Journal of Pharmacovigilance

Global Regulatory Strategy, AbbVie, Inc., North Chicago, IL, USA

Biography

Thomas Podsadecki completed his Bachelor of Arts (1981 – 1985) from University of Chicago; Master of Business Administration (1987 – 1989) from  The University of Chicago Booth School of Business and Doctor of Medicine(1985 – 1991) from The University of Chicago Pritzker School of Medicine. His Research interests lies in Drug Safety, Drug Monitoring, and Clinical Trials. He has skills interests in Business Strategy, Change Management, Business Development. Thomas Podsadecki has worked as an Assistant Professor of Medicine (1994-2000)at University of Chicago Hospitals; then in Abbot Laboratories as Medical Director ( 2003-2008).

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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