Development of Positron Emission Tomography (PET) precursor. (Q4294470): Difference between revisions
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Revision as of 12:58, 22 June 2022
Project Q4294470 in Latvia, Estonia
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Development of Positron Emission Tomography (PET) precursor. |
Project Q4294470 in Latvia, Estonia |
Statements
469,913.08 Euro
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567,644.48 Euro
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82.78 percent
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1 March 2017
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31 May 2019
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TBD-Biodiscovery Ltd.
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58°22'27.52"N, 26°42'36.83"E
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56°47'52.87"N, 23°55'42.24"E
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Project’s background: Positron emission tomography/Computed Tomography (PET/CT-scanning) is becoming the most versatile diagnostic tool for early/metastatic cancer detection as well as examination of Parkinson and Alzheimer patients. Nuclear medicine procedures are capable of mapping physiological function and metabolic activity and thereby giving specific information about the organs. The Project partners TBD-Biodiscovery and PharmIdea have acquired all the competence and experience necessary to enter the PET diagnostic market: production of active ingredients and final dosage drug forms. Both partners are business-driven enterprises with a mission, focusing on both rewarding sales to the customers and making the product available for end-users — oncology and neurology patients in Estonia and Latvia. The outcome of the Project is final dosage form of the PET-product with all the documentation package, necessary for its implementation in nuclear medicine centers and hospitals. After the first Product is developed and marketed, TBD and PharmIdea plan to continue the cooperation and develop the next PET-products for oncology studies, studies of Alzheimer and Parkinson disease and seek the marketing channels to reach the hospitals worlwide. Project’s cross-border nature: Application of PET-radiopharmaceuticals for use in patients is subject to strict legislation. In the European Union, all steps in the manufacturing of PET-products are to be produced under Good Manufacturing Practices regulations. The PET-product is to be manufactured in two parts: firstly the chemical steps and then the production of final dosage drug form. TBD-Biodiscovery has all the necessary competence in GMP-manufacturing of chemicals and is also the only company in Estonia with the GMP certificate for the production of pharmaceutical ingredients. TBD does not have any facility for the production of final dosage drug forms. Vice versa, PharmIdea is a Latvian contract manufacturer of final dosage drug forms under GMP regulations and in sterile environment, but Pharmidea does not perform the chemical steps. The alliance between two companies is very natural. The outcome of the Project is the PET-product (final dosage form) with all necessary documentation package, ready to be implemented firstly in the brand new Latvian Centre of Nuclear Medicine and also Tallinn North-West Hospital Radiology department.<br><br>The Project has significant added value: it will increase the level of medicine services in Baltic region. The oncology and neurology patients will be provided with all necessary medical investigations at home country with no need to travel abroad. During the Project, new jobs will be created in Latvia and Estonia.<br><br>The common benefit of both partners is to have long-term contracts with Baltic hospitals, increasing turnovers and companies’ profits. Project’s objectives: The main objective of the Project is to develop a PET-product used in Positron emission tomography-computer tomography (PET-CT) for cancer, Alzheimer or Parkinson diagnostics. This Product will be created as a result of very tight cross-border cooperation between Estonian and Latvian companies TBD-Biodiscovery and PharmIdea. The second objective of the Project is to manufacture the Product ready for marketing and commercialization. The Estonian and Latvian hospitals are considered to be the first and the most valuable partners for implementation of the PET-product. Both partners realize that there are more than 30000 cancer patients in Estonia and 75000 in Latvia, and hope to address a significant portion of those patients, making the modern diagnostic tools more available and cheaper. The highest challenge here is to reduce the mortality for the cancer patients, especially for the ones having already metastatic cancer: the efficient treatment of small tumors is impossible without having good approach to diagnostics. The third objective of the Project is to fully explore cooperation between Estonian and Latvian partner. After the Project is completed, TBD and PharmIdea plan to continue their cooperation and develop a set of PET-products for oncology and neurology diagnostics. The current Project is a start of a much bigger collaboration on international level with special attention to the needs of Latvia and Estonia. Project’s main activities: To select the most promising PET-product, partners have to perform market studies and patent research. After the product is selected, TBD will immediately undertake the technology development. The goal is to obtain general method of manufacturing and to be ready to go to GMP level (Good Manufacturing Practice) at the next stage. PharmIdea will develop the quality control methods for PET-product. TBD will proceed with the GMP-validation of the manufacturing process with support of PharmIdea in quality controls. PharmIdea will also develop the final dosage form of the PET-product, followed by GMP-validation of this process. (English)
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