Public | Virtual

Event Title

FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics

September 23, 2026

Date:: September 23, 2026
Time:: 8:30 a.m. - 5:00 p.m. ET

The FDA's Center for Biologics Evaluation and Research (CBER) will convene a virtual scientific public workshop on September 23, 2026, titled "Next-Generation Sequencing (NGS) for Adventitious Agent (AA) Detection in Biologics." The workshop will include subject matter experts and key stakeholders to discuss the readiness of NGS technologies for AA detection, identify challenges, and explore potential solutions to accelerate the adoption of NGS-based methodologies for AA detection in biological products.

Background:

NGS-based AA detection methods have emerged as new approach methodologies (NAMs) that can broadly detect AA to enhance the safety of biological products while reducing reliance on testing in animals. Contamination with AA, such as viruses, bacteria, fungi, mycoplasma, and parasites, can jeopardize the safety, efficacy, and supply integrity of CBER-regulated biological products including cell and gene therapies, xenotransplantation products, blood products, and vaccines. The detection of adventitious viruses can be particularly challenging, given the high degree of sequence diversity inherent to viral populations, which drives the continual emergence of viral variants and novel viruses.

For additional information on FDA’s current thinking on NGS for adventitious agent testing, please refer to the FDA Q5A(R2) Guidance for Industry (January 2024), adopted from the ICH Q5A(R2) Guideline.

Workshop Objectives:

Facilitate scientific exchange among key stakeholders and regulators regarding current advances in NGS technology and their application to AA detection in biological products.
Gather perspectives on existing methodologies, implementation challenges, and emerging technical requirements for NGS-based AA detection.
Understand challenges associated with the adoption of NGS-based methods, including analytical validation, data interpretation, and integration into existing safety testing frameworks.
Identify knowledge gaps that must be addressed to support the broader application of NGS-based methods for ensuring the safety of biological products.

Meeting Logistics and Registration:

Date: Wednesday, September 23, 2026
Time: 8:30 a.m. to 5:00 p.m. ET
Location: The workshop is fully virtual and will be held via Microsoft Teams.
Registration: Registration is free but is required. Please register for the event now.

Registration for this meeting is limited and will automatically close once capacity is met. Accordingly, FDA encourages early registration and will also broadcast the meeting on YouTube for those who are unable to register.

An updated agenda and YouTube link will be posted closer to the date of the workshop.

Draft Agenda

Time	Agenda
8:30 a.m. – 8:45 a.m. ET	Introductory Remarks David Kaslow, MD – Director, OVRR, CBER, FDA
8:45 a.m. – 9:40 a.m. ET	Session 1: Perspectives from FDA CBER Moderator: Robin Levis, PhD – Deputy Director, Division of Viral Products, OVRR, CBER, FDA Speakers and Panelists: Arifa Khan, PhD – Head, Molecular Retrovirology Unit, Laboratory of Retroviruses, Division of Viral Products, OVRR, CBER, FDA Sandip De, PhD – Principal Investigator and CMC/BI Reviewer, Office of Cellular Therapies and Human Tissues, OTP, CBER, FDA
9:40 a.m. – 9:45 a.m. ET	BREAK
9:45 a.m. – 12:00 p.m. ET	Session 2: CROs Efforts for NGS Implementation Moderator: Jianyang Wang, PhD – Biologist, Office of Gene Therapy, OTP, CBER, FDA Speakers and Panelists: Andy Bailey, PhD – Chief Scientific Advisor, ViruSure Sivan Bercovici, PhD – Chief Technology and Business Officer, Karius Marc Eloit, PhD – Founder and Scientific Advisor, PathoQuest Bradley Hasson – Director of Lab Operations for Next Generation Sequencing Service, BioReliance
12:00 p.m. – 12:30 p.m.	BREAK
12:30 p.m. – 2:20 p.m.	Session 3: NGS Applications for Adventitious Virus Detection Moderator: Cinque Soto, PhD – Acting Chief Bioinformatics & Artificial Intelligence Staff, Office of Cellular Therapies and Human Tissues, OTP, CBER, FDA Speakers and Panelists: Sandra Fuentes, PhD – Microbiologist, Laboratory of Retroviruses, Division of Viral Products, OVRR, CBER, FDA Binsheng Gong, PhD – Bioinformatician, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, FDA Siemon Ng, PhD – Senior Director, Analytical Development and Quality, Notch Therapeutics
2:20 p.m. – 2:25 p.m.	BREAK
2:25 p.m. – 4:40 p.m.	Session 4: NGS Detection of Nonviral Agents Moderator: Arifa Khan, PhD – Head, Molecular Retrovirology Unit, Laboratory of Retroviruses, Division of Viral Products, OVRR, CBER, FDA Speakers and Panelists: Joe DeRisi, PhD – Professor, Biochemistry and Biophysics, University of California, San Francisco Scott Jackson, PhD – Founder and Principal, The NEST Jason Kralj, PhD – Researcher, National Institute of Standards and Technology Padmini Ramachandran, PhD – Research Microbiologist, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, FDA
4:40 p.m. – 4:45 p.m.	Closing Remarks

Submitting Electronic or Written Comments

FDA will open a docket following the workshop to accept electronic or written comments on the topic of this public meeting.

Contact

This workshop is being hosted by CBER’s Office of Therapeutic Products and Office of Vaccines Research and Review. For questions regarding this public workshop, email OTPEvents@fda.hhs.gov.

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