Tim Green, Director; Research and Clinical Bioanalytics, CSL
Discovering and developing a new medicine is an expensive
and time-consuming business. It is estimated that the average cost of a new, registered
medicine, is around US$2.6billion, with the average time from discovery to
launch being more than 10 years.
In order to mitigate the risk of investing in an ineffective
therapy, pharmaceutical companies apply rigorous testing mechanisms that
provide early feedback about whether or not to proceed with their development.
These mechanisms operate throughout the R&D life-cycle of
a candidate drug; from initial concept through pre-clinical and clinical
research of molecules, right through to final product registration and launch.
As one of Australia’s most successful biopharmaceutical companies, CSL carefully selects and rigorously tests new therapies in the development of a new generation of high tech medicines based on recombinant protein technologies.
In collaboration with colleagues around the world, CSL research scientists develop biological tests called ‘novel bioassays’ that are designed to evaluate the effectiveness and mechanism of action of new drugs.
These bioassays often use cells separated from human blood
to demonstrate whether the investigational medicine is targeting and inhibiting
the right molecules or pathways that are believed to be driving a particular
disease process. The tests provide information about the safety, efficacy and
potency of the candidate drug.
In order to develop these bioassays, researchers require blood
samples from patients with relevant diseases as well as blood from healthy
volunteers. Blood from healthy volunteers is critical to the research, enabling
rigorous scientific comparison between the effects of the candidate medicine on
disease processes compared with normal biological mechanisms.
To facilitate these comparison tests, CSL scientists have
been working with the online patient recruitment service, Clinical Trials
Connect (CTC) to source blood for medical research from volunteers attending
the Skin and Cancer Foundation (SCF) Clinic in Carlton.
The donation process, which is approved by an independent
ethics committee under the terms of the Human Tissue Act (Vic), is carefully
managed to ensure donors are fully informed about what their blood will be used
Once collected, the bloods are transported to research labs
and are usually used the same day in bioassays for drug development.
Occasionally the blood is processed in a way that allows it to be frozen for
use at a later time.
Over the past three years, CSL has utilised donations of
blood samples from more than 500 volunteers. These donations have been used to
support research and development of new medicines designed to treat cancer,
cardiovascular, metabolic, inflammatory and immune deficiency related diseases.
CSL researchers are grateful for the support provided by
Clinical Trials Connect and the Skin & Cancer Foundation and above all, the
volunteers, whose blood samples have enabled significant progress to be made in
the development of a number of new medicines.