From risk to readiness: how proactive safety assessments help AAV manufacturers meet regulatory demands with confidence

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Sponsor

From risk to readiness: how proactive safety assessments help AAV manufacturers meet regulatory demands with confidence

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

One of the most current and pressing challenges is the need to demonstrate clearance of residual reagents used during upstream processing, a requirement increasingly emphasized by regulatory agencies such as the US FDA. However, for many manufacturers, the real burden runs deeper: it's the pressure to anticipate regulatory demands before they become submission hurdles, to understand agency expectations before formal guidance is issued, and to translate US regulatory guidance into actionable strategies for teams operating around the world.

In this webinar, Lloyd Achirem from Mirus Bio will explore how AAV manufacturers can address these challenges through a proactive approach to regulatory readiness. A key part of that preemptive approach is product safety risk assessment. The speaker will outline how a product safety risk assessment can identify, address, and mitigate potential risks well ahead of regulatory submissions. Through this process, potential patient exposure can be determined as well as how to leverage residual assays to demonstrate clearance.

The session will also discuss how to align with US FDA expectations from the outset of IND and BLA submissions. That institutional understanding translates directly into reassurance for customers navigating complex IND and BLA submissions, helping them align with agency expectations from the outset. The webinar will also highlight how US FDA expectations can be interpreted and applied alongside other regional requirements, including those of the EMA and PMDA.

The takeaways from this session include:

What the US FDA expects from sponsors for ancillary materials used in bioprocessing workflows
How a product safety risk assessment can identify and mitigate risks well ahead of IND and BLA submissions
Residual assays that can be used to determine potential patient exposure and demonstrate clearance
Applying US FDA expectations alongside other regional requirements, including those of the EMA and PMDA

Lloyd Achirem

Field Regulatory Specialist at Mirus Bio

Lloyd is an experienced regulatory affairs professional with a strong foundation in the pharmaceutical and biopharmaceutical sectors, specializing in Chemistry, Manufacturing & Controls (CMC), global regulatory submissions, and regulatory support for ancillary materials used in cell and gene therapy. He has led and supported regulatory strategies aligned with FDA, EMA, and ICH expectations, prepared eCTD Quality Modules, and advised stakeholders on compliance pathways for various submission types.

Lloyd’s background includes direct FDA exposure as a Staff Fellow Microbiologist, where he reviewed regulatory submissions, giving him a unique perspective on regulatory requirements and risk-based decision-making. His industry expertise spans regulatory intelligence, quality assurance, and cross-functional collaboration to ensure products meet global standards and withstand regulatory scrutiny.

Miguel Dominguez

Director, Field Applications and Support at Mirus Bio

Miguel has a technical background and prides himself in supporting the customer journey from both a technical and customer service perspective. He currently leads the Field Application Scientists, Technical Support Scientists and the Customer Service department. Miguel has overseen various technical and commercial roles at Mirus over the past decade. He and his teams have supported the launch of various products, including the TransIT-X2 Dynamic Delivery System, CHOgro High Yield Expression System, Ingenio EZporator Electroporation System and the VirusGEN RUO and GMP product lines.

His experience includes support and management for over 30 distributors in over 40 countries worldwide. Most recently, he has dedicated himself to enhancing the customer experience with his global FAS team, in-house Technical Support team and Customer Service department. His avid desire to support the customer drives his ambition to make Mirus Bio a leader in the cell and gene therapy space. He holds a BS in Genetics from Texas A&M University and an MS in Genetics from the University of Wisconsin.

In 26 Days

You have registered for this webinar