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in patients with severe disease then, ‘the magic number for subjects to be exposed
needs to be around 50’. On soliciting a final group view from the whole project
team on numbers of patients, the project manager commented, ‘you might as well
stick your finger in the air as to how many patients you need’. This doubt over on
patient numbers possibly reflected BIOTECH’s lack of experience in Phase II clinical
trials. However, equally it was felt that potential partners may not have the experi-
ence either ‘it’s our guess against their guess, so let’s stick with 48 – it’s the answer
to everything isn’t it?’
A decision was taken in January 2007 as to who the partner pharmaceutical firm
was to be to take development forward on BIOTECH 123. The partner was referred
to by a code name ‘Stallion’ in order to maintain the strictest confidentiality both
internally and externally until the deal was finalized. The project team decided that
the 123–3 study should go ahead with BIOTECH taking the lead. So although it was
expected at this time that BIOTECH would have signed the deal with the partner
before the trial was finished BIOTECH was still responsible for the study and the costs
associated with it. It was initially thought that this study would be complete by mid
2007. However, this trial experienced significant problems.
In order to conduct a multiple dose safety study the therapeutic needed to be sus-
pended in a solution, then bagged and labelled for each patient, to be administered to
the patient intravenously. Further through the development process, the therapeutic
would actually be administered in much smaller, concentrated doses and the suspen-
sion and bagging process would not occur. However, suspending in a solution was
a requirement in this early trial. A clinical unit in a hospital 100 miles from BIOTECH
was going to run the trial. The suspension was going to be bagged by BIOTECH and
then delivered to the hospital where patient labels would be added. This constituted
an amendment to the manufacturing process for which approval needed to be given
by the FDA. It also came to light that whilst the majority of prescribing/trials units in
hospitals are exempt from the need to have a license to carry out labelling processes,
this particular hospital – because of its charitable status – was not exempt and it did
not have a license! This was discovered quite late in the day and the clinical trials
manager felt that manufacturing should have made them aware of this requirement
much sooner. BIOTECH therefore needed to find a licensed facility that could add the
labels to the bags in transit to the hospital where the trial was to be conducted. This
was not easy as many manufacturing firms were not keen to be involved in such a
minor process.
A firm was eventually found 50 miles away to carry this out. Unfortunately how-
ever when the labelled bags were returned to BIOTECH for inspection, particles were
discovered in the suspension. No one had any idea why this had occurred. Clearly
however, the solution could not be intravenously administered to patients containing
particles as it could well cause death! It seemed to be more prevalent in the higher
concentrations of 123. BIOTECH’s chemists, who are usually involved primarily in
basic research, were called in to try and discover why this was occurring. This was a
major problem affecting the start of the new trial but it was also recognized that the
FDA had also not yet given approval for the change in protocol (labelling external to
BIOTECH) and this was also a delaying factor. By February 2007 the chemists could

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