Marketing and Pharmaceutical Development

1992 ◽  
Vol 22 (2) ◽  
pp. 221-234
Author(s):  
Maven J. Myers
Keyword(s):  
Cumulative Effect ◽  
Basic Research ◽  
Decision Processes ◽  
New Drugs ◽  
The Political ◽  
Market Demand ◽  
Pharmaceutical Development ◽  
New Drug ◽  
The Cost ◽  
Political Decisions

New pharmaceuticals are developed in response to therapeutic need, scientific feasibility, and market demand. As research and development (R&D) decision processes becomes more sophisticated, marketing input plays a greater role in these decisions. Industry-financed R&D is dependent on basic research financed by government. The political decisions which determine government-financed research are significant determinants of the scientific feasibility of a new drug. Many new drugs offer only minor advantages over existing therapies. The cumulative effect of these minor improvements are significant. In addition, new drugs often increase competition in a market. The Orphan Drug Act has contributed to the marketing of drugs where sufficient market demand may not otherwise exist. While some portion of R&D funds are spent on imitative drugs, the incentive for this use of R&D funds decreases as buyers become more sophisticated and as the cost of marketing a new drug increases.

scholarly journals Comparative Analysis of the QbD Approach in the Pharmaceutical Industry

2019 ◽  
Vol 8 (4) ◽  
pp. 20-26 ◽  
Author(s):  
S. A. Rozhnova ◽  
A. V. Tsypkina
Keyword(s):  
Comparative Analysis ◽  
Drug Development ◽  
Systematic Approach ◽  
New Drugs ◽  
Pharmaceutical Development ◽  
Drug Products ◽  
New Drug ◽  
Eurasian Economic Union ◽  
Pharmaceutical Manufacturers ◽  
Economic Union

Introduction. In the development and introduction of medicines into production, the aim of pharmaceutical manufacturers is to comply with the principle of «Quality-by-Design» (QbD). The International Council for Harmonisation (ICH) has created a number of GxP standards, which have become the regulatory framework for the development of documentation regulating the requirements for the development and production of drug products for countries focused on bringing their products to the world pharmaceutical market. The analysis of the system of regulation of pharmaceutical stages of development of new drugs in the territory of the Eurasian Economic Union was not considered, but for the formation of a systematic approach to the management of the process of pharmaceutical development it is necessary to describe them.Aim. To analyze the possibility of applying the QbD principle to the process of drug development at domestic pharmaceutical enterprises.Materials and methods. Content analysis of scientific publications, system and comparative analysis, sociological methods of research in the field of pharmaceutical development.Results and discussions. Regulatory state requirements to the organization and conduct of drug development procedures are analyzed and described. A number of systemic and sectoral problems typical for domestic pharmaceutical manufacturers in the organization of the development and implementation of new drug products. It is established that one of the main problems for Russian enterprises was the organization of the process as a whole and its individual procedures. To solve the problem of organization of procedures for the development and implementation of new medicines, we formed a methodological support, developed on the basis of a systematic approach and international requirements from the quality system.Conclusion. The main problem identified by the manufacturers is the lack of methodological support for the organization of the processes of pharmaceutical development and the introduction of new drugs in the part of research going to the stage of preclinical and clinical development. The decisions adopted by the Eurasian Economic Union do not affect such aspects of pharmaceutical development regulation as the organization of processes, their management and methodological support aimed at the implementation of the QbD principle. To solve this problem, we have developed guidelines for the implementation of the processes of pharmaceutical development and the introduction of new drug products, which allowed us to apply unified and formalized approaches to their organization. 

scholarly journals Government as the First Investor in Biopharmaceutical Innovation: Evidence From New Drug Approvals 2010–2019

2020 ◽  
pp. 1-72
Author(s):  
Ekaterina Galkina Cleary ◽  
Matthew J. Jackson ◽  
Fred D. Ledley
Keyword(s):  
Public Sector ◽  
Public Investment ◽  
Basic Research ◽  
Linear Process ◽  
New Drugs ◽  
Biomedical Science ◽  
Biological Targets ◽  
Working Paper ◽  
New Drug ◽  
Nih Funding

The discovery and development of new medicines classically involves a linear process of basic biomedical research to uncover potential targets for drug action, followed by applied, or translational, research to identify candidate products and establish their effectiveness and safety. This Working Paper describes the public sector contribution to that process by tracing funding from the National Institutes of Health (NIH) related to published research on each of the 356 new drugs approved by the U.S. Food and Drug Administration from 2010-2019 as well as research on their 219 biological targets. Specifically, we describe the timelines of clinical development for these products and proxy measures of their importance, including designations as first-in- class or expedited approvals. We model the maturation of basic research on the biological targets to determine the initiation and established points of this research and demonstrate that none of these products were approved before this enabling research passed the established point. This body of essential research comprised 2 million publications, of which 424 thousand were supported by 515 thousand Funding Years of NIH Project support totaling $195 billion. Research on the 356 drugs comprised 244 thousand publications, of which 39 thousand were supported by 64 thousand Funding Years of NIH Project support totaling $36 billion. Overall, NIH funding contributed to research associated with every new drug approved from 2010-2019, totaling $230 billion. This funding supported investigator-initiated Research Projects, Cooperative Agreements for government-led research on topics of particular importance, as well as Research Program Projects and Centers and training to support the research infrastructure. This NIH funding also produced 22 thousand patents, which provided marketing exclusivity for 27 (8.6%) of the drugs approved 2010-2019. These data demonstrate the essential role of public sector-funded basic research in drug discovery and development, as well as the scale and character of this funding. It also demonstrates the limited mechanisms available for recognizing the value created by these early investments and ensuring appropriate public returns. This analysis demonstrates the importance of sustained public investment in basic biomedical science as well as the need for policy innovations that fully realize the value of public sector investments in pharmaceutical innovation that ensure that these investments yield meaningful improvements in health.

scholarly journals Creating new drugs design patterns.Step one. Pharmaceutical development

2019 ◽  
Vol 1 (1) ◽  
pp. 22-31
Author(s):  
Anna V. Basevich ◽  
Anatoliy S. Dzjuba ◽  
Irina E. Kaukhova ◽  
Polina I. Andreeva
Keyword(s):  
Production Process ◽  
Pharmaceutical Company ◽  
Generic Drug ◽  
Quality By Design ◽  
New Drugs ◽  
Modern Approach ◽  
Control Card ◽  
Pharmaceutical Development ◽  
New Drug ◽  
Conducting Research

To optimize the process of pharmaceutical development, it is necessary to take into account the timeframes of the processes and to track all its key stages. To do this, it is necessary to create an algorithm for conducting research, taking into account the modern approach to pharmaceutical development the concept of Quality by Design. The aim of this work was to create an algorithm of actions in conducting research when developing a new drug that can be used in the production process. Flowcharts were used for depicting algorithms. To account the timeframes of the processes, a Gantt diagram was used. The process of pharmaceutical development when launching a new generic drug has been studied at an operating pharmaceutical company. An algorithm for the actions of staff involved in research is proposed The algorithm minds the concept of Quality by Design. A temporary Gannta scheme and a project manager's control card for the process of pharmaceutical development of a generic drug have been developed. Based on the results of the work, an algorithm of actions in conducting research when developing a new drug that can be used in the production process was proposed.

La politique forestière vaudoise: une orientation résolument «patrimoine multifonctionnel» | Forestry policy in the canton of Vaud: the “multifunctional heritage” option

2011 ◽  
Vol 162 (7) ◽  
pp. 209-215
Author(s):  
Jean-François Métraux
Keyword(s):  
Driving Force ◽  
Management Plan ◽  
The Political ◽  
Wood Production ◽  
Forest Owners ◽  
Forestry Policy ◽  
Forestry Management ◽  
Political Decisions ◽  
Forest Managers

In the years since 2000, the authorities in charge of forests in canton Vaud have made some substantial changes as a reaction to the political decisions arising from the Swiss Forest Programme and the projected revision of the Federal forestry Law, as well as to the deterioration of the economic situation in forestry enterprises. This article gives a survey of the directions taken. Thus the canton recognises the primordial role of wood production as a driving force behind the creation of a multifunctional forest. The Service for Forests, Wildlife and Nature has invested a great deal in planning, and has redefined the management plan to be an instrument intended for forest owners and forest managers. The canton has innovated by introducing forestry groups and a scheme of equalisation of forestry costs between communes. Hence the conception of forestry management in canton Vaud is resolutely that of a multifunctional natural heritage.

Synthesis and Biological Activity of Hydrazones and Derivatives: A Review

2020 ◽  
Vol 20 (5) ◽  
pp. 342-368 ◽  
Author(s):  
Juliana de Oliveira Carneiro Brum ◽  
Tanos Celmar Costa França ◽  
Steven R. LaPlante ◽  
José Daniel Figueroa Villar
Keyword(s):  
Biological Activity ◽  
Medicinal Chemistry ◽  
Biological Activities ◽  
New Drugs ◽  
New Drug ◽  
Cancer Inflammation

Hydrazones and their derivatives are very important compounds in medicinal chemistry due to their reported biological activity for the treatment of several diseases, like Alzheimer’s, cancer, inflammation, and leishmaniasis. However, most of the investigations on hydrazones available in literature today are directed to the synthesis of these molecules with little discussion available on their biological activities. With the purpose of bringing lights into this issue, we performed a revision of the literature and wrote this review based on some of the most current research reports of hydrazones and derivatives, making it clear that the synthesis of these molecules can lead to new drug prototypes. Our goal is to encourage more studies focused on the synthesis and evaluation of new hydrazones, as a contribution to the development of potential new drugs for the treatment of various diseases.

scholarly journals The Adjustment of China’s Grain Planting Structure Reduced the Consumption of Cropland and Water Resources

2021 ◽  
Vol 18 (14) ◽  
pp. 7352
Author(s):  
Yu Zhang ◽  
Jieyong Wang ◽  
Chun Dai
Keyword(s):  
Water Resources ◽  
Structural Adjustment ◽  
Land Reclamation ◽  
National Level ◽  
Cumulative Effect ◽  
Northern China ◽  
Semiarid Region ◽  
Market Demand ◽  
Continuous Growth ◽  
Northern Regions

Driven by technological progress and market demand, the optimization and adjustment of grain planting structure played an important role in increasing grain output. Due to the great difference between the yield per unit area of different types of food crops, the consumption of cropland and water resources has a significant change during the grain growth. From the perspective of structural adjustment, rather than the usual productive factor input, we analyze the process of adjustment for grain planting structure in China and its effect on the consumption of cropland and water resources by using the scenario comparative analysis method. The results show that: (1) From 2003 to 2019, China’s grain output has increased steadily and the planting structure has changed greatly. Rice was replaced by corn to become the grain crop with the maximum proportion of planting area since 2007. The increase of corn planting structure proportion is concentrated in the northern regions. (2) At the national level, according to the adjustment of grain planting structure, the saving of cropland and water resources consumption showed a “cumulative effect” as time went on. (3) The saving effects of structural adjustment in the northern regions on cropland and water resources consumption are better than that in the southern regions, such as Northeast China Plain, Northern arid and semiarid region and Loess Plateau. (4) In reality, although the adjustment of grain planting structure saved lots of cropland and water resources, the continuous growth of grain output has increased the pressure on the ecological environment in the northern regions according to theirs water limits. Therefore, it is necessary to continuously optimize the grain planting structure and restrict land reclamation in northern China. In addition, to ensure food security, it is feasible to encourage the southern regions with abundant water and heat resources to increase the grain planting area and meet its self-sufficiency in grain demand.

scholarly journals Advances in Applying Computer-Aided Drug Design for Neurodegenerative Diseases

2021 ◽  
Vol 22 (9) ◽  
pp. 4688
Author(s):  
Mootaz M. Salman ◽  
Zaid Al-Obaidi ◽  
Philip Kitchen ◽  
Andrea Loreto ◽  
Roslyn M. Bill ◽  
...  
Keyword(s):  
Drug Design ◽  
Neurodegenerative Diseases ◽  
Docking Studies ◽  
New Drugs ◽  
Computer Aided Drug Design ◽  
Biological Assays ◽  
Advantages And Disadvantages ◽  
Computer Aided ◽  
Research Challenge ◽  
The Cost

Neurodegenerative diseases (NDs) including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and Huntington’s disease are incurable and affect millions of people worldwide. The development of treatments for this unmet clinical need is a major global research challenge. Computer-aided drug design (CADD) methods minimize the huge number of ligands that could be screened in biological assays, reducing the cost, time, and effort required to develop new drugs. In this review, we provide an introduction to CADD and examine the progress in applying CADD and other molecular docking studies to NDs. We provide an updated overview of potential therapeutic targets for various NDs and discuss some of the advantages and disadvantages of these tools.

scholarly journals The 2011 National Science Foundation Political Science Awards

2012 ◽  
Vol 45 (01) ◽  
pp. 124-126
Keyword(s):  
Political Science ◽  
National Science Foundation ◽  
Research Training ◽  
Basic Research ◽  
Science Research ◽  
Fiscal Year ◽  
The Political ◽  
Science Program ◽  
Political Processes ◽  
National Science

The Political Science Program at the National Science Foundation (NSF) announces it awards for basic research support and dissertation improvement grants for fiscal year 2011. The Program funded 25 new projects and 44 doctoral dissertation improvement proposals. The Political Science Program spent $5,234,470 on these research, training and workshop projects and $483,822 on dissertation training grants for political science students. The program holds two grant competitions annually —Regular Research, August and January 15; Dissertation Improvement, September 16 and January 15— and constitutes a major source of political science research funding as part of fulfilling NSF's mission to encourage theoretically focused empirical investigations aimed at improving the explanation of fundamental social and political processes and structures.

Preclinical Principles of the Investigation of New Drugs

1972 ◽  
Vol 1 (1) ◽  
pp. 1-3
Author(s):  
F J Sanen
Keyword(s):  
Team Work ◽  
New Drugs ◽  
Drug Trials ◽  
New Drug ◽  
Preclinical Investigation ◽  
Research Challenge

From this presentation it becomes apparent that preclinical investigation of new drugs is a multi-disciplinary endeavour. The need for close team work between the various scientists is necessary to meet this complex research challenge successfully. With the development of an ever-increasing number of potent drugs, it is mandatory that the physician responsible for monitoring new drug trials broaden his understanding of preclinical investigations. In doing so, he will soon learn the need for consistent interplay between the preclinical scientist and clinician.

scholarly journals Resultan Politik dan Putusan Mahkamah Konstitusi Nomor 14/PUU-XI/2013 dalam Politik Hukum Pemilu

2018 ◽  
Vol 15 (2) ◽  
pp. 327
Author(s):  
Sholehudin Zuhri
Keyword(s):  
Political Parties ◽  
The Political ◽  
Constitutional Court ◽  
New Paradigm ◽  
Political Interests ◽  
Election System ◽  
The Law ◽  
Democratic Election ◽  
Political Configuration ◽  
Political Decisions

Dalam perkembangan politik hukum kontemporer, keputusan politik dalam pembentukan regulasi sering dihadapkan pada dua persoalan sekaligus yang saling berhadapan. Konfigurasi politik dalam pembentukan Undang-Undang Nomor 7 Tahun 2017, partai politik di parlemen tidak hanya merepresentasikan kepentingan politiknya, tetapi juga dihadapkan pada keharusan mengakomodir putusan Mahkamah Konstitusi Nomor 14/PUU-XI/2013 sebagai koreksi keputusan politik yang otoriter. Penelitian ini adalah penelitian yuridis normatif dengan metode kualitatif, studi ini menitikberatkan pada pemahaman komprehensif yang meliputi interaksi politik dan hukum dalam terciptanya konfigurasi politik hukum pemilu. Hasil studi ini dapat menjelaskan kepatuhan partai politik terhadap hukum dalam menciptakan konfigurasi politik di parlemen, namun di sisi lainnya lemahnya partai politik dalam membangun koalisi dalam mewujudkan sistem pemilu demokratis justru menjadikan keputusan politik yang dipilih menjadi otoriter dalam pelaksana teknisnya. Kehadiran hukum dalam perkembangan konfigurasi politik kontemporer, dapat menjadi paradigma baru dalam terciptanya konfigurasi politik demokratis yang pada akhirnya terbentuknya hukum pemilu yang demokratis.In the development of contemporary political laws, political decisions in regulatory formation are often confronted with two issues at once facing each other. The political configuration in the Law No. 7 year 2017, political parties in parliament not only represent political interests but also face the necessity to accommodate the decision of the Constitutional Court Number 14/ PUU-XI/2013 as a correction of authoritarian political decisions. This research is normative juridical research with qualitative method. The results of this study can explain the compliance of political parties to the law in creating the political configuration in parliament. Yet on the other hand, the weakness of political parties in building coalitions in realizing the democratic election system makes the selected political decision become authoritarian in its technical execution. The presence of law in the development of contemporary political configuration can be a new paradigm in creating democratic political configuration which ultimately the formation of democratic law of elections.

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