The oncology market is a fast-paced environment and more biologic drugs are obtaining expedited review pathways with the FDA, including breakthrough therapy designation and accelerated approval process due to their specific indications in treating patients with a life-threatening illness and for whom there is no current viable therapy.
The intense competitive landscape – and the end of an era where cancer therapy was “one size fits all” – means that developers need to strategize all aspects of their business and operating models to realize their goals.
The 2020 trend report examines the progress and innovation in precision oncology drug development, and why partnering with the right CDMO is critical to thrive in this dynamic environment. The report examines: