Challenges and Opportunities in Drug Development

This post discusses the challenges and opportunities in drug development, focusing on adaptive designs, public-private partnerships, and big data. It explores how these approaches can improve efficacy and meet medical needs.

Post 1
The development of drugs is faced with the double challenge of the increased pressure on
pricing and increased costs. To avoid the lack of perceived commercial perspective which will
leave unmet medical needs. To cub this the pharmaceutical companies and other
stakeholders are strategizing how to improve the drug Research and Development efficacy.
The areas to be focused on are; adaptive designs, public–private partnerships, and big data.
Public–private partnerships have different forms with regard to duration, scope, number of
participants and type. They can be strategic alliances, project-specific collaborations or large
multi-party consortia. Each of these forms offers opportunities unique from the other and they
are faced with challenges that are distinct. In the collaborations, studies that are investigator-
initiated are becoming increasingly popular although they have ethical, legal and financial
constraints. The adaptive trial designs are also increasingly discussed. However, adaptive
designs are not to be used as euphemism to repurpose trials that have failed; rather before
trial starts specifications and careful planning is required. The Big Data offers an opportunity
to use the existing information into knowledge that is used in drug development and
discovery. A key challenge in Big Data is respecting privacy, and attaining voluntary informed
consent.
From all the above it can be concluded that development of new drugs is no longer a job for
pharmaceutical industry only. Rather it should be multidisciplinary; pharmaceutical
companies, regulatory authorities, academic investigators, payers, bodies for health
technology assessment. Of most important, patients will increasingly shape ways of
developing new drugs for the medical needs.
Reason to be one of the best posts:
The increasing costs in the development of drugs and the increased pressure on the drug
pricing challenges the pharmaceutical industry current models. These models; adaptive
designs, public-private partnerships, and the use of big data offers opportunities to improve
the efficacy of developing drugs. Only the time will prove which approaches been most
beneficial. At present time, all models are promising in increasing the efficiency in drug
development and research more efficient. Although to implement this the limitations of this
models should be understood.
Post 2
Personalized medicine and tailored therapeutic has led to the development patient-centred
medicine. Improving the patients’ health outcomes, considering patients’ preferences, their
values, their objectives and the availability of the economic resources are its major objectives.
The patient-centred medicine requires a paradigm shift between doctors and patients’
relationship. It also requires the patient-oriented research, that is not based on the evaluating
the of medical interventions in the average patient, but coming up with best solutions for
individual patients, that is individualization of care. In addition to this, the growth and
development of the information that is based on technologies is of help in filling the gap
between the clinical practice and the clinical research.
Reason to be one of the best posts:
The industry's key role is to develop medicines and science for primary(prevention) and
curative/treatment of diseases. In the dynamics of the current environment in health care.
The industry efforts are on initiatives to improve and impact patients and carers. The most
valuable data set in trails is the patients-reported outcomes. Their reports are able to capture
information that is relevant to the patients, identifies their preferences, and come up with

better treatment regimens based on informed decision-making. Having an understanding of
the experience of the patient helps in improving the management of the disease at its critical
points in the continuum of the disease. The patient’s future lies on different multi-disciplinaries
which needs to collaborate together. The industry is one of the team players and it plays an
important role.
Post 3
Despite the challenges facing the pharmaceutical industry, it has continued to thrive, although
these challenges have impacts in future. The drug prices are at an all-time high, the
productivity is gradually increasing from the 2016/2017 that was shortened and the landscape
of pharmaceutical constantly changes due to the biosimilars rapid growth and the disruptions
of the health technology.
Pharmaceutical industry success is important to the global and the notational economy so it
needs to be relevant to all. The bright side in this is that in future there is likelihood of growth
in this industry.
For success the industry should address the following challenges:
The future of biosimilars
Biosimilars are highly marketable, and these is predicted to rise by 20% in five years. Despite
its rise in the market and the treats it poses, it faces challenges in production. These
changelings are unique and distinct. Despite the market growth it is still at the developmental
stages. Secondly, the growth is further slowed by lawsuits over biologic patents. Lastly, the
regulatory processes aren’t solidified and for the ones that are developed requires costly
clinical trials so as to be approved in the market.
Patient-centric healthcare
Patient-centric care provides both rewards and challenges to the pharmaceutical industry.
The key challenge in the year 2019 is in determining on how to grasp the power of health
technology and be able to shift its partnership focus from the medical community to be
consumer orientated that is directly to the consumer. This will be the major partnership
strategy in the pharmaceutical company’s in future.
Reason to be one of the best posts:
To get a better knowledge on the efficacy and the safety of biosimilar drugs data should be
collected, clinical studies and the marketing safety and efficacy (this will include the clinical
studies that evaluated specific endpoints, patient’s population and therapeutic regimens)
should be planned. Studies that are well-designed and switching are highly advisable, this is
of most importance in the biosimilar drugs that are used in the oncology settings. Lastly,
studies monitoring the drug therapeutic is useful in achieving optimization of the treatment.