The Economics of the Biopharmaceutical Industry

2011 ◽  
pp. 519-554 ◽  
Author(s):  
Patricia M. Danzon
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Future Research ◽  
Neglected Diseases ◽  
Market Demand ◽  
Global Issues ◽  
Insurance Reimbursement ◽  
Development Costs ◽  
The Us ◽  
Differential Pricing

This article summarizes the literature, and considers the issue of paying for research and development. It reviews research and development costs, regulation, productivity and incentives for innovation. It discusses market demand and pricing, effects of insurance, reimbursement regulation, alternatives to patents, and generics. Further, it reviews trends in promotion, regulation of promotion and its effects. It discusses global issues, including differential pricing and R&D for neglected diseases. The focus is on the US, as the home of the largest number of multinational pharmaceutical and smaller biotech companies. This article notes the important differences in regulatory and reimbursement systems in other countries. Finally it suggests that although there is large and growing literature on the pharmaceutical industry that has produced valuable information, important issues remain for future research.

scholarly journals Psychiatry and the pharmaceutical industry: who pays the piper?

2005 ◽  
Vol 29 (3) ◽  
pp. 84-85 ◽  
Author(s):  
Joanna Moncrieff ◽  
Steve Hopker ◽  
Philip Thomas
Keyword(s):  
Pharmaceutical Industry ◽  
Private Investment ◽  
Marketing Strategies ◽  
Us Economy ◽  
Development Costs ◽  
Major Development ◽  
The Us ◽  
Public Citizen ◽  
Disease Concepts ◽  
The Relationship

There is increasing concern about the relationship between medicine and the pharmaceutical industry. In July the BMJ devoted a themed issue to this, and critical discussions have featured in other leading medical journals recently. The industry has grown in profitability and influence over the past 20 years, and is now second only to armaments in the US economy (Public Citizen, 2002). Its influence is enhanced through its control of research, and it employs sophisticated and wide-reaching marketing strategies. This level of influence is concerning because the private investment necessary to enable drug development demands ever more vigorous struggles to maintain and expand market presence. In other words, commercial rather than clinical or scientific demands are becoming the dominant driving force for ‘innovation’. This leads to the popularity of developing cheaper ‘me too’ options, and the promotion of new ‘disease concepts' to allow the re-badging of old products to expand markets without major development costs.

Economics of the Pharmaceutical Industry

2018 ◽  
Vol 56 (2) ◽  
pp. 397-449 ◽  
Author(s):  
Darius N. Lakdawalla
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Pharmaceutical Products ◽  
Pharmaceutical Firms ◽  
Economics Literature ◽  
The Us ◽  
Pharmaceutical Prices ◽  
Normative Implications

The pharmaceutical industry accounts for a substantial chunk of the US economy's research and development investments, which have resulted in significant medical breakthroughs. At the same time, the costs of pharmaceutical products continue to rise, as does pressure to adopt direct or indirect controls on pharmaceutical prices. We review the economics literature on the pharmaceutical industry, focusing particularly on its positive and normative implications for the innovation, pricing, and marketing decisions of pharmaceutical firms. We discuss the major achievements of, and persistent gaps in, the literature, along with lessons for policy. (JEL I11, L11, L65, M31, M37, O31, O34)

Creative and Innovative Statistics in Clinical Research and Development

2005 ◽  
Vol 44 (04) ◽  
pp. 551-560 ◽  
Author(s):  
W. Maurer
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Clinical Research ◽  
Development Process ◽  
Critical Path ◽  
Clinical Development ◽  
Compound A ◽  
The Us ◽  
The Right ◽  
Reduced Time

Summary Objectives: The aim of this paper is to show that even in a highly regulated area such as clinical research and development in pharmaceutical industry, there are needs and ample opportunities for statisticians and other medical informatics professionals to further creatively develop and implement methods in order to support the collection, analysis and interpretation of clinical data. Methods: The recently published “Critical Path” initiative of the US Food and Drug Administration discusses the decline in new drug submissions in the last decade and illustrates potential causes in the present clinical development process. Areas where statisticians can and have begun to look for new innovative ways to overcome these shortcomings are presented and examples of such novel approaches that have been developed by statistical methodologists in the pharmaceutical industry together with statisticians in academia are given. Results: In Early Development, i.e., in the first studies in man with a new compound, a combination of Bayesian methods and modeling approaches is particularly promising to increase the efficiency of decision making whereas in later phases (IIb and III) a marriage of modeling and classical frequentist approaches together with novel adaptive designs is expected to help to chose the right dose regimen and to perform the trials more efficiently in reduced time. Conclusions: The combination of known statistical methods and thinking and the development of new approaches are in line with the present paradigm of “learning and confirming” in regulated clinical development while increasing the efficiency of both.

New models for research and development in the treatment of mental illness

2016 ◽  
Vol 33 (S1) ◽  
pp. S542-S543
Author(s):  
J.N. Kjær
Keyword(s):  
Mental Illness ◽  
Pharmaceutical Industry ◽  
Infectious Diseases ◽  
Research And Development ◽  
New Drugs ◽  
Neglected Diseases ◽  
Novel Treatments ◽  
New Models ◽  
Competing Interest ◽  
New Treatments

The pharmaceutical industry's investments in research and development of novel treatments for mental illness have heavily declined in the past decade. Major private investments are, by most experts, seen as necessary to develop new treatments. However, psychiatry is not the only area overlooked by the industry. For decades infectious diseases have also lacked investments in research and development.AimsThe aims of this study were to investigate the new models of research and development in infectious diseases that emerged after the pharmaceutical industry ceased their investments and to model how these can be used in psychiatry.MethodA systematic review. We searched PubMed, EMBASE and Web of Science for the keywords “infectious diseases”, “research and development” and “pharmaceutical industry”.Preliminary resultsThe searches gave a total of 248 references. Among the findings, we want to highlight the Drugs for Neglected Diseases initiative (DNDi) and the WHO Research and Development Treaty (R&D Treaty). DNDi is a non-profit organization that has developed six new drugs since 2003. The development costs were €150 millions per drug, which is considerably below the costs for drug development claimed by the pharmaceutical industry. The R&D Treaty will commit member states of the WHO to fund development for neglected health needs using alternative incentives like milestone prizes, patent pools and direct grants. The treaty has not yet been agreed upon.ConclusionsThough a low priority from the pharmaceutical industry, other funding models have proven able to deliver new treatments. This could also lead to more development of non-patentable treatments, e.g. psychotherapy.Disclosure of interestThe author has not supplied his/her declaration of competing interest.

Translational medicine

2011 ◽  
Vol 152 (47) ◽  
pp. 1894-1902
Author(s):  
János Antal ◽  
Attila Timár
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Patient Care ◽  
Computer Modeling ◽  
Translational Medicine ◽  
Scientific Discipline ◽  
Laboratory Research ◽  
Basic Sciences ◽  
Industry Research ◽  
Underlying Basis

Translational medicine is the emerging scientific discipline of the last decade which will set the benchmark for the pharmaceutical industry research and development, integrates inputs from the basic sciences of computer modeling and laboratory research through the pre-clinical and clinical phases of human research to the assimilation of new therapies and treatments into everyday practice of patient care and prevention. With this brief insight authors tried in their humble way to summarize the underlying basis, the present and the potential future of this emerging view, to draw attention to some of the challenges and tasks it faces and to highlight some of the promising approaches, trends and model developments and applications. Orv. Hetil., 2011, 152, 1894–1902.

Reaching Spanish-Speakers in Self-Administered Surveys

2019 ◽  
Vol 3 (4) ◽  
Author(s):  
J Michael Brick ◽  
Andrew Caporaso ◽  
Douglas Williams ◽  
David Cantor
Keyword(s):  
Single Phase ◽  
Spanish Language ◽  
Spanish Speakers ◽  
English Speakers ◽  
Future Research ◽  
The Internet ◽  
English Only ◽  
Eligible Population ◽  
The Us ◽  
Survey Estimates

Decisions on public policy can be affected if important segments of the population are systematically excluded from the data used to drive the decisions. In the US, Spanishspeakers make up an important subgroup that surveys conducted in English-only underrepresent. This subgroup differs in a variety of characteristics and they are less likely to respond to surveys in English-only. These factors lead to nonresponse biases that are problematic for survey estimates. For surveys conducted by mail, one solution is to include both English and Spanish materials in the survey package. For addresses in the US where Spanish-speakers are likely to be living, this approach is effective, but it still may omit some non-English-speakers. Traditionally, including both English and Spanish materials for addresses not identified as likely to have Spanish-speakers was considered problematic due to concerns of a backlash effect. The backlash effect is that predominantly English-speakers might respond at a lower rate because of the inclusion of Spanish materials. Prior research found no evidence of a backlash, but used a twophase approach with a short screener questionnaire to identify the eligible population for an education survey. In this paper, we report on experiments in two surveys that extend the previous research to criminal victimization and health communication single-phase surveys. These experiments test the effect of the inclusion of Spanish language materials for addresses not identified as likely to have Spanish-speakers. Our findings confirm most results of the previous research; however we find no substantial increase in Spanish-only participation when the materials are offered in both languages for addresses that are not likely to have Spanish-speakers. We offer some thoughts on these results and directions for future research, especially with respect to collecting data by the Internet.

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