John Lewis, vice president of clinical affairs at the Association of Clinical Research Organisations (ACRO) told Outsourcing-Pharma.com that - from the research sector’s perspective - running clinical trials and producing drugs on behalf of sponsors are still very different disciplines.
“ACRO specifically defines “CRO” as a “Clinical Research Organization” and, to date, none of the major CROs are engaged in contract manufacturing as there are significant differences in the core competencies and business dynamics of research versus manufacturing.”
“However, with ongoing consolidation in this space it is not unforeseeable that clinical research and manufacturing services may be combined under a common umbrella of “contract” services but, at this time, the distinction remains meaningful. “
Mark Quick, executive vice president of corporate development at Recipharm, is of a similar opinion. He told Outsourcing-pharma.com that distinguishing between the two sectors is a must for CMOs, CROs and indeed the customers they aim to serve.
“We believe it is vital to differentiate between a CMO and a CRO in order to give customers a proper picture of the services offered. A CMO may offer clinical trial materials to be used in clinical development, but is most often limited to this part of the development.
“Furthermore, the CROs of today very seldom offer manufacturing services. In fact we believe we should also use the expression of CDMO for a company offering pharmaceutical development services in addition to the manufacturing part.”
Quick also speculated that while contract development and manufacturing organisations (CDMO) - like Recipharm - and counterparts in the CRO sector may collaborate more closely in future, the terms used to characterise such partnerships are still to be defined.
“We may of course also see further integration where CDMOs and CROs merge to be pharmaceutical contract providers. It remains to be seen how we shall name such companies but for the time being CMO and CRO definitely has a separate meaning in their own right.”
Almac spokesman Jonathan Calderwood has a different take. He told Outsourcing-pharma.com that: “Many service providers are adding activities to their portfolio that do not sit easily within a "two box" definition.
Yet despite such expanded offerings - Calderwood continued - companies still define themselves as either a CRO or a CMO.
“The range of disciplines within the clinical development world are numerous and contractors tend to assemble their portfolios closely around their core market strengths.”
So it seems that – for the foreseeable future at least – the terms CRO and CMO need to remain separate for the good of contractors and pharmaceutical industry customers.