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