A carefully designed approach to very-early-phase development that includes rapid generation of accurate, high-quality data supporting relevant candidate evaluation allows the efficient elimination of candidates not likely to succeed. By failing fast, or more specifically sufficiently early, the cost, resources, and effort involved in advancing these molecules to later stages can be redirected to candidates with a much higher likelihood of success. Working with a contract development and manufacturing organization (CDMO) like Mikart with extensive formulation, method, and process development expertise and dedicated very-small-scale lab equipment, drug developers can make go/no-go decisions with confidence even before they reach the preclinical development stage, saving time, money, and resources.

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.

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