tecnologie dal laboratorio all impresa

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1 Mauro Giacca, MD PhD Director-General ICGEB Trieste-Italy, New Delhi-India, Cape Town-South Africa International Centre for Genetic Engineering and Biotechnology (ICGEB) Il trasferimento di Trieste tecnologie dal laboratorio all impresa Adriatic sea

2 ICGEB International Centre for Genetic Engineering and Biotechnology An International Organisation in the United Nations System Trieste, Italy New Delhi, India Cape Town, South Africa 80+ Signatory States, 60+ Member States, 3 Components: Trieste (Italy) - New Delhi (India) - CapeTown (South Africa)

3 Mid 70's: recombinant DNA and molecular cloning

4 Biopharmaceutical Products Product Insulin Human Growth Hormone (hgh) α-interferon Hepatitis B Vaccine Tissue Plasminogen Activator (TPA) Erythropoietin-α γ-interferon Granulocyte Colony Stimulating Factor (G-CSF) Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Interleukin 2 Factor VIII β-interferon DNase (Pulmozyme ) Glucocerebrosidase (Cerezyme ) ReoPro several others Source: Consulting Resources Corp. Year

5 Hybridoma Cell Lines Provide a Permanent Source of Monoclonal Antibodies

6 The Health Bioeconomy Over 350 biotechnological drugs have now gained clinical approval and over 400 have entered clinical trials Biotechnology products are expected to account for 48% of the top 100 drugs of 2016 (S&P) Monoclonal antibody market estimated to be worth no less than 75 billion USD Global In Vitro Diagnostic (IVD) market forecast to reach 75 billion by 2020 Biogenerics market expanding rapidly for recombinant gene products and with enormous prospects for monoclonal antibodies

7 Humira (adalimumab) Monoclonal antibody against TNFalpha Enbrel (etanercept) Fusion between the p75 TNFalpha receptor and an Ig Remicade (infliximab) Monoclonal antibody against TNFalpha Seretide/Advair Salmeterol and fluticasone Lantus insulin glargine Rituxan (rituximab) monoclonal antibody against B cell CD20 Avastin - monoclonal antibody against VEGF-A Herceptin (trastuzumab) monoclonal antibody against HER2/neu Crestor (rosuvastatina) - statin Abilifty (aripiprazolo) schizophrenia and bipolar disorders

8 Biotechnology for development Health Biopharmaceuticals Vaccines Diagnostics for viral and genetic disease Agriculture Enhance productivity Pest protection Herbicide tolerance Environmental adaptation Improve nutritional composition of foods Reduce allergenicity Environment Sanitation Clean water Bioremediation Energy Synthetic biology and biofuels

9 Biosimilars Biosimilar opportunities timeline, The global biosimilar market was valued at $1.8 billion in 2013 and nearly $2.0 billion in The market is expected to reach nearly $4.0 billion by 2019, with a compound annual growth rate (CAGR) of 15% from 2014 through (BCC Library - Biosimilars: Global Markets; BIO090B; 2015)

10 ICGEB R&D collaborations and technology transfers to industry since TT and collaboration agreements +80 scientists trained spending total of +60 months in ICGEB labs Technologies transferred: G-CSF, Interferon, Epo, Insulin +20 different countries Countries in which industries have signed TT agreements with ICGEB Countries in which products obtained through ICGEB technologies are in the market

11 The changing landscape of biotechnology

12 The tremendous burden of noncommunicable diseases

13 Common degenerative conditions due to unrecoverable loss of cells Cardiomyocytes: Ischemic cardiomyopathy and heart failure 15 million people with HF worldwide; 50% of patients die within 4 years from diagnosis Neurons: Dementia and Parkinson s disease 30% of people over 80 years develop Alzheimer disease; 1-3% of those over 65 years of age develop Parkinson's disease β-cells: Diabetes >170 million people affected worldwide Photoreceptors: Retinal degeneration 30% in people over age 75 affected by age-related macular degeneration (AMD), the leading cause of irreversible blindness Cochlea hair cells: Presbycusis (age-related hearing loss) >50% people over age 75 affected

14 Innovation gap for traditional drugs

15 Biotherapeutics for degenerative conditions Genes Protein-coding cdnas, sirnas, mirnas, mirna inhibitors Proteins Recombinant proteins, synthetic peptides, monoclonal antibodies Syringe containing factor, vector or stem cells Cells Stem cells? Ex vivo tissue Organoids, artificial organs Tissue protection Improved function Regeneration

16 Business model for the new biotechnologies?

17 Biotech Companies are Entrepreneurial Founded by an individual or perhaps a small group, usually scientists Technology obtained from tech transfer Angel or Venture capital backed High risk

18 Financing: a Critical Path 3 F s (friends, family, fools) Public Grants Angel investors Venture capital Partnering Public offering (institutions) Merger/acquisitions

19 Capital Financing Needs Company Stage Private investment Proof of Concept $25,000 $100,000 Pre-seed $50,000 $500,000 Seed $150,000 $2 million Early-stage $1 million $5 million Expansion-stage Up to $10 million

20 Source: Coupofy Infographic 2015

21 Source: Coupofy Infographic 2015

22 How to promote start-up development IP consultancy (freedom to operate) Patent office Business development Initial economic support to startups Bridge to Angels and VCs Bridge to large pharmacompanies

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