Back To Schedule
Tuesday, June 25 • 3:15pm - 4:15pm
#275 EE: Access to Investigational Drugs Outside of Clinical Trials: What's Fair?

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Component Type: Workshop
Level: Basic

Requests for investigational drugs are increasing, posing ethical, regulatory, and logistical challenges for companies. After discussing a fictional case, participants will understand these challenges and be better prepared to address them.

Learning Objectives

Discuss ethical, legal, and practical concerns surrounding patient requests for access to investigational drugs outside of clinical trials (preapproval access); Apply this knowledge to a fictitious case study; Analyze the pros and cons of different possible responses in real world scenarios.


Alison Bateman-House, PhD, MA, MPH


Beverly L Harrison

avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Langone Health, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair, with Arthur Caplan PhD, of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies... Read More →
avatar for Beverly Harrison

Beverly Harrison

Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
Leading the Patient Support Group @ Janssen R&D (a J&J Co.), reporting directly to the Chief Medical Officer, Beverly focuses on developing strategies for patients’ needs by working with internal/external stakeholders & engaging patient advocacy organizations. She is a R&D & nonprofit... Read More →

Tuesday June 25, 2019 3:15pm - 4:15pm PDT
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA