Skip to Content

In-Person Interactive Roundtable Discussion | Long-Term Follow-Up for Gene Editing Workshop: How to Implement the FDA Guidance

Wed, Aug 24th 2022 - Wed, Aug 24th 2022, 9:00 am - 10:30 am
Editas Medicine, One Main Street, Cambridge, MA 02141

In January 2020, the FDA issued a guidance on long-term follow-up after administration of human gene therapy products because of the potential long-term safety concerns with gene editing. Many gene editing biotechs are still left with questions and concerns on how to implement the draft guidance. Examples, aside from overall logistics and feasibility considerations, include but are not limited to, how to select the most appropriate study format, data points to capture, where to host the data, how to contextualize the observations, and how to embark upon such a long-term engagement with the study centers and CRO partners.

There are multiple ways to obtain the data and no one way that may work for all development companies. So, how do we as an industry, find common ground on this expectation and work through solutions and best practices together? We can start by talking it out.

Please join Halloran Consulting Group, experts from Editas Medicine, Intellia Therapeutics, and other local gene editing biotech organizations for an interactive roundtable workshop on August 24th from 9 -10:30 am ET on “Long-Term Follow-Up for Gene Editing Workshop: How to Implement the FDA Guidance.”

This small roundtable style event will be led by:

The conversation will be centered around the following:

We look forward to working through these questions with you, hearing your feedback, and aligning on best practices together since there is a great deal emerging with gene editing technology and study operations of such technology.

Location:

Editas Medicine

One Main Street, Cambridge, MA 02141

Coffee and breakfast will be served.

NOTE: This is an invite-only event. To request an invite, please click the more details link to email Halloran’s Event Manager.

More Details