scholarly journals PCP9 - GENE THERAPY CRISIS: HOW WILL THE CURRENT PRODUCT PIPELINE AFFECT THE PHARMACEUTICAL INDUSTRY AND HEALTHCARE SYSTEMS?

2018 ◽  
Vol 21 ◽  
pp. S83
Author(s):  
M. Fabiani ◽  
P. Sogokon ◽  
S. Morrison
Keyword(s):  
Gene Therapy ◽  
Pharmaceutical Industry ◽  
Healthcare Systems ◽  
Current Product ◽  
Product Pipeline

scholarly journals An expanding role for cell biologists in drug discovery and pharmacology

2012 ◽  
Vol 23 (21) ◽  
pp. 4162-4164 ◽  
Author(s):  
Peter K. Sorger ◽  
Birgit Schoeberl
Keyword(s):  
Drug Discovery ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Basic Structure ◽  
Healthcare Systems ◽  
New Drugs ◽  
Conceptual Basis ◽  
The Face ◽  
Programming Skills ◽  
In Cells

The profound challenges facing clinicians, who must prescribe drugs in the face of dramatic variability in response, and the pharmaceutical industry, which must develop new drugs despite ever-rising costs, represent opportunities for cell biologists interested in rethinking the conceptual basis of pharmacology and drug discovery. Much better understanding is required of the quantitative behaviors of networks targeted by drugs in cells, tissues, and organisms. Cell biologists interested in these topics should learn more about the basic structure of drug development campaigns and hone their quantitative and programming skills. A world of conceptual challenges and engaging industry–academic collaborations awaits, all with the promise of delivering real benefit to patients and strained healthcare systems.

The Interaction of Pharmaceutical Regulations in Saudi Arabia With the Presence of FDI

2017 ◽  
pp. 132-145
Author(s):  
Majed Asiri
Keyword(s):  
Saudi Arabia ◽  
Pharmaceutical Industry ◽  
Intimate Relationships ◽  
Direct Investment ◽  
Healthcare Systems ◽  
Regulatory Regime ◽  
Kingdom Of Saudi Arabia ◽  
Trade Relations ◽  
Foreign Companies ◽  
Drug Companies

Recent literature on pharmaceutical regulations focuses on the apparently increasing scope for intimate relationships between the regulation framework and FDI opportunities in the pharmaceutical industry. This chapter deals with these interactions within the context of the Kingdom of Saudi Arabia (KSA). In 2015, Saudi Arabia was the largest market in the Middle East for drug companies and has one of the most sophisticated healthcare systems in the region. Yet, the Saudi drug regulatory regime have been criticized for having ambiguous procedures from both domestic and foreign companies. In addition, many international agreements have been signed by the Saudi government to encourage and protect foreign direct investment (FDI) in different sectors including the pharmaceutical industry. This research pursued to discover whether the international regulatory regime, based on the theoretical principles of free trade and applied to the international trade relations of KSA, interacts in any manner with the pharmaceutical industry's trends.

scholarly journals Development and Use of Gene Therapy Orphan Drugs—Ethical Needs for a Broader Cooperation Between the Pharmaceutical Industry and Society

2020 ◽  
Vol 7 ◽  
Author(s):  
Sandor Kerpel-Fronius ◽  
Varvara Baroutsou ◽  
Sander Becker ◽  
Roberto Carlesi ◽  
Luis Collia ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Pharmaceutical Industry ◽  
Real World ◽  
Risk Sharing ◽  
Local Health ◽  
Orphan Gene ◽  
Specific Patient ◽  
Number Of Patients

Gene therapy orphan medicinal products constitute a unique group of new drugs which in case of hereditary diseases are usually administered only once at an early age, in the hope to provide sufficient gene product to last for the entire life of the patients. The combination of an exceptionally large single payment and the life-long clinical follow-up needed for understanding the long-term benefits and safety of gene therapy, represent new types of scientific, financial, social and ethical challenges for the pharmaceutical industry, regulators and society. With special consideration of the uniqueness and importance of gene therapy, the authors propose a three points plan for a close cooperation between the pharmaceutical industry and society to develop orphan gene therapy. (1) In fully transparent health technology negotiations a close and long-lasting, contractually fixed cooperation should be established between the manufacturers and local health-care stakeholders for sharing the medical and scientific benefits, the financial risks as well as the burdens of the post-authorization clinical and regulatory development. (2) The parties should agree on a fair, locally affordable drug price without the usually very high premium price calculated to compensate for the low number of patients. In case of high manufacturing costs, the companies should offer prolonged, 15–20 years long payment by installment with risk-sharing, especially considering that the late outcome of the treatment is unknown. Society should assist scientifically and financially organizing a specific patient registry, treatment in specialized hospitals and adequate long-term follow-up of patients, the coordinated management of financial transactions related to the risk sharing program. (3) The post-authorization treatment and prolonged observation of additional new cases coordinated by society should provide real world data needed for the modern complex regulatory evaluation of gene therapy products by the competent authorities. We assume that fair sharing of the benefits and risks as well as a well-organized cooperation of society with the industry in collecting real world evidence might result in better drug evaluation and improved accessibility due to lower prices. The outlined concept might support gene therapy more efficiently than the presently requested outstandingly high prices.

Medicine quality, physicians, and patients

2020 ◽  
pp. 124-126
Author(s):  
Paul N. Newton
Keyword(s):  
Drug Resistance ◽  
Pharmaceutical Industry ◽  
Diagnostic Tests ◽  
Formal Analysis ◽  
Healthcare Systems ◽  
Poor Quality ◽  
Economic Losses ◽  
Objective Evidence ◽  
Medicine Quality ◽  
Selection Of

Poor-quality medicines negate the enormous advantages of modern pharmaceuticals and lead to avoidable morbidity and mortality; loss of confidence in medicines and healthcare systems; economic losses for patients, their families, governments, and the pharmaceutical industry; and—for anti-infectives—engender pathogen drug resistance. There are many examples of both falsified (due to fraudulent production) and substandard (due to in-factory negligence) medicines, vaccines, diagnostic tests, and devices. New portable diagnostic devices offer hope that they could empower medicine inspectors and pharmacists to obtain objective evidence for selection of suspicious samples for formal analysis. Much greater international effort is needed for the reporting of poor-quality medicines so that detection can be acted upon and patients protected.

Pharmaceuticals in Environment

2019 ◽  
pp. 270-296
Author(s):  
Alka Bali
Keyword(s):  
Biological Activity ◽  
Pharmaceutical Industry ◽  
Healthcare Systems ◽  
Water Bodies ◽  
Personal Care ◽  
Terrestrial Environments ◽  
Regulatory Bodies ◽  
Pharmaceutical Practice ◽  
Soil And Water

Pharmaceuticals and personal care products (PPCPs) constitute an integral part of modern healthcare systems which enter the environment through various routes. Because of their inherent biological activity, their presence in soil and the aquatic environment poses several eco-toxicological problems. Antibiotic contamination of soil and water bodies is leading to the development of microbial resistance to antibiotics and this has been recognized by several global bodies like WHO and EPA. Effective steps need to be taken in this regard including increased awareness, reduced pharmaceutical discharges in environment, green and sustainable pharmaceutical practice by pharmaceutical industry and healthcare professionals and improved remediation/bioremediation methods. This chapter outlines the various anticipated routes of exposure of pharmaceuticals to the environment along with their detrimental effects, fate and degradation in aquatic and terrestrial environments. The chapter also dwells upon the role of various regulatory bodies and plausible measures that may be adopted to alleviate the problem.

scholarly journals Fostering R&D of novel antibiotics and other technologies to prevent and treat infection

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Renwick ◽  
E Mossialos
Keyword(s):  
Antimicrobial Resistance ◽  
Value Chain ◽  
National Level ◽  
Drug Discovery And Development ◽  
Current Product ◽  
Cost Distribution ◽  
New Policies ◽  
Economic Need ◽  
Antibiotic Discovery ◽  
Product Pipeline

Abstract Generating innovative antibiotics is an essential part of addressing antimicrobial resistance. New policies and incentives are necessary to overcoming the multiplicity of scientific, regulatory, and economic hurdles that obstruct antibiotic discovery and development. This presentation assesses the changing landscape of the antibiotics market, barriers to drug discovery and development, incentive mechanisms and strategies to overcome these barriers, and the current product pipeline for antibiotics and alternative therapies. Over recent years, many incentive programmes have been implemented to foster the antibiotic value chain. This chapter proceeds to review the key multilateral, European Union, United States, United Kingdom and regulatory initiatives incentivizing antibiotic research and development. While these initiatives have helped lift the antibiotic pipeline out of dormancy, the recent progresses in development are not sufficient to counter the unrelenting advancement of antimicrobial resistance. We argue that the current global incentive package could be strengthened by ensuring that a continuum of incentives is offered to developers, reflecting the economic need, cost distribution, and barriers of the antibiotic value chain. A global governing body that provides overarching guidance to international and national-level incentive programmes will be critical to achieving such a continuum.

Global Pharmaceutical Industry

2019 ◽  
pp. 57-85
Author(s):  
Agnieszka Szmelter
Keyword(s):  
Developing Countries ◽  
Pharmaceutical Industry ◽  
Healthcare Systems ◽  
Global Market ◽  
Current Situation ◽  
The Other ◽  
Economic Environment ◽  
Market Forces ◽  
Research Results ◽  
The Right

The pharmaceutical industry is seen as one of the most dynamic, volatile, and innovative parts of the global economic environment. It also has a big impact on the society and is an indicator of the healthcare systems' condition. Some changes have happened in the last decades, for example, shifting the production facilities to the developing countries, new market entries, or the new law changed the previously established and stable layout of market forces. The chapter aims at presenting the current situation of the global pharmaceutical industry including the main trends influencing the changes in this sector. Describing this part of the global market will ensure the right interpretation of the research results of the other parts of the book.

Gene Therapy for Cancer - A New Dimension and Challenge for Insurers

2019 ◽  
Vol 48 (1) ◽  
pp. 58-64
Author(s):  
Achim Regenauer
Keyword(s):  
Gene Therapy ◽  
Side Effects ◽  
Molecular Targets ◽  
Basic Research ◽  
Healthcare Systems ◽  
Insurance Companies ◽  
Gene Therapies ◽  
Potential Applications ◽  
Health Insurance Companies ◽  
The Cost

Due to an increasingly better understanding of the human genome, the number of potential molecular targets, and therefore, potential applications by gene therapies is also increasing. After almost two decades of basic research, the first gene therapeutics are now entering the market. They are among the most expensive types of treatment in medicine. Over the next 10 years, the number and volume of their applications will increase significantly. So, our healthcare systems and inherently health insurance companies will face considerable challenges that will require new approaches to financial solutions. This article first describes the mode of action of the first gene therapies of cancer and their by now known side effects. Subsequently, the cost problems are dealt with and possible financing options are pointed out.

scholarly journals Healthcare systems, the State, and innovation in the pharmaceutical industry

2016 ◽  
Vol 32 (suppl 2) ◽  
Author(s):  
Ignacio José Godinho Delgado
Keyword(s):  
United States ◽  
Developing Countries ◽  
Pharmaceutical Industry ◽  
Health Systems ◽  
Developed Countries ◽  
The United States ◽  
Healthcare Systems ◽  
Catching Up ◽  
Pharmaceutical Industries ◽  
Brazilian Health System

Abstract: This article discusses the relations between healthcare systems and the pharmaceutical industry, focusing on state support for pharmaceutical innovation. The study highlights the experiences of the United States, United Kingdom, and Germany, developed countries and paradigms of modern health systems (liberal, universal, and corporatist), in addition to Japan, a case of successful catching up. The study also emphasizes the experiences of China, India, and Brazil, large developing countries that have tried different catching up strategies, with diverse histories and profiles in their healthcare systems and pharmaceutical industries. Finally, with a focus on state forms of support for health research, the article addresses the mechanisms for linkage between health systems and the pharmaceutical industry, evaluating the possibilities of Brazil strengthening a virtuous interaction, favoring the expansion and consolidation of the Brazilian health system - universal but segmented ‒ and the affirmation of the innovative national pharmaceutical industry.

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