amadix.com Pre-Commercial Procurement - Opportunity for the Industry 26 March 2015
PCP An important Pipeline of tool Products to estimulate Innovation Opportunity for Public Authorities, Industry and Patients Public Authorities 1. Driving innovation from the demand side 2. Steering the development of innovative solutions that meet their needs (i.e. modernizing public services faster) 3. Optimizing resources while creating opportunities for companies in Europe Industry - Public procurers as first buyers of R&D will shorten the time-to-market for the suppliers, with better alignment of our products to fulfil concrete customer needs Patients Improving health through innovation Pre-CommercialProcurement Improving health through Innovation 2 2
Amadix s Objetive Improve Survival of Cancer Patients Tumor Identification NOT Diagnosed Patients Blood, serum, plasma, stool, urine, saliva Therapy Selection Patients ALREADY Diagnosed Formalin-fixedparaffin embedded (FFPE) tissue 3
Prognostic Test for Colorectal Cancer (CRC) Unmed Medical Need Innovative Prognostic tool for stage II CRC patients Prognostic and Predictive Test to identify CRC patients in stage II with a poor prognosis, who might benefit from administration of chemotherapy to avoid the recurrence of the tumor 4 4
An example of a Spanish PCP Project Innovasumma Pre-Commercial Procurement (PCP) to implement innovative technologies in oncology protocols of Galician Hospitals INNOVASAUDE program (SERGAS MINECO), 45 m. FEDER Funds Fondo Tecnológico 2007-2013 Objective Improve health and efficiency, implementing innovative technologies based on biomarkers Public Procurer Galician Public Health System(SERGAS) through Dirección General de Recursos Económicos
An example of a Spanish PCP Project Risk-benefit sharing between the public procurer and the supplier. Competitive development in phases. Based on SUMMA Project, ASEBIO 2013 Identification of demand of innovative technologies in Personalized Medicine by Spanish Public Health System (105 oncologists and hematologists coming from 65 Spanish hospitals) Inspired on similar European experiences in PCP Silver Project SUMMA PROJECT
Silver An example of a European PCP Project The SILVER project searches for new technologies to assist elderly people in their everyday lives by using a Pre-Commercial Procurement process Budget 2,150K, funded by the European Commission under the 7 th Framework Programme(FP7) Started in January 2012, for 56 months March2013-aninternationalPCPcallwasopened Partners in Denmark, Finland, the Netherlands, Sweden and United Kingdom. The consortium includes research institutions and public sector organizations 7
Before issue a PCP Call for Tenders Needs Identification to find a solution- Priorities of Public Health in Galicia 2011-2014(lung, colorectal and breast cancer, between the main 8 priorities) Concept Viability - To be sure there is no technology available yet in the market that canmeettheneed(r&disneededtodevelopasolution).summaproject,asebio Contract Management Especific Clauses as Intellectual Property and royalties. Involvement of different stakeholders Oncology Societies (Galician Oncology Society), Oncologists, MINECO, Industrial Association (ASEBIO), Innovación Department, Legal, Tecnology Evaluation, Ethic Comittees(CEICs), etc. Issue an open Call for Tenders by a ContractingAuthority, tocompetetowin a PCP Framework Contract.
Industry Competing in 3 Phases Phase 1 (opened to 8-10 companies) - 1 month. Each supplier explores the feasibility of their innovative ideas, adapting the solution to the needs of Oncology Galician s Services. Selection of 3 companies Phase 2 (opened to 6 companies) - 6 months. Completion of the prototype development. Selection of 2 companies. Phase 3(opened to 4 companies)- 6 months. Suppliers develop their small-batch production of products/services.
Pre-Commercial Procurement(PCP) Commercial Procurement Phase 0 Phase 1 Phase 2 Phase 3 Phase 4 Solution Selection Batch 1 Solution Design Supplier1 Supplier 2 Supplier 3 Supplier 4 Prototype Development Supplier1 Supplier 2 Supplier 3 Small-batch Production Supplier1 Supplier 2 Commercialization Supplier X Batch 2 Supplier1 Supplier 2 Supplier1 Supplier 2 Supplier1 Supplier 2 Supplier 3 Supplier 3 Supplier 4 18,960 4,740/supplier max 4 165,900 55,300/supplier max 3 63,200 31,600/supplier max 2 1 month 6 months November 2015 11
Conclusión Dialogue with the Contractor Authority, is key for facilitating the process Strict deadlines - risk for startups, lack of administrative departments Lack of experience on practical PCP implementation(not only for SMEs) Questions to be solved: legal, financial and technical specifications Complex requirements and procedure Pre-CommercialProcurement Improving health through Innovation 12 12
Thank you! amadix.com 4, José Antonio Primo de Rivera, St, 2nd floor 47001 Valladolid -Spain