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CASE STUDY 5.1

THERAGNOSTIC AND SKIN CASES

Below you will find two different cases that each describe different approaches to
managing across projects.

>> THERAGNOSTIC

DiagnosticLabs is a small private company in the United Kingdom specializing in
the development, manufacture and distribution of diagnostic assays for a number
of diseases. In early 2004, DiagnosticLabs initiated a new ‘THERAGNOSTIC’ devel-
opment project, where they hoped to combine one of their diagnostics with a new
therapeutic, the logic being that availability of a drug would increase the market for
the diagnostic, and vice versa. They had multiple options in terms of the disease area
to go for, and in the end decided on a specific inflammatory disease characterized by
a high mortality rate where currently there is no approved treatment.
The new project aimed to build upon a diagnostics kit that had been developed
through an earlier project within DiagnosticLabs. Whilst DiagnosticLabs’ development
team continued to develop this diagnostic, at the same time its strategic team, cham-
pioned by the CEO, began to look for a partner to develop the associated therapeutic.
There were again multiple options here and the CEO used her personal connections
to identify a company (TherapeuticCo) that held IP that could be used to develop this
therapeutic. However, being traditionally a diagnostics company, DiagnosticLabs lacked
clinical trials and regulatory experience and so, again via the personal networks of the
CEO, formed an alliance with a third organization, Bioclinical, who specialized in clinical
trials consulting and services, to conduct ‘due diligence’ on the therapeutic. The THER-
AGNOSTIC project was therefore initiated, bringing together IP from projects previously
conducted at DiagnosticLabs and TherapeuticCo, with a team at Bioclinical providing
the regulatory and commercial expertise. The logic of the alliance between the three
companies was based on their complementarities in terms of resources and expertise:
It could be an interesting conglomerate of a company that has IP and availability
of a diagnostic with a therapeutic company that wanted to out-license some of
their non-core technology and a group that can actually bring the two together
and make it work.
(CEO, Bioclinical)

It was originally believed that the IP from TherapeuticCo was supported by suffi-
ciently robust pre-clinical data to allow the THERAGNOSTIC project to go straight to
human clinical trials. However, the Bioclinical due diligence project revealed that whilst

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