Translating predictive biomarkers within oncology clinical development programs

2015 ◽  
Vol 9 (9) ◽  
pp. 851-862 ◽  
Author(s):  
Robert A Beckman ◽  
Cong Chen
Keyword(s):  
Predictive Biomarkers ◽  
Clinical Development ◽  
Development Programs

Regulatory and Technical Challenges in Incorporating Surrogate Tissue Profiling Strategies into Clinical Development Programs

2005 ◽  
pp. 249-261
Author(s):  
William Trepicchio ◽  
Monica Cahilly ◽  
Lisa Speicher ◽  
Judith Oestreicher ◽  
Michael Burczynski ◽  
...  
Keyword(s):  
Clinical Development ◽  
Development Programs ◽  
Tissue Profiling ◽  
Surrogate Tissue ◽  
Technical Challenges

scholarly journals Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

Drug Safety ◽  
2019 ◽  
Vol 42 (6) ◽  
pp. 751-768 ◽  
Author(s):  
Subrata Ghosh ◽  
Lianne S. Gensler ◽  
Zijiang Yang ◽  
Chris Gasink ◽  
Soumya D. Chakravarty ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Psoriatic Arthritis ◽  
Crohn's Disease ◽  
Phase Ii ◽  
Clinical Development ◽  
Integrated Analysis ◽  
Development Programs

Raising Orphans: How Clinical Development Programs of Drugs for Rare and Common Diseases Are Different

2012 ◽  
Vol 92 (2) ◽  
pp. 262-264 ◽  
Author(s):  
M Orfali ◽  
L Feldman ◽  
V Bhattacharjee ◽  
P Harkins ◽  
S Kadam ◽  
...  
Keyword(s):  
Clinical Development ◽  
Development Programs ◽  
Common Diseases

Integrating predictive biomarkers and classifiers into oncology clinical development programmes

2011 ◽  
Vol 10 (10) ◽  
pp. 735-748 ◽  
Author(s):  
Robert A. Beckman ◽  
Jason Clark ◽  
Cong Chen
Keyword(s):  
Predictive Biomarkers ◽  
Clinical Development

Preparing for Subsequent Entry Biologies in Dermatology and Rheumatology in Canada

2013 ◽  
Vol 17 (5) ◽  
pp. 340-346 ◽  
Author(s):  
Kim Papp ◽  
Marc Bourcier ◽  
Vincent Ho ◽  
Karen Burke ◽  
Boulos Haraoui
Keyword(s):  
Clinical Practice ◽  
Clinical Development ◽  
Draft Guidance ◽  
Therapeutic Equivalence ◽  
Development Programs ◽  
Regulatory Pathway ◽  
Key Issues ◽  
Therapeutic Interchange ◽  
Health Canada ◽  
Case Basis

Background: Patents on several biologies will expire in Canada in the coming years. As they expire, applications to market subsequent entry biologies (SEBs) may be filed in Canada. Objective: To provide an understanding of the regulatory pathway and types of trials used for SEB authorization in Canada. Methods: Health Canada's draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs. Results: Health Canada states that SEBs are not “generic biologies” and their authorization is not a declaration of pharmaceutical or therapeutic equivalence to the originator. The agency recommends that physicians make well-informed decisions regarding therapeutic interchange. Conclusions: Decisions on how to determine the place of SEBs in clinical practice for biologic-naive patients and those already receiving biologies should be made on a case-by-case basis, considering the patient's needs, the characteristics of the biologic required, and the clinical development programs of the applicable SEB.

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