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Eric Cohen
Pharmacovigilance & Patient Safety, AbbVie, Inc., North Chicago, IL, USA
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Research Article
Internal Safety Advisory Groups (ISAG): A Win-Win for Effective Decision-Making in Biopharmaceutical Companies
Author(s): Eric Cohen*, Carolyn Setze and Thomas Podsadecki
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 rece.. View more»