IVD/CDx design, validation & regulatory submissions
Jude O’Donnell has joined the Qserve Group within the in vitro diagnostics (IVD) team and is based in Northern Island.
Jude has over fifteen years of experience in the IVD industry, specializing in the development, validation, and regulatory approval of clinical trial and companion diagnostic (CDx) assays. Within Qserve, Jude is a Principal Consultant within the IVD Team, supporting Qserve’s IVD clients to access global markets.
Jude about working at Qserve
“To be part of the IVD industry means we collectively contribute to the provision of diagnostic results which are critical to the medical management of patients. Therefore, the importance of the validity of these results cannot be understated. Through Qserve, I am committed to working with members of the broader IVD community to make it possible for clinicians and patients to have access to safe, reliable, and effective diagnostic tests, so as to improve patient’s clinical outcomes and progress the field of both diagnostic and precision medicine.”
Jude obtained a PhD in molecular oncology, and after post-doctoral research, acted as Program Manager, within an IVD diagnostics company, for the development and validation of a series of complex clinical trial and companion diagnostic assays on behalf of global pharmaceutical and biotechnology companies, to facilitate precision medicine patient selection and stratification. Jude subsequently held the role of Global Head of Regulatory Strategy, responsible for defining and evolving company IVD/CDx regulatory strategy in support of pharmaceutical partners’ drug development plans across a range of therapeutic indications and for regulatory submissions throughout the IVD product’s lifecycle.
The key expertise areas of Jude:
- Knowledge of the European Union (EU) In Vitro Diagnostic Regulation (IVDR) and the US Code of Federal Regulations Title 21 Part 820
- Knowledge of ISO13485:2016, ISO14971:2019, ISO20916:2019 and IEC 62304
- Application of international standards to the design control, verification, and validation of complex IVDs across a range of technologies (e.g. qPCR, next-generation sequencing (NGS)), inclusive of development and validation of software as a component of clinical trial and CDx assays for purposes of regulatory submissions (e.g. premarket approval (PMA) submission to the US Food and Drug Administration (FDA))
- Pre-submission engagements with the US FDA, including generation of briefing book and associated documentation, participation in and subsequent minuting of the pre-submission meetings
- US FDA investigational device exemption (IDE) submissions, inclusive of initial application, reporting, and change notification
- Planning, conducting, monitoring, and close-out of IVD clinical studies for purposes of generation of performance evaluation evidence, in compliance with ISO20916
- Definition of the content of a modular US PMA submission (PMA Shell) for a CDx IVD and subsequent experience as regulatory lead during the PMA submission process
- IVD change management
- IVD risk-benefit analysis in line with state of the art
- IVD vigilance and associated reporting to US and EU regulatory authorities
- Independent reviewer for IVD technical V&V documentation (plans, reports, change management)
- IVD medical writing for generation of Technical File documentation
- Excellent communicator in both verbal and written format
- Generation and presentation of product development plans and business development materials (blogs, presentations, white papers, etc.) to secure commercial contracts
- Program leadership and project management experience
- Strong leadership, line management, and mentorship experience