scholarly journals Corrigendum: Tumor growth dynamic modeling in oncology drug development and regulatory approval: Past, present, and future opportunities

2021 ◽  
Vol 10 (2) ◽  
pp. 173-173
Keyword(s):  
Drug Development ◽  
Tumor Growth ◽  
Dynamic Modeling ◽  
Regulatory Approval ◽  
Growth Dynamic ◽  
Oncology Drug ◽  
Oncology Drug Development

scholarly journals Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities

2020 ◽  
Vol 9 (8) ◽  
pp. 419-427
Author(s):  
Nidal Al‐Huniti ◽  
Yan Feng ◽  
Jingyu (Jerry) Yu ◽  
Zheng Lu ◽  
Mario Nagase ◽  
...  
Keyword(s):  
Drug Development ◽  
Tumor Growth ◽  
Dynamic Modeling ◽  
Regulatory Approval ◽  
Growth Dynamic ◽  
Oncology Drug ◽  
Oncology Drug Development

scholarly journals Economics of New Oncology Drug Development

2007 ◽  
Vol 25 (2) ◽  
pp. 209-216 ◽  
Author(s):  
Joseph A. DiMasi ◽  
Henry G. Grabowski
Keyword(s):  
Drug Development ◽  
Basic Research ◽  
The United States ◽  
Global Market ◽  
Regulatory Approval ◽  
Priority Review ◽  
Success Rates ◽  
Oncology Drug ◽  
Market Diffusion ◽  
Oncology Drug Development

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 drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. Conclusion The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

scholarly journals Next generation oncology drug development: opportunities and challenges

2009 ◽  
Vol 6 (5) ◽  
pp. 259-265 ◽  
Author(s):  
Martin E. Gutierrez ◽  
Shivaani Kummar ◽  
Giuseppe Giaccone
Keyword(s):  
Drug Development ◽  
Next Generation ◽  
Oncology Drug ◽  
Oncology Drug Development

scholarly journals Patient-derived tumour xenografts as models for oncology drug development

2012 ◽  
Vol 9 (6) ◽  
pp. 338-350 ◽  
Author(s):  
John J. Tentler ◽  
Aik Choon Tan ◽  
Colin D. Weekes ◽  
Antonio Jimeno ◽  
Stephen Leong ◽  
...  
Keyword(s):  
Drug Development ◽  
Oncology Drug ◽  
Oncology Drug Development ◽  
Tumour Xenografts

Cardiovascular Safety Monitoring During Oncology Drug Development and Therapy

2014 ◽  
Vol 21 (6) ◽  
pp. 512-522 ◽  
Author(s):  
J. Rick Turner ◽  
Gopi Krishna Panicker ◽  
Dilip R. Karnad ◽  
Christopher H. Cabell ◽  
Ronald Lieberman ◽  
...  
Keyword(s):  
Drug Development ◽  
Safety Monitoring ◽  
Cardiovascular Safety ◽  
Oncology Drug ◽  
Oncology Drug Development

Abstract 529: Characterization of a humanized TLR8 mouse model and its application in immuno-oncology drug development

2021 ◽  
Author(s):  
Hongjuan Zhang ◽  
Ruilin Sun ◽  
Annie X. An ◽  
Henry Q.x Li ◽  
Davy Xuesong Ouyang
Keyword(s):  
Mouse Model ◽  
Drug Development ◽  
Oncology Drug ◽  
Oncology Drug Development
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