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CONCLUSIONS   251

                            being circulated across BIOTECH so that future projects could hopefully avoid making
                            the same mistakes.
                              This is the first time that the firm has adopted such techniques and ways of
                            working. In the past line managers were perceived as taking too much responsi-
                            bility for ‘their babies’ (i.e. projects) and insufficient delegation occurred. Those
                            involved in the satellite teams were now empowered to make decisions. That said,
                            there were hints in the DPT meetings of lack of agreement and differences of inter-
                            pretation despite outward consensus. For example, in discussing a clinical study
                            update a figure of 10 per cent false negatives was described by some as ‘nice data
                            that works really well’ even though there was clearly some disagreement across the
                            whole about whether this data was in fact good or bad. Another potential impact
                            of the new project team structure was increased pressure on the satellite teams to
                            meet very tight deadlines. This was because the clinical team now had to report
                            back to the DPT who in turn reported to the PSC. For example, because the clinical
                            team now had to report back in time to the DPT who in turn reported to the PSC,
                            members were reporting to very tight timescale. If one person was on holiday (or
                            training), for example, these deadlines were almost impossible to meet. Interest-
                            ingly the language used in meetings – particularly around trials – was imbued with
                            imperatives to meet timescales and report deadlines, for example ‘close outs’, being
                            ‘on track for a hard lock by’, ‘dropdead lock’. In this context ‘scheduling well ahead’
                            for the clinical team meant in practice giving people only two weeks’ notice to com-
                            plete particular tasks as ‘every day counts’.


                            >> TO CONCLUDE

                            At the time the study ended, the problems with the granules had been solved but by
                            then Stallion had been made aware of the issue. Stallion had decided they needed time
                            to consider their position so negotiations had been temporarily suspended. BIOTECH
                            however had to continue with the trial and hope for favourable results regardless of
                            whether Stallion or some other large pharmaceutical finally licensed the therapeutic.

                            >> GLOSSARY OF TERMS

                            Efficacy – in terms of new drugs this means demonstrating the effectiveness of the
                              development drug compared to other therapeutics that are already on the market.
                            Out license – ‘sell-on’ the developmental drug to a larger firm who would take it
                              through Phase II/III trials and hopefully to commercialization for which the origi-
                              nating firm receives royalties.
                            Pharmokinetics – establishing optimum drug dosages for different populations.
                            Due diligence – the due diligence process varies for different types of companies. In
                              this instance it is about establishing the financial, legal, labour, tax, environment
                              and market/commercial situation of BIOTECH by partner firms and in this case
                              vice versa (i.e. BIOTECH establishing as far as possible that a potential partner has
                              the capabilities and the will to proceed with development.)









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                  9780230_522015_11_cha10.indd   251                                         6/5/09   7:21:37 AM
                  9780230_522015_11_cha10.indd   251
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