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Tavola Rotonda: Il processo di innovazione in atto:
dalle strategie di brevettazione al fundraising fino alle collaborazio...
2
Why biopharma
needs to pursue
innovation?
Dynamic global
megatrends
Breakthrough
science fueling
cutting-edge
medicines
...
Our model of innovation
4R&D Hubs
across Asia, France,
Germany and North America
15.3%of company sales invested in R&D
Inc...
Our operational
model:
Offering wide-reaching
therapeutic and
commercial expertise
Primary Care
Vaccines
(Sanofi Pasteur)
...
Our Challenge in Research
• Sanofi needs to raise the number and quality of research projects in order
to support long-ter...
Seeding
• Novel targets and
assets from:
• Academia
• Biotech
• Sanofi Units
• Crowdsourcing
• Championed by
Sanofi scient...
• seed
• Will translate innovative biology into
commercial projects
• Will derisk early drug discovery
• Will deliver inno...
The Structure of a Typical Seed Project
Provides at risk:
Drug discovery
Potentially validation
Receives:
Milestones and r...
9
Building BRIDGEs over the Funding Gap
https://european-biotechnology.com/up-to-date/latest-news/news/sanofi-and-evotec-l...
German biotechnology company
An innovative stem-cell based platform which
strengthens Sanofi’s quest to cure diabetes
Evot...
Bioverativ: A Leading Hemophilia Portfolio
U.S. biotechnology company
Leadership position in the
large hemophilia market
T...
INNODIA: An Example of Public-Private Partnership
Largest global Public-Private-
Partnership in type-1 diabetes
Budget and...
The Working Structure
https://www.innodia.eu/
Advanced Analytics for Drug Indication Expansion
14
Core
indications
All content copyright © 2017 QuantumBlack, a McKinsey...
All content copyright © 2017 QuantumBlack, a McKinsey company
Benefits of Advanced Analytics vs. Other Methods
Advanced An...
All content copyright © 2017 QuantumBlack, a McKinsey company
Benefits of Advanced Analytics vs. Other Methods
Advanced An...
17
Onduo: a Joint Venture between Sanofi and Google-Verily
Expanding
Sanofi’s partnership
network with a
flexible approach
Continually seeking
innovative collaborations
that create ...
Sanofi,
a Health
Journey
Partner
More than
100,000
employees
>500M
people helped
worldwide
annually
€34.5bn
net sales in
2...
THANK YOU
https://www.linkedin.com/in/racheleberria
https://twitter.com/rberria (@rberria)
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Il processo di innovazione in atto: dalle strategie di brevettazione al fundraising fino alle collaborazioni con le big pharma e le organizzazioni di pazienti - R. Berria (Sanofi)

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L'intervento di Rachele Berria (Global Vice President Primary Care Medical Unit Sanofi) in occasione dell'evento "Il valore della ricerca biomedica" che si è tenuto a Pula (CA) il 3 aprile 2019.

Published in: Health & Medicine
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Il processo di innovazione in atto: dalle strategie di brevettazione al fundraising fino alle collaborazioni con le big pharma e le organizzazioni di pazienti - R. Berria (Sanofi)

  1. 1. Tavola Rotonda: Il processo di innovazione in atto: dalle strategie di brevettazione al fundraising fino alle collaborazioni con le big pharma e le organizzazioni di pazienti ©CulturaRMExclusive/EdwinJimenez/GettyImages Rachele Berria, MD PhD Global Vice President, Primary Care Medical Unit, Sanofi
  2. 2. 2 Why biopharma needs to pursue innovation? Dynamic global megatrends Breakthrough science fueling cutting-edge medicines Digital enabling new ways of working Rise of the ‘empowered patient’ Ever present health economic agendaRising gap between life span & health span
  3. 3. Our model of innovation 4R&D Hubs across Asia, France, Germany and North America 15.3%of company sales invested in R&D Increasing annual R&D investments up to €6bn by 2020 16,000employees committed to R&D Key collaborations More than Diabetes(1) Genetic Diseases Oncology & Immunology (1) With Verily, ex-Google Life Sciences. 3
  4. 4. Our operational model: Offering wide-reaching therapeutic and commercial expertise Primary Care Vaccines (Sanofi Pasteur) Consumer Healthcare Specialty Care (Sanofi Genzyme) General Medicines & Emerging Markets 4
  5. 5. Our Challenge in Research • Sanofi needs to raise the number and quality of research projects in order to support long-term goals of delivering firs in class drugs • We are creating an innovative portfolio of project options leveraging: • innovation with key opinion leaders and institutions • risk-sharing with best-in-class drug discovery partners • Sanofi’s big pharma expertise, capabilities and assets • This allows us to nurture and select the best opportunities to optimize and bring to the clinic, while creating value with partners by translating their ideas into therapies 5 Example of model for early stage partnerships
  6. 6. Seeding • Novel targets and assets from: • Academia • Biotech • Sanofi Units • Crowdsourcing • Championed by Sanofi scientists Farming • Drug discovery provider network • In-kind support • Targeted funding • Simple transactions • Sanofi input to shape project Harvesting • Exclusive options at lead stage • In-licensing packages shaped by Sanofi • Validated data generation in areas of highest interest Farming Early Stage Potential Breakthrough Biology Project initiation Advanced leads 6
  7. 7. • seed • Will translate innovative biology into commercial projects • Will derisk early drug discovery • Will deliver innovative in-licensing opportunities to the Sanofi portfolio • Will leverage Sanofi’s excellence in disease biology and translation A New Approach to Early Stage Partnering Photocredits:© 7
  8. 8. The Structure of a Typical Seed Project Provides at risk: Drug discovery Potentially validation Receives: Milestones and royalties or return of IP Help to build an asset of value to big pharma Some upfront Academia / Innovator Discovery Partner Provides at risk: Expertise in disease biology Disease assays in vitro and in vivo eADME and PK if necessary Compound collections or mAb platforms Receives: First right of negotiation at Lead stage Opportunity to shape asset Provides: Targets, mechanisms or early assets Validation Assays Receives: Stake in IP: milestones or royalties Tool compounds Freedom to publish Potential research funding 8
  9. 9. 9 Building BRIDGEs over the Funding Gap https://european-biotechnology.com/up-to-date/latest-news/news/sanofi-and-evotec-launch-drug-discovery-ppp.html
  10. 10. German biotechnology company An innovative stem-cell based platform which strengthens Sanofi’s quest to cure diabetes Evotec: a Stem Cell-based Technology Platform Expanding our diabetes franchise1 Goal of the “Target BCD” collaboration is to develop a beta cell replacement therapy based on beta cells derived from human iPS cells Complementary R&D programs Human beta cells for high-throughput drug screening to identify beta cell active small molecules or biologics 1. https://www.evotec.com/f/3badc8d1b7f10d12796774bb703def92.pdf Strengthening the R&D pipeline 10
  11. 11. Bioverativ: A Leading Hemophilia Portfolio U.S. biotechnology company Leadership position in the large hemophilia market Two marketed products R&D programs Cold agglutinin disease, hemophilia, Beta- Thalassemia and other rare blood disorders Expanding our platform in rare blood disorders 11 https://www.businesswire.com/news/home/20180516005404/en/Bioverativ-Sangamo-Announce-FDA-Acceptance-IND-Application
  12. 12. INNODIA: An Example of Public-Private Partnership Largest global Public-Private- Partnership in type-1 diabetes Budget and Timing Total budget: €35.3 M; Sanofi Lead (€8.4 M) Time frame: 7 years (11-2015 to 11-2022) 12 https://www.innodia.eu/ 33 Partners 26 Academic Institutions, 4 Pharma Companies 2 US-based Associated Partners (JDRF & Helmsley Charitable Trust) 1 small-mid size enterprise
  13. 13. The Working Structure https://www.innodia.eu/
  14. 14. Advanced Analytics for Drug Indication Expansion 14 Core indications All content copyright © 2017 QuantumBlack, a McKinsey company Analytics driven R&D input KOL driven R&D input Rich data Large patient database over several years Analytics bolstered by experts’ insights Analytics Unsupervised algorithms with clinical input Novel patient groups Identifying indications Prioritization Running RCTs Experts & analytics- informed New unexpected indications New sub- populations New cross- disease clusters (mechanisms) Established methods and leveraging data • RWE disease burden • Cost to system Classic data Expert judgement Literature Expertise Epi data Main approach in Pharma industry Epi Clinical relevance Commercial feasibility Clinically relevant diseases Single indication Single indication with sub-populations Multiple indications New approach Established methods
  15. 15. All content copyright © 2017 QuantumBlack, a McKinsey company Benefits of Advanced Analytics vs. Other Methods Advanced Analytics Rapid execution Approach can be re-deployed in ~2 weeks in a new TA Novel insights Can surface unexpected and novel linkages for long-term research Reflects Real- World patient experience Based on rich, real world dataset Generalizable across TAs Analysis can be rapidly “re- pivoted” to compare against other pathways Validated Approach validated from scientific, clinical, business and statistical perspectives, Traditional expert-driven approach Driven by experts’ intuition and what others are doing Vulnerable to experts’ bias with little insight into decision- making process Highlights the “obvious” indications Drawn from experts with know- how in one specific niche of the pathway Other analytics approaches Normally a simple analysis of ~1000s of patients Models not robust or built with no clinical oversight Identifies single indications within 1–2 core TAs Model built for one pathway of interest 2+ months to generate a list per pathway 3–6 months for supervised models on RCT data Ranked outputs Validated, ranked and testable hypotheses A dozen indications that cannot be compared like for like 15
  16. 16. All content copyright © 2017 QuantumBlack, a McKinsey company Benefits of Advanced Analytics vs. Other Methods Advanced Analytics Rapid execution Approach can be re-deployed in ~2 weeks in a new TA Novel insights Can surface unexpected and novel linkages for long-term research Reflects Real- World patient experience Based on rich, real world dataset Generalisable across TAs Analysis can be rapidly “re- pivoted” to compare against other pathways Validated Approach validated from scientific, clinical, business and statistical perspectives, Traditional expert-driven approach Driven by experts’ intuition and what others are doing Vulnerable to experts’ bias with little insight into decision- making process Highlights the “obvious” indications Drawn from experts with know- how in one specific niche of the pathway Other analytics approaches Normally a simple analysis of ~1000s of patients Models not robust or built with no clinical oversight Identifies single indications within 1–2 core TAs Model built for one pathway of interest 2+ months to generate a list per pathway 3–6 months for supervised models on RCT data Ranked outputs Validated, ranked and testable hypotheses A dozen indications that cannot be compared like for like 16 Summary: advantages of Advanced Analytics compared to other methods  Rapid execution  Output is validated, ranked and testable  Can identify novel associations  Represents real-world setting  Analysis can be used across different pathways  Robust methodology with minimal bias
  17. 17. 17 Onduo: a Joint Venture between Sanofi and Google-Verily
  18. 18. Expanding Sanofi’s partnership network with a flexible approach Continually seeking innovative collaborations that create value Deliver the best, most innovative solutions for patients Tap into our deep expertise in bringing products to market Accelerate the development of ideas and assets Industrial Base Global Partnership Network Worldwide Exposure Ongoing Support High Quality Compounds Collection https://innovation.pactepme.org/uploads/blog/20170224_partneringbrochure.pdf 18
  19. 19. Sanofi, a Health Journey Partner More than 100,000 employees >500M people helped worldwide annually €34.5bn net sales in 20181 Present in >100 countries 1 Source: sanofi Press Release, 7th February 2019. 19
  20. 20. THANK YOU https://www.linkedin.com/in/racheleberria https://twitter.com/rberria (@rberria)

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