Evaluation-Therapeutic Industry



                The future of drug development in the pharmaceutical industry heavily relies on therapeutical development, driven by advancement in systems therapeutics and molecular biology. This presents a challenge for the pharmacists to collaborate more with other health professionals or experts, especially biotechnologists, to assist in adapting to the pathology-based era of system therapeutics[1]. The progress in molecular genetics and cell biology determines the primary driving force currently and in the future development of therapeutics. The advancement in technology, such as genome editing technology, has been instrumental in understanding biomolecules that can be exploited to improve drug development and explore therapeutic agents that offer new opportunities in pharmacology[2]. In the background, a socio-cultural environment acts as the driving force to current and future models of therapeutical development due to changes in lifestyle and increase in the number of illnesses both communicable and non-communicable diseases. Some of the prevalent issues include ageing and obesity, and now Covid-19. The legal environment is trying to keep up with the new advancements in the industry and providing opportunity to explore the new developments through granting more funding and providing relevant laws to enable the field to grow such as intellectual property laws, renegotiation of licensing through the patent system.
This article will evaluate the current pharmaceutical industry both at the local and global scale through examining the socio-cultural environment, technology and legal issues that would lead to changes in current and future models of therapeutics development.

Socio-Cultural Environment

                In developed countries, life expectancy, is generally increasing due to the rapid improvement in healthcare as the World is highly characterised by an ageing population. Older people have a weak immune system; thus, they experience more underlying health issues and a greater demand for pharmaceutical products. Today, research and development spending by pharmaceutical companies across the globe has increased. According to Singh (2019), the global pharmaceutical industry has the second-highest research (R) & development (D) intensity, increased the global R&D intensity by 3.9% from 2016 to 2017[3]. United States Pharmaceutical companies are the biggest R&D spenders across the globe with more than 50% of the global spending done in the U.S[3]. The increase in this expenditure is driven by the need to provide therapeutically products to the ageing population as well as other health needs such as an increase in obesity rates that posed a significant health risk in the population.
                Ageing is a primary risk factor for chronic diseases, but there are no therapies readily available to prevent and slow the progression of these diseases. The need to stop the progression of diseases such as Alzheimer’s disease has necessitated the use of biological gerontology principles that will assist in developing therapeutical models to manage chronic diseases among the elderly[4]. Sodium Phenylbutyrate is a therapy approved by the FDA in treating urea cycle disorders but is currently under test to establish its ability to prevent neural loss among the elderly because of its HDAC inhibiting capabilities[4]. Pharmacists are exploiting combination therapies to treat Alzheimer’s disease among the elderly population because of the synergetic effect[5]. One of the combination therapies that is being tested is gantenerumab whose mechanism of action is to act as an antibody against Aβ fibrils and soluble monomeric Aβ[5, 6].
                Globally, the swift epidemiological and nutritional shift characterised by tenacious nutritional deficiencies provide evidence for incidence and prevalence of zinc, stunting, anaemia and iron insufficiencies[7]. Concurrently, there has been observed on obesity, diabetes, cardiovascular disease, and other cancer prevalence[7]. One of the most affected population by obesity are children and adolescents due to the increase in sedentary lifestyle and fast-foods[7]. The growing concern has pushed researchers to develop therapies to deal with obesity especially among the children[8]. One of the therapies under evaluation is the Peripheral Endocannabinoid or CB1R Blocker whose expected mechanism of action is to reduce activity of the endocannabinoid system which will eventually reduce appetite[9]. Another therapy under evaluation is Tesomet therapy which is a combination of metoprolol and tesofensine[10]. The therapy is expected to increase fat utilization, decrease food craving, and reduce appetite[9].
                While mental illness has had a far-reaching effect in the society, researchers have not found evidence to one of the causes of mental illness[11]. Some of the cases arise from a family genetic, environmental, discrimination, violence, poverty, among others[11]. Currently, the use of mindfulness and cognitive therapies is on the rise to deal with increasing mental problems[12]. Although psychotherapy is widely used to treat people with mental problems, pharmacotherapy has gained prominence as a medication is equally important in countering mental illnesses[13]. With the increase in the use of pharmacotherapy, most pharmaceutical firms are overrating the positive effects of drug treatment, thus putting the people with mental illnesses at risk. The issue can be solved by FDA firming its grip through enforcement measures that ensure unapproved products do not penetrate the market. Other challenges associated with pharmacotherapy in treating mental illness include the side effects and patients developing resistance[14]. Other than FDA ensuring they are protecting the population against such shortcomings, pharmacotherapy is should be handled with caution and used alongside psychotherapy which enhances mind control[15]
Technological Environment

                Today, technology is a significant driving factor in therapeutical models across the globe, which has received interest and focuses over the past couple of years due to its potential to produce quality and sustainable products in different sectors. In pharmaceuticals, biotechnology has assisted in the production of a variety of drug therapies which has improved the revenues for pharma companies as well. Biotechnology is increasingly being adopted in the pharmaceutical circles with noting that approximately 15% of drug revenues are realized from biopharmaceutical products[16, 17]. The relevance of biopharmaceuticals is increasing, and it is going to play a huge role in the future of the pharmaceutical industry[17]. Most of the pharma companies that have adopted biotechnology are producing three primary products: proteins, antibodies, and recombinant DNA products[17].
                Currently, RNA therapeutics development is the new trend due to its potential to change the present and the future[18]. Previously there has been little exploitation of various biomolecules that play significant roles in disease progression. RNA species provide great potential to develop therapeutic agents to develop life-changing drugs[18, 19]. There is light at the end of the tunnel for some areas that have always hit a dead end with respect to developing new drugs. Some of the therapeutics under development include mRNA vaccines for cancer and replacement/supplement of proteins using in-vitro transcribed mRNAs[19, 20].
The introduction and integration of biotechnology to pharmaceuticals are beneficial but very costly in terms of operations[21]. The technology involved in biotechnology is sophisticated and equally requires advanced equipment and highly skilled human resource to develop new products[17, 21]. Furthermore, developing of biotechnology products takes many years, up to a decade or more, and because the technology is still at its infancy, some of these huge investments in particular products end up in failure, thus having a huge financial impact on the pharma companies[17, 21]. There are three solutions to this problem. Firstly, the government needs to provide financial assistance that will necessitate the adoption of biotechnology in the pharmaceutical industry due to the huge initial and working capital required[22]. Secondly, the industry needs to invest in continuous improvement practices that will bring down the cost of operation and increase efficiency such as reduce time to launch biopharmaceutical drugs[22]. Thirdly, economies of scale are critical in sailing through this challenge, as companies are required to pull resources together through strategic alliances, mergers, acquisitions, and joint ventures to meet this resource-intensive initiative[22]. The collaboration between pharma companies will not only ensure the availability of biotechnology resources but also reduce risk in individual firms.
                Despite the cost involved in realizing biopharmaceutical drugs, the future and success of pharmaceutical products lies in biotechnology integration and growth[23]. One of the prospects of biotechnology in pharmaceutical is an examination of the various genomes and developing drugs and antibodies that agree with the different genomes[24]. One of the greatest challenges in public health is lack of tailor-made therapeutics and medications that are specific to a group with similar genetic makeup. Biopharmaceutical products will shape the future of pharmaceutical products by providing customized drugs that provide better value to the patients as opposed to current medications that are designed to fit all thus their ineffectiveness.
                Technology has made it possible to develop therapeutics for the future. Development of small-molecule RNA modulators by various companies has assisted the pharmaceutical industry make huge steps in the treatment of cancer through RNA-modifying enzymes. Other opportunities to develop therapeutics include technology that target splice-variant control sequences.

Legal Environment

                Therapeutical development cannot thrive without laws that protect the originator, the user, and approval process. One of the most important regulations in the pharmaceutical industry regarding therapeutical development is intellectual property (IP) regulations[25]. IP regulations give exclusive rights to the owner to prevent others from making, using, or selling the product without the permission of the owner[25]. The research-based, innovation-led organizations or companies developing new medical equipment, pharmaceutical or process, improve or adapt to already made drugs heavily depend on the patent systems[25]. The regulation encourages pharmaceutical companies to develop therapeutics, knowing they will receive a return on their investment. The investments return in the development through pharmaceutical industries required a patent system to recover the input in the R&D, hence granting wealth of information for further innovation and renegotiate fair and balanced licensing contract[25]. The process of drug approval is regulated under The Federal Food, Drug, and Cosmetic Act and it is enforced by the FDA[25]. The regulation is meant to protect the consumer from unsafe and unhealthy food, drugs, cosmetics, devices, and other items described in the legislation[25].

                The three main drivers in current and future models of therapeutical development are social-cultural, technology and legal environment. The socio-cultural drivers of therapeutical development are tied to changes in lifestyle and an increase in the number of chronic diseases. The demand and needs due to the social environment have compelled companies to increase R&D expenditure on therapeutics. Technology has grown exponentially over the years with the increase in knowledge and equipment. One of the driving forces behind therapeutics development is RNA sequences and molecules that provide an opportunity to treat diseases such as cancer. Lastly, the legal environment provides a platform for researchers to develop therapeutics that are safe for patients and give them an opportunity to get their returns.


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