药物警戒杂志

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Internal Safety Advisory Groups (ISAG): A Win-Win for Effective Decision-Making in Biopharmaceutical Companies

Eric Cohen, Pamela Puttfarcken, Carolyn Setze , Elizabeth Mandel Bausch, Cheryl Foit, Meenal Patwardhan

Consultation of external experts (EE) has been a standard used by biopharmaceutical project teams (PT) to help evaluate signals of drug toxicity. This process is challenging and cannot address all the complexities associated with patient safety throughout the lifecycle of a drug. AbbVie is a biopharmaceutical company that launched organspecific Internal Safety Advisory Groups (ISAG) in 2017 to address these unmet needs. Objective: To describe AbbVie’s ISAG experience from 2017 to the present, including the consultation process, breadth of consultations and methods of self-assessment. Methods: Detailed records for 7 ISAGs (hepatic, renal, ocular, cardiovascular, skin/immunology, neuropsychiatric and health literacy) were reviewed. ISAG recommendations were compared to feedback from EE and regulatory agencies as a means of comparison to industry standards. Results: The ISAGs received 41 consultations within three main categories: (a) clinical case review, (b) clinical trial management and (c) external-facing documents. The hepatic ISAG was consulted with the greatest frequency (n=24). Phase 1 (34%) and post-market (34%) were the phases with the most frequent consultations. Recommendations mirrored feedback from industry standards in 12 of 13 consults. Discussion: ISAGs provide AbbVie with broad, cross-functional expertise that is objective and readily available. Standard approaches to collection, analysis and presentation of data help guide PT and the company as a whole. ISAGs provide guidance to mitigate safety risks and communicate these risks to regulatory authorities, healthcare providers and patients. This ISAG model can be adopted within other biopharmaceutical companies and serve as a template for current or future safety advisory activities.