGF Trap-Eye
Contraception / LCS (ULD LNG)
Contraception / FC Patch Low
VV Atrophy / FSD / Vaginorm
Oncology
Cardiology/Hematolog MRI LCM / Gadovist
y
Women’s Multiple Sclerosis / Alemtuzumab
Healthcare
Diagnostic Submental fat removal / ATX-101
Imaging
Ophthalmolog
y
Other
s

Status as of July 2011
Table provides a selection of major pipeline projects of Bayer HealthCare


More Than 40% From In-Licensing Or
Together With External Partners
Cancer / PI3K Inhibitor Cancer / Regorafenib NSCLC / Sorafenib
Cancer / CDK Inhibitor Cancer / MEK-Inhibitor Thyroid Cancer / Sorafenib
Cancer / HIF1a Inhibitor Bone Mets Breast Cancer / Alpharadin Breast Cancer / Sorafenib
Anemia / HIF-PH Ovarian / Peritoneal Cancer / Sorafenib CRC / Regorafenib
Hemophilia / BAY 94-9027 CRC / Sorafenib GIST / Regorafenib
Hemophilia / BAY 86-6150 Additional Indications / Sorafenib VTE Treatment / Rivaroxaban
Sympt. Uterine Fibroids / S- CHF / MR Antagonist ACS / Rivaroxaban
PRAnt PH / Riociguat (sGC Stimulator) PAH / Riociguat (sGC Stimulator)
MCI / Florbetaben ED / BAY 60-4552/Vardenafil CTEPH / Riociguat (sGC
Diagnostic Imaging / PET-Tracer Atopic Dermatitis / Mapracorat (SEGRA) Stimulator)
Lung Infection / Cipro DPI Myopic CNV / VEGF Trap-Eye
Gram-neg. Pneumonia / Amikacin DME / VEGF Trap-Eye
inhale CRVO / VEGF Trap-Eye
Contraception / LCS (ULD LNG)
Contraception / FC Patch Low
VV Atrophy / FSD / Vaginorm
Oncology
Cardiology/Hematolog MRI LCM / Gadovist
y
Women’s Multiple Sclerosis / Alemtuzumab
Healthcare
Diagnostic Submental fat removal / ATX-101
Imaging
Ophthalmolog
y
Other
s

Status as of July 2011
Table provides a selection of major pipeline projects of Bayer HealthCare


Companies harbor only a small portion
of the biomedical knowledge
Even with a budget of >1.5 billion €, BHC Pharmaceuticals R&D
●
only represents <1% of the annual spending on biomedical R&D
globally
●Closer relationship to partners in academia and biotech needed
to make better use of the existing knowledge and to address the
major challenges in biomedical R&D
●Research collaborations with academic, small biotech firms or
large pharmaceutical corporations are an integral element of our
innovation strategy
●Collaborations in all phases of the value chain – from research to development
and production to marketing.

The Global Innovation Sourcing Team is your partner at
BHC when it comes to discussions about early assets and
technologies, for licensing as well as for out-partnering
activities.


Partnering Organization Works Along
The Value Chain
Lead
Researc Pre- Clinical
discovery Clin.
TD h LD LO development
Dev. Ph I Ph II Ph
III
Driven by scientific concepts and data Driven by clinical PoC data

Innovation Business
Sourcing development

Access to projects and new sources of
●
innovation through partnerships and
licenses
●Innovative / flexible partnership models
to find mutually beneficial solution
●Responsibility for licensing, out-
partnering of early assets, collaborative
research


Feedback from Our Academic Partners
Prof. Otmar D. Wiestler, Scientific Director of DKFZ, Heidelberg,
Germany:
“Bayer HealthCare is an ideal partner for German Cancer Research Center because
it is committed to pursue innovative therapeutic concepts and invest in high-risk
ideas. We experience Bayer HealthCare as a reliable, highly competent partner with
an open mindset. Our alliance clearly generates a win-win situation and can serve as
a model for public-private partnerships in the biomedical field.”
Prof. Wang, Moores UCSD Cancer Center, La Jolla,
USA: are two advantages in the G4T program. The first being the speed with which
“There
the grant is funded. The second being the potential of further collaboration in the
future to advance the common research interests between my laboratory and
Bayer AG.”
Prof. Multhaup, Free University of Berlin,
Germany:
“We have experienced an excellent support by Bayer HealthCare Scientists and have
had encouraging discussions.”


Feedback from Our Biotech Partners
Paul Hastings, President and CEO, OncoMed
Pharmaceuticals
“We have greatly enjoyed working with Bayer on our Wnt Pathway partnership, which
was forged in June 2010. The collaborative spirit of the interactions has resulted in
significant R&D progress, including our first antibody in the pathway (OMP-18R5)
advancing to clinical testing earlier this year, and significant progress on our 2nd
biologic program and small molecule discovery efforts. This is a great example of how
biotech and pharma companies can bring the best of their respective talents to
advance innovation.”
Jens Hennecke, Ph.D., SVP, Business Development,
Micromet
“Our collaboration with Bayer is built on trust and a shared desire to utilize the skills
and strengths of both organizations to develop a new therapy for prostate cancer. We
view Bayer to be an ideal partner on account of its expertise in oncology, shared
conviction in the promise of our technology, excellent collaborative spirit and ability to
aggressively advance a product through development and onto the market. We are
very pleased with the rapid progress achieved so far under this collaboration since its
inception in 2009 and look forward to continuing to work together to ultimately treat
cancer patients with BAY2010112 / MT112.”

Some Examples in More Detail …
OncoMed / Tumor Stem Cells
Global strategic alliance signed in June 2010
● Wnt
●Focus on the discovery, development and Pathway
commercialization of novel anti-cancer stem cell Biologics

therapeutics targeting the Wnt signaling pathway
●Bayer with the option to exclusively license
antibody and protein therapeutic product
candidates at any point up to the completion of
Phase I testing
●Bayer and OncoMed share technology and
know-how to discover and develop small molecule
inhibitors of the Wnt pathway
Small Molecules
●FDA accepted OncoMed‘s IND filing for a
monoclonal Anti-Frizzled antibody
(OMP-18R5 ) in April 2011 Transcription on


Some Examples … German Cancer
Research Center Alliance
First agreement signed in 2007, collaboration extended for another 3 years
●
in 2011
●German Cancer Research Center (DKFZ) as the largest biomedical oncology research
center in Europe
●Collaboration along the entire drug discovery and development value chain
●Novel risk and reward sharing approach to collaborate with joint financing
(1 million Euro / year / partner) and project selection (currently >9 joint projects)
●Ideal partnership due to high strategic fit and complementary competencies

Bench Bedside


Some Examples …
Tsinghua University Beijing
Comprehensive collaboration agreement signed in 2009
●
●The 1st strategic partnership with long-term commitment to discover new
targets/molecules in China
●Tsinghua University is the No.1 university in China with the fastest growing life science
disciplines, led by world renowned structural biologist, Prof. Yigong Shi
●Bayer-Tsinghua Joint Research Center of Innovative Drug Discovery (BTC) founded

Letter of Intent Signing, November BTC Inauguration Ceremony, June
2008 2009


Some Examples …
Grants4Targets Initiative
Background
●Numerous targets exist, but are “invisible” for us
●The knowledge outside > inside

Idea
Join forces with academia and biotech start ups to translate innovative targets
●
into drugs
●Provision of grants to evaluate and validate novel targets – “Grants 4 targets”

Approach
●Easily accessible Internet site and submission tool
●Low bureaucratic burden for both partners
●Clear communication on “needs” – what are we looking for?
●Fast processing of requests

Lead
Target Lead
Optim Preclinic Clinic Submissio
Disco Generat
i- al al n
very ion
zation

http://www.grants4targets.com


Some Examples … The Innovative
Medicines Initiative (IMI)
●Biggest Public Private Partnership in Life Science; joint budget of €2
billion
●Focus on efficacy in 5 disease areas, safety, knowledge management
and
education & training
●IMI projects address key pre-competitive bottlenecks identified by
Pharma
●Public funding goes exclusively to non-pharma partners like academia,
small and medium enterprises, patient organizations and regulators

Projects


Conclusion

Bayer HealthCare is committed to innovation
●
●Partnerships are key for being world-class in research & development
●Complementary skills and expertise offer excellent basis for future collaborations
●We look forward to establishing joint projects – to find and evaluate
new targets and define new treatment options for the benefit of patients

External innovation is a key component in our R&D strategy


Global Partnering with Academia
and Industry Along the Value Chain
Lead
Target Pre- Clinical/PO
Generation/
Discovery clinical C
Optimization
Innovative Medicines Initiative
OncoMed Public private partnership between
Corporate partnership on European Commission & Pharma
cancer stem cell therapies

German Cancer Center (DKFZ)
Strategic partnership with joint
Ardea Tsinghua University
financing; > 9 projects running
Corporate licensing of 10 collaborative projects
MEK inhibitors for cancer across therapeutic areas

Singapore
Multiple programs for diagnosis:
treatment of Asian specific cancer

Grants4Targets (Global)
Online crowd sourcing; over 70 grants for new target research provided


Small Molecule Candidate
Generation Platform
Generation of innovative small molecule lead structures using ultra-high-
●
throughput screening of a ca. 3 million compound library in 1536-well format,
supported by structural biology, fragment based technologies, etc.
●Optimization of leads to development compounds with high clinical

success rate, origin of marketed drugs like Nexavar® and Xarelto®
●Close collaboration with Global Biologics on drug-antibody conjugates

Preclinical Clinic
Target Compound Lead Lead
Discovery Screening Generation Optimization Phase I
Development

Compound Collection, Medicinal Chemistry, Pharmacophore Structural Biology,
High-Throughput and Automated Synthesis Informatics, Computational
High-Content Screening and Purification Property Prediction Chemistry


GDD-Global Biologics R&D
Core capabilities Biologics Pipeline

Coagulation factor (CF)
●
Marketed
engineering
●Human antibody technology
●HTP protein optimization
●Antibody drug conjugates, incl.
analytics Post-
and clinical manufacturing PoC
VEGF Trap-Eye Alemtuzumab KG-PF
Disease
areas
●Oncology Research and Pre-clinical
●Hematology
mAbs Engineered
●Cardiology
CFs
●Gynecology
IgG
●Ophthalmology antigen
Toxophore

Fab ADCs


Common Mechanism Research
Platform
Search for new indications for clinical development candidates using
●
bioinformatic pathway analysis, data mining, phenotypic in vitro assays and in
vivo models
●Inflammation platform to explore development of compounds across multiple
indications to identify an optimal path forward
●Identification of new therapeutics for age-related macular degeneration

Preclinical Clinic
Target Compound Lead Lead
Discovery Screening Generation Optimization Phase I
Development

Bioinformatics
platform, data mining Phenotypic in vivo
(Phylosopher) in vitro Models Pharmacology


Bayer Oncology Research
●Addressing key pathomechanisms and novel treatment
paradigms with SMOL and monoclonal antibodies
●In the top group in areas like antibody-drug-conjugates,
cell cycle regulation and survival signaling
●Strong interest in areas like tumor metabolism, hypoxia,
chromatin modulation, oncogenomics, cancer stem cells
and cancer immunotherapy
●Broad network of partners in academia and biotech


Bayer Cardiology Research
●Over 20 years experience with cardiovascular
pharmacology and the identification and optimization of
innovative compounds such as Adalat®, Xarelto® and
riociguat
●Focused on heart diseases (heart failure, atrial
fibrillation), vascular diseases (pulmonary hypertension)
and acute care (thrombosis, acute coronary syndrome,
ischemic stroke)
●State-of-the-art in vivo pharmacology with disease-
mirroring animal models for CV indications in
8 different species from mouse to dog. Clinical methods
are used for the evaluation of compound efficacies which
can then easily be translated into clinical studies
●Broad network of KOLs and academic institutions in all
focus disease areas


BHC Global Innovation Sourcing

Science

We Talk

Understand

and Live

Partnership Business
s

Probability of success from research to
market approval: <1%
Evaluation Phase IV
Drug research Preclinica Clinical / studies
l trials Approval
Lab and Phase I: 20-100 healthy (up to (more
animal volunteers 2 years) than
experiments 2 years)
Phase II: 100-500 patients ➔
safety, dosing
Phase III: 1,000-10,000 patients
➔
efficacy, adverse events

1 drug ap-
proved by
10,000 <250 <5 Test compounds
Test Test
health
compounds compounds authoritie
s
€ >1 billion

0 2 4 6 8 1 1 1 1 1 Y
0 2 4 6 8 ears
Source: based on PhRMA Profile Pharmaceutical Industry
2010

Improving R&D Efficiency and Maximizing
the Value of Transformational Late-Stage
Pharmaceutical Pipeline Assets

Establish Xarelto® (rivaroxaban) as an ideal
●
anticoagulant with the potential to redefine the market
®
●Demonstrate Nexavar ’s potential as a pan-tumor drug
and a building block of Bayer’s global oncology franchise
●Transform hemophilia market by developing

a long-acting Kogenate®
●Establish a new paradigm in the treatment of
age-related macular degeneration with VEGF Trap-Eye

Page * Bayer HealthCare Overview • – February 2012

Technology scouting at Bayer Healthcare

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