Entrepreneurship+Academy+2016+ TechnologyValidaon€¦ · AGREEMENTS SIGNED** 78* * Join us in making a difference in patient lives. ... & Partnering Identification, assessment and

2016 Biomedical + Engineering Entrepreneurship Academy

7/13/16

(c) Sylvaine Cases, Sanofi 1

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Entrepreneurship Academy 2016 Technology Valida;on

Sylvaine Cases

Outline

●  Sanofi & Sanofi External Innovation

●  Focusing on partnering at Sanofi: What is a good Business Opportunity?

●  Managing uncertainty in drug discovery & development: The Value = f(uncertainty, returns)

●  Examples of Collaborations & Partnerships

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Sanofi & Sanofi External Innovation

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SANOFI: A Global Life Sciences Company


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(1)  Source: Annual Report on Form 20-F 2015. Includes all R&D positions within the Group (Affiliates, Industrial Affairs, etc) (2)  Investor Relations quarterly Results Meeting dated February 9th, 2016, excluding Merial R&D (3)  Investor Relations quarterly Results Meeting dated February 9th, 2016

Millions invested in R&D in 2015(3)

Sanofi R&D Footprint

Employees worldwide contributing to the research and development of innovative health solutions(1)

16,200 Approximately R&D Hubs

Across Europe, North America and Asia-Pacific

4 Clinical Study Units in more than

countries 40

5,259 € Molecules and vaccines being developed for patients (2)

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PARTNER WITH US

50% OF THE PORTFOLIO FROM

EXTERNAL RESEARCH

122 PARTNERS WORLDWIDE

18 IN-LICENSING DEALS COMPLETED

*For the year 2015

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NEW COMPANIES CREATED

NEW SGBV INVESTMENTS

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NEW RESEARCH AGREEMENTS SIGNED**

78 * *

Join us in making a difference in patient lives. We look forward to hearing from you

**- Does not include MTA’s, extensions, amendments


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Think Globally, Act Locally

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CALIFORNIA

BOSTON

FRANCE

GERMANY

ASIA-PACIFIC

NEW-JERSEY

External Science & Partnering

R&D site

Integrated Cross-Functional Teams Accountable for Early Stage Deal Making

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Therapeutic Area External Innovation

GlobalTeams

External Science & Partnering

Identification, assessment and

evaluation of early opportunities

NA West

NA East Europe

Asia/Pacific

Therapeutic Area

Leads strategy development and

drives championship

R&D Transactions & Business

Development Leads internal deal

approval process, and external negotiations

Alliance Management

Manages integration and progression and

disputes with partners

Support Functions

Legal, Finance, Competitive

Intelligence,…


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What is a Good Business Opportunity?

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Business Opportunity Evaluation – Key Steps

●  The problem Identify unmet clinical/healthcare need

●  The strategic fit Determine alignment with therapeutic priorities and impact on pipeline

●  The solution Concept, current supporting data, plan to obtain missing validation

●  The best solution Technology differentiation, Competitive positioning

● How will a deal look like?

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Unmet Need – Which One to Tackle?

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Strategic Fit – Who Are Your Clients?

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Pharma

Health care provider

Device group

Patients


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Diabetes Cardiovascular

Oncology

Immunology

Rare Diseases Multiple Sclerosis

Neurodegeneration Infectious Diseases

Biologics Platforms

Drug Discovery Platforms

Strategic Fit – Example of Sanofi Therapeutic Areas

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R&D Pipeline – Pharma & Vaccines


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Early-Stage Drug Discovery

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Lead Identification

Candidate Selection

Preclinical Development

M0 M1 M2 FIH Start POC

Results POC

Ph I Ph 2a Target

Validation

Confidential

Early-Stage Drug Discovery

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Lead Identification

Candidate Selection

Preclinical Development

M0 M1 M2 FIH Start POC

Results POC

Ph I Ph 2a Target

Validation

•  Pre-M0 – M0: Understand disease Biology and identify new targets

•  M0- M2: Generate new candidates New molecule licensing

•  Pre-M0 – FIH Enable existing projects in our R&D pipeline Develop new differentiating technologies

Confidential


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The Value = f(uncertainty, returns)

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Big Pharma: Risk Takers or Risk Adverse?

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Drug Discovery & Development: a Long Risky Road

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Overall Clinical Development Risk Phase transition success rates from Phase I for all diseases, all modalities.

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BIO www.bio.org https://www.bio.org/press-release/bio-releases-largest-study-ever-clinical-development-success-rates

NDA: New Drug Application BLA: Biologic License Application

Estimated POS from Preclinical:

•  To Phase I: 50-69 % •  To approval: 1-8%


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De-Risking Drug Development

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●  Clarity of strategy & roadmap ●  Technical validation criteria and

milestones (applied to both internal and external projects)

●  Partnering External assets & technologies (collaborations and in-licensing)

* Regulatory, Commercial, Clinical operation, Finance, Market access,….

Translatability

Safety Developability (Path to POC)

Relative medical value

Others* Technical feasibility

What are the remaining challenges of ultimately developing the selected development candidate to meet the TPP?

●  identify the issues/risks for each field

●  provide de-risking approaches with clear go/no go as needed

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Technical Validation Criteria and Milestones around Key Issues and Known Risks


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Technical Risks and Attrition in Drug Development

23 MJ Waring et al., Nature Reviews Drug Discovery 14, 475–486 (2015)

Total Compounds Clinical Candidates Phase 1 Compounds

Compiled attrition data for small-molecule drug candidates from four large pharmaceutical companies — AstraZeneca, Eli Lilly, GlaxoSmithKline and Pfizer — nominated for development in the period between 2000 and 2010.

Technology Differentiation Immuno-Oncology Example

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Technology Differentiation – Looking back at Ipilimumab/Yervoy …..

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Axel Hooks, Nature Reviews Drug Discovery (2016)

De-risking Drug Development via Partnering

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§  Early stage, more speculative academic research funding in line with R&D strategy

§  Company creation and co-creation equity investments §  Strategic rights for Sanofi and deep collaboration §  Fund to plan approach: Deal size varies and is tailored to

R&D plan

§  Equity participation within a syndicate, strategic interest, business driven

§  No strategic rights for Sanofi §  Specific investment guidelines and boundaries

Partnering with

Academia

§  Licensing, Collaborations and M&A (upfront, milestones, royalties etc.)

§  Target products and technologies supportive to R&D §  Early to late stage technology/products

Sunrise

Sanofi – Genzyme

Bioventures

Corporate Business

Development


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Examples of Collaborations & Partnerships

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●  2012 DEAL: Target Identification collaboration à new targets to enhance beta-cell function

●  2014 DEAL: Sanofi Sunrise co-founding of Portal Instruments from MIT

Examples of Academic Collaborations


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Our collaborative model

SANOFI SPONSOR ACADEMIC / BIOTECHS

•  In-kind contribution up to lead identification •  No upfront funding •  2 year-operating model with clear go/no go decisions jointly defined

•  All joint results and inventions will be co-owned •  First right of refusal for Sanofi with the option to negotiate on a case-by-case basis

(e.g. licensing fees) for the partner

TARGET Target Validation / Assay Development

PRE-PROGRAMS Screening / Hits / Lead Identification

PROGRAMS Lead optimization

DRUG CANDIDATE

Sustaining our Leadership in Rare Diseases

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(1)  In 2012, Alnylam and Genzyme formed an exclusive alliance to develop and commercialize Alnylam’s lead product, patisiran, which is in Phase 3 development for the treatment of transthyretin (TTR)-familial.

Rare Diseases Collaboration Expansion

●  Signed on January 13, 2014

●  Genzyme and Alnylam expand strategic agreement to develop and commercialize treatments for rare genetic diseases (1)

Rare diseases drug development platform - Preclinical and Clinical ●  Alnylam’s portfolio of clinical and pre-clinical

stage drug candidates

Neuro Gene Therapies Collaboration ●  Signed on February 11, 2015

●  Broad collaboration to develop gene therapies for neurological diseases such as Parkinson’s, Friedreich’s Ataxia and Huntington’s Disease

Parkinson’s drug candidate - Phase 1b

Friedreich’s drug candidate - Preclinical

Huntington’s candidates - Preclinical ●  Developing gene therapies to either cure or

significantly reverse the effects of a broad range of neurological disorders


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Rebuilding our Competitive Position in Oncology

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Cancer Immunotherapy Collaboration and License Agreement ●  Signed on November 03, 2015

●  Multiyear exclusive collaboration and license agreement to leverage the scientific expertise of the two organizations to discover and develop cancer immunotherapies, each consisting of a mixture of synthetic messenger RNAs (mRNAs)

Cancer Immunotherapies

●  Developing of up to five immune-stimulating pharmaceuticals

Immunology

Immuno-Oncology Research Collaboration and License Agreement ●  Signed on January 11, 2016

●  Research collaboration and licensing agreement for new bispecific antibodies using Innate Pharma’s technology and Sanofi’s technology and tumor targets

Biospecific NK Cell Engagers ●  Generation and evaluation of up to two

bispecific NK cell engagers


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US West External Science & Partnering Team

Sylvaine Cases ([email protected]) ● Oncology ● Drug Discovery Platforms ● Biologics Platforms

Wendy Peters ([email protected])

●  Immunology and Inflammation ●  Infectious Disease

Isaac Veinbergs ([email protected]) ●  Diabetes ●  Cardiovascular ●  Neurodegeneration

Greg Fond ([email protected])

●  Rare Disease ●  MS

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Documents

Entrepreneurship+Academy+2016+ TechnologyValidaon€¦ · AGREEMENTS SIGNED** 78* * Join us in making a difference in patient lives. ... & Partnering Identification, assessment and