Ryan Woodhouse Discusses PMA Approval Process, Foundation Medicine & More!

Session & Speaker Preview

Ryan Woodhouse is Manager, Regulatory Affairs at Foundation Medicine and will be presenting twice during the 11th Annual IVD Regulatory Affairs Conference on December 5-6. Check out a sneak peak of his presentations below!

Please describe your role as Manager, Regulatory Affairs, at Foundation Medicine?

As a Regulatory Affairs Manager at Foundation Medicine, I contribute to many different projects and aspects of the business. My main focus is FoundationOne Liquid, FMI’s blood-based NGS panel. I also spend a good amount of time working with our software teams as this is a critical component of Foundation Medicine’s products and an aspect of the industry that is rapidly evolving.

Can you give a brief description of what your presentations will address?

In my presentation, “Case Study: FDA Approval Of FoundationOne CDx” on December 5th, I will be discussing the work that went into getting FoundationOne CDx through the PMA approval process. As part of this, I will cover the non-clinical study designs that supported an indication for tumor mutation profiling across tumor types and an indication for the detection of a range of variant classes, including de novo variants, across 324 genes. I will also discuss how Foundation Medicine was able to achieve a broad array of companion diagnostic indications and how F1CDx has been set up for an expanding list of companion diagnostic indications.

In my presentation, “Case Study: Efficient Management & Navigation Of The Pre-Market Approval Process” on December 6th, I will discuss best practices for managing an effective PMA approval process from product development through approval. Based on my previous experiences, I will provide real-life examples of which aspects of the product development and PMA preparation and approval process are most likely to cause delays or misalignment between the sponsor and FDA. The examples discussed will include examples of both successful approaches and those that can be improved upon.

What do you hope attendees take away from your presentation?

For the first presentation, my goal is to clarify what is required to achieve PMA approval of an NGS panel like FoundationOne CDx. This required a huge amount of work through all aspects of the product lifecycle. Learning from this experience can help others to plan for more effective product development and verification and validation processes that are more likely to lead a successful FDA review.

For the second presentation, my goal is to provide specific experiences that I have encountered through multiple PMA approvals to help others understand what does and doesn’t work. Bringing an IVD through PMA approval is a complicated process to navigate, which means that there are many opportunities to avoid potential regulatory hurdles and plan for a more streamlined process. I hope that after hearing of some of my experiences, others will be able to better plan for their next (or first) PMA.

Do you have any advice or suggestions for companies who are in beginning stages of the NGS and companion diagnostic innovations?

This is a difficult question to answer in a generic sense, but one of the first things I would recommend is to spend time building a strong system of process from the beginning. A strong quality system should not only be built for compliance with regulations, but also to improve the quality and ease with which teams can produce their required deliverables. In order to do this, the processes need to be designed in cooperation with those who will be required to follow these process, not only the quality and regulatory functions. If a strong design control process is followed from the beginning of development, navigating the FDA approval or clearance process can be much less complicated. In line with this, if a company is considering going down the FDA clearance or approval path, then these requirements should be considered and targeted from the beginning. It’s much more efficient to do things right the first time around.

Hear from Ryan Woodhouse directly by joining us at Q1’s IVD Regulatory Affairs Conference on December 5-6 in Alexandria, VA. Access full program details today!

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