Adriana Racolta
Seminars
Wednesday 7th October 2026
Regulatory Strategies for Dx-Rx Approvals for Gene Therapies & Impact of Marketing Requirements
12:50 pm
- 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
Wednesday 7th October 2026
Panel Discussion: Innovating Global Rx-Dx Trial Pathways Through Strategic & Compliant Co-Development Partnerships to Deliver Harmonized Precision Medicine Solutions
3:10 pm
- 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?
