Thought Leadership
At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.
We call it Thought Leadership.
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25-02-2021
Starting out with the end in mind
Since 2009, Paul Chamberlain has pioneered the submission of a multidisciplinary section of the CTD format to provide regulatory assessors with an extended data analysis.
20-05-2020
Presentation of immunogenicity-related information in regulatory dossiers
How can an integrated summary report can be created to consolidate the information required for assessment of immunogenicity-related risks of different types of biopharmaceuticals.
15-02-2019
Effective presentation of immunogenicity related data in regulatory dossiers
NDAs Paul Chamberlain provides practical advice about how to present immunogenicity-related information in regulatory dossiers in the latest publication of Bioanalysis.
02-08-2018
CAR T-Cells for Cancer Immunotherapy – Moving Target for Industry?
This article discusses the product-and patient-related variables that may pose challenges for the industry and developers both from the scientific and regulatory perspective.