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Information updated to: 31/08/2016

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Project

Research, Application, Innovation, SErvices in Bioimaging (R.A.I.SE. in Bioimaging)

Code PON01_03054

Related training project

Description
Beneficiaries
Objectives

Results

Field/s	Health and wellbeing
Description	The main goal of the project is the optimization of radio tracing production processes, used in imaging diagnosis to have information about the development of chronicle degenerative pathologies to improve the therapeutic approach and allow to cure patients before the pathology reveals its symptoms. The research lines and the expected results of RAISE in bio imaging consist in: Clinical Suggestions for Alzheimer, Parkinson and Dementia with Lewy bodies. Demonstration production of 18F-DOPA with the current process in order to carry out an experimental investigation able to verify the efficacy of the radiodrug in the diagnosis of these pathologies. This development line will lead to a Patent (AIC):ITELDOPA. It widens the range of action and the use of DOPA which becomes a new instrument for “precocious” diagnosis, currently lacking across Apulia and south Italy; Increase in the production profit with the study of distribution in asepsis. The current machines on the market for distributing the radiodrug require using specific procedures for making the drug sterile and injectable. The autoclaving of the radiodrug requires about 40 minutes and this leads to chemical impurities and a loss of 30% of the production. RAISE for bioimaging intends studying and validating, by using various bio-decontamination instruments (UV, Operational Procedures, Biocides) a process in asepsis that avoids autoclaving and increases the production rate. Then, a new machine that uses this process will be designed. It will have as characteristics higher security for the operators and environment, in the production and manufacturing of the drug; Increase of the production profit improving the synthesis instrumentation. Use of micro-fluidic instruments in parallel to increase the production profit. Prototype design of a new synthesis model that can be patented. This synthesis model after the project, can be industrialized for use in ITELPHARMA processes and manufactured internationally, even through multinational alliances (GE, IBA); Increase of the production profit changing the synthetic path. The intention is to improve the profit of the production by changing the reagent and the synthesis to obtain the drug. A new kit for synthesis will be necessary along with its prototype in order to achieve a patented process. This line also requires, at termination, an industrialization of the KIT and of the process so they can be used in the production of ITELPHARMA and can be sold to a Radiodrug multinational; Change of excipients for 18F-DOPA. This development line is needed to reduce the pain during the injection of the tracer. By changing the excipients, the stability of the drug will increase bringing it, in solution, to a pH closer to the blood, and therefore reducing the pain during the injection; Quality system for GLP authorization. Another important step to obtain a patent is the study in vivo on bioequivalent samples (the produced drug in an alternative way is equivalent to the one described in the European Farmacopea) verifying the kinetics and dynamics of the 18F-DOPA. These preclinical studies require a laboratory and a quality system, Standard Operational Procedures, Protocols for Qualifying Instrumentation and Validating Analytical Methods compliance to Good Laboratory Practice for validating the processes and laboratory resources as appropriate for obtaining the GLP authorizations on behalf of the Superior Health Institution, during the industrialization of the results of the current project. Today in Italy there are no R&D laboratories in Radiopharmaceutical sectors authorized GLP by the Health Ministry; During the industrialization a meta-model for producing 8F-DOPA will be developed. During the project and after the industrialization phase, results of the experiments and of the experiences on field will be collected with refer to both research and industrialization results.
Total cost	5,745,125.00 euro
Public contribution		Total public contribution 4,625,367.50 euro NOP R&C contribution 4,625,367.50 euro PAC contribution 0.00 euro
Distribution	Advancement of distribution in %	Total amount distributed 3,955,901.00 euro NOP R&C distributed amount 3,955,901.00 euro PAC distributed amount 0.00 euro

Legend

Field/s – Indicates the field or fields in which the project has the most relevance. A project may have more than one field. For some projects it is not assigned. The field are the following 8: "Health and wellbeing", "Food", "Energy", "Environment and Ecology", "Transport and Logistics", "Cultural goods and activities", "Social Innovation" and "Smart Cities".

Description – Descriptive summary of project.

Total cost – Total cost of project.

Public contribution – Three elements are reported:

Total commitment – total amount admitted to financing, may include more than contribution to be valued on NOP R&C, also on other funds.
NOP R&C admitted contribution
PAC admitted contribution
Contribution with other funds

Distribution – The following elements are reported:

Total distributed amount – takes into account the distributed amount considering both NOP R&C distribution and other funds if provided for
NOP R&C distributed amount – amount distributed to financing of project to be valued on NOP R&C
PAC distributed amount – amount distributed to financing of project to be valued on PAC
Amount distributed with other funds – amount distributed to financing of project with other funds

The distributions refer to the date of last update indicated at top.

Type of beneficiary

Public commitment for beneficiary

University	2
Small business	1
Public research organisation	1
Total Beneficiaries	4

Università degli Studi di Bari Aldo Moro

Tax File Number: 80002170720
Unique Project Code: B91H11000890005
Location of financial commitments: Puglia

Type: University

See beneficiary profile >

Presentation date	09/04/2010
Approval date	16/02/2015
Start of activity	Expected date 01/09/2011	Effective date 01/09/2011
End of activity	Expected date 30/05/2015	Effective date -
Total cost	1,900,000.00 euro
Public contribution	Total 1,615,000.00 euro	Eligible of NOP R&C 1,615,000.00 euro
Distribution	Total 1,615,000.00 euro	Amount of NOP R&C 1,615,000.00 euro Date of last distribution of NOP R&C -

ITEL TELECOMUNICAZIONI S.r.l.

Tax File Number: 02954150724
Unique Project Code: B91C11000660005
Location of financial commitments: Puglia

Type: Small business

See beneficiary profile >

Presentation date	09/04/2010
Approval date	16/02/2015
Start of activity	Expected date 01/09/2011	Effective date 01/09/2011
End of activity	Expected date 30/05/2015	Effective date -
Total cost	2,928,875.00 euro
Public contribution	Total 2,231,555.00 euro	Eligible of NOP R&C 2,231,555.00 euro
Distribution	Total 1,562,088.50 euro	Amount of NOP R&C 1,562,088.50 euro Date of last distribution of NOP R&C -

CNR - Consiglio nazionale delle ricerche

Tax File Number: 80054330586
Unique Project Code: B81H11001040005
Location of financial commitments: Puglia

Type: Public research organisation

See beneficiary profile >

Presentation date	09/04/2010
Approval date	16/02/2015
Start of activity	Expected date 01/09/2011	Effective date 01/09/2011
End of activity	Expected date 30/05/2015	Effective date -
Total cost	716,250.00 euro
Public contribution	Total 608,812.50 euro	Eligible of NOP R&C 608,812.50 euro
Distribution	Total 608,812.50 euro	Amount of NOP R&C 608,812.50 euro Date of last distribution of NOP R&C -

Università del Salento

Tax File Number: 80008870752
Unique Project Code: B81H11001030005
Location of financial commitments: Puglia

Type: University

See beneficiary profile >

Presentation date	09/04/2010
Approval date	16/02/2015
Start of activity	Expected date 01/09/2011	Effective date 01/09/2011
End of activity	Expected date 30/05/2015	Effective date -
Total cost	200,000.00 euro
Public contribution	Total 170,000.00 euro	Eligible of NOP R&C 170,000.00 euro
Distribution	Total 170,000.00 euro	Amount of NOP R&C 170,000.00 euro Date of last distribution of NOP R&C -

Axis - Operational objective	I - Scientific and technological fields, generators of industry transformation processes and creators of new sectors (Go to )
Action	Strategic scientific and technological areas
Action line	Industrial Research (Go to)
Instrument of implementation	Invitation to presentation of Industrial Research projects (DD 1/Ric 18/01/10)
NSF - objective	Strengthen and evaluate the whole chain of research and cooperation networks between the research system and businesses, to contribute to competitiveness and economic growth; sustain maximum distribution and use of new technologies and advanced services; heighten level of scientific and technical knowledge and skills in the production system and in institutions