DEVELOPMENT AND INNOVATION IN CANCER MEDICINE - Innovation in the Biopharmaceutical Industry - page 56

Fig. 3. The future of cancer drug development. For the first time, drugs will be administered to
patients accompanied by effective biomarkers. These in turn will be used to identify surrogate mark-
ers of response, and therefore selecting the patients early in pivotal studies who should either continue
or stop a specific trial. In addition to this, continued laboratory research will be used to create diag-
nostic kits which will identify signatures of response. (Pts

Pharmacodynamic;
MTD = Maximum Tolerated Dose; IHC = Immunohistochemistry; sNDA = Supplemental New
Drug Application; CRO = Contract Research Organisation).

= Patients; PD =

much more predictable. Biomarkers will allow those who treat people for cancer to
measure a drug's effect on its target. If it is not working, an alternative treatment
strategy will be sought. Tumour regression will become less important as clinicians
look for molecular patterns and responses of disease (Fig. 3).
There will be more of a focus on cancer-preventing therapies. A tangible risk
indicator and risk reducing therapy, along the lines of cholesterol and statins, would
allow people to monitor their risk and intervene when necessary. Delivering treat-
ment early in the disease process will also be made possible as subtle changes
in cellular activity become detectable, leading to less aggressive treatment. The
role that the industry plays in the development of new therapies will continue to
change. Smaller, more specialised companies that are affiliated with universities will
increasingly deliver drug candidates and innovative diagnostics to 'Big Pharma' for
development and marketing (Fig. 4).
People will become used to living with risk, and they will have more knowledge
about their propensity for disease. Programmes will enable people to determine
their own predisposition to cancer. This, in turn, will encourage health-changing
behaviour and lead people to seek out information about the treatment options that
are available to them. As medicine becomes more personalised, patients will become
more involved in decision-making. Indeed, doctors may find themselves directed