Evaluation and Planning of Idead for a New Test for the Disagnosis of Alzheimer's Disease - Article Example

Name Еvаluаtiоn and Рlаnning of Idеаs for а new test for the diagnosis of Аlzhеimеr’s Disеаsе Ownership Course Date Executive Summary Alzheimer’s disease presents a diagnostic challenge worldwide. The research team consists of two professors and one postdoctoral researcher who own the idea of inventing the new test for Alzheimer’s disease. The idea need to be patented because it is an innovation and patenting the idea will prevent it from being copied or used without the owners’ authorization. The research team needs to get permission from the patented owners of the devices they are going to use. The technology involves measuring the level of enzyme ERK3 from the skin sample of individuals displaying symptoms of Alzheimer’s disease. The enzyme ERK3 is seems to be higher in skin samples of patients showing symptoms of Alzheimer’s disease. Similarly, ERK3 also appears to be higher in patients with other neurodegenerative disorders (NANDs), though not as high as in patients with Alzheimer’s disease. For commercial viability, Alzheimer's disease (AD) is the leading cause of memory decline as well as dementia. Alzheimer World Report (2011) indicate that about 36 million individuals have dementia where about 20-25 million have Alzheimer’s disease. These numbers are anticipated to increase significantly among the aged individuals over the next coming years. Therefore, this diagnostic test that suggests that the elevated levels of ERK3 in skin samples of patients showing symptoms of Alzheimer’s disease is essential and this indicates the commercial viability of the project because the product will have a very high demand. Еvаluаtiоn and Рlаnning of Idеаs for а new test for the diagnosis of Аlzhеimеr’s Disеаsе Introduction Group of researchers intend to start a company for the idea of developing a new test for Alzheimer’s disease. This report seeks to carry out a technical and commercial assessment of their ideas. Specifically, the report will analyse the ownership and patentability, technical feasibility and commercial feasibility of the product; the new test for Alzheimer’s disease. Ownership The two professors and the one postdoctoral researcher are the ones who have the rightful entitlement to the idea as a whole. However, the firm that is funding the project, as well as the other related stakeholders such as concerned laboratories, research authorization bodies and hospitals are partly entitled to the idea because they are stakeholders who are partly participating in the project. The funding agreement is that the project will be funded for one year for a sum of £50,000, 000. Patententability The idea is inherently patenable because it is an original innovation and the idea has not been claimed yet. The intellectual property landscape entails identification of patents allied to the key technology platform (prototype algorithm and effect of ERK3 enzyme) and the devices that will be used for the project. The only people who can be able to come with a similar technology are the ones with science skills and have the required education and skills in the field. This means that not everyone has the art of coming up or working on the idea. Intellectual property arrangements will affect both the patenting and licensing of diagnostic technology that the researchers are using and this includes the devices and tools allied to the product, the material transfer agreement for reference specimens as well as accessing the pre-clinical and clinical testing data. Data inputs may benefit from pooling arrangements that enable the cross licensing of the intellectual property and thus patent pools within the electronics industry, specific standards will be needed to implement a standard. The patent portfolio requires the fundamental patents that will facilitate innovation as well as implementation of the new diagnostic test of Alzheimer’s disease (Mabey 2004). However, the idea of using enzymes to diagnose Alzheimer’s disease is not original and thus this will require the patenting of the invention that will improve the intellectual property within the patent portfolio license and this would necessitate grant back to the pool. To be certain that the commercial viability of the proposed technology works, innovative funding via push and pull mechanisms may be used in combination with the pool. Pull funding that pays for the outputs of the technology can be used in buying out patents to license within the patent portfolio license or present milestone payments for diagnostics to meet the specifications of the target product profile which is the new test for Alzheimer’s disease (Englund 2006). Technology Feasibility Technical/scientific approach The team has identified a new enzyme, ERK3 which is involved in modifying some peptides that result to inflammatory process. The method involves measuring the level of enzyme ERK3 from the skin sample of individuals displaying symptoms of Alzheimer’s disease. The enzyme ERK3 seems to be higher in skin samples of patients showing symptoms of Alzheimer’s disease. Similarly, ERK3 also appears to be higher in patients with other neurodegenerative disorders (NANDs), though not as high as in patients with Alzheimer’s disease. The approach shows that after measuring the activity within the skin samples in comparison to enzyme ERK1 and erk2, varying ratios of activities of the three enzymes seem to follow a unique pattern for samples obtained from normal individuals, patients having NANDs and patients having Alzheimer’s disease. A prototype algorithm that is constructed displays varying indices allied to the activity of the three enzymes that appear to be uniquely associated with normal, NAND and Alzheimer’s subjects. At the beginning, strategic meeting can be held to map the roadmap forward, identification of all stakeholders, flagging of hindrances that require more evaluation and discussion. In the first one year, the project milestones may involve: Developing target product profiles for the diagnostic test Developing a scientific roadmap to guide how the diagnostic tool will be developed and this should include major performance indicators for a specimen bank, the pooling of fundamental patents for the devices to be used in the entire project A legal as well as a policy evaluation for examining the intellectual property for the technology platform as well as the identification of specific enzymes; ERK3, ERK2, and EKR1, the likely licensing forms for guaranteeing delinkage, as well as optimal way of structuring the required pooling arrangements. A strategic plan to link involved networks of centers at various points within the diagnostic value chain A business plan to ensure there is sustainable resourcing of the required project activities as the time goes (Santos 2012). Benchmarking The scientific approach holds a great promise in making various diagnoses. Numerous diseases can be diagnosed using this scientific approach. There are high performing bench-top assays, assay cards with the required reagents and a portable reader where prototype algorithm is possible through automation and quantification of the software being used (Mabey 2004). Involved Risks The major risk involved in this technology is failure to get the right individuals and talent. Basically, this involves two matters associated with individuals and talent in such technologies. One, it is somehow hard to find individuals who have skill set with pharma and diagnostics, and secondly there is lack of clear career path in disease diagnosis research to other areas and this is viewed as limiting by high potential candidates. The reason is because the team of the three researchers will require other individuals to be recruited once the company is established. The recruited individuals are obviously required to be conversant with the technology being used. Likewise, there is lack of enough individuals with translation medicine skills, for instance individuals having MD/PhD backgrounds with good understanding of bench science along with clinical applicability (Mabey 2004). The new diagnostic test for Alzheimer’s disease can be developed successfully because the technology being used is reliable and has been used in previous experiments and thus there is a high probability of the technology being a success in this test. Commercial Feasibility Alzheimer's disease (AD) is the leading cause of memory decline as well as dementia. Alzheimer World Report (2011) indicate that about 36 million individuals have dementia where about 20-25 million have Alzheimer’s disease. These numbers are anticipated to increase significantly among the aged individuals over the next coming years. For instance, it is expected that in 2050 about115-200 million individuals will b suffering from dementia while 70-150 million people will be having Alzheimer’s disease. Accordingly, it is important to develop new diagnostic methods for Alzheimer’s disease for detecting and diagnosing this complex chronic neurodegenerative brain disease (Santos 2012). At present, there is no single diagnostic test that can clearly indicate if an individual has Alzheimer’s disease or not. Therefore, this diagnostic test that suggests that the elevated levels of ERK3 in skin samples of patients showing symptoms of Alzheimer’s disease is fundamental. Researchers and scientists might not yet have discovered the exact causes of Alzheimer’s disease and its diagnosis, but with ongoing clinical diagnostic trials such as this one, a new method of diagnosing the disease might be discovered which eventually might lead to discovering new ways of treating the disease (Englund 2010). Generally, the new test for Alzheimer’s disease is likely to have a high demand because up to date a clear diagnostic test for Alzheimer’s disease has not been developed yet and thus the success of this test is likely to have a very high demand. Market developments aimed at educating all relevant specialists and pathologists about the diagnostic test is critical to increasing adoption of the test in hospitals and related fields. Generally, approaches to ensure that the diagnostic test penetrates in the market consist of health practitioner-directed activities, like establishing training groups and preparation of lab-specific educational materials, as well s diagnostics partner-directed activities, for instance recruiting medical representatives who will target clinical laboratories or recruitment of education force that will target prescribing physicians. Test like EGFR did not have a successful penetration for the first two-three years following its launch although there were some clinical researches indicating that these tests of the drug’s mutation. Estimates show that sub-optimal testing levels of EGFR resulted to a loss of $50,000,000 in America alone. In order to ensure accuracy of the test among the users, it is important for the product users to be educated on how best to lessen erroneousness during testing (Higgins 2008). Compared to drugs, the landscape for diagnostic tests such as this one illustrates less product development partnerships and several lesser candidate technologies further than the short term time horizon. This partly reflects the much shorter time it takes to bring a diagnostic technique from bench to bedside. However, for a test such as; a new test for Alzheimer’s disease, there is a probability of having a collective action failure, whereby several companies working on the same disease target might not have a convincing reason for developing diagnostic tests that other companies would free ride off. The new diagnostic test for Alzheimer’s disease may not only lower the expense of avoidable treatments as well as avert the necessity of more costly medications prior to de-escalation and also reduce clinical trial recruitment expenses. This also indicates the significance of the new test. The development of the new test for Alzheimer’s disease presents a unique opportunity for the launching of a successful test in the market and thus the demand for the product is likely to be high. Consequently, the costs of developing the test will be met by the demand for the product because from the current market analysis, the demand is likely to be high (Mattson 2010). Conclusion The owners of the idea include the two professors and one postdoctoral researcher. The idea needs to be patented because it is an innovation and patenting the idea will prevent it from being copied or used without the owners’ authorization. The technology involves measuring the level of enzyme ERK3 from the skin sample of individuals displaying symptoms of Alzheimer’s disease. For commercial viability, Alzheimer's disease (AD) is the leading cause of memory decline as well as dementia and the numbers are anticipated to increase significantly among the aged individuals over the next coming years. Hence if the invention of the new test for Alzheimer’s disease is successful, the product will have a very high demand and this confirms the commercial viability of the productt. Bibliography Lecture Notes Higgins GA, 2008, Alzheimer’s disease: the amyloid cascade hypothesis. Science. 256(5054):184-185. Englund E, 2006, A white matter disorder in dementia of the Alzheimer type: a pathoanatomical study, Ann Neurol, 19(3):253-262. Englund E, 2010, White matter changes in dementia of Alzheimer’s type: the difference in vulnerability between cell compartments, Histopathology, 16(5):433-439. Mabey D, 2004, Diagnostics for the developing world, Microbiology, 2: 231, 240. Mattson, M, 2008, Glutamate and neurotrophic factors in neuronal plasticity and disease, Ann N Y Acad Sci,1144:97-112. Mattson N, 2010, Biochemical markers in Alzheimer’s disease clinical trials, Biomark Med, 4(1):91-98. Santos AN, 2012, Amyloid-β Oligomers in Cerebrospinal Fluid are Associated with Cognitive Decline in Patients with Alzheimer's Disease, J Alzheimers Dis., 1;29(1):171-6. Read More