Self sufficiency program

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1 KEDRION contribution on Self sufficiency program Andrea Benassi

2 KEDRION WORLDWIDE PRESENCE Melville (NY US) Gödollo (Budapest Hu) Bolognana (Lucca) S. Antimo (Naples)

3 Self sufficiency program Support plasma collection Optimize logistics Donation Hospitals Products availabilities Time to market Capillary Distribution Health System (MoH) Quality programs Technology investment Transfusional centers Industrial partnership Act as partner

4 Story of success: Italian case The Italian blood system is totally public and part of the National Health Service Blood Transfusion Centers (BTCs) are, by law, hospitalbased services Blood collection may be organized by authorized blood donor associations under the technical direction of BTCs Government and regional health authorities are strongly engaged to promote voluntary, responsible, nonremunerated, periodical blood donations National blood donors: donors 2.9 % of total population 4.3% of yrs 1,6 donation rate per year Source: National Blood Center (CNS) 339 Blood transfusion centers 4

5 Essential Data Population: 60 millions collection sites including BTCs 2,6 millions of whole blood (WB) and 0,5 millions of apheresis donations 45% whole blood collection outsourced to authorized blood donor associations, under technical supervision of BTCs Source: National Blood Center (CNS) 5

6 Voluntary Donation Principles Donors Association National blood self sufficiency is a primary need for the Country. Association Since Million of Donors Regional presence Voluntary, anonymous, non remunerated blood donation is recognized as an essential activity by the national health service. The 4 main Donors Associations have more than 1.8 million voluntary donors Social value and strategic role of voluntary blood donors are officially recognized Blood transfusion and toll manufacturing activities are essential healthcare services. Free distribution to any citizen is regulated by Italian law ,2 20 regions ,5 17 regions ,1 14 regions 1950s 0,1 19 regions Source: Data from Donors Association and Federation

7 Tons Principles Plasma collection trend Plasma collection in Italy, Compound Annual Growth Rate (CAGR) is of 4,6% in the last ten years Italy has reached almost 70% self sufficient needs of plasma-derived In Italy all collected plasma is currently fractionated by Kedrion through contract manufacturing (CM) Kedrion is the only plasma fractionator in Italy with full-cycle production capabilities CAGR +4, In the last year (2013) the plasma collection for fractionation has reached 780 tons Source: National Blood Center (CNS)

8 KEDRION value proposal Contract Manufacturing Customer's Service 8

9 Kedrion operation model Best practice to follow Collecting Coding and Validation Fractionation This model have been developed to meet Blood System expectations and needs Transportation Storage Finished Products Storage This model is prepared for all stakeholders, from donors to patients Acceptance and Feedback Industrial Planning Distribution This model represents a strong partnership between Kedrion and National Health System Kedrion services Kedrion industrial activities Source: Kedrion Model 9

10 Tons The Italian story: Win Win cooperation with National Health System Investments in Technology and Know How Improved quality and safety Italian Plasma fractionation 10

11 Few Asian Countries have already started CM activities with local and foreign Companies Kedrion is interested to offer his services helping the local National System to improve the PDs (plasma-derived) selfsufficiency program The availability of plasma is a prerequisite for the realization of a self-sufficiency program Setting up the self sufficiency plasma derived program through a win win partnership 11

12 Andrea Benassi Thanks for your attention

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