Regulatory & Commercialisation

Nicole Dale

Can Large Language Models Solve More Rare Disease Genomes?

Pharmatica image showing a clinical geneticist using LLM-assisted rare disease diagnosis tools to analyse genome sequencing data and generate evidence-based diagnostic hypotheses for precision medicine.

LLM-assisted rare disease re-assessment improved genomic analysis, increasing diagnostic yield and supporting clinician-led precision medicine and possibly drug development.

Nicole Dale

Can Large Language Models Solve More Rare Disease Genomes?

LLM-assisted rare disease re-assessment improved genomic analysis, increasing diagnostic yield and supporting clinician-led precision medicine and possibly drug development.

Shubhangi Dua

How AI Is Reshaping Data Integrity in Pharma Manufacturing

In the recent episode of The Chain Reaction podcast, Nour AlSaleh, Founder and CEO of Veragence Pharma Consultancy, sat down with host Shubhangi Dua, Podcast Producer and B2B Journalist at Pharmatica.io and EM360Tech. AlSaleh shares her expertise on maintaining data integrity in this new era of AI and changing policies.

Veragence CEO Nour AlSaleh discusses how AI is transforming data integrity in pharma manufacturing, regulatory compliance, the "human-in-the-loop" requirement, and patient safety in the era of AI-driven GxP systems.

Nicole Dale

What Drives Pharmaceutical R&D Success? New Benchmarking Reveals Why Some Drug Pipelines Outperform Others

Pharmatica image showing a pharmaceutical R&D portfolio management meeting reviewing drug discovery pipeline progression, translational science, and pharmaceutical R&D success rates using evidence-based portfolio strategy.

Explore new benchmarking research on pharmaceutical R&D success rates, revealing why some drug pipelines consistently achieve higher approval rates than others.

Nicole Dale

FDA Draft Guidance on Gene Editing Safety (2026)

DNA double helix illustrating the FDA gene editing draft guidance 2026, highlighting next-generation sequencing (NGS) safety assessment, off-target editing analysis, genomic integrity testing, and regulatory requirements for cell and gene therapy development.

The FDA’s 2026 gene editing draft guidance could change your regulatory strategy. Explore the new NGS requirements for cell and gene editing therapies.

Nicole Dale

CRO and Vendor Oversight in Clinical Trials

Clinical research professional reviewing operational data and regulatory documents on dual-monitor workstations, illustrating CRO vendor oversight in clinical trials, vendor performance monitoring, compliance management, and quality assurance across outsourced clinical research operations.

ICH E6(R3) raises the governance bar for CRO and vendor oversight in clinical trials. Here's what sponsors must build into outsourcing relationships to protect trial quality and timelines.