REPORT/RECOMMENDATION TO THE BOARD OF SUPERVISORS
OF SAN BERNARDINO COUNTY
AND RECORD OF ACTION
August 4, 2026
FROM
ANDREW GOLDFRACH, ARMC Chief Executive Officer, Arrowhead Regional Medical Center
SUBJECT
Title
Confidential Disclosure Agreement with Amgen, Inc.
End
RECOMMENDATION(S)
Recommendation
Approve non-financial Confidential Disclosure Agreement with Amgen, Inc., to allow for the exchange of proprietary information to enable Arrowhead Regional Medical Center to evaluate potential participation in a clinical trial study, for a period of five years from the date fully executed.
(Presenter: Andrew Goldfrach, ARMC Chief Executive Officer, 580-6150)
Body
COUNTY AND CHIEF EXECUTIVE OFFICER GOALS & OBJECTIVES
Provide for the Safety, Health and Social Service Needs of County Residents.
FINANCIAL IMPACT
Approval of this item will not result in the use of Discretionary General Funding (Net County Cost), as the Confidential Disclosure Agreement (Agreement) with Amgen, Inc. (Amgen) is non-financial in nature.
BACKGROUND INFORMATION
Approval of the Agreement is required by Amgen prior to Amgen agreeing to provide Arrowhead Regional Medical Center (ARMC) information about a research study, entitled “A Randomized, Double-Blind, Placebo Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants with Antineutrophil Cytoplasmic Antibody (ANCA) - associated Vasculitis,” for ARMC to evaluate potential participation as a clinical site for the clinical trial.
A randomized double-blind study is a rigorous clinical trial where neither the participants nor the researcher knows who is receiving the actual treatment versus a placebo. Participants are assigned to groups by chance to prevent bias and ensure accurate, reliable results regarding the treatment’s safety and effectiveness. A placebo-controlled Phase 4 trial is a post-marketing study conducted after a drug is FDA-approved, comparing the approved drug against an inactive placebo to monitor long-term safety and real-world effectiveness.
ANCA are autoantibodies produced by the immune system that mistakenly attack healthy white blood cells (neutrophils), causing them to damage small blood vessels. This process leads to rare autoimmune diseases known as ANCA-associated vasculitis (AAV), which cause inflammation, damage organs like the kidneys and lungs, and can be detected via a blood test.
ARMC would like to review the clinical study’s protocols to determine if participation in the study would benefit county residents with ANCA where other treatments have not been effective.
ARMC recommends approval of the Agreement with Amgen because participation in this clinical trial will provide county residents with access to investigational treatment options while supporting advances in medical research that promote the health, safety, and well-being of the community.
PROCUREMENT
Not applicable.
REVIEW BY OTHERS
This item has been reviewed by County Counsel (Charles Phan, Supervising Deputy County Counsel, 387-5455) on July 22, 2026; ARMC Finance (Chen Wu, Finance and Budget Officer, 580-3165) on July 10, 2026; and County Finance and Administration (Jenny Yang, Administrative Analyst, 387-4884) on July 13, 2026.