Gilead Sciences at ACT 2026

Nov 15–18, 2026 San Antonio, TX ~1.4k attendees Website

Gilead Sciences takes part in 4 sessions at ACT 2026 in San Antonio. Its program centres on extractables and leachables, the chemicals that can migrate from packaging into drugs, under the new ICH Q3E guideline. It also uses read-across to set a class-wide safe exposure level for cyclic siloxanes and covers the role of nonclinical scientists in new approach methods.

Organization	ACT 2026 Attendance
Gilead Sciences Foster City, CA
gilead.com Pharmaceutical companies Biopharmaceutical company with marketed HIV, liver disease and oncology medicines; presents on NAMs and extractables and leachables safety.	Talk Sun Nov 15 1:30pm–2:00pm Part of Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples (CE5) New Approach Methodologies (NAMs): Role of Nonclinical Scientists (CE5-3) New approach methods Session Tue Nov 17 2:00pm–5:00pm Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11) Chemical risk assessment · Regulatory · with U.S. Food and Drug Administration 2:00pmWelcome (S11-1)Gilead Sciences 2:05pmIntroduction to the ICH Q3E Draft Guideline: Extractables & Leachables - A Pharmaceutical Industry Perspective (S11-2)Bristol Myers Squibb 2:40pmAssessing the Data Landscape of Extractables and Leachables and Implications for Read Across Strategies (S11-3)Instem 3:45pmSafety Assessment Principles for Extractable/Leachables from an FDA Perspective (S11-4)U.S. Food and Drug Administration 4:15pmApplication of Read-Across Methodology for Extractables and Leachables to Derive a Class-based Acceptable Exposure Level for Cyclic Siloxanes (S11-5)Gilead Sciences Talk Tue Nov 17 2:00pm–2:05pm Part of Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11) Welcome (S11-1) Chemical risk assessment Talk Tue Nov 17 4:15pm–4:45pm Part of Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11) Application of Read-Across Methodology for Extractables and Leachables to Derive a Class-based Acceptable Exposure Level for Cyclic Siloxanes (S11-5) Chemical risk assessment · In silico and AI

Organization

ACT 2026 Attendance

Gilead Sciences

Foster City, CA

gilead.com

Pharmaceutical companies

Biopharmaceutical company with marketed HIV, liver disease and oncology medicines; presents on NAMs and extractables and leachables safety.

Talk

Sun Nov 15
1:30pm–2:00pm

Part of Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples (CE5)

New Approach Methodologies (NAMs): Role of Nonclinical Scientists (CE5-3)

New approach methods

Session

Tue Nov 17
2:00pm–5:00pm

Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11)

Chemical risk assessment · Regulatory · with U.S. Food and Drug Administration

2:00pmWelcome (S11-1)Gilead Sciences
2:05pmIntroduction to the ICH Q3E Draft Guideline: Extractables & Leachables - A Pharmaceutical Industry Perspective (S11-2)Bristol Myers Squibb
2:40pmAssessing the Data Landscape of Extractables and Leachables and Implications for Read Across Strategies (S11-3)Instem
3:45pmSafety Assessment Principles for Extractable/Leachables from an FDA Perspective (S11-4)U.S. Food and Drug Administration
4:15pmApplication of Read-Across Methodology for Extractables and Leachables to Derive a Class-based Acceptable Exposure Level for Cyclic Siloxanes (S11-5)Gilead Sciences

Talk

Tue Nov 17
2:00pm–2:05pm

Part of Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11)

Welcome (S11-1)

Chemical risk assessment

Talk

Tue Nov 17
4:15pm–4:45pm

Part of Safety Assessment of Extractables and Leachables under the New ICH Q3E Guideline (S11)

Application of Read-Across Methodology for Extractables and Leachables to Derive a Class-based Acceptable Exposure Level for Cyclic Siloxanes (S11-5)

Chemical risk assessment · In silico and AI

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Not affiliated with or endorsed by the American College of Toxicology (ACT). Organization details are derived from ACT’s published program, exhibitor floor plan and supporter list, and each organization’s own website. Submit a correction