Search Results for: GE Healthcare Advances the Delivery

Articles

August 27, 2018

DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development August 27, 2018

Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.

May 1, 2017

ASSAY VALIDATION - Biomarker Assay Validations – A Time for Change? May 1, 2017

John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.