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Institution

Tufts Center for the Study of Drug Development

About: Tufts Center for the Study of Drug Development is a based out in . It is known for research contribution in the topics: Drug development & Clinical trial. The organization has 78 authors who have published 258 publications receiving 16047 citations.


Papers
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Journal ArticleDOI
TL;DR: Since 2015, the Chinese government has introduced numerous reforms with the aim of establishing a more scientific and efficient drug regulatory system, which are highlighted here.
Abstract: Since 2015, the Chinese government has introduced numerous reforms with the aim of establishing a more scientific and efficient drug regulatory system, which are highlighted here.

18 citations

Journal ArticleDOI
TL;DR: The need for the FDA to make designation and implementation decisions with a view that reaches beyond the immediate horizons of political expediency and patient advocacy to encompass the broader expanse of factors that now influence R&D decisions is betokened.
Abstract: Broadly speaking, the goals of the US Food and Drug Administration (FDA) special-designation programs—orphan, priority review, accelerated approval, and fast track—have been to expedite and sustain development and facilitate authorization of new medicines for unmet medical needs through so-called “push–pull” incentives. Although generally successful over time, their success has been confined to certain therapeutic areas and, within those areas, certain diseases. Times have changed. The research and development (R&D) burdens and public health urgency that acted as an impetus for the FDA to intervene more actively for certain disease areas are now broadly experienced across many disease areas. This betokens the need for the FDA to make designation and implementation decisions with a view that reaches beyond the immediate horizons of political expediency and patient advocacy to encompass the broader expanse of factors that now influence R&D decisions—global competitiveness, the needs of investors, emerging sponsors, and patient-focused drug development. Clinical Pharmacology & Therapeutics (2013); 95 1, 98–109 advance online publication 30 October 2013. doi:10.1038/clpt.2013.155

18 citations

Journal ArticleDOI
TL;DR: This article addresses current challenges facing pharmaceutical and biopharmaceutical developers, including the expiration of patents on many high-revenue–generating products, increasing competition in the marketplace, low public support, high regulatory hurdles, and the increasing time, cost, and risk of new product development.
Abstract: This article addresses current challenges facing pharmaceutical and biopharmaceutical developers, including the expiration of patents on many high-revenue-generating products, increasing competition in the marketplace, low public support, high regulatory hurdles, and the increasing time, cost, and risk of new product development. To meet these challenges, drug developers are looking to new models of innovation to improve efficiency, lower risk, and increase output. These new models include codevelopment agreements with small companies, multicompany consortia, and strategic partnerships with academic research centers. In the United States and the European Union, the government is supporting these efforts by creating incentives for academic centers to foster translational research and become more "commercially minded". The goal for all stakeholders is to reduce the barriers to product development and bring new medicines to market in a timely and cost-efficient manner.

18 citations

Journal ArticleDOI
TL;DR: Developing greater insight into therapeutic area needs, gaining market access, and greater understanding of drug effectiveness were the top measures identified for return on investment for use of RWE.
Abstract: Background:The adoption and use of real-world evidence (RWE) is becoming increasingly important to drug development and patient safety.Methods:The Tufts Center for the Study of Drug Development (CSDD) conducted a benchmark survey of pharmaceutical and biotechnology companies and contract research organizations in a number of areas that support real-world data (RWD) and evidence, including operations and performance areas. Data were gathered on organizational functions, staff, roles and responsibilities, and skill sets required. Also, current and future allocation of budgets and spending were examined as well as return on investment measures. A total of 30 unique companies responded to the survey.Results:Nearly all respondents (29/30 companies) reported that their organizations had an RWE function and most companies indicated that their RWE functions were increasing in size (21 companies). From a postapproval regulatory and labeling perspective, there were two primary areas for company use of RWD to genera...

17 citations

Journal ArticleDOI
TL;DR: Social media has both potential for improving orphan drug development and pitfalls, but with proper oversight on the part of companies, support and participation of patients and their advocacy groups, and timely guidance from regulatory authorities, the positives outweigh the negatives for this powerful and patient-centric tool.

17 citations


Authors
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Performance
Metrics
No. of papers from the Institution in previous years
YearPapers
20219
20208
201914
201815
201710
201611