Timeline and Cost Pressures
Drug development is a complex and lengthy process that must be pursued in a manner that ensures that the ultimate result is a safe and effective therapeutic — which can be manufactured with consistent quality using sustainable processes with attractive economics. Ultimately, 90% of new chemical entities never advance past the preclinical testing phase.
Despite the complexity of the drug development process, rapid development and approval of COVID-19 vaccines has created growing expectations that all new candidates should advance through the drug development cycle much more quickly than has been considered realistic in the past. Simultaneously, insurers and governments are placing increasing pressure on drug developers to only bring to market drugs that offer real advantages over existing products in terms of efficacy, cost, and/or attributes that increase medication adherence.
Complicating the picture for small and emerging pharma companies is their need to expend significant effort raising the funding needed to support discovery, preclinical, and chemistry, manufacturing, and controls (CMC) activities that generate Investigational New Drug application (IND)-enabling data, all with the hope of entering first-in-human clinical trials. Securing and maintaining that funding has become more difficult over the last two years as funding availability has decreased. Small and emerging pharma firms are thus driven to shrink development timelines and generate valuable data as quickly as possible.