Providing top line recommendations on the design of the clinical development strategy, ensuring critical success factors are understood and included
- Path to Market Option Design: Reviewing clinical development analogues, generating and validating options for differentiation
- Indication Sequencing Strategy Development: Developing an indication sequencing strategy that balances first launch expediency with long-term commercial opportunities
- Clinical Strategy Development: Identifying the key pillars of the clinical development strategy that will need to be addressed to meet regulatory requirements
- Scientific and Clinical Messaging and Communication Development: Developing scientific and clinical narratives that achieve clear and differentiated positioning and early clinical advocacy
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