The Life Saving Therapies Network (LSTN) is an international network of patients, patient groups, oncologists, researchers, regulators, medical ethicists, corporations and others that is focused on solving a major problem in the fight against lethal diseases such as widely metastasized cancer. LSTN is also a call to action… LISTEN… we will be heard.
Although we will contribute generally to crafting an international personalized medicine strategy, LSTN’s focus is on creating progress-centred regulations that facilitate:
- Clinical research reform to permit faster, less expensive access to new therapies for lethal diseases, and
- Reforming regulatory frameworks for the development and approval of treatment for lethal diseases.
LSTN’s work is to provide thought leadership and resources to mobilize the network members in a responsible partnership to effect change.
Developments in precision, gene-targeted medicine, as well as other approaches such as immunotherapy and viral oncolytics are showing great promise for treating lethal diseases. Sometimes referred to collectively as personalized medicine, these targeted therapies also highlight a profound gap in the US and Canada. We don’t have a comprehensive policy or strategy for capitalizing on the promise of personalized medicine. From the perspective of people who have incurable diseases, this lack is deadly. Simply put, it takes too long and costs too much to develop and provide access to effective drug treatments for these diseases. Current regulatory and research regimes are cumbersome, expensive and fraught with unnecessary delays.
The regulatory system is clogged and strained:
- The average $800 million it takes to bring a treatment to market means, among other things, that very few drugs actually make it to market. Others that should be tested are not and promising treatments fall by the wayside.
- Tragically, millions of life-years are lost due to approval delays. It can take up to 14 years for a drug to be approved; fast-tracked drugs take about six years.
- Clinical trials are often too complicated and rigid; they must be simpler and easier to access, especially in the case of personalized treatments.
- Reimbursement for the use of approved drugs takes too long, even in the best jurisdictions.