From Workgroup to Enterprise Standard: the Evolution of Investigational Drug Risk Assessment

Broadcast Date: September 11, 2026

ABOUT THIS PODCAST

This episode reviews the development and sustainability of a system-wide, pharmacy-led assessment of risk process for investigational products. The conversation highlights lessons learned from building a multidisciplinary governance model, applying toxicologic and biosafety criteria, and translating USP <800> requirements into practical workflows for research pharmacy practice.

SHOW NOTES

Zinchuk KM, Volf H, Li K, et al. Establishing a system-wide assessment of risk process for investigational drugs. Am J Health-Syst Pharm. 2026;00:1-9. Doi:10.1093/ajhp/zxag074
Additional resources referenced in the discussion:

USP General Chapter <800>
Hazardous Drugs - Handling in Healthcare Settings
NIOSH List of Hazardous Drugs in Healthcare Settings, 2024
AJHP Voices

SPEAKERS

Kevin Zinchuk, PharmD, MPH, CCRP
Manager, Investigational Drug Services, Brigham and Women's Hospital
Helen Volf, PharmD
Clinical Specialist, Investigational Drug Service, Brigham and Women's Hospital
Kay Li, PharmD
Pharmacist II, Clinical Trial Pharmacy, Massachusetts General Hospital

LISTEN ON

The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

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