Journal of Pharmacovigilance

Data & Statistical Sciences, AbbVie, Inc., North Chicago, IL, USA

Biography

Carolyn completed her BS Mathematics in 1991 from St. Olaf College BDS in 2003 and completed her masters in statistics from University of Minnesota in the year 1995 . Presently working as Associate Director in Statistics in a company by the name of AbbVie. Inc . She has done many endorsements like in Clinical Trials, Clinical Development and Biostatics She has even contributed her work in Abbot Company. More than 30 articles have been published on PubMed.  Her Research interests lies in Drug Safety, Drug Monitoring, and Clinical Trials.

Publications

• 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»
  

  DOI: 10.35248/2329-6887.21.9.324

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