The incidence of cancer will increase within the next 5 years up to 15 million patients per year worldwide with a further increasing tendency. Therefore, there is a requirement for more emphasis on cancer prevention, research and effective anticancer drugs including a rapid licensing and market availability for the patients. In the EU, the centralized procedure (CP) of the European Medicine Agency (EMA) is mandatory for marketing authorization for innovative anticancer drugs. At variance, numerous independent healthcare systems are in operation across the EU, and each Health Technology Assessment (HTA) body follows its own methodologies and scientific value judgements in the assessment of the added value of an innovative anticancer drug. Consequently, drug access for patients differs considerably within the EU. Initiatives to improve the interface between the different stakeholders are currently on the way, but are unlikely sufficient enough to overcome these fundamental problems.
In order to accelerate drug development, reduce costs, increase efficacy and bring new and effective agents to patients as rapidly as possible, a huge clinical need remains for minimally invasive tests to determine subgroups of patients with a high probability for response to therapy. Biomarkers are characteristics that can be objectively measured and evaluated as an indicator of normal or pathogenic biological processes or of pharmacologic responses to therapeutic interventions. Therefore biomarkers hold great potential to predict clinical outcome and define a personalized treatment strategy tailored to a specific tumor.
In many instances a single marker cannot offer the necessary sensitivity and specificity. Given the complexity of the neoplastic process a panel of multiple markers is required. Consequently, many investigations now focus on the development of multiplexed assays that screen multiple genes and proteins in the same specimen at the same time.
The future will see the widespread use of biomarkers. The regulatory challenges and the hurdles such as finances, access to clinical data and reimbursement will be addressed. There is a need for a better science-based common position on methodology, greater commitments by politicians and healthcare decision makers to ensure equal access for patients across the EU to innovative antitumor medicines.
The multi-stakeholder workshop on Biomarkers and Patients’ Access to Personalized Oncology Drugs in Europe is organised by the Cancer Drug Development Forum (CDDF), in collaboration with the European Cancer Patient Coalition (ECPC). CDDF is a not-for-profit association whose mission is to improve the efficiency of oncology drug development and delivery by providing a unique forum for discussion where all those involved in cancer drug development can meet to address hurdles and explore potential solutions together.
This workshop will aim at giving an overview about developments in European regulatory and health technology assessment of new cancer drugs as well as at facilitating a collaborative discussion between regulatory bodies, HTA organisations, healthcare providers, academics, patients and industry on the challenges of equal access to personalized therapy within and between European countries.
- Personalized medicine
- Access to biomarkers
- Hurdles of getting biomarkers to the market
- Health Technology Assessment
- Harmonization of biomarkers development in Europe
The target is a multidisciplinary audience of Academia Representatives, European Regulatory Bodies (HTA and EMA), Policymakers, Pharmaceutical Industry, Patient Associations, and Payers.