BY BENGT GUSTAVSSON
The clinical development of new cancer drugs has increased over the past fifteen years. Enormous progress has been made since modern genetic engineering broke through in the early 1990s. This has often involved cancer cells as a model, because they are basically immortal when cultured under normal conditions in the laboratory. Our understanding is accelerating when it comes to insights into the errors in the cell that cause a normal cell to being to grow uncontrolled and spread throughout the body.
Increasing our understanding of the molecular mechanisms that drive cancer development increases the targets that can be identified for new drug candidates. This means that more anti-cancer drugs can be developed and registered.
The examples are many: tyrosine kinase inhibitors have revolutionized treatment for patients with chronic myeloid leukaemia and have improved treatment for a variety of solid tumour forms. Aromatase inhibitors and EGFR inhibitors have helped in tailoring the treatment of breast cancer. Immunomodulating therapies and protease inhibitors have given patients with bone marrow cancer (multiple myeloma) an expected survival of five to ten years, instead of maybe just a couple of years. Immuno-oncology with different tumour-specific antibodies and so-called checkpoint inhibitors has opened completely new doors for the treatment of multiple tumour types, and we have probably only seen the beginning. At the same time, the more classic chemotherapeutic agents continue to be developed for cases where the tailor-made drugs are insufficient.
At the same time, we have an ever-aging population. The need for more effective cancer drugs coincides with increasing knowledge in molecular biology, information technology and computer power that enables these new therapies.
Drug development is costly, takes a long time, and does not deliver guaranteed success to the drug developer in terms of efficacy and minimal adverse drug profiles. However, cancer drugs have proven to be a type of drug that has often, but not always, involved shorter clinical development. And when showing a good risk/benefit profile, such drugs often show health-economic gains for society. This can also be the case for rare diagnoses where a few patients are to be treated with the new drug.
This has led to increasing numbers of clinical drug studies in oncology and haematology. Many pharmaceutical companies choose to increasingly outsource their clinical research studies to CRO companies. This often minimizes their own risk of taking on many employees in their own large and complex organizations. But it can also be because they lack the manpower.
Twenty years ago, it was not uncommon for individual academic researchers to conduct their own clinical research studies, but this has diminished today as the complexity of these studies has increased due to compliance with all the laws, guidelines and regulations. Good Clinical Practice (GCP) must be followed, and it is not always easy to cope with all this work. This has lead to an increase in the cooperation between academia and CROs. In recent years, this has increased in particular in oncology and haematology, both nationally and internationally.
In a country like Sweden, there are good opportunities for conducting good research, ‘real world data’ research and valuable health studies in, for example, oncology and haematology. This also opens new doors for academic groups, pharmaceutical companies and CROs.
Overall, a company like SCRO faces an extremely exciting and dynamic future. Collaboration and spreading risk, not least in malignant diseases, is something that will lead to many new and exciting research projects. Projects where cancer patients are the big winners.
Bengt Gustavsson, Senior Advisor Scandinavian CRO
