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246 MANAGING KNOWLEDGE WORK AND INNOVATION

In September 2006, BIOTECH announced that following recent approval from the
FDA (the US regulatory agency) it would start a Phase I clinical trial coded BIOTECH-123.
This Phase I, placebo-controlled, single dose, dose escalating, trial in 34 patients was
initiated at a Drug Development Clinical Research Centre located close to BIOTECH.
Results reported nine months later demonstrated that BIOTECH-123 was well toler-
ated at all doses and no safety concerns were identified. BIOTECH’s Chief Medical
Officer commented, ‘We are very optimistic about BIOTECH-123 as a potential treat-
ment for this respiratory disease’.
At this point in time BIOTECH took the strategic decision to actively attempt to
out license (see ‘Glossary of terms’) and announced it was looking for a partner for
BIOTECH-123. The team also decided to attempt a second Phase I trial which would
involve inducing a severe respiratory reaction in patients who had a mild form of the
disease and then treating with BIOTECH-123. The clinical team believed that if this
trial was successful then this would make partnering arrangement far more attractive,
potentially increasing future revenues. Setting up this trial however proved problem-
atic as it was very difficult to recruit sufficient patients so in practice the trial did not
go ahead. This time-consuming mistake was seen as something that needed to be
avoided in the future.
Subsequent discussion on another proposed trial centred on where it would most
likely get regulatory approval. Canada was seen as ‘less restrictive in requirements for
reproductive toxicity but more restrictive in other ways’ (Regulatory Manager) and
she was asked to talk to a regulator she knew personally to ‘sound out’ the feasibility
of the proposed study. As the clinical team suggested (jokingly), it was important to
find ways of ‘getting around regulators by fair means or foul’. The likely reactions of
regulators were frequently being ‘anticipated’ in project meetings and drove several
of the discussions around clinical trials (more so, it seemed, that the science itself).
BIOTECH had also experienced ‘miscommunication’ with the regulatory agency – the
FDA – in the past and wanted to avoid this in all future projects.
Around this time BIOTECH had also already received regulatory approval to com-
mence a repeat-dose (multiple dose) safety study of BIOTECH-123 in patients with
mild/moderate forms of the disease. This was to be another safety study to assess tol-
erability and pharmacokinetics (see ‘Glossary of terms’). This trial was planned to run
in the first quarter of 2007 with three dose groups (1, 5, 10 mg/kg, max dose three
per month), containing 12 patients per group and a placebo group with a further 12
patients (total 48). This trial was named BIOTECH 123–3. Given BIOTECH’s limited
experience in trials they were taking advice from a clinical research organization
who could provide specialist advice on clinical trials development and regulation. In
addition BIOTECH had also contracted a local specialist unit in a hospital to recruit
patients and run trials. Results were expected no later than six months time at a
cost of $1.6 million. However, at a project meeting late in 2006, BIOTECH was still
debating whether 48 patients were necessary. The trial itself could be done with
fewer (24) and it was unclear from the future trial plans (see section on ‘Partnering
process’) that had been proposed by potential partners, whether a larger sample was
needed. However if, as the project team leader believed the main purpose was to
have a large enough sample to be able to go on to conduct Phase III large-scale trials

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