Developing Drugs to Neglected Tropical Diseases
13 Abril, 2016
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The World Health Organization states that neglected tropical diseases are a group of parasitic and bacterial diseases that affect more than 1.5 billion people worldwide. Because they are related to poverty and lack of access to minimum health and sanitation, these diseases affect physical and cognitive development of the poorest populations, trapping them in the poverty (WHO, 2015). Few examples of these diseases are barber bug fever, ascariasis, elephantiasis, leishmaniasis.
According to the Organization for these diseases the development of drugs and forms of treatment has not evolved in a similar way as observed to other diseases such as heart disease, which also affect populations of rich countries. One of the explanations is the risk involved in the return of the investment needed to develop new drugs that would not be covered for cases of drugs targeted to people in poor countries.
So there is the launch of a new product on the market, it must pass a rigorous feasibility analysis on the market, followed by a series of tests, research and regulatory actions. In the pharmaceutical industry, innovation is handled in a very sensitive way because, by relating directly to the welfare of human beings, this is different from all other industries. The great pressure on these industries is due to the fact that new drugs need to be made but at the same time, the accuracy should have a much higher level, since no other industry deals directly with people’s lives (Ding et al , 2014).
The R&D process for drugs consists of a long chain of innovation that goes from basic research, through proof of concept to clinical trials to make sure both the certainty and effectiveness, until the manufacturing and launch process. According to the FDA (Food and Drug Association), the development of a new drug takes on average 10 to 15 years and goes through several processes from pre-discovery, through the discovery, at least three clinical stages and approval of licenses .
By the year 2010, more than half of the drugs introduced to the market were not new invented molecules but modifications of existing drugs that somehow had their incremental innovation and improved the lives of patients and their treatments and less rejection, however, the action taken by the industries of an incremental innovation was not radical having the purpose of creating new drugs for diseases (Ding et al, 2014).
In short, it is known that there is great interest and the scientific community effort to make their research result in the development of new products to treat or prevent these diseases, however there are limitations in the public’s purchasing power in general and the corresponding lack the expected return on investment, discouraging production.
Considering all these facts, the objective of this project is to propose the creation of a new business model, which can integrate drug innovation research with the producers and, therefore, contemplate in all the process of research and development of new pharmaceuticals (R&D) which responds to the demands of neglected tropical diseases.
After reading the IEEE CS 2022 report and analysis of 23 technologies in 2022, it was decided that the best alternative for this project would be The Open Intellectual Property Movement.
The idea of using this tool is to disseminate the use of collaborative platform and encourage that instead of applying for a patent, the players of the pharmaceutical industry should join forces and ensure that they are focused on trying to do a greater good, for 1.5 billion people worldwide.
Thus, the suggestion is to develop a system where recorded four stages of the production process, each corresponding to a player involved a total of 4, which is explained below:
Player 1: Research institutions
This group is responsible for the first part of creating a new drug where there is the idea of creating a new molecule. It is usually composed of scientists and university professors. The platform would own an environment for relationship between existing research and the possibility of co-creating ideas.
Player 2: Institutes of Clinical Analysis
Here are the groups with know-how to conduct analysis for drugs invented by Player 1. After the creation of a new drug, the player collects the molecule and is in charge for the next part of the drug development process, which is the clinical analysis.
Player 3: Pharmaceutical Companies
This player is responsible for the final product. Once a drug has passed through the development and analysis, it must be made the production of the same. In this part of the platform shall include companies that have the capacity to develop this product on a large scale and puts it on the market
Player 4: Manager (may be the World Health Organization)
This player is the most important of all, because it will be responsible for managing the entire system. He must perform the check and include other players in the system so that there is integration on the platform. It also will be the moderator and should follow all the steps, from the beginning to the final production.
The platform would be used as follows: the player selects the other 4 to be part of the system database. Institutions and scientists and knowledge to develop new drugs should be chosen. From there, the research would start with members known as player 1, then pass to the second and finally the third.
The advantage of using this system is that the parties, which are now divided, would be integrated for the sake of a greater good. The basic research agencies could finally talk to the companies that make the final product and drugs for neglected tropical diseases could finally be launched.