With more than 80% of novel compounds to treat cancer coming from emerging biopharma, small biotechs are clearly betting big on oncology. But to achieve regulatory and scientific success, these drug programs must first clear some serious hurdles:
- Scientific: How will you develop a dose optimization strategy in light of the FDA’s Project Optimus?
- Regulatory: How do you navigate the regulatory requirements of various global health authorities?
- Commercial: How will you justify your product’s value to payers and other relevant stakeholders?
