The global biotech industry is driven by innovation, and emerging biotechs are at the wheel. Emerging biotechs are taking control of drug development pipelines. In 2018, 74% of new drugs launched were registered by emerging biopharma companies. The key? Successful drug development strategies.
Aided by important drug development partners, such as big pharma and contract research organizations (CROs), biotechs are contributing to the success of the biotech industry.
However, despite these supportive collaborations, emerging biotechs have to face a large part of drug development on their own. A key step before working with a suitable partner is the establishment of a robust drug development strategy.
A carefully planned strategy can allow emerging biotechs to remain competitive in a continuously growing industry by providing flexibility, mitigating risks, and improving the chances of a drug’s success. But mistakes can have detrimental outcomes, such as loss of money, prolonged timelines, and even failure of the development program.
Strategic planning involves several different stages: laboratory management, therapeutic development, and regulatory processes.
At the heart of the laboratory strategy, for instance, lie the correct biomarkers. Biomarkers can be used to support safety and efficacy studies, can eliminate unnecessary testing, support the identification of patient populations, and help researchers choose viable cell lines.
Throughout therapeutic development, it is essential to understand the consequences of each and every step. This means that emerging biotechs need to identify different approaches. Furthermore, the therapeutic development strategy involves understanding the critical aspects of the drug development program and allocating resources accordingly. Following these steps will allow biotechs to be more flexible and agile, especially when obstacles occur.
Lastly, it is important for emerging biotechs to work with the regulatory authorities from a very early stage. Collaborating with an experienced drug development partner, such as a CRO, can help to follow regulatory guidelines.
Having a solid drug development strategy is of paramount importance for emerging biotechs. Created in collaboration with Medpace, this playbook is designed to guide you through the most important steps of planning a successful drug development strategy, will show you how to manage your drug development partners, and provide an insight into the future of the biotech industry.