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Agnes Westelinck
Researcher at GlaxoSmithKline
Publications - 3
Citations - 139
Agnes Westelinck is an academic researcher from GlaxoSmithKline. The author has contributed to research in topics: Drug development & Pharmacogenomics. The author has an hindex of 3, co-authored 3 publications receiving 136 citations.
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Journal ArticleDOI
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact
Federico Goodsaid,Shashi Amur,Jiri Aubrecht,Michael E. Burczynski,Kevin Carl,Jennifer Catalano,Rosane Charlab,Sandra L Close,Catherine Cornu-Artis,Laurent Essioux,Albert J. Fornace,Lois Hinman,Huixiao Hong,Ian Hunt,David Jacobson-Kram,Ansar Jawaid,David Laurie,Lawrence J. Lesko,Heng-Hong Li,Klaus Lindpaintner,James T. Mayne,Peter Morrow,Marisa Papaluca-Amati,Timothy W. Robison,John Roth,Ina Schuppe-Koistinen,Leming Shi,Olivia Spleiss,Weida Tong,Sharada Louis Truter,Jacky Vonderscher,Agnes Westelinck,Li Zhang,Issam Zineh +33 more
TL;DR: A selection of case studies from the first 5 years of the US Food and Drug Administration's voluntary exploratory data submission programme, which also involves collaboration with the European Medicines Agency, are discussed, and general lessons are highlighted.
Journal ArticleDOI
Prospective-retrospective biomarker analysis for regulatory consideration: white paper from the industry pharmacogenomics working group.
Scott D. Patterson,Nadine Cohen,Maha Karnoub,Sharada Louis Truter,Eileen Emison,Shirin Khambata-Ford,Brian B Spear,Ekopimo Ibia,Rizwana Sproule,Diane M. Barnes,Anahita Bhathena,Michael R Bristow,Chris B. Russell,Dai Wang,Amelia Wall Warner,Agnes Westelinck,William Brian,Amir Snapir,Monique A. Franc,Peggy H. Wong,Peter M. Shaw +20 more
TL;DR: The Industry Pharmacogenomics Working Group provides, for regulatory consideration, its perspective on the rationale for the conduct of what is commonly referred to as the prospective-retrospective analysis (PRA) of biomarkers.
Journal ArticleDOI
PhRMA survey of pharmacogenomic and pharmacodynamic evaluations: what next?
N Grecco,Nadine Cohen,Amelia Wall Warner,Catalina Lopez-Correa,Sharada Louis Truter,Amir Snapir,S P Piccoli,Dai Wang,Agnes Westelinck,Lois Hinman,Monique A. Franc +10 more
TL;DR: The survey results showed that, while the industry has made some attempt to incorporate PG/PD studies into drug development, application has been inconsistent and several validPG/PD markers have since emerged in drug labels.