At the end of September 2021, the Conference on Pharmaceutical Research & Innovations in Pharma Industry was held in Washington, United States. The conference the widest range of topical issues of modern medicine and pharmacy. The participants discussed problems related to the health of the population, improving the provision of medical care and drug provision. At the same time, one of the key issues raised in the reports of the conference participants was the creation and introduction of innovative drugs that can radically affect the prognosis of diseases and the quality of life, which means that they can actually change the fate of a person. Two keynote speeches were devoted to this topic, which aroused genuine interest of the audience.
The information provided in the report “Pharmaceutical Industry and the Creation of Modern Medicines”, presented by Robert Pelzer, the general sponsor of the conference, aroused huge interest. Robert is a Chief Clinical Pharmacologist of TrustedTablets, one of the largest online pharmacies in the USA. The drugstore is known for low-cost but high-quality drugs, an easy online ordering process and fast international delivery. TrustedTablets pharmacists attend pharmaceutical conferences annually to discuss the most relevant topics and share their extensive experience. The successes and problems of modern pharmacy will be discussed below.
Innovative medicines or technologies 2021
Innovative drugs or technologies are new drugs, dosage forms or means of delivery of active substances that are protected by a patent. Their creation and widespread introduction into medical practice allows to improve or even radically change the prognosis of many diseases, modify their course, reduce mortality, and also significantly reduce government costs for the treatment and rehabilitation of patients, and extend the working period. The most striking examples confirming the importance of the development of fundamentally new drugs are the discovery of antibacterial drugs that drastically reduced the mortality rate from infectious diseases and purulent complications, the creation of insulin drugs that save the lives of patients with diabetes mellitus, drugs for chemotherapy of malignant neoplasms.
Today, the following priority areas can be identified in the creation of innovative pharmaceutical technologies:
- obtaining new chemical products;
- synthesis of pharmacologically active metabolites or their isomers (as an example of the successful implementation of this strategy, we can cite the relatively recent antibacterial drug levofloxacin – the L-isomer of ofloxacin, the antisecretory drug esomeprazole, which is the S-isomer of omeprazole, an anticonvulsant agent oxcarbamazepine);
- creation of new dosage forms with improved pharmacokinetic properties, which can reduce the frequency of drug intake;
- new drug delivery vehicles – inhalation, nasal, transdermal;
- biotechnological and bioengineering technologies, which are currently one of the most dynamically developing scientific areas;
- development of multicomponent drugs (for example, the combination of amlodipine and atorvastatin – the drug Caduet (“Pfizer”); the combination of atorvastatin currently in phase III clinical trials and torcetrapib, which increases the level of high-density lipoproteins in the blood plasma; a combination of a new lipid-lowering agent that blocks the absorption of cholesterol in the digestive tract, ezetimibe and simvastatin – Vytorin (“Merck”), the use of which allows you to achieve a very pronounced lowering the level of LDL cholesterol and triglycerides in blood plasma, etc.).
Each innovative drug goes through a kind of evolution, the main stages of which are well known: development and clinical study of a drug, lasting on average 10–15 years; “Maturity” is the introduction of an innovative drug or technology into clinical practice and the period of patent protection, and, finally, “old age” is the time after the expiration of the patent, when generic drugs are reproduced and introduced into practical healthcare. Robert Pelzer drew attention to the fact that the search for new molecules and the subsequent production of innovative drugs is a very long and costly process that requires huge investments from pharmaceutical companies. In order for a drug to enter the market and become applied in clinical practice, an average of 15 to 20 years of laborious laboratory, experimental and clinical research is required. At the same time, most of the molecules are eliminated at the preclinical stage or during the I, II, III phases of clinical trials, and only a small amount of pharmacologically active substances reach the stage of clinical use.
What are the challenges facing an innovative pharmaceutical product?
First of all, one should bear in mind that today, special importance is attached to a comprehensive study of the effectiveness and especially the safety of drugs that appear on the market for the first time. Previously existing concepts and approaches to safety assessment are now being revised; new, more stringent requirements appear to ensure the safe use of a particular drug. Each new drug will have to successfully pass the examination of the regulatory authorities of different countries, prove its effectiveness in different categories of patients, and finally become in demand on the market.
As noted by Robert Adams, at present, more than 5000 new potential drugs are under development in different countries of the world, most of which are still undergoing the stage of the preclinical study. As for the most common indications for the use of new drugs under development, one cannot fail to note the transformation that has taken place: for example, 10 years ago most of the research was focused on the prevention and treatment of cardiovascular diseases, but now scientists test anticancer agents and drugs intended for use in neurological diseases, in particular multiple sclerosis, Alzheimer’s disease, Parkinson’s disease and a number of other currently incurable ailments, prevail. According to the mechanism of action, they are mainly inhibitors of various enzymes, immunomodulators, agonists and antagonists of various receptors. Nevertheless, given the importance of cardiovascular and cerebrovascular diseases as the leading causes of morbidity and mortality in the population in developed countries, innovative drugs for their prevention in the presence of risk factors continue to be widely introduced into clinical practice.
Robert Pelzer singled out among them a number of the most promising and interesting novelties in terms of the mechanisms of action. So, if a patient has type II diabetes mellitus and a combination of such common risk factors as hyperlipidemia, obesity and smoking, the original drug Acomplia (rimonabant ) has a great chance of becoming in demand. Acomplia is currently in phase III clinical trials. To prevent cerebrovascular and cardiovascular complications in patients with metabolic syndrome, the drug Muraglitazar (Bristol Myers Squibb / Merck Sharp & Dohme) can be widely used. For the prevention and treatment of patients with type II diabetes mellitus and obesity, Bietta (Byetta (exenatide – synthetic exendin-4) can be used. The attention of scientists is also attracted by the molecule SB 480848 (GSK), a potential inhibitor of phospholipase A2, which is expected to be used for the prevention of thrombotic complications due to its effect on inflammation in the atherosclerotic plaque. In addition to creating fundamentally new substances, the possibilities of already known agents with proven efficacy have not been exhausted. As Robert Pelzer emphasized, it seems promising to create multicomponent drugs on the basis of drugs of various pharmacotherapeutic groups, which will provide an opportunity for a kind of “summation” of their positive effects. For example, the creation of fixed combinations of statins, antihypertensive drugs of various classes and antithrombotic drugs will help to further reduce the risk of developing cardiovascular complications and reduce mortality due to cardiovascular diseases.
Drugs obtained from biotechnology
A wide range of modern drugs is also made up of innovative drugs obtained by biotechnology. Pharmacologists and clinicians are especially interested in drugs based on monoclonal antibodies, which are currently in phase III clinical trials or have already begun to be used in clinical practice:
- natalizumab – a selective inhibitor of leukocyte adhesion, intended for the prevention of multiple sclerosis;
- CDP 870 – a fragment of an antibody to TNF-alpha, which blocks inflammation and immune response in rheumatoid arthritis;
- ranibizumab – a recombinant fragment of an antibody to vascular endothelial growth factor (VEGF), intended for use in age-related macular degeneration;
- rituximab – a drug for the treatment of patients with non-Hodgkin’s lymphoma, which binds to specific receptors of B-lymphocytes and causes their lysis;
- bortezomib – an inhibitor of proteasomes that regulate the life cycle of cells; it stimulates apoptosis of tumor cells, is used in multiple myeloma and can also find application in other malignant neoplasms.
Of course, the creation of these drugs can rightfully be attributed to the outstanding achievements of world pharmacy.
Concluding his speech, Robert Pelzer emphasized that the creation of innovative drugs that would save the lives of seemingly doomed patients is a task only for developed societies. And if the country considers itself to be such, this work must be carried out. At the same time, the introduction and production of generics requires much lower costs and allows to subsequently direct them to innovative developments.
Undoubtedly, the modern pharmaceutical industry, which creates innovative medicines, plays a key role in increasing human life expectancy and improving its quality. However, there are certain difficulties along this path. Robert Pelzer noted that currently the vast majority of new drugs appear on the market thanks to their own developments of pharmaceutical companies, and only a small number of them are created in state research centers. At the same time, the development of the pharmaceutical industry takes place in two main directions – the discovery of fundamentally new drugs and the improvement of dosage forms of already existing drugs. It is obvious that the development of the first direction is the most resource-intensive and requires much higher financial costs. While government support certainly plays a role in financing the development of new drugs, large pharmaceutical companies invest incomparably large amounts of money in this area every year.
Where does funding for new drugs come from?
It takes many years to go from concept to market launch of a new drug. A huge number of molecules can be at the stage of laboratory development, but only a few of them eventually reach consumers in the form of finished medicines. Over the past 2-3 decades, the absolute number of drugs that enter the market for the first time has practically not changed, however, due to new, more stringent requirements for their effectiveness and especially safety, costs for their creation and production, and this trend will continue in the near future. At the same time, the observance of patent rights is becoming very important. A patent is a legal right that protects a new development for a specified period of time from generic copies and the production of the given drug by other companies. Upon expiration of its validity period, any company is entitled to manufacture this medicinal product. Therefore, a company that has developed an innovative product and made significant investments in it has a very limited time – only a few years – to inform the medical community about its properties and benefits, justifying its costs and making a profit.
It is extremely difficult to overestimate the contribution of innovative medicines to the development of society: after all, it is measured both by the time that the use of such drugs adds to someone’s life, by the improvement in its quality, and by the funds saved by the health care and social security system.
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