Before diving into a specific regulatory strategy, there are often corporate strategy questions to consider and answer:
- What are the prospects of a pathway or class of therapeutics in light of the competitive landscape?
- Should the biggest markets be pursued right off the bat? Or are there niche areas that might require less time, cost less, and increase the odds of a clear quick ‘win’ first?
- Should the quickest route to regulatory clearance or approval be taken for a device, or is there a combination drug-device product strategy that could enable the company to access a drug pricing premium over device pricing?
- What should the company pursue for the first target indication, in light of scientific, medical, regulatory and commercial considerations?
Our experts can help you think through such strategic questions, which could be some of the most consequential decisions you will make for fundraising, partnering and commercialization.
- Target Product Profile
- Program Prioritization and Portfolio Planning/Management
- Competitive Landscape, Commercial Assessment and Valuation
- Development Plan, Timeline and Budget
- Commercial, Partnering and Payer Considerations
- Fundraising
