There are a number of common reasons why drug applications are not approved, often due to lack of certainty around…
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Cancer drugs are under fire across the globe for their putatively high prices and modest benefits. As probability of clinical success has risen, the probability of commercial success has fallen. What defensive strategies can you take to mitigate commercial risks?
Defensive development strategies for cancer drugs can help manage the substantial and increasing commercial risk in today’s marketplace. To develop defensively, three steps are essential:
1. Make sure the sum of your market model is made up of accurate parts
2. Embed economically relevant endpoints in clinical trials
3. Learn from the past
Business as usual is not an option for developers trying to navigate the still-promising but increasingly crowded and complex cancer marketplace. Gaining a thorough understanding of market opportunities, running trials with economically quantifiable endpoints, and studying the market access track record of both successful and unsuccessful cancer drugs are three ways to manage and mitigate commercial risks more effectively.
In this paper we will discuss the five requirements for local affiliates to conduct credible observational research,…
Early Planning & Modelling
Pricing & Reimbursement
Regulatory & Payer Submissions