Senior Data Scientist with 25+ years in the pharmaceutical industry. Specialising in GxP-validated AI, pharmacovigilance NLP, multi-agent LLM systems, and the regulatory science of AI in drug safety.
Design, development and validation of ML systems in controlled pharmaceutical environments. CFR Part 11, GAMP5, FDA TPLC lifecycle. Fractional k-fold methodology for training data sufficiency.
NER systems for adverse event detection in unstructured text (social media, publications, patient reports). Production ML at Bayer AG. WHO Drug Dictionary mapping. Corpus design for regulated environments.
Architecture and development of heterogeneous LLM ensembles. Adversarial advocate systems, fact-checking agents, supervisor consensus logic. Multi-provider (OpenAI, Anthropic, Google).
Graph Neural Networks for drug toxicity prediction. Gap taxonomy methodology for structure-based prediction limits. GNNExplainer-based pharmacophore attribution. MNAR quantification in cheminformatics.
AI governance in pharmaceutical contexts. GVP Module IX signal management. NAM qualification and mechanistic coverage assessment. EMA AI Workplan implications for drug safety systems.
AI project management for pharma. Validation consulting for AI-based CROs. Training data development for client-specific NLP systems. CRO qualification audits for AI service providers.
Creator of TRUST (multi-agent LLM pipeline for democratic discourse analysis). Developer of medDetect (pharmaceutical NER system, commercially deployed). CRO qualification audits for AI-based pharmacovigilance service providers. AI system validation consulting.
Subject Matter Expert and designer of AEDE — Bayer's production ML system for automated adverse event detection from unstructured sources (Twitter/X, PubMed, customer calls). Novel fractional k-fold cross-validation methodology for GxP environments. 2 patent applications.
Bayer's representative in IMI WEB-RADR (EU initiative for social media in pharmacovigilance). Innovation projects: signal detection, NLP for benefit analysis, deep learning for case processing. 4 Drug Safety publications.
Responsible for GCP-compliant maintenance of Bayer's global pharmacovigilance system ARGUS — adverse event collection, evaluation, and regulatory reporting.
GCP-compliant global planning and tracking system for clinical studies (IMPACT). GMP-compliant manufacturing system for Investigational Drug Supplies. Full lifecycle GxP computer system validation.