Dr. Dirk Bernhardt is an expert in Market Access, Government Affairs and Commercialisation for innovative pharmaceuticals, biotechnology assets, radiopharmaceuticals, diagnostics and hospital-based medical technologies.

He supports companies in translating clinical evidence into reimbursement-relevant decisions for Germany, Europe and the USA. His work focuses on EU-HTA/JCA readiness, AMNOG strategy, G-BA/IQWiG evidence requirements, PICO and comparator alignment, GKV-SV pricing preparation, hospital reimbursement, and OPS/NUB/ZE/DRG pathways assessments.

Dirk brings more than 30 years of experience in Pharma and Biotech. He has built and led Global Market Access and Government Affairs functions, aligned specialty pharmaceutical / radiopharmaceutical pipelines with AMNOG, EU HTA, General Pharma Legislation frameworks, and integrated payer evidence requirements into clinical development, regulatory planning and launch preparation.

His service portfolio addresses six concrete client needs: 
• EU-HTA/JCA-to-AMNOG readiness, 
• German hospital reimbursement roadmaps, 
• biotech Market Access due diligence, 
• radiopharmaceutical Market Access and policy strategy, 
• RWE/Integrated Evidence Generation for HTA, and 
• evidence-to-launch translation for Medical, Market Access and Commercial teams.

Typical deliverables include PICO and comparator mapping, endpoint-gap assessment, JCA/AMNOG risk maps, OPS/NUB/ZE/DRG route-to-reimbursement plans, hospital value cases, payer evidence packages, pricing headroom assessments, evidence risk registers, launch readiness checklists and field access briefings. His work is especially relevant for companies preparing Phase II/III evidence decisions, EU-HTA/JCA submissions, AMNOG dossiers, hospital adoption, payer negotiation or investor due diligence.