by Roger Hayes, Senior Vice President and General Manager, Laboratory Sciences, MPI Research
In today’s world of drug development, almost every aspect of the development continuum is related to speed, efficiency, precision, and quality. Whether it is a generic company racing to first-to-file status, a virtual or biotech company looking to entice Sponsors with promising data, or a mid-large pharma organization seeking its next promising candidate for New Drug Application (NDA) filing and approval – every aspect of the development process needs to progress seamlessly.
Drug development today is typically handled by outsourcing vendors or contract research organizations (CROs) that provide a mix of in-house capabilities and outsourced activities. Looking across the continuum, most development processes start with preclinical toxicology, progress through the proof of concept stages, and then continue on to first-in-human studies after having submitted the Investigational New Drug (IND). Once a successful Phase I trial is complete, it’s on to Phase IIa, Phase IIb, and Phase III trials. Sounds simple, right? But what must be noted is the common thread across the entire continuum-bioanalytical testing. Many consider this a rather simple process, but many development groups lose sight of efficiency and speed in the process that could have been achieved by a “one-stop shopping” model. Because of extended timelines associated with the drug development process, the big picture vision is lost.
Typically, in supporting toxicology and preclinical testing, a bioanalytical laboratory (internal or external) is tasked with developing a biological fluid assay to support these activities. These assays are performed in a variety of matrices and species over a period of time. Depending on the CRO’s expertise, or the structure of the pharma organization, the bioanalytical process may be performed by many laboratories and individuals as the drug moves through the development process. At each phase of the process, the assay is transferred and reinvented with each group, putting its own mark on it before validation. Each reinvention has the potential to invalidate or put into question all of the previous work come submission time. When we allocate parts of the program to one group and then another, the challenge of reconciliation at the time of submission can be a nightmare due to the potential for inconsistency. At the very least, it may leave the reviewing party spinning their proverbial wheels. In essence, there is a struggle through the process without a larger vision and continue without foresight, efficiency, or speed. We forget the common feature/thread in the process–bioanalytical testing. Why do drug developers make their lives so hard?
In larger organizations, it simply may be a matter of too many “cooks in the kitchen.” The make-up of the development team becomes so fractured that, collectively, they lose sight of any common thread in the process. On the other hand, in the world of biotech or virtual company development, there may not be individual expertise in niche areas of development, so the company may rely on consultants to support different segments of development. Ultimately, developers end up losing sight of efficiencies when there are multiple team members, service providers, and consultants involved with the project.
Many toxicology and preclinical CROs are built as niche providers, but very few have the knowledge or expertise to support a one-stop-shop for bioanalytical testing support through human trials. This is also the case when for stand-alone clinical/bioanalytical CROs, built to process large quantities of human samples, but may not have development expertise within a variety of matrices. Not to mention, they may refrain from supporting 100 rabbit plasma samples, and would rather support 2,000 human plasma samples.
Priority of analysis can become a simple case of economics at these CROs. Not only is there a break up the development continuum from the “developer’s” perspective, but the vendors providing the outsourcing activities are segmented as well.
The industry needs to step back to refocus on big picture of process execution. Doing so will enhance the efficiencies with drug development, leading to a healthier world.