| Recent projects: |
| • |
Comprehensive risk assessment
for a biological, which determined and justified the
risk minimisation activities for a US Risk Evaluation
and Mitigation Strategy (REMS) |
| • |
Mapping of potential safety hazards
within healthcare systems for a new cardiovascular drug,
and subsequent design of approaches and tools to overcome
them |
| • |
Comparative risk/benefit analysis
of marketed and pipeline competitors to a first-in-class
CNS drug |
| • |
Evaluation of the best approach to
navigate a biosimilar regulatory pathway |
| • |
Analysis of value drivers and associated
challenges for a first-in-class cardiovascular drug
that supported its pricing and reimbursement strategy. |