Adriana Racolta
Senior Director, Global Regulatory Leader, IVD Bayer
Adriana Racolta, PhD, is a seasoned industry leader with 13 years of experience in diagnostics and regulatory affairs. As Senior Director, Global Regulatory Leader IVD at Bayer, she drives the implementation of diagnostic regulatory strategies to enable precision medicine development in oncology and gene therapy.
In her role, Adriana leads cross functional and cross industry engagement, collaborating closely with internal teams, regulatory authorities, and industry partners to advance innovative approaches in pharmaceutical and diagnostic development. She helps shape industry dialogue through Bayer’s contributions to key trade associations, focusing on initiatives that address regulatory challenges related to clinical studies involving pharmaceuticals and in-vitro diagnostic devices.
Adriana holds a PhD in Molecular and Cellular Biology from the University of Arizona and is deeply committed to advancing education in the scientific, medical, and regulatory fields.
Seminars
- Current regulatory challenges for Dx-Rx co-development in GT
- Strategies for approval for GT diagnostics
- EU and US payer’s policies impact on regulatory decision making in GT diagnostics
- When and how should biomarker evidence maturity trigger formal CDx development to ensure alignment with therapeutic strategy, clinical endpoints, and global regulatory expectations?
- How can organizations define and evolve CDx strategies that align with clinical trial design and biomarker science while accommodating regional variability in regulation, testing infrastructure, and clinical practice?
- What cross-functional models, partnerships, and data strategies are needed to embed CDx considerations seamlessly across the drug development lifecycle and enable synchronized evidence generation and assay readiness?
![Adrianna_Racolta[1]](https://world-cdx.com/wp-content/uploads/sites/138/2026/05/Adrianna_Racolta1-300x300.png "Adrianna_Racolta[1]")