Before diving into a specific regulatory strategy, there are often corporate strategy questions to consider:
- What are the competitive prospects of a certain pathway or class of therapeutics?
- Should the largest markets be immediately pursued? 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 obtain a drug pricing premium?
- What target indication should the company pursue first, in light of scientific, medical, regulatory and commercial considerations?
Our experts can help you think through such strategic questions, which could be the most consequential decisions you make for fundraising, partnership, and commercialization.
Kinexum’s areas of expertise include:
- Program prioritization and portfolio management
- Navigation of competitive landscapes, commercial assessment, and valuation
- Development plans, timelines, and budgets
- Fundraising and partnership
