Patent issues and future trends in drug development

10.5912/jcb42 ◽  
1969 ◽  
Vol 9 (4) ◽  
Author(s):  
Faiz Kermani ◽  
Pietro Bonacossa
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Trade Agreements ◽  
Pharmaceutical Companies ◽  
Future Trends ◽  
Patient Access ◽  
Market Exclusivity ◽  
Political Issues ◽  
International Trade Agreements ◽  
Industrial Sectors

The global biopharmaceutical industry has been one of the most productive and profitable industrial sectors; however, the drug development process remains risky and expensive, with no guarantees of success. The industry believes that a system for the effective intellectual property protection is key to its ability to maintain innovation for drug development. But some critics think that the market exclusivity offered by patents simply allows companies to maximise profits without benefiting patients.Social issues such as patient access to new AIDS treatments and political issues such as international trade agreements mean that the manner in which pharmaceutical companies operate at a business level is becoming subject to closer scrutiny.

scholarly journals Risks of Integration of Trans-Siberian and Baikal-Amur Railways with International Transport Corridors of Eurasia

2020 ◽  
Vol 4 (1) ◽  
pp. 53-63
Author(s):  
Darya Dinets
Keyword(s):  
Financial Burden ◽  
Trade Agreements ◽  
Rolling Stock ◽  
Investment Projects ◽  
International Trade Agreements ◽  
Transport Services ◽  
Industrial Sectors ◽  
International Transport ◽  
Place Of Origin ◽  
Energy Balances

The article is devoted to describing the main trends of Eurasian transport corridors integration in terms of assessment of the participants’ risks. It shows that the format of the transport integration peculiar to the trans-regional alliances initiates risk synergy at the level of business profiles of the amalgamating countries, but not only in the sphere of the transport communication. Besides, the inconformity in the structure of the frights, carried in various directions in Eurasia, means additional financial burden to support the infrastructure and the rolling stock to meet the integration challenges. All these problems lead to impossibility of payback of the transport investment projects both at the level of a single country and any union of countries. Thus, the financial and economic risks of integration projects in transport, with respect to the structure of the energy balances of the countries uniting the transport corridors, request higher demands for the return of capital employed, and, consequently, they are translated into all related industrial sectors on the continent. Ignoring the integration risks in substantiating the projects of international transport corridors leads to increased expectations in regard to socio-economic and geopolitical consequences for international trade agreements, holds back on the volumes of foreign economic activity of the countries, leads to isolationist tendencies at the level of economic entities. As a measure directed to obtaining an effect of the scale sufficient to compensate the business risks of the transport integration, the article offers to organize the transport communication on the continent on the principle of “Management of United Corridor”, involving various types of transport, using the transport logistic hubs. This kind of principle of international cooperation in the transport is particular profitable for the Russo-Chinese relationships, with Russia being a provider of the transport services, and China being the place of origin of the major part of freights transported through international transport corridors.

scholarly journals Research on the development of cancer drugs for children

2021 ◽  
Vol 308 ◽  
pp. 02014
Author(s):  
Yihan Wang
Keyword(s):  
Survival Rate ◽  
Drug Development ◽  
Pediatric Cancer ◽  
Development Process ◽  
Drug Market ◽  
Market Condition ◽  
Pharmaceutical Companies ◽  
Cancer Drugs ◽  
Significant Development ◽  
The Government

The development of pediatric cancer drugs is inefficient and must requires a significant development to improve the current situation. According to the research on the development of pediatric cancer drugs, the market condition is analyzed and compared with adult cancer drugs. It is found that even though the drug market for pediatric cancer is significantly smaller than adult cancer’s drug market, it is still important that pediatric cancer drugs are developed in order to better serve the treatment for childhood cancer, and increase the survival rate for malign cancer cases. Through thorough research it also appeared that while the government provides some beneficial programs and insurances for children experiencing pediatric cancer, better insurance plans should be identified. Another important finding throughout research results in the government and legislation area, where the pediatric cancer drugs development process is analysed and has found some potential for the future. As a whole, the effort of the government in both the drug development period and the legislation area with the combination of big pharmaceutical companies’ efforts and the potential creation of new kinds of insurances, the situation for pediatric cancer drugs development can experience a positive change.

scholarly journals Patents, Data Exclusivity, and the Development of New Drugs

2020 ◽  
pp. 1-49
Author(s):  
Fabian Gaessler ◽  
Stefan Wagner
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Patent Protection ◽  
Sole Source ◽  
New Drugs ◽  
Market Exclusivity ◽  
Pharmaceutical Firms ◽  
Data Exclusivity ◽  
One Year ◽  
And Shifts

Pharmaceutical firms enjoy market exclusivity for new drugs from concurrent patent protection and exclusivity of the clinical trials data submitted for market approval. Patent invalidation during drug development renders data exclusivity the sole source of protection and shifts the period of market exclusivity. In instrumental variables regressions we quantify the effect of a one-year reduction in expected market exclusivity on the likelihood of drug commercialization. The effect is largely driven by patent invalidations early in the drug development process and by the responses of large originators. We hereby provide estimates of the responsiveness of R&D investments to market exclusivity expectations.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

scholarly journals Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process

2015 ◽  
Vol 35 (7) ◽  
pp. 1063-1089 ◽  
Author(s):  
Sylwia Bujkiewicz ◽  
John R. Thompson ◽  
Richard D. Riley ◽  
Keith R. Abrams
Keyword(s):  
Drug Development ◽  
Analytical Methods ◽  
Development Process ◽  
Surrogate Endpoints ◽  
Drug Development Process

Energy reform will hit investor confidence in Mexico

2021 ◽  
Keyword(s):  
United States ◽  
International Trade ◽  
Trade Agreements ◽  
The United States ◽  
Energy Prices ◽  
Content Type ◽  
Investor Confidence ◽  
International Trade Agreements ◽  
The Government ◽  
Energy Reform

Significance The government will appeal the rulings, which follow action by renewables firms. With constitutional battles over energy investments already unfolding, the future of Mexico’s energy framework has been thrown into turmoil. Impacts Increasing energy prices will probably push inflation above Banxico’s upper target limit of 4%. AMLO’s apparent disregard for international trade agreements will strain relations with the United States. AMLO’s pro-austerity fiscal stance could take a toll on his popularity.

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