Epoch 21: Modernizing Clinical Development

Headwinds and Tailwinds for Optimizing Clinical Trials

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Hello Avatar! Welcome back for another week of biotech analysis. Today is Sunday, which means this is our Building Biotech newsletter that is focused on discussing biopharma strategy topics. Today we are going to continue our discussion around R&D productivity. Last Sunday we reviewed the topic from the perspective of the classical markers of clinical success rates (i.e., survival rates) and cycle times. Today, we continue our analysis by exploring various ways pharma and biotech are approaching modern clinical development. These include optimizations around geography, use of expedited regulatory pathways, integration of artificial intelligence and real world data, as well as novel clinical design approaches.

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R&D PRODUCTIVITY ENABLERS

The clinical trial landscape is undergoing a period of change. While regulatory agencies are working towards simplifying and expediting approvals, there are still regional delays. Pharmaceutical companies are responding by employing various strategies to optimize their trials, including expanding trial locations and incorporating novel designs like single-arm trials. However, there are concerns about the declining inclusion of minority patients. Encouragingly, the use of artificial intelligence in drug discovery is showing promise, although it hasn't yet delivered a completely new drug to market.

Today we will dive deep into these topics including analysis of how the industry is focused on improving efficiency and reducing setbacks in clinical trials.

KEY HEADWINDS TO BIOPHARMA R&D PRODUCTIVITY