Page 260 -
P. 260
CONCLUSIONS 249
most things that are going on’. BIOTECH had previously had a bad experience with
a partner who took almost a year to get things going (and ‘then screwed it up’). The
uncertainty created by future partnering for clinical decisions was summarized neatly
by the clinical trials manager, ‘In the absence of knowledge about what’s happening
with partnering we have to assume that we will have partnered by September (2007)
and base our decisions on that assumption.’
When the clinical team reported options on trials to the DPT, the trials plans for
each partner were also considered to see whether they ‘gave any clues’ as to what tri-
als were likely to be wanted and/or needed by the partner. The problem here was that
each plan proposed by the four potential partners was completely different, with var-
ied combinations of studies. Moreover, some of the partners plans were ‘not very well
developed’ and some seemed to be at odds with what BIOTECH themselves would
suggest or what they thought would be acceptable from a regulatory standpoint. The
major issue then appeared to be estimating what risk to take on (in terms of com-
mitting financial resources to a particular trial when outcomes may not be favorable)
for an expected return from the partnering arrangements that are finally agreed. The
more robust the evidence for the efficacy of BIOTECH 123, the better the financial
deal would be with a partner. However, there was a risk that the results of further tri-
als may not be ideal. At worst, that they may jeopardize the partnering agreement
by putting the partner off completely, or by the partner wanting to await trial results
before proceeding to complete the agreement. Given partners were also likely to stop
progress on trials it was also important only to commit to those that could do some-
thing worthwhile in the timeframe. BIOTECH would also have accrued significant
costs as trials typically cost anywhere between $1–2 million each to conduct.
Some of the team were concerned that particular firms were not serious about tak-
ing the project further given what the team considered to be the poor quality of the
trial designs that were being suggested (see above). All of the partner’s plans for fur-
ther clinical trials were presented and they were all very different insofar as the patient
numbers they presented were much larger and varied wildly as did the recommended
dosages they would use which some people on the team considered not feasible from
a regulatory perspective.
Finally a shortlist of two firms was decided upon and these firms had to go through
another round of capability presentations with the team where all of the detail about
how the development process would progress was discussed. From a business perspec-
tive, BIOTECH would receive payments at particular stages of the development process
and royalties if and when the product went to market. Eventually the decision was
taken to go with Stallion. The only commitment BIOTECH had – other than a very large
knowledge share issue – was to conduct the 123–3 trials which had recently stalled.
>> KNOWLEDGE SHARING AND PROJECT MANAGEMENT
Knowledge sharing was going to be major issue at this stage in the project. A KM
system – TARGET – had been introduced in the firm and a document management
structure had been agreed for all projects ongoing in BIOTECH and 123 had adopted
this system. The only problem that had been found was inputting information from
6/5/09 7:21:37 AM
9780230_522015_11_cha10.indd 249 6/5/09 7:21:37 AM
9780230_522015_11_cha10.indd 249