Preparing for the Aggregate Safety Analysis- An Introduction for Interested Independent SMEs, Part 1

Going gig LifeSciHub News

LifeSciHub is thrilled to present Greg Ball of ASAP Process Consulting, Inc.  Greg, one of a handful of leading Aggregate Safety Assessment Planning (ASAP) experts in the world, recently left Novovax to help industry as a whole adapt to this new multidisciplinary process, soon to be required by FDA.

It’s a long time coming.  The first FDA Guidance was issued in 2010, refined in the following years, culminating in FDA’s June  2021 draft Guidance, Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.

Once this Guidance becomes final, expected soon, sponsors will need to adopt this new process.  As with any change in drug development operations, it will not be easy.  Drug sponsors need experts who know how to do this, who can help them implement it across programs.

The two groups most involved are Clinical Safety and Biostat.  To add further complication and challenge, ASAP is multidisciplinary, requiring unprecedented amount of collaboration between these two groups.  Other stakeholders include Clinical Development/Affairs, Regulatory, Statistical Programming, and Data Science.

LifeSciHub exists to support small businesses like yours and Greg’s.  We believe industry needs rapid access to new skills and capabilities that are emerging at a rate that no drug sponsor internal training group could ever keep up with.  If your subject matter expertise involves any of these stakeholder groups, you are invited to participate in this introduction, taking place on February 1, 2023 at 12 noon on Zoom.  Please email for details and calendar invite.

We hope this information sharing will help you deliver additional value to your clients by becoming knowledgeable in an up and coming challenge they will need to rise to, eventually.  As Greg presents ASAP Process Consulting, Inc. to industry as THE go-to center of excellence for all things ASAP, he anticipates high demand for these services.  Greg anticipates high demand, and may need help on projects.  What better source than the LifeSciHub Independent small business community?  Part 2 will be more in depth training for any interested parties in the LifeSciHub small business community.