Competencies/Services
Therapeutic Area Expertise
- Oncology/Hematology
- Immunology
- Gastroenterology
- Nephrology
Translational Science/Translational Medicine
- Knowledge transfer and seamless transition of development product candidates from discovery/preclinical research into early phase development until Proof-of-Concept (Phase IIb)
- Advice on development of diagnostic and therapeutic biomarkers
- Definition and implementation of strategy for early and late phase clinical development (target product profile, strategic clinical development plan)
Clinical Development - Definition and implementation of early and late phase regulatory (FDA, EMEA) and clinical development strategy
- Implementation of clinical operations plans (Phase I-IV)
- Key opinion leader development and management
Medical Marketing/Medical Affairs
- Life cycle and project management (“roadmaps”, process development)
- Alignment and implementation of medical marketing, business strategies and market access
- Advice on and implementation of medical marketing mix (message development, advisory boards, publication strategy, market research)
Market Access
- Advice on Pharmacoeconomics, Health Resource Utilization + Health Outcomes tools for pricing + reimbursement (AMNOG legislation)
Business Development
- Scientific and commercial portfolio evaluation (in/outlicensing)
- Due Diligence preparation (“fit for Due Diligence”)
- Consultancy for life-science start-up companies