Domanda di innovazione nel mondo industriale. Modalità di interazione tra pubblico e privato

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1 Domanda di innovazione nel mondo industriale. Modalità di interazione tra pubblico e privato Ennio Ongini Nicox Consiglio Nazionale delle Ricerche Quarta Giornata Informativa "Dalla ricerca al Trasferimento Tecnologico"

2 Investments in pharmaceutical R&D are growing while the number of new drugs remains stable Number of drugs approved Expenditures (billion$) Expenditure data from Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry profile

3 10 Year Comparison of New Molecular Entity Approvals NME Approvals (FDA) Year Orphan drugs account for 33-37% of approval 3

4 Do we need new medicines? HIV muscle dystrophies cancer neurodegenerative disorders diabetes stroke genetic disordes multiple sclerosis Alzheimer neglected diseases COPD metabolic syndrome 4

5 Current hot topic in drug research Cancer Rare disease Anti-infectives 5

6 Organizations focused on drug discovery big pharma small biotech academia 6

7 Evolution of models of Industry-Academia partnership over > 30 years 1980s Unrestricted grants Fee-for-service Company sponsored institutes 1990s/2000s Corporate VC funds Increased partnership Industry-Academia Academic drug-discovery centers 2000s More collaborations with high-science Academic centers Risk-sharing (Academic centers) Competitive fees 2010s Academics/Public Inst. have efficient Tech Transfer Office Increased interaction Academics/Public with Biotech/Pharma industry 7

8 Growing expansion of Pharma-Academic collaborations Pharma/Biotech companies have increased collaborations rapidly with Academic/Public Research Institutes in the hope to identify novel drug targets Key collaboration structure o Intellectual Property (IP) Patent ownership / payments o License agreements Rights to IP o Alliance management Joint Research Committee o Academic freedom vs Right to publish 8

9 Example of partnership from Industry-Academia collaborations announced in

10 More recent examples of collaboration Industry other Institution Company Partner Therapy GSK Telethon (Italy) Orphan diseases Vertex Intrexon / Ziopharm Foundation Cystic Fibrosis Uni Texas Anderson Cancer Cystic Fibrosis Oncology Chimeric antigen receptor T cell techno 10

11 Drug Discovery & Development pipeline in pharmaceutical and biotech companies Discovery (Research ) Development Regulatory Target Identification Target Validation Lead Identification Lead Optimization Preclinical Phase I Phase II Phase III Marketing 3-5 years 1-3 years 3-5 years 1-2 years M 2-10M M 1M 11

12 Efficient interaction Academia - Pharma\Biotech Academia\Public Research Institutes together with small biotech bring innovation Large pharma move the lead compound through development 12

13 Spin-off e Start-up: le tappe più importanti 13 13

14 Start-up e Spin-off: le tappe più importanti 14

15 Drug Discovery Process Discovery (Research) Target Identification Target Validation Lead Identification Lead Optimization Development Candidate 3-5 years M 15

16 What have we learnt about partnerships? Factors critical to success High quality of the data Strong personal interactions and trust between researchers (i.e., frequent meetings) Create one virtual lab (work as one team ) Entrepreneurial spirit / flexibility 16

17 Why partnerships Pros 1. Access to development capability 2. Visibility / credibility 3. Financial support 4. Biotech may focus on key projects 5. Allow continuation of projects on hold Cons 1. Lose project / assets 2. Risk of dissemination platform / technology 3. Project may be discontinued for nonscientific reason 4. If stopped, then damage 17

18 Nicox global network over > 10 years Nicox Headquarters Sophia-Antipolis, France Nicox Research Institute Bresso, Italy Nicox Inc, Dallas, TX, USA 18

19 Thank you!! Ennio Ongini Nicox Headquarters Nicox S.A. Drakkar CD 2405 Route des Dolines BP Sophia Antipolis Cedex France T: +33 (0) F: +33 (0) Nicox Inc Sherry Lane #1000 Dallas Texas U.S.A. T: F: Nicox Research Institute S.r.l. Via Ariosto Bresso Milano Italy T: F:

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