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Special Issue "Economics of New Drug Development and Approval"

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A special issue of International Journal of Environmental Research and Public Health (ISSN 1660-4601).

Deadline for manuscript submissions: closed (14 February 2014)

Special Issue Editor

Guest Editor
Dr. Joseph A. DiMasi (Website)

Economic Analysis, Tufts Center for the Study of Drug Development, Tufts Medical School, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02109, USA
Interests: biopharmaceutical R&D costs; risks; and time; drug and biologics regulation; innovation incentives; economic structure of the biopharmaceutical industry

Special Issue Information

Dear Colleagues,

The development of new drugs is an important source of medical innovation. It is also exceptionally lengthy, risky, and costly. The economics of the pharmaceutical and biotechnology industries are driven, to a large extent, by these realities. That has led to numerous regulatory programs and policies designed with the hope that the regulatory approval process will be streamlined while maintaining review standards and also that the development of important new therapies will be facilitated. Industry, for its part, has experimented in recent years with reorganizing internal R&D activities and developing new models of interacting with academic medical centers, non-profit institutes, government agencies, and with each other. This issue welcomes articles on policies, programs, and processes that can affect incentives to develop new drugs and biologics, and generally on development, regulatory, promotional, and market processes that impact the economics of new drug development and approval.

Dr. Joseph A. DiMasi
Guest Editor

Submission

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. Papers will be published continuously (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are refereed through a peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. International Journal of Environmental Research and Public Health is an international peer-reviewed Open Access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1600 CHF (Swiss Francs).

Keywords

  • pharmaceutical R&D processes
  • drug regulatory approval policies
  • incentives for pharmaceutical innovation
  • metrics on new drug development and approval
  • medical and economic impact of new drug development

Published Papers (2 papers)

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Research

Open AccessArticle Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance
Int. J. Environ. Res. Public Health 2014, 11(5), 5069-5080; doi:10.3390/ijerph110505069
Received: 20 February 2014 / Revised: 29 April 2014 / Accepted: 30 April 2014 / Published: 12 May 2014
Cited by 6 | PDF Full-text (187 KB) | HTML Full-text | XML Full-text
Abstract
Protocol design complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct [...] Read more.
Protocol design complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct cost of conducting less essential and unnecessary protocol procedures and of implementing amendments to protocol designs. Indirect costs including personnel time, work load and cycle time delays associated with complex protocol designs are also discussed. The author concludes with an overview of steps that research sponsors are taking to improve protocol design feasibility. Full article
(This article belongs to the Special Issue Economics of New Drug Development and Approval)
Open AccessArticle New Zealand’s Drug Development Industry
Int. J. Environ. Res. Public Health 2013, 10(9), 4339-4351; doi:10.3390/ijerph10094339
Received: 25 July 2013 / Revised: 9 September 2013 / Accepted: 10 September 2013 / Published: 13 September 2013
PDF Full-text (225 KB) | HTML Full-text | XML Full-text
Abstract
The pharmaceutical industry’s profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of [...] Read more.
The pharmaceutical industry’s profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of developing new drug candidates. There is an opportunity for academia to further develop as a source of drug discovery. The rising levels of industry outsourcing also provide prospects for organisations that can reduce the costs of drug development. We explored the potential returns to New Zealand (NZ) from its drug discovery expertise by assuming a drug development candidate is out-licensed without clinical data and has anticipated peak global sales of $350 million. We also estimated the revenue from NZ’s clinical research industry based on a standard per participant payment to study sites and the number of industry-sponsored clinical trials approved each year. Our analyses found that NZ’s clinical research industry has generated increasing foreign revenue and appropriate policy support could ensure that this continues to grow. In addition the probability-based revenue from the out-licensing of a drug development candidate could be important for NZ if provided with appropriate policy and financial support. Full article
(This article belongs to the Special Issue Economics of New Drug Development and Approval)

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