Conference Dates: 12-13th October, 2011
Venue: Vienna, Austria
When running early clinical trials for experimental new drugs across a range of therapeutic areas, demonstrating “proof of concept” is a critical milestone of the development process, yet one that is very difficult to achieve. It is at this stage where exploratory studies become confirmatory studies and there is a basis for studying the efficacy in a larger population.
Due to the prevalence, diversity and complexity of cancer, oncology clinical trials have evolved along a different path than trials for other therapeutic areas and trial failure rates are amongst the highest amongst all therapy areas. The toxicity ratings, patient recruitment and stratification, and the regulatory and ethical aspects are all challenging considerations specific to oncology trials.
It is widely acknowledged that the current oncology clinical trial system is in desperate need of new breakthroughs as costs are increasing, and the regulatory authorities impose more extensive and complex regulatory guidelines. In recent years, the regulatory bodies have become more receptive to more advanced phase 0 micro-dosing studies, as well as adaptive clinical trials where predetermined modifications can occur in an ongoing study. Challenges in accelerating the proof of concept of oncology drugs include knowing how to integrate multiple disciplines and the latest scientific techniques and weighing the demand made by different stakeholders to make logical decisions earlier with the right information.
This two day event will showcase essential industry, scientific, ethical, academic and regulatory perspectives regarding the latest and most critical issues surrounding early-phase oncology drug development. Experts in the field will talk about their experiences in the pre-clinical, translational and clinical development and how they created a program that satisfies all stakeholders.
Attendees of this event will learn how to utilize resources and the latest science and satisfy major regulations to efficiently translate laboratory theories into clinical practice and achieve proof of concept for innovative oncology therapeutics.
• Discover the most efficient methods of creating an advanced pre-clinical and translational program to understand disease biology and drug mechanism of action and to obtain approval for FIH studies
• Meet highly experienced experts that are directly involved in anti-cancer agent clinical trial design and implementation.
• Learn about the regulatory requirements in North America and Europe for small and large molecules.
• Work-out the best ways of integrating advanced biomarkers, delivery systems, modelling & simulation, micro-dosing and adaptive trials into your clinical programs.
Who will benefit?
Experienced executives from Pharma, Biotechs and Academia involved in:
oncology drug development
VPs, Professors, Senior Directors and Managers involved in:
biologics, small molecules, discovery, pre-clinical development, exploratory development, early phase clinical development, clinical operations, clinical science, clinical pharmacology, biomarkers, senior scientists, licensing, translational medicine, regulatory affairs, therapy area heads, and R&D.
To request the full agenda please follow the link:
For Booking Information contact:
Tel: +421 232 660 382
Fax: +421 2 3301 0331