Optimizing Early Phase Oncology Studies to Accelerate Proof of Concept

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. It is at this stage where exploratory studies become confirmatory studies and there is a basis for studying the efficacy in a larger population. From a business perspective, showing proof of concept is also an essential bargaining chip when negotiating licensing agreements.

Due to the prevalence, diversity and complexity of cancer, oncology clinical trials have evolved along a different path than trials for other therapeutic areas. The toxicity ratings, patient recruitment and stratification, and the ethical aspects all have considerations specific to oncology trials. Despite these differences, oncology drugs face the same industry-wide problem of high attrition rates and low levels of efficiency in clinical trials. The potential therapeutic and commercial value of these drugs need to be determined at an early stage so resources can be allocated more efficiently.

It is widely acknowledged that the current oncology clinical trial system is in desperate need of reform as funding is decreasing, costs are increasing, and the health authorities impose more extensive and complex regulatory guidelines. In recent years, the regulatory bodies have become more receptive to adaptive clinical trials where predetermined modifications can occur in an ongoing study. Challenges to accelerating the proof of concept of oncology drugs include knowing how to integrate multiple disciplines and the latest techniques and weighing the demand made by different organizations to make logical decisions early.

This two day event will showcase essential industry, scientific, ethical, academic and regulatory perspectives regarding the latest and most critical issues surrounding oncology drug development. Experts in the field will talk about their experiences in the pre-clinical and clinical development and how they created a program that satisfies all stakeholders. Attendees of this event will learn how to utilize all resources and take advantage of all regulations to efficiently run early phase clinical trials for innovative oncology therapeutics.

Why Attend

• Discover the most efficient methods of creating a solid pre-clinical program to get approval for FIH studies.
• Meet highly experienced experts that are directly involved in anti-cancer agent trial design and implementation.
• Learn about the regulatory requirements in North America and Europe regarding the level of proof required to satisfy the governing bodies.
• Find out how what resources are available and what duties should be outsourced and what should be done in-house.
• Understand best practice when it comes to patient recruitment, including when and how to stratify patients.

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, licensing, translational medicine, regulatory affairs, therapy area heads, and R&D.

Expert Speaker Panel