Not Like Everyone Else: Unique Challenges For Small And Emerging Biopharma Companies

By Dr. Lindsay McNair, MD, MPH, MSB, Chief Medical Officer, WCG

While “biopharma” is often referred to as a single category, the actual diversity of biopharma companies is often under-recognized by those outside the industry. Small and emerging biopharma companies are conducting almost 50% of the clinical trials in the United States today. Unlike “big pharma”, small companies are usually working with lean teams, limited resources, and minimal infrastructure- or are trying to build an infrastructure and manage ongoing clinical trials at the same time. When product pipelines are small, there is significant internal and external attention on every study and every milestone. Working in rare disease indications with small populations also brings new challenges to clinical study design and recruitment planning. These conditions create unique challenges for the clinical development teams within these companies. In this paper, we explore some of those challenges, and solutions that can reduce the pressure on teams and timelines.