Episode description
This is audio from RQM+ Live! #58, recorded 14 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Companion diagnostics (CDx) are critical to patient safety when taking potentially life-saving drugs, e.g. in oncology. CDx can help identify which patients will benefit from a specific drug treatment to improve patient outcomes and identify those patients who have an increased risk for serious side effects from a certain treatment. Hence, CDx are essential in the evolution of precision medicine “providing the right therapy to the right person and the right time” and helps tackle rising healthcare costs, by minimizing drug use to only those who will definitely benefit from a drug.
CDx is an in-vitro diagnostic medical device which are governed by the IVDR in Europe and need to undergo a CE-marking process with a Notified Body to place the CDx on the market. The CE-marking conformity assessment includes a separate consultation procedure between the NB and a medical authority, depending on who is responsible for the authorization of the corresponding medicinal product.
The regulatory framework for drugs and CDx (IVDs) in Europe are governed by two different European legislations with separate registrars. The terminology of these two legislations is not fully aligned which leads to confusion across all stakeholders, the medicinal agencies, the Notified Bodies and the CDx manufacturer. A notified body working group on CDx has taken on this challenge, trying to align multiple notified bodies and the European Medicines Agency (EMA) on the expectations for CDx.
Our expert panel includes TÜV Rheinland’s CDx Teamlead Rolf Thermann, who is also the leader of the notified body CDx working group. Rolf’s role includes building a successful team of experts for auditing and certification of CDx manufacturers, interacting with key opinion leaders in the field of personalized medicine/CDx and establishing communication channels with relevant authorities. In this show, we discuss areas of confusion in industry and notified bodies, and what manufacturers can expect, including:
- Where is the line between a CDx and a non-CDx IVD?
- What data is required for CDx approval for both scenarios: CDx co-developed with the drug, or a follow-on companion diagnostic?
- What does the consultation process between the notified body and the EMA look like?
- Why do manufacturers need to do double work in the approval process? The manufacturer pays for EMA to review both the drug and CDx, but EMA only provides approval for the drug. Then the manufacturer must pay the notified body and again EMA to review and assess the CDX to obtain specific CDx approval from the notified body.
We’ll kick off this panel discussion with a brief presentation by CDx expert Rolf Thermann. Our panel also includes Heike Moehlig-Zuttermeister and Carlos Galamba – both of whom are RQM+ VPs of Intelligence & Innovation, and former BSI IVD Technical Team Managers and IVDR implementation leaders. Heike and Carlos are now working on the consulting side of industry, supporting manufacturers with challenging IVDR submissions.
Panelists:
- Rolf Thermann, Ph.D. – Teamleader Companion Diagnostics, TÜV Rheinland
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation, RQM+
- Heike Möhlig-Zuttermeister, Ph.D. – Vice President of IVD Intelligence & Innovation, RQM+