The Future of Drug Development and the Pharmaceutical Industry
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Several unusual characteristics of the pharmaceutical industry, both in terms of its organisational structure and the nature of its business operations, are little known outside the industry but have a significant impact on the process of bringing new pharmaceuticals to the market and bringing them to the patient. The development of a new pharmaceutical takes a long time, is extremely expensive, and involves a high level of risk, with only a slim chance of success. The process of research and development is described, as well as all of the challenges it faces, including those related to the environment.
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1 Introduction
Pharma has a unique set of characteristics that sets it apart from other types of businesses in the economy. Also, despite the fact that the industry has made an undeniable contribution to human well-being and the reduction of ill health and suffering for more than a century, it is a contradictory industry. The general public believes it to be extraordinarily profitable, despite the fact that it is unquestionably one of the riskiest businesses in which to put money into. Most people believe that pharmaceutical companies spend more on marketing than research, despite the fact that the major pharma companies rightfully promote themselves as research-based organisations (RBOs), 1,2 Despite the well-documented dangers and costs of pharmaceutical development, many people believe that pharmaceuticals should be developed to meet all human needs and that, once they are, they should be distributed to every one according to need.
2. Historical Background
For more than three thousand years, humans have used “drugs” to treat illness and disease. From as early as 1100 BCE, the Chinese were using at least a few dozen different remedies derived from plants and animals and as many as 1900 different remedies by the end of the 16th century. More than 13,000 drugs are now recognised by Traditional Chinese Medicine.
Outside China, the first known pharmacopoeia, the five volumes of De Material Medica, were written in the first century CE by Dioscorides, a Greek botanist. Herbal practitioners of this early period have been identified in many indigenous populations across the globe, such as North and South America, India and Australia. In the later mediaeval period, herbalism flourished in both the Islamic and Christian parts of the world. This tradition continued up to the 17th century, encompassing the work of Paracelsus in Switzerland and Culpepper in England. Culpepper’s work, The English Physician, published in 1652, was one of the first English language pharmacopoeias.
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Empiricism had been the only basis for herbal medicine use until the 18th century: practitioners knew what worked but did not understand why or how it did so. However, in the late 18th century the foundations of pharmacology, the study of the actions of drugs and how they exert their effects, began to emerge. In the 1780s, William Withering was one of the first to study and isolate a herbal remedy’s active ingredient. He isolated digitalis from the foxglove, describing its extraction from various parts of the plant, its subsequent effects and the optimum way of using it to treat patients. The science of pharmacology developed slowly during the next century and Oswald Schmiedeberg (1838–1921) is now generally recognised as the founder of modern pharmacology. In 1872 he became professor of pharmacology at the University of Strassburg in Austria where he studied the pharmacology of chloroform and chloral hydrate and in 1878 published the classic text, Outline of Pharmacology.
At the same time as modern pharmacology was taking shape, so was modern organic chemistry, by chance. Compounds derived from living organisms were thought to have a “vital force” that differentiated them from inorganic compounds prior to the 19th century. Ammonium cyanate, an inorganic compound, was converted by Friedrich Wöhler in 1828 into the organic chemical urea, a component of urine. Despite Wöhler’s reluctance to claim that he had disproved the theory of vital force, this event has been widely regarded as the origin of organic chemistry in the scientific community. The pharmaceutical industry was founded in the late 19th century as a result of these two scientific developments in pharmacology and organic chemistry.
What is a Pharmaceutical?
This may appear to be an odd question given that we are all well aware of what pharmaceutical is. However, despite the apparent simplicity of the question, there is no straightforward scientific answer. Pharmaceuticals do not belong to the same category of substances as phthalates or PCBs. There are no chemical, physical, structural, or biological similarities between the two of them. It follows that there is no scientific justification for treating pharmaceuticals as if they were a cohesive collection of chemical substances.
According to many commentators, pharmaceuticals should be subjected to different regulatory treatment than other substances because they are “designed to be biologically active,”24 with the implication that this criterion is sufficient to distinguish pharmaceuticals from other substances. However, this is not the case. This, on the other hand, is incorrect because it is derived from a misunderstanding of pharmaceutical development and implies incorrectly that pharmaceuticals are designed to be uniquely biologically active by design. According to a more accurate statement, drugs are selected from among the many substances that have been shown to produce a particular effect in various animal species, including humans, based on their overall safety.
The Pharmaceutical Industries
As far as the general public is concerned, the pharmaceutical industry is comprised of a small number of extremely large multinational corporations with household names such as AstraZeneca, GlaxoSmithKline (GSK), Eli Lilly, Merck, Novartis, Roche, and Pfizer, to name a few examples. These corporations are collectively referred to as Big Pharma, a term that is intended to be derogatory. This, however, is a blatant misrepresentation. Despite the fact that Teva is the 11th largest pharmaceutical company in the world47 and may very well be supplying the medicine that they are currently taking, there is a high likelihood that they will have never heard of either of these companies if you ask a member of the general public if they have heard of either of them.
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Research, Discovery and Development
The process of developing a new pharmaceutical is described in greater detail in the following section, which is intended to be concise. Because of the low success rate, the research and development departments of research pharmaceutical companies will not only be investigating one drug, but will also be investigating a large number of different substances at various stages of the development cycle at any given time. At any given time, a large corporation may have 100–200 substances in the development pipeline of its research and development department.
Pre-clinical Trials
The process of discovering a new drug begins with research into the specific illness or disease that is of interest. In addition to being carried out in pharmaceutical companies’ research laboratories, this can also be carried out in academic institutions, government research organisations, small “boutique” pharmaceutical companies, or any combination of these. Medical research has become so complex that large pharmaceutical companies are now conducting the vast majority of their research in collaboration with other organisations.
Clinical Trials
At this point, a choice must be made on whether to forward the candidate into clinical development, where prices will skyrocket even further. Although the scientific team’s opinion is helpful, this is mainly a business choice. Parallel to the scientific operations, a significant amount of additional work will have been done to assess the candidate’s commercial prospects. Have there been any bad signs throughout the pre-clinical stage? How well does the medicine match the medical requirements? Are there any substantial formulation or production difficulties that need to be addressed? If these questions are adequately answered, the applicant advances to the first round of clinical trials.
Environmental Issues
The majority of the R&D effort invested in the development of a new drug is focused on its human effects. The environmental impact of the pharmaceutical industry in general, and its products in particular, was not considered significant until the late twentieth century, as we saw in Section 1.3. However, in the R&D process, work is now being done in two specific areas related to the environment. One is a shift toward more environmentally friendly manufacturing, and the other is a better understanding of any potential environmental consequences of using a new pharmaceutical.
Conclusions
The research pharmaceutical industry continues to be plagued by issues, the majority of which appear to have no obvious solutions.
Although it has exclusive rights to sell a new drug for the duration of its patent, increased regulation is driving up costs and lengthening development times, resulting in a shorter time to patent expiry. Increased risk aversion among executive management teams is contributing to a slowdown in the introduction of novel pharmaceuticals; reduced risk tolerance among patient populations and regulatory bodies is resulting in a lower success rate for marketing authorization approvals; cost pressures within national health systems are putting downward pressure on prices; market penetration by generics is rapidly increasing, and many people believe that the current recession is temporary.
Conference Keywords: Pharmacology, Pharmaceutical Sciences, Pharmaceutical Biotechnology, Smart Drug Delivery Systems, Vaccine, Pharmaceutical Engineering, Quality Assurance, Pharmacognosy, Digital Pharma, Medico Marketing, R&D Advancement: Road to New Medicines, Clinical Pharmacy, Pathophysiology, Pharmaceutical Microbiology, Computer Applications in Pharmacy, Pharmacy Practice, Pharmaceutical Analysis, Pharmaceutical Chemistry, Pharmaceutical Formulations, Pharmaceutical Regulatory Science, Drug Regulations, Pharmaceutics, Industrial Pharmacy, Pharmacy Development Services, Drug Delivery Technologies, Pharmacy Development Services, Biopharmaceuticals
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