DEVELOPMENT AND INNOVATION IN CANCER MEDICINE - Innovation in the Biopharmaceutical Industry - page 57

Diagnostic Value

Predisposition screen Identify patients for chemo-

prevention

Screen for presence of cancer Increase in patients - earlier disease

Pharmacodynamic biomarker Establish pharmacological dose

Surrogate marker of clinical efficacy Early indication of proof of concept

Predictive reclassification of disease Target therapy to those likely to

respond

Patient-specific toxicity prediction Avoid adverse events, adjust dose

Fig. 4. Cancer diagnostics in drug development. There are six areas where diagnostics could help to
personalise cancer medicine.

Table 6. The uncertainty of novel drugs for cancer.

Will the new generation of small molecule kinase inhibitors really make a difference, or
just be expensive palliation?
How will big pharma cope with most high value cytotoxics becoming generic by 2008?
Can expensive late stage attrition really be avoided in cancer drug development?
How will sophisticated molecular diagnostic services be provided?
Will effective surrogates for cancer preventive agents emerge?
Will patient choice involve cost considerations in guiding therapy?

by well-informed patients. All of this coupled with an environment where patients
are able to demonstrate choice, will help drive innovation towards those who stand
to benefit from it. However, inequity based on education, wealth and access will
still continue (Table 6).

Barriers to Innovation

Innovation in cancer treatment is inevitable (Dixon et al. 2003). The nature and
intensity of treatment will be critically influenced by the way innovation is rewarded.
However, there are certain prerequisites for the introduction of new therapies. First,
innovation must be translated into usable therapies that must be deliverable to the
right biological target, and to the right patient in a way that is acceptable to the
patient, the healthcare professional and society. Innovation must also be marketed
successfully to professionals, patients and those who pay the cost, so that they
all understand the potential benefits. Those making the investments in research
will create a market for innovation, even if the benefits achieved are minimal. The