Pharmaceutical/Biotech, Clinical, Global (non-specific), Oncology
- Key challenges in early phase oncology recruitment.
- Therapeutic, supportive and other compounds from trial management perspective.
- Pros and cons of early phase trials for the investigator and for the cancer patient.
- Role and potential of professional CPU (Clinical Pharmacology Unit) within indication.
- Satellite Centre Concept for proper recruitment and controlled quality.
Medical Director, Project Director of Oncology
SGS LSS Clinical Research, Belgium
Pharmaceutical/Biotech, Europe, Clinical, Central Eastern Europe, Oncology
- Patient pharmacology services: Concept and operational set up.
- ADME concepts, incl. micro-dose and tracer-dose.
- Underlying dossier requirements incl. preclinical safety package.
- General design considerations incl. radiodose and radioburden calculation.
- Devil is in the details: Operational challenges.
- Selection of geographic region and patient population.
- Ethical aspects.
Associate Director of Clinical Operations
EDS Patient Pharmacology Services
PRA Health Services