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.
About the Author
Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.Follow on Twitter More Content by Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG