Expedited development: Leveraging prior knowledge (PK) for marketing approval filings in accelerated settings
This presentation details the benchmark survey conducted by the member companies of the CMC Considerations for Expedited Development Point Share . The purpose of the survey was to help members understand how companies are defining and using Prior Knowledge (PK) to support marketing approval (eg BLA) filings in accelerated settings.
The survey was completed by 16 companies and covers 11 key questions including,
- Types of data considered as PK
- How PK is obtained and used
- Form of PK
- Perceived and real benefits
This presentation was given to the CASSS WCBP 2020, Washington DC, January 2020.
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