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Format:

Hybrid (virtual via Zoom and in person)

Location:

The Universities at Shady Grove; Building II, 9630 Gudelsky Drive, Rockville, MD

Registration information:

Register Now

The purpose of this workshop is to engage stakeholders industry, academia, and FDA in a discussion on the scientific and regulatory challenges associated with immunogenicity risk assessment for proposed generic peptide and oligonucleotide drug products.

Experts from the FDA, new and generic drug developers, academic institutions, contract research organizations (CROs), consultants and other scientists involved in generic peptide and oligonucleotide drug product development will collaborate to improve our understanding of the role of immunogenicity risk assessment in supporting generic peptide and oligonucleotide drug product development and enhancing the consistency of risk assessment. The workshop will also allow all interested parties to participate in in depth discussions via working sessions to analyze examples.

Through coordinated talks from regulatory, academic and industrial experts, attendees will gain an understanding of useful strategies, potential pitfalls (such as cell viability), considerations for reference standard selection, and statistical approaches to assess differences between datasets, as well as gaining clarity about regulatory expectations.

Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person) working sessions. Virtual attendees will be able to:

• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Enjoy free access to workshop recordings of presentations and panel discussion (not including the working sessions)

In-Person Attendees will enjoy all the benefits of virtual attendees, and will also play an active part in improving how immunogenicity risk assessment can support generic peptide and oligonucleotide drug products development by:

• Collaborating in person with FDA, industry, and academic experts throughout the workshop, and particularly during small group working sessions
• Engaging in dialogue with attendees and faculty about the challenges associated with conducting both adaptive and innate immunogenicity assays and the basis for regulatory expectations when conducting such assays
• Conversing with panelists during discussion panel Q&As
• Networking with colleagues during breaks

For more information please visit Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products - The Center for Research on Complex Generics (CRCG).