Early phase challenges for biotechs

Approaching early phase trials strategically and anticipating obstacles can be critical to the later success of a therapeutic. 

For biotechs, which frequently have fewer resources and face pressure to proceed through trials quickly, there is little room for error. Yet biotechs are often composed of small, tight teams that specialise in the science and development of the drug candidate, with little headroom for staff expertise in the coordination of complex clinical trial logistics. Additionally, biotechs tend to drive innovation in drug development, exploring and advancing new approaches to medicine — but also encountering complexities and considerations that are not applicable in more traditional modalities, such as small molecules.

To better understand the unique challenges facing biotechs, ICON conducted a survey of 149 biotech professionals, gaining insight into how they approach various elements of early clinical trials. Combining this insight and expert perspectives, this whitepaper delves into key concerns for biotechs entering early phase clinical trials, as well as considerations for emerging modalities and multi-indication targets throughout early clinical phases

• Insights on biotech challenges and approaches to early phase trials from the ICON survey
• Elements of understanding a therapeutic profile, including clinical pharmacology and adverse events
• Key early phase decision points, such as dosing determination methods and patient selection
• The utilisation of novel study designs in early phase trials
• Approaches to building a scientific case for multi-indication targets
• Endpoint selection and the use of biomarkers
• Considerations for developing a regulatory strategy
• The role of chemistry, manufacturing and controls in early phases
• Ways in which external partnerships can be used to benefit biotechs