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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: It is necessary to select patients suitable for vaginal or laparoscopic mesh placement for use in the neonatal intensive care unit based on prior history and once they provide informed consent for surgery.
Abstract: Clinical Pharmacology & Therapeutics (2001) 69, 297–307; doi: 10.1067/mcp.2001.115446

451 citations

Journal ArticleDOI
TL;DR: Trends in the clinical development and regulatory approval of monoclonal antibodies for cancer since 1980 are overviewed with the aim of informing future research and development for this class of therapeutics.
Abstract: Monoclonal antibodies are now established as a key therapeutic modality for a range of diseases. Owing to the ability of these agents to selectively target tumour cells, cancer has been a major focus of development programmes for monoclonal antibodies so far. Here, we overview trends in the clinical development and regulatory approval of monoclonal antibodies for cancer since 1980, with the aim of informing future research and development for this class of therapeutics.

408 citations

Journal ArticleDOI
TL;DR: The pharmaceutical sector, as currently structured, is unable to deliver enough new products to market to generate revenues sufficient to sustain its own growth.
Abstract: Forged in the early 1960s, the paradigm for pharmaceutical innovation has remained virtually unchanged for nearly 50 years. During a period when most other research-based industries have made frequent and often sweeping modifications to their R&D processes, the pharmaceutical sector continues to utilize a drug development process that is slow, inefficient, risky, and expensive. Few who work in or follow the activities of the pharmaceutical industry question whether change is coming. They know that the pharmaceutical sector, as currently structured, is unable to deliver enough new products to market to generate revenues sufficient to sustain its own growth. Nearly all major drug developers are critically examining current R&D practices and, in some cases, considering a radical overhaul of their R&D models. But key questions remain. What will the landscape for pharmaceutical innovation look like in the future? And, who will develop tomorrow’s medicines?

340 citations

Journal ArticleDOI
TL;DR: Despite entering its maturation phase, the recombinant protein sector will continue to drive the growth of medical biotechnology over the next six years.
Abstract: Despite entering its maturation phase, the recombinant protein sector will continue to drive the growth of medical biotechnology over the next six years.

330 citations

Journal ArticleDOI
TL;DR: It was found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs.
Abstract: Purpose Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. Methods We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. Results We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other ...

319 citations


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