technology scouting at bayer healthcare

TECHNOLOGY SCOUTING (TS) –we serve your needs

Dr. Jörg KnäbleinTECHNOLOGY SCOUTINGBayer HealthCare Pharmaceuticals; Berlin, S107, 01, 117Phone: +49 30 468-1 6852; Fax: +49 30 468-9 6852 Mobile: +49 160 972 06850E-mail: [email protected]: http://www.bayer.com

Workshop Czech RepublicPharma TechTransfer 11th of October 2012

Dr. Jörg Knäblein TECHNOLOGY SCOUTING (TS), GDD Global Innovation Sourcing# * +49 30 468 1 6852, [email protected]

TS – we serve your needs

TECHNOLOGY SCOUTING (TS) – we serve your needs

ANIMAL MODELS ●Preamble ●Search criteriaBIOBANKING and BIOMARKER●Preamble●Search criteriaTRG 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

Topics and keywords for external search performed by TECHNOLOGY SCOUTING for focused search in academia:

Animal Models





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)

1/2

☑

● 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



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

Animal models (transgenic, syngeneic, knock-out, knock-in, xenografts, orthotrop)

2/2

●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

TRG CARDIOLOGY (updated 06-2012)☑

Biobanking and Biomarker




TS – we serve your needsHuman 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

☑●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

Oncology/Gynecological Therapies (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

Cardiovascular (updated 06-2012) ☑

Cardiology (updated 06-2012)





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

●Chronic treatment, high risk patients●No acute therapy●New biomarkers

Acute Coronary Syndromes (ACS) anticoagulation, antiplatelets

☑CARDIOLOGY – Acute Care Research (ACS, PAOD, Ischemic Stroke, DIC, ALI/ARDS)

●Novel therapeutic approaches●Predictive animal models e.g. innovative imaging techniques●New biomarkers

Peripheral Arterial Occlusive Disease (PAOD), Ischemic Stroke (IS) prevention, and Critical Limb Ischemia (CLI)

●Novel therapeutic approaches●Predictive animal models with respect to development state●Identifying disease-stage specific biomarkers

Acute/Intensive Care e.g. Acute Lung Injury (ALI) / Acute Respiratory Distress Syndrome (ARDS), Acute Kidney Injury (AKI), Disseminated Intravascular Coagulation (DIC)



Bayer Healthcare Pharmaceuticals’ goal with its Cardiology business is to sustainably 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 improve and protect heart function in patients with heart failure and other heart diseases as well as 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

●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

Heart Failure (HF)

☑CARDIOLOGY –Heart Diseases (Heart Failure, Atrial Fibrillation, Cardioprotection)

AFib

Sinus rhythm●Novel therapeutic approaches for rate and rhythm control●Predictive animal models

Atrial Fibrillation (AF)

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

Cardioprotection (ischemia/reperfusion)

AFib

Sinusrhyth

m



Bayer Healthcare Pharmaceuticals’ goal with its Cardiology business is to sustainably 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 improve and protect renal function in patients with acute and chronic kidney dysfunction and insufficiency. 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

●Novel therapeutic approaches to protect diabetic patients from developing and worsening of DN●Predictive animal models●Biomarkers for early monitoring of therapeutic success

Diabetic Nephropathy (DN)

☑CARDIOLOGY –Kidney Diseases (Diabetic Nephropathy, CKD, Acute Renal Insufficiency)

AFib

Sinus rhythm

●Novel therapeutic approaches ●Predictive animal models●Biomarkers for early monitoring of therapeutic success

Chronic Kidney Disease (CKD) progression


Acute Renal Insufficiency

●Novel therapeutic approaches ●Predictive animal models and biomarkers

Cardiovascular Diseases associated with CKD


Ischemia- or hypertension- induced CKD



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

●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

Pulmonary Arterial Hypertension (PAH)

☑CARDIOLOGY – Vascular Disease (Pulmonary Hypertension)

AFib

Sinus rhythm

Secondary Pulmonary Hypertension (e.g. assoc. with lung diseases)

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

Arterial Hypertension

●Novel therapeutic approaches for sec. PH●Focus on the interaction of PH and underlying (lung) disease●Predictive animal models for sec. PH●Relevance of PH for underlying disease●Subgroup analysis of pat. with secondary PH-forms incl. underlying diseases

Chronic forms of peripheral vascular diseases

●Novel therapeutic approaches●Predictive animal models e.g. innovative imaging techniques●New biomarkers



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

☑CARDIOLOGY – Hemoglobinopathies (Sickle Cell Disease, Beta-Thalassemia, Hemophilia A and B)

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.

Oncology (updated 06-2012)





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

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

●Cell cycle inhibition●Tumor cell selective induction of apoptosis or other forms of cell death

Cell cycle / Survival Signaling

●Transcription and chromatin modulators●Specific antagonism/suppression of steroid receptors

Chromatin Modulation and OncoGenomics

●Inhibition of tumor metabolism ●Selective targeting of tumor-specific metabolic dependencies

Tumor Metabolism

●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)

Cancer Immune Therapy and Antibody Drug Conjugates (ADCs)

Disease-relevant & predictive animal models for● all types of cancer● tumor metabolism● triggering immune responses

3D-in-vitro technologies● Cell/cell and Cell/ECM interactions

●Uterine fibroids ●Endometriosis / adenomyosis uteri

Hyper-proliferative Diseases



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

Chromatin Modulation

Cancer Stem Cells

Cancer Immuno-therapy

Tumor Metabolism & Hypoxia

Cell Cycle & Survival Signaling

Antibody-Drug Conjugates

Cancer Genomics

Bayer Oncology Research Areas

Page * Global Innovation Sourcing • – February 2012

Bayer HealthCare Pharmaceuticals Research Focus

Cardiology

Gynecological Therapy

Oncology●Pulmonary Hypertension /

Heart Failure●Thrombosis / Acute Coronary

Syndrome●Cardiorenal Syndrome (CRS)

● Endometriosis- Uterine Fibroids

●Cell Cycle / Survival Signaling ●Immunotherapy / Antibody-

Drug Conjugates●Tumor Metabolism / Hypoxia●Chromatin Modulation /

OncoGenomics

Hematology●Anemia and other blood diseases●LCM long acting factor VIII

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

TECHNOLOGY SCOUTING (TS)– presentation available upon request

Dr. Jörg Knäblein TECHNOLOGY SCOUTINGBayer Healthcare PharmaceuticalsPhone: +49 30 4681 6852 Mobile: +49 160 972 06850E-mail: [email protected]

Reasons to Partner with Bayer



Page * • Global Innovation Sourcing • – February 2012

BHC Global Innovation Sourcing

We Talk Science,

and LivePartnerships!

Understand Business,

Page * • Global Innovation Sourcing – February 2012

Our Strengths

We want to share our experience with external innovative partners

●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


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 SelectedPartner of Choice For Many

You are welcome to join us!

Discovery/Technologies

Development/Distribution

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

Overview: Bayer HealthCare




Bayer HealthCare’s Top-Selling Productsof Today

Sales FY2010, currency-adjusted, € mio.


Bayer: Science For A Better LifeSales 2010

Bayer CropScience

Bayer MaterialScience Bayer HealthCare (BHC)€17 billion€10.1 billion

€6.8 billion

28.9%

19.5%

54.2%

Thank you!

Page * Bayer HealthCare Overview – February 2012

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.

TECHNOLOGY SCOUTING (TS) –we serve your needs

Dr. Jörg KnäbleinTECHNOLOGY SCOUTING, Global Innovation SourcingBayer HealthCare Pharmaceuticals; Berlin, S107, 01, 117Phone: +49 30 468-1 6852; Fax: +49 30 468-9 6852 Mobile: +49 160 972 06850E-mail: [email protected]: http://www.bayerpharma.de


Scope:

Source, identify & evaluate valuable Tech Offers / ASSETS (compounds, biomarker, animal models, cells, biospecimens, technologies, co-operations, projects) from academic groups world wide

Clients:

Internal customers are from all indications & all sites: GTR, LGO, ER groups, BUs, but also GD; plus special requests from GPTs 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

TS is complementary to other Innovation Sourcing activities → value add is focus on “terra incognita” (unpublished)

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

●Conferences / Active Role●Networking / Personal Contacts●Reach Out / Efficient Trips●Educational Advertising /

Trustful Scientist●Leverage Internal Resources

TS addresses “Innovation Gap”: maturity, communication, and confidence

TS


Unique Selling Proposition of TS is access to ASSETS notyet published – enabled by global network of personal contacts

Focused search in continuously extended network.Ask for specific technologies at appropriate partners.Follow-up with experts for other possible sources.

Focused Scouting: specific requests at personal contacts yield maximum ASSETS

Trust & scientific acceptance → ASSETS from invisible “terra incognita”

t

ASSETS

visible

invisible “terra incognita”

Evolution of scouting strategy

receiving offers

passive

screen databases

active

ask TTOs

proactive

specific requestdirectly @experts

focused


Bayer BD&L

DDIUSA

NBV

… BUs

CANADA

JAPAN

… ROW

BHC

●Research institutes ●Universities / TTOs

Sources/Offers

“multiplier“what‘s needed

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

GDDTechnologyScouting

push

pull

push

pull

TS presentation●Summary of what BHC needs

External: Team Rooms (PIx)●“Target-specific” repositories

Internal:

●ER groups, BUs●GPTs,

individuals

BHC Needs

what‘s needed & what we have

“identifier”


Team Rooms (PIx)

precise & tight criteria

Filter One:

ASSETS

selected byBU/Functions

Filter Two:

WIP

acceptable conditions(e.g. resources)& sponsor

Filter Three:

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

in-house@Bayer

Animal ModelsBiomarker/ -BanksCell LinesCompoundsProjectsTechnologies

ONC WH DI CV

Rigorous filtering (e.g. 98% attrition @Filter One) yields in valuable Tech Offers → ASSETS

> 10

.000

Tec

h O

ffers



Bayer HealthCare Pharmaceuticals - Research Focus

Cardiology

Gynecological Therapy

Oncology●Pulmonary Hypertension /

Heart Failure●Thrombosis / Acute Coronary

Syndrome●Cardiorenal Syndrome (CRS)

● Endometriosis- Uterine Fibroids

●Cell Cycle / Survival Signaling ●Immunotherapy / Antibody-

Drug Conjugates●Tumor Metabolism / Hypoxia●Chromatin Modulation /

OncoGenomics

Hematology●Anemia and other blood diseases●LCM long acting factor VIII

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

TECHNOLOGY SCOUTING (TS)– presentation available upon request

Dr. Jörg Knäblein TECHNOLOGY SCOUTINGBayer Healthcare PharmaceuticalsPhone: +49 30 4681 6852 Mobile: +49 160 972 06850E-mail: [email protected]

TechTransfer Initiative


TECHNOLOGY SCOUTING (TS) – presentation available upon request

Pharma perspective on TechTransfer in Germany

TECHNOLOGY TRANSFER – Meeting in Berlin in August 2011

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 PharmaCommon 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)



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

TECHNOLOGY TRANSFER – proposal for standardized TechOffers

Prerequisite – all data and information non-confidential 1. Summary of mode of action, target or new pathway/mechanism in the context of relevant indication2. 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 applications6. Further information – citation of relevant publications, patents, or links



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

TECHNOLOGY TRANSFER – proposal for standardized TechOffers

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 education3. Improvement of skills by continues training of technology transfer professions at academia and institutes4. Start dialogue with academic partners on TT optimization on both ends



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

TECHNOLOGY TRANSFER – additional thoughts from pharma colleagues

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 setBesides 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.



TT Curriculum for TT offices and companies

TECHNOLOGY TRANSFER – proposal for TT Curriculum (1/2)

A. Innovation1. Discovery and invention process2. Product design and innovation3. Managing the innovation process in a company

kindly provided by Johns Hopkins

B. Intellectual Property1. Concept of intellectual property and different type of IP2. Patenting, what constitutes something that can be patented3. Patent landscaping4. Patent claims and patenting strategy

C. Market Research1. 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



TT Curriculum for TT offices and companies

TECHNOLOGY TRANSFER – proposal for TT Curriculum (2/2)

D. Go-to-Market Strategies1. Types of go to market strategies (start up, merger/acquisition, license)2. Valuation of the IP3. Financing the go-to-market strategy (sources of financing and costs)

E. Business Planning1. Concept of the business model2. Writing the business plan: key elements3. The Elevator Pitch4. Governance and ownership structure of the company


Global Innovation SourcingPartnering Activities @ Global Drug

Discovery



Bayer HealthCareDivisions


●Hematology ●Biologics Research &

Development●Science Hub US

●Oncology●Women’s

Healthcare●Diagnostic Imaging

●Cardiology●Oncology●Biologics Research &

Development●Animal Health Research

●GDD InnovationCenter China

●Bayer TsinghuaCenter for InnovativeDrug 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)

Berkeley / San Francisco

Berlin

Wuppertal / Cologne

/Monheim

Beijing

Bayer HealthCareResearch at a Glance

Page * Global Innovation Sourcing – February 2012

Our R&D Pipeline Provides a Balanced Mix of NME and LCM Opportunities

New MolecularEntities (NME)Life CycleManagement (LCM)

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

Phase I (10)CancerPI3K Inhibitor (BAY 80-6946)CancerCDK-Inhibitor (BAY 1000394)CancerHIF1a – Inhibitor (BAY 97-2243)CancerBAY 94-9343 (Mesothelin-ADC)AnemiaBAY 85-3934 (HIF-PH)Sympt. Uterine FibroidsBAY 1002670 (S-PRAnt)Diagnostic ImagingPET-TracerMCIBAY 94-9172 (Florbetaben)HemophiliaBAY 94-9027 (peg rFVIII)HemophiliaBAY 86-6150 (rFVIIa)

Phase II (11)Ovarian/Peritoneal CancerSorafenibAdditional IndicationsSorafenibLung InfectionCipro inhaleGram-negative PneumoniaAmikacin inhale

CHF BAY 94-8862 (MR Antagonist)Pulmonary HypertensionRiociguat (sGC Stimulator)CancerRegorafenibCancerBAY 86-9766 (MEK-Inhibitor)Bone Mets Breast CancerAlpharadinAtopic DermatitisMapracorat (SEGRA)EDBAY 60-4552/Vardenafil

Phase III (19)CRVOVEGF Trap-EyeMyopic CNVVEGF Trap-EyeDMEVEGF Trap-EyePAHRiociguat (sGC Stimulator)CTEPHRiociguat (sGC Stimulator)CRCRegorafenibGISTRegorafenibAlzheimer PET ImagingBAY 94-9172 (Florbetaben)Submental fat removalATX-101

VTE TreatmentRivaroxabanACSRivaroxabanNSCLCSorafenibThyroid CancerSorafenibBreast CancerSorafenibMultiple SclerosisAlemtuzumabContraception LCS (ULD LNG)Contraception FC Patch LowMRI LCM GadovistVV Atrophy Vaginorm


Strong BHC Clinical Pipeline

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

Phase III (19)NSCLC / SorafenibThyroid Cancer / SorafenibBreast Cancer / SorafenibCRC / RegorafenibGIST / RegorafenibVTE Treatment / RivaroxabanACS / RivaroxabanPAH / Riociguat (sGC Stimulator)CTEPH / Riociguat (sGC Stimulator)Myopic CNV / VEGF Trap-EyeDME / VEGF Trap-EyeCRVO / VEGF Trap-EyeContraception / LCS (ULD LNG)Contraception / FC Patch LowVV Atrophy / FSD / VaginormMRI LCM / GadovistMultiple Sclerosis / AlemtuzumabSubmental fat removal / ATX-101

Phase II (12)Cancer / RegorafenibCancer / MEK-InhibitorBone Mets Breast Cancer / AlpharadinOvarian / Peritoneal Cancer / SorafenibCRC / SorafenibAdditional Indications / SorafenibCHF / MR AntagonistPH / Riociguat (sGC Stimulator)ED / BAY 60-4552/VardenafilAtopic Dermatitis / Mapracorat (SEGRA)Lung Infection / Cipro DPIGram-negative Pneumonia / Amikacin inhale

Phase I (9)Cancer / PI3K InhibitorCancer / CDK InhibitorCancer / HIF1a InhibitorAnemia / HIF-PHHemophilia / BAY 94-9027Hemophilia / BAY 86-6150Sympt. Uterine Fibroids / S-PRAntMCI / FlorbetabenDiagnostic Imaging / PET-Tracer

Oncology Cardiology/HematologyWomen’s HealthcareDiagnostic ImagingOphthalmologyOthers


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

Phase III (19)NSCLC / SorafenibThyroid Cancer / SorafenibBreast Cancer / SorafenibCRC / RegorafenibGIST / RegorafenibVTE Treatment / RivaroxabanACS / RivaroxabanPAH / Riociguat (sGC Stimulator)CTEPH / Riociguat (sGC Stimulator)Myopic CNV / VEGF Trap-EyeDME / VEGF Trap-EyeCRVO / VEGF Trap-EyeContraception / LCS (ULD LNG)Contraception / FC Patch LowVV Atrophy / FSD / VaginormMRI LCM / GadovistMultiple Sclerosis / AlemtuzumabSubmental fat removal / ATX-101

Phase II (12)Cancer / RegorafenibCancer / MEK-InhibitorBone Mets Breast Cancer / AlpharadinOvarian / Peritoneal Cancer / SorafenibCRC / SorafenibAdditional Indications / SorafenibCHF / MR AntagonistPH / Riociguat (sGC Stimulator)ED / BAY 60-4552/VardenafilAtopic Dermatitis / Mapracorat (SEGRA)Lung Infection / Cipro DPIGram-neg. Pneumonia / Amikacin inhale

Phase I (9)Cancer / PI3K InhibitorCancer / CDK InhibitorCancer / HIF1a InhibitorAnemia / HIF-PHHemophilia / BAY 94-9027Hemophilia / BAY 86-6150Sympt. Uterine Fibroids / S-PRAntMCI / FlorbetabenDiagnostic Imaging / PET-Tracer

Oncology Cardiology/HematologyWomen’s HealthcareDiagnostic ImagingOphthalmologyOthers

More Than 40% From In-Licensing Or Together With External Partners


The Global Innovation Sourcing Team is your partner atBHC when it comes to discussions about early assets andtechnologies, for licensing as well as for out-partneringactivities.

Companies harbor only a small portionof the biomedical knowledge

●Even with a budget of >1.5 billion €, BHC Pharmaceuticals R&Donly represents <1% of the annual spending on biomedical R&Dglobally

●Closer relationship to partners in academia and biotech neededto make better use of the existing knowledge and to address themajor challenges in biomedical R&D

●Research collaborations with academic, small biotech firms orlarge pharmaceutical corporations are an integral element of ourinnovation strategy

●Collaborations in all phases of the value chain – from research to development and production to marketing.


Partnering Organization Works AlongThe Value Chain

Clinical development Ph

IIIPh II Ph I

Pre-Clin. Dev.

Lead discoveryTD LOLDResearch

Driven by scientific concepts and data Driven by clinical PoC data

Innovation Sourcing

Business 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. Multhaup, Free University of Berlin, Germany:“We have experienced an excellent support by Bayer HealthCare Scientists and have had encouraging discussions.”

Prof. Wang, Moores UCSD Cancer Center, La Jolla, USA:“There are two advantages in the G4T program. The first being the speed with which the grant is funded. The second being the potential of further collaboration in the future to advance the common research interests between my laboratory andBayer AG.”

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.”


Feedback from Our Biotech Partners

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.”

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.”


●Global strategic alliance signed in June 2010●Focus on the discovery, development and

commercialization of novel anti-cancer stem cell 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

●FDA accepted OncoMed‘s IND filing for a monoclonal Anti-Frizzled antibody (OMP-18R5 ) in April 2011

Some Examples in More Detail … OncoMed / Tumor Stem Cells

Wnt PathwayWnt Pathway

Biologics

Small Molecules

Transcription on


Some Examples … German Cancer Research Center Alliance

●First agreement signed in 2007, collaboration extended for another 3 yearsin 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 2008

BTC Inauguration Ceremony, June 2009


Some Examples …Grants4Targets Initiative

Preclinical

Submission

Clinical

LeadGeneration

TargetDiscovery

LeadOptimi-zation

http://www.grants4targets.com

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


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 andeducation & 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 Academiaand Industry Along the Value Chain

Clinical/POC

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

OncoMedCorporate partnership on cancer stem cell therapies

ArdeaCorporate licensing of MEK inhibitors for cancer

Innovative Medicines InitiativePublic private partnership between European Commission & Pharma

German Cancer Center (DKFZ)Strategic partnership with joint financing; > 9 projects running Tsinghua University

10 collaborative projects across therapeutic areas

SingaporeMultiple programs for diagnosis: treatment of Asian specific cancer

Pre-clinical

Lead Generation/Optimization

Target Discovery


Small Molecule CandidateGeneration Platform

Structural Biology,ComputationalChemistry

PharmacophoreInformatics,Property Prediction

Medicinal Chemistry,Automated Synthesisand Purification

Compound Collection,High-Throughput andHigh-Content Screening

●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

Target Discovery

Compound Screening

Lead Generation

Lead Optimization

Preclinical Development

Clinic Phase I


GDD-Global Biologics R&D

Marketed

Post-PoC

Research and Pre-clinical

Disease areas

Core capabilities

mAbs

ADCs

Engineered CFs

Fab

antigenIgG

Toxophore

VEGF Trap-Eye KG-PFAlemtuzumab

Biologics Pipeline

●Coagulation factor (CF) engineering

●Human antibody technology●HTP protein optimization●Antibody drug conjugates, incl.

analyticsand clinical manufacturing

●Oncology●Hematology●Cardiology●Gynecology●Ophthalmology


Common Mechanism Research Platform

Target Discovery

Compound Screening

Lead Generation

Lead Optimization

Preclinical Development

Clinic Phase I

●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

Bioinformaticsplatform, data mining(Phylosopher)

Phenotypic in vitro Models

in vivoPharmacology


●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 Oncology 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 in8 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

Bayer Cardiology Research


BHC Global Innovation Sourcing

Understand

We Talk

and Live

Science

BusinessPartnerships


Drug research Preclinical

Clinical trials

Evaluation/Approval

Phase IV studies

Probability of success from research to market approval: <1%

Source: based on PhRMA Profile Pharmaceutical Industry 2010

Years

0 2 4 6 8 10

12

14

16

18

(up to2 years)

(more than2 years)

10,000Test compounds

<250Test compounds

<5 Test compounds

Lab and animalexperiments

1 drug approved byhealthauthorities

€ >1 billion

Phase I: 20-100 healthy volunteersPhase II: 100-500 patients ➔

safety, dosing

Phase III: 1,000-10,000 patients ➔

efficacy, adverse events

Page * Bayer HealthCare Overview • – February 2012

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

●Establish Xarelto® (rivaroxaban) as an idealanticoagulant with the potential to redefine the market

●Demonstrate Nexavar®’s potential as a pan-tumor drugand a building block of Bayer’s global oncology franchise

●Transform hemophilia market by developinga long-acting Kogenate®

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

Thank you!


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.

technology scouting at bayer healthcare

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