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SIDEBAR
Here's a detailed and targeted summary of the Hanson Wade/Liang et al. white paper, "Why Diagnostic Regulation Matters in Pharmaceutical Development — and Current Best Practices", geared toward your blog audience of senior genomics and biopharma professionals:
🔍 Summary: Why This White Paper Matters — and to Whom
This white paper, developed by a consortium of diagnostic regulatory leaders following the June 2024 World CDx Regulatory Affairs & Policy Summit, breaks new ground by offering the clearest articulation yet of how diagnostic regulation—especially Companion Diagnostics (CDx)—should be integrated into global drug development strategy. It is essential reading for:
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Genomics professionals developing LDTs, RUOs, or investigational IVDs who now face the 2024 FDA rule to phase out enforcement discretion for LDTs.
NOTE - Based on Summer 2024 conference, this point not updated to July 2025.
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Biopharma leaders who increasingly partner with diagnostics firms and must navigate cross-agency co-development, regulatory timing mismatches, and country-specific hurdles.
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Diagnostic Regulatory Affairs teams or those building that function, as the paper provides the most complete blueprint yet for its role and value.
🧬 What’s New and Groundbreaking?
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Elevation of Diagnostic Regulatory Affairs (DRA) as a distinct, strategic function within pharma—akin to the rise of Clinical Operations 25 years ago. The authors argue persuasively that without dedicated DRA expertise, pharmaceutical programs risk delays, regulatory nonalignment, or failed global submissions.
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First truly global regulatory map for CDx, comparing FDA, EU IVDR, Japan PMDA, and China NMPA in terms of timelines, co-approval rules, and investigational pathways. A key insight: IVDR’s “one-size-fits-all” PSA requirement is slowing EU trials, while China's “Original CDx” concept is in its infancy and favors domestic partners.
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Integration of digital diagnostics and AI/ML tools into the CDx paradigm, including regulatory ambiguity over whether these qualify as SaMD (Software as a Medical Device) or clinical decision support. The authors point readers to tools like the FDA’s Digital Health Policy Navigator.
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Actionable best practices: A rich section on embedding diagnostic thinking into trial design and regulatory timelines, using retrospective bridging studies, pre-submission strategies, and parallel drug/CDx development timelines.
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Case studies and technical discussion of emerging issues, such as:
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Use of CDx in non-oncology areas (e.g., cardiology, neurology), where biomarker-disease links are fuzzier and regulatory pathways less defined.
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Tensions between central lab testing (favored for CDx approval) and local testing (favored for real-world utility and trial access).
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Risk-based regulatory frameworks (e.g., FDA’s NSR/SR device classification) vs. Europe's flat, burdensome PSA requirements.
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🧠 Why Genomics Professionals Should Read It
Although this white paper is pharma-centered, it's critical reading for genomics and diagnostics professionals for three reasons:
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Your work now intersects with global regulatory jurisdictions—this paper demystifies the CDx landscape across FDA, IVDR, PMDA, and NMPA. It helps you speak the same language as your biopharma partners and anticipate their requirements.
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You’ll be seen as a more valuable collaborator if you understand how diagnostic design impacts trial design, patient selection, and labeling. This paper shows how bridging studies, label coordination, and analytical vs. clinical validity are negotiated.
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It provides a playbook for those transitioning from LDT/RUO frameworks into FDA-regulated CDx pathways, especially as FDA phases in full oversight.
⚙️ Most Useful to...
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Precision medicine leads at pharma companies designing co-development programs or integrating new biomarkers.
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Clinical trial designers and translational scientists managing complex trial inclusion/exclusion rules based on evolving biomarkers.
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Reimbursement and market access teams, who must understand how CDx co-approval affects global launch timelines and regional pricing.
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CDx developers or platform companies trying to support one test across multiple indications or drugs (e.g., leveraging FDA’s group labeling guidance).
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Biotech–Genomics BD professionals, especially when negotiating companion diagnostics partnerships with pharma sponsors.
🧭 Bottom Line Takeaway
The diagnostic regulatory environment has become as complex and globalized as therapeutic regulation itself. Precision medicine cannot succeed without early and integrated regulatory planning for diagnostics—ideally, led by specialized Diagnostic Regulatory Affairs professionals. This white paper is the most comprehensive guide yet to what that means in practice, including timelines, country nuances, digital evolution, and organizational strategy.
