A blog with insightful reflections and reviews in the pharmaceutical industry, medical Affairs, pharmacovigilance, clinical trials, health technology assessment and regulatory affairs both in Australia and international level. The views span around pharmaceutical medicine, including medicines discovery that requires evidence-based medicine or epidemiology that support new therapeutics development and clinical trials to assess safety and efficacy of use of the new medicine in a population.
EVALUATION THE DRIVER OF CURRENT AND FUTURE MODELS OF THERAPEUTICS DEVELOPMENT
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.
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
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.
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.
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.
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
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.
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.
Pharmacists are exploiting combination therapies to treat Alzheimer’s disease
among the elderly population because of the synergetic effect.
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].
the swift epidemiological and nutritional shift characterised by tenacious
nutritional deficiencies provide evidence for incidence and prevalence of zinc,
stunting, anaemia and iron insufficiencies.
Concurrently, there has been observed on obesity, diabetes,
cardiovascular disease, and other cancer prevalence.
One of the most affected population by obesity are children and adolescents due
to the increase in sedentary lifestyle and fast-foods.
The growing concern has pushed researchers to develop therapies to deal with
obesity especially among the children.
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.
Another therapy under evaluation is Tesomet therapy which is a combination of
metoprolol and tesofensine.
The therapy is expected to increase fat utilization, decrease food craving, and
mental illness has had a far-reaching effect in the society, researchers have
not found evidence to one of the causes of mental illness.
Some of the cases arise from a family genetic, environmental, discrimination,
violence, poverty, among others.
Currently, the use of mindfulness and cognitive therapies is on the rise to deal
with increasing mental problems.
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.
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.
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.
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.
Most of the pharma companies that have adopted biotechnology are producing
three primary products: proteins, antibodies, and recombinant DNA products.
RNA therapeutics development is the new trend due to its potential to change
the present and the future.
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
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.
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.
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
The collaboration between pharma companies will not only ensure the availability of
biotechnology resources but also reduce risk in individual firms.
the cost involved in realizing biopharmaceutical drugs, the future and success
of pharmaceutical products lies in biotechnology integration and growth.
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
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.
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.
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.
IP regulations give exclusive rights to the owner to prevent others from
making, using, or selling the product without the permission of the owner.
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.
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.
The process of drug approval is regulated under The Federal Food, Drug, and
Cosmetic Act and it is enforced by the FDA.
The regulation is meant to protect the consumer from unsafe and unhealthy food,
drugs, cosmetics, devices, and other items described in the legislation.
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.
1.Danhof, M., et al., The future of drug development: the paradigm
shift towards systems therapeutics. Drug Discovery Today, 2018. 23(12): p. 1990-1995.
P.S. Kowalski, and D.G. Anderson, Advances
in the delivery of RNA therapeutics: from concept to clinical reality.
Genome medicine, 2017. 9(1): p.
4.Daosukho, C., Chen,
Y., Noel, T., Sompol, P., Nithipongvanitch, R., & Velez, J. et al., . Phenylbutyrate, a histone deacetylase
inhibitor, protects against Adriamycin-induced cardiac injury. Free Radical
Biology and Medicine 2007[cited 12 42];
1818-1825]. Available from: https://doi.org/10.1016/j.freeradbiomed.2007.03.007.
5.Schilling, S., et
al., Passive Aβ Immunotherapy: Current
Achievements and Future Perspectives. Molecules (Basel, Switzerland), 2018.
23(5): p. 1068.
and N.L. Kocovski, Mindfulness-based cognitive
therapy for depression: trends and developments. Psychology research and
behaviour management, 2016. 9: p.
13.Ji, N., &
Findling, R., Pharmacotherapy for
mental health problems in people with intellectual disability. Current
Opinion in Psychiatry, 2016. 29(2):
14.Al-Harbi, K.S., Treatment-resistant depression: therapeutic
trends, challenges, and future directions. Patient preference and
adherence, 2012. 6: p. 369-388.
Council (US) Committee to Update Science, M., and Animals. Science, Medicine,
and Animals. Washington (DC): National Academies Press (US); 2004. Safety
Testing. Available from: https://www.ncbi.nlm.nih.gov/books/NBK24645/.
16.Gaisser, S., &
Nusser, M., , Stellenwert der
Biotechnologie in der pharmazeutischen Wirkstoffentwicklung. Zeitschrift
Für Evidenz, Fortbildung Und Qualität Im Gesundheitswesen, 2010. 104(10): p. 732-737.
17.Gaisser, S. and M.
Nusser, [The role of biotechnology in
pharmaceutical drug design]. Z Evid Fortbild Qual Gesundhwes, 2010. 104(10): p. 732-7.
JJ., RNA-based Therapeutics- Current
Progress and Future Prospects. Chem Biol, 2012. 19(1): p. 60-71.
19.Mauer, J., Luo, X,
Blanjoie, A, and et al., , Reversible
methylation of m6Am in the 5’ cap control mRNA stability. Nature, 2017. 541(7637): p. 371-375.
INTRODUCTION TO THE THERAPEUTICS INDUSTRY The Master of Pharmaceutical Medicine program at the University of New South Wales went with many engagements on the number of activities that prepare a way for my studies in next semester two. As usual, the first day began with induction in my view as part of the university actions, informing students with processes and systems in pursuing the course while at the university. The induction processes at some stage prepare me to understand the University of New South Wales systems and procedures relevant to the Master of Pharmaceutical Medicine. It helps me settle down quickly in the new environment, which gives a sense of belonging and enthusiasm. In the first week, as part of an assessment task or activities for the rest of the semester. We expected to complete the class introduction. It was fascinated to learn that the degree course has attracted many fellow students from various diverse cultural, socioeconomic, and professional backgr