Regulatory Considerations and Companion Diagnostics

  • Elizabeth VanAlphenEmail author
  • Omar Perez
Part of the Cancer Drug Discovery and Development book series (CDD&D)


The combination of a small molecule and a biologic in an ADC has consequences for regulatory requirements and guidances with respect to nonclinical evaluation as well as clinical development. The complexity of ADCs with regards to manufacturing and analytics presents additional challenges from the regulatory perspective. The clinical development of most ADCs involves patient selection; companion diagnostic products are regulated as a medical device in the US and in most ex-US markets and require a development plan that is integrated with the clinical development strategy from the earliest stages.


Regulatory FDA Companion diagnostic Precision medicine Patient selection GLP GMP Manufacturing 


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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Pfizer Inc., Worldwide Safety and RegulatoryGrotonUSA
  2. 2.Pfizer Inc., DiagnosticsSouth San FranciscoUSA

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