2019 is here! In our latest blog series, we unpack four predictions for late phase clinical trials in 2019. First up, prediction #1: strategic as opposed to transactional R&D relationships.
Prediction #1: Strategic as Opposed to Transactional R&D Relationships
The demarcation of “early phase” versus “late phase” clinical development is increasingly becoming archaic. Highly truncated and accelerated R&D programs coupled with a permissive regulatory environment have rendered the concept of “phase” moot across many therapeutic areas. Clinical-based CROs emerged from a strategic business model that was applicable for “overflow” business and a “feast-or-famine” business cycle. Their staffing and services were predicated on single points of contact, with a discrete request for services as an ancillary contribution.
As an interesting anecdote – in 18 years of responsibility for research and development, including full responsibility for several NDA applications, I did not request clinical CRO services once because I had no need for additional staffing and did not regard CRO contributions as particularly differentiated.
However, the radical transformation of R&D over the last decade and the rise of small, midsize, and virtual organizations has caused most sponsors to emphasize the importance of creating portfolio value by establishing integrated R&D teams with external as well as internal contributors. These teams are created at product initiation, follow the product through clinical development, and continue in support through early commercialization.
Innovative R&D companies are transforming the concept of portfolio value from one focused on product attributes to a radically different definition, which requires strategic partnering. Maximizing portfolio value by considering a wider audience of stakeholders across the continuum of research becomes a valuable exercise within discovery and development. Given the many antecedents and inflection points that vary in timing and complexity, CRO and sponsor alignment becomes a differentiator.