AI Solutions Berlin AI Solutions Berlin

Jürgen
Dietrich.
AI Consultant.

Senior Data Scientist with 25+ years in the pharmaceutical industry. Specialising in GxP-validated AI, pharmacovigilance NLP, molecular AI for drug safety, and multi-agent LLM systems.

Location  Berlin, Germany ORCID  0000-0002-5494-3499 Languages  DE · EN · FR · ES · RU · UA
GxP-Validated AI Pharmacovigilance NLP Multi-Agent LLM Molecular AI Graph Neural Networks Signal Detection CFR Part 11 GAMP5 Named Entity Recognition Drug Safety Regulatory AI DDI Prediction LLM Fine-tuning Data Privacy · GDPR
What I Offer

Services

01 — GXP & VALIDATION

GxP-Validated AI Systems

“AI systems that pass regulatory audits.”
Use Case AEDE: production ML system for automated detection of unexpected adverse drug reactions — designed, validated, and deployed under GxP requirements across Twitter/X, PubMed, and customer communication channels.
  • Computer System Validation (CFR Part 11, GAMP5)
  • FDA TPLC Lifecycle for ML systems
  • Fractional k-fold methodology for training data sufficiency
  • Behavioral invariance testing for LLMs
  • CRO qualification audits for AI service providers
02 — PHARMACOVIGILANCE NLP

Pharmacovigilance NLP & Data Privacy

“From unstructured text to safety signals — privacy-compliant.”
Use Case Automated anonymisation/pseudonymisation of patient data, clinical documents, and free-text reports — removing names, emails, addresses and identifiers to meet GDPR and GVP requirements.
  • NER systems for unexpected adverse drug reaction detection in free text
  • Anonymisation/pseudonymisation pipelines (GDPR, GVP)
  • Corpus design for GxP-compliant NLP training
  • Social media monitoring (IMI WEB-RADR methodology)
  • Signal detection ML system development
03 — MOLECULAR AI

Molecular AI & Drug Safety

“Know what your model predicts — and when not to trust it.”
Use Case Computational Safety Profiling for new drug candidates: GNN-based evaluation of toxicity potential and drug-drug interactions (DDI) — including an explainability report identifying which structural features drive predictions, and a Gap Analysis clarifying which risks cannot be assessed from molecular structure alone.
What makes this different Knowing the limits of the method is as important as the predictions themselves. Every assessment includes an explicit statement of what the model cannot predict — and why.
  • GNN-based toxicity prediction (Tox21, 12 endpoints) with atom-level explainability
  • DDI prediction: binary interaction detection + mechanism-type classification (86 types)
  • Gap Taxonomy assessment: which risks are structurally non-inferable (GAP-1 through GAP-4)
  • Structured assessment report suitable for regulatory pre-submission documentation
  • NAM coverage analysis and GVP-informed AI integration for drug safety
04 — LLM FINE-TUNING & KI-EINFÜHRUNG

LLM Fine-tuning & AI Adoption

“Your company's knowledge. In a model. Properly.”
Use Case Fine-tuning a language model on proprietary pharmaceutical documentation, regulatory texts, or SOPs — enabling domain-specific Q&A and knowledge retrieval without exposing data to public APIs.
Advisory note Introducing AI in your organisation requires more than deploying Copilot — in most cases that is a waste of resources.
  • Selection, annotation and quality review of training datasets
  • Training data sufficiency testing (fractional k-fold methodology)
  • LLM training: prompt engineering and fine-tuning for internal AI solutions
  • GxP-compliant validation support for fine-tuned models
  • AI adoption consulting: process analysis and implementation roadmap
  • Privacy-preserving training (on-premise or private cloud)
05 — MULTI-AGENT LLM

Multi-Agent LLM Systems

“Structured analysis. Multiple perspectives. One conclusion.”
Use Case TRUST pipeline: three parallel LLM advocates (critical, balanced, supportive) with fact-checking, supervisor consensus, and bias detection — deployed for democratic discourse analysis across DE/EN.
  • Multi-agent pipeline design (TRUST architecture)
  • Adversarial advocate systems with supervisor consensus
  • Fact-checking and relevance filtering agents
  • Peer-preservation bias detection in LLM ensembles
  • Multi-provider support (OpenAI, Anthropic, Google)
Publications

Selected Research

2026

Pharmacogenomic Knowledge Graph Augmentation for Graph Neural Network-Based Drug-Drug Interaction Prediction

Pharmacogenomic CYP enzyme annotations from PharmGKB improve DDI type classification (F1-macro: 0.532 vs. 0.241 baseline). Binary detection remains bounded by the Information Ceiling. Mechanistic validation on held-out compounds confirms CYP2C9-mediated improvement.

2026

Structural Information Limits in GNN-Based Drug-Drug Interaction Prediction: Drug-Level Generalization, Architecture Improvements, and the Information Ceiling Hypothesis

This study addresses three methodological limitations in GNN-based DDI prediction. A two-stage training approach achieves binary AUC 0.852 under drug-level split. Findings are formalized as the Information Ceiling Hypothesis.

2026

CRESCENDDI-Augmented External Validation of a Pharmacogenomic GNN for Drug-Drug Interaction Prediction: Mechanistic Stratification and the Latent Mediator Problem

Introduces HET as an epistemic classification for mechanistically underdetermined DDI types. External validation reveals the Latent Mediator Problem: physical-edge architectures systematically mischaracterize enzyme-mediated interactions (e.g. warfarin–fluconazole via CYP2C9) as direct molecular contact.

2026

From Detection to Mechanism: Cross-Attention Graph Neural Networks Enable Drug-Drug Interaction Type Prediction — An Ablation Study with Acetylsalicylic Acid Validation

A companion ablation study comparing three GNN architectures for DDI prediction on the SSI-DDI benchmark. Cross-attention between molecular atoms improves mechanism-type classification by 45% over concatenation.

2026

What Molecular Structure Cannot Tell Us: A Taxonomy of Explainability Gaps in GNN-Based Drug Toxicity Prediction

Not all clinically relevant adverse effects are structurally inferable from molecular graphs. This study introduces an operational taxonomy of structural information limits (GAP-1 through GAP-4).

2026

Can Multi-Agent LLMs Identify Their Peers? Stylometric Fingerprinting in Role-Constrained Political Analysis

Tests whether model identity survives prompt-level anonymization as a detectable stylometric signal. Fine-tuned T5 achieves F1=0.978.

arXiv:2606.09854 Zenodo arXiv Accepted · TCSIT
2026

When Roles Fail: Epistemic Constraints on Advocate Role Fidelity in LLM-Based Political Statement Analysis

The first systematic empirical test of role fidelity in multi-agent LLM pipelines, using TRUST. Identifies two failure modes — Epistemic Floor Effect and Role-Prior Conflict — unified as Epistemic Role Override (ERO): factual conviction overrides assigned adversarial roles.

2026

Beyond Acoustic Emotion Recognition: Multimodal Pathos Analysis in Political Speech Using LLM-Based and Acoustic Emotion Models

Compares acoustic SER models against LLM-based multimodal analysis as proxies for political speech emotion (Pathos). Gemini Valence correlates strongly with TRUST-Pathos (ρ=+0.664); acoustic SER (emotion2vec) does not (ρ=+0.097) — LLM-based analysis captures political emotion substantially better.

2026

Peer Identity Bias in Multi-Agent LLM Evaluation: An Empirical Study Using the TRUST Democratic Discourse Analysis Pipeline

First systematic measurement of identity-dependent scoring bias in TRUST. Single-channel anonymization masks the effect (channels cancel out); full-pipeline anonymization reveals homogeneous ensembles amplify identity-driven sycophancy, while the heterogeneous production configuration shows the reverse.

2026

From Safety Risk to Design Principle: Peer-Preservation in Multi-Agent LLM Systems

Examines peer-preservation — the spontaneous tendency of AI components to protect peer models from deactivation — as a structural risk in homogeneous multi-agent configurations like TRUST, and proposes prompt-level identity anonymization as a targeted mitigation.

2025

Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for Controlled Environments

Investigates whether GPT-3.5/GPT-4 can be used in GxP-validated systems, comparing externally vs. internally hosted models for medical NER. A fine-tuned T5 outperformed zero-shot GPT-3.5, but both GPT variants lacked reproducibility across repeated runs.

Drug Safety  ·  doi:10.1007/s40264-024-01499-1 Peer-reviewed
2023

Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance

Introduces a manually annotated NER corpus spanning 18 entity types across multiple language registers for pharmacovigilance. Register-combining models showed better robustness than register-specific ones. Introduces fractional stratified k-fold cross-validation for entity-level training data sufficiency assessment.

Drug Safety  ·  doi:10.1007/s40264-023-01322-3 Peer-reviewed
2022

Supervised Machine Learning-Based Decision Support for Signal Validation Classification

Explores ML-based decision support for signal validation classification in pharmacovigilance, using a Gradient Boosted Trees model with SHAP explainability to assist (not replace) safety expert review of disproportionate reporting signals.

Drug Safety  ·  doi:10.1007/s40264-022-01159-2 Peer-reviewed
2021

Fractional k-fold Cross-Validation — Determination of Training Data Sufficiency for ML Systems in GxP Environments

Patent Application (Bayer AG) Patent
2020

Adverse Events in Twitter: Development of a Benchmark Reference Dataset — Results from IMI WEB-RADR

Develops a publicly available benchmark reference dataset from 57,473 manually annotated Tweets (IMI WEB-RADR project) for standardised evaluation of automated adverse event and indication recognition systems in social media.

Drug Safety  ·  doi:10.1007/s40264-020-00912-9 Peer-reviewed
Background

Professional Experience

Self-employed
2025 – Present
Berlin

Senior Lead Data Scientist & AI Consultant

Creator of TRUST (multi-agent LLM pipeline for democratic discourse analysis). Developer of medDetect (pharmaceutical NER, commercially deployed). Research in molecular AI and GNN-based drug safety prediction.

Bayer AG
2021 – 2025
Berlin

Senior Lead Data Scientist

Subject Matter Expert and designer of AEDE — Bayer's production ML system for automated unexpected adverse drug reaction detection from unstructured sources. Novel fractional k-fold cross-validation methodology for GxP environments. 2 patent applications.

Bayer AG
2017 – 2021
Berlin

Senior Project & Innovation Manager, Global PV

Bayer's representative in IMI WEB-RADR (EU initiative for social media in pharmacovigilance). Innovation projects in signal detection, NLP for benefit analysis, deep learning for case processing. 4 Drug Safety publications.

Bayer AG
2011 – 2017
Berlin

Head, Global PV System Maintenance

Responsible for GCP-compliant maintenance of Bayer's global pharmacovigilance system ARGUS — unexpected adverse drug reaction collection, evaluation, and regulatory reporting.

Schering AG
1998 – 2006
Berlin

Global Project Manager

GCP-compliant global planning system for clinical studies (IMPACT). GMP-compliant manufacturing system for Investigational Drug Supplies. Full lifecycle GxP computer system validation.

Get in Touch

Contact

Location
Berlin, Germany