Public | Virtual

Event Title

FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics – September 23, 2026

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) convened a virtual scientific public workshop on September 23, 2026, titled "Next-Generation Sequencing (NGS) for Adventitious Agent (AA) Detection in Biologics." The workshop included subject matter experts and key stakeholders that discussed the readiness of NGS technologies for AA detection, identified challenges, and explored 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.

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: CRO's Efforts for NGS Implementation Moderator: Jianyang Wang, PhD – Biologist, Office of Gene Therapy, OTP, CBER, FDA Speakers and Panelists: Marc Eloit, PhD – Professor of Virology, Veterinary School of Maisons-Alfort and Founder and Scientific Advisor, PathoQuest Bradley Hasson – Director of Lab Operations for Next Generation Sequencing Services, BioReliance Andy Bailey, PhD – Chief Scientific Advisor, ViruSure Sivan Bercovici, PhD – Chief Technology and Business Officer, Karius
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 Siemon Ng, PhD – Scientific Lead – Genomics, Canadian Blood Services Binsheng Gong, PhD – Bioinformatician, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, FDA
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: Scott Jackson, PhD – Founder and Principal, The NEST Jason Kralj, PhD – Researcher, National Institute of Standards and Technology co-presenting with Tyler Laird, PhD - Computational Biologist / Bioinformatician, National Institute of Standards and Technology Joe DeRisi, PhD – Professor, Biochemistry and Biophysics, University of California, San Francisco Padmini Ramachandran, PhD – Research Microbiologist, Office of Applied Microbiology and Technology, Human Foods Program, FDA
4:40 p.m. – 4:45 p.m.	Closing Remarks Megha Kaushal, MD, MSc - Acting Deputy Director, OTP, CBER, FDA

Submitting Electronic or Written Comments

In addition to holding the virtual public workshop, FDA has opened a docket and is accepting electronic or written comments. Electronic or written comments on this workshop must be submitted no later than 11:59 p.m. ET on November 22, 2026.

Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: visit http://www.regulations.gov and type FDA-2026-N-10100 in the search box. For assistance in submitting electronic comments, please see regulations.gov/help. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2026-N-10100 for “A Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics – September 23, 2026.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments, and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, FDA-2026-N-10100, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Contact

This workshop was 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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Event Materials

Title	File Type/Size
FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics – September 23, 2026	pdf (208.39 KB)