Implementing and Effectively Performing Phase 0 Trials in Drug Development

Event Overview

Despite the ever evolving and improving technology available for biomedical research, the pharmaceutical market has seen a decline in the number of innovative, regulatory-approved medical therapies that have become available for commercial use. One major factor that has contributed to the decline of the industry’s product pipeline is that the advancements in methods for early identification of efficacious drugs have not been on par with the advancements in methods for drug discovery. The latest methods for drug discovery yield a number of candidates and the challenge lies in distinguishing those candidates that have the best chance of success from those that are destined to fail.

One increasingly important step to solve this problem is to run a phase 0 trial, or microdosing study. The PK/ PD, metabolic, immunogenicity and toxicology data received from an actual human patient can be invaluable when making the go/ no-go decision that determines a drug candidate’s fate. When designed and executed properly, a phase 0 trial can enable companies to reduce expenses and the timeline by identifying the most promising agents earlier.

However, for companies who wish to explore the potential benefits of conducting phase 0 trials there remains a significant amount of uncertainty involving the best way to integrate it into the drug development process. Besides the regulatory and ethical considerations, companies also need to find out if their drug candidates are appropriate for phase 0 studies. Furthermore, they need to develop microdosing models and learn the best way to identify targets using available methods. Given that there are numerous challenges and few real-life examples, there is skepticism in the industry regarding the need for such studies, whether they really alleviate any challenges in future stages, and if the output can prove anything at all. Regardless of this view, an increasing number of industry experts agree that a successful phase 0 trial can lay the ground work for rationally designing later clinical trials and improving overall efficiency in the drug development network.

This interactive webinar will allow participants to hear insight on critical issues from some of the industry’s most experienced stakeholders in phase 0 studies, all without leaving the home or office. Presentations include perspectives from regulators, academics, and pharmaceutical companies. Those that are experienced in phase 0 trials can benchmark and get the most up-to-date information needed to improve their studies while those that are only beginning to explore phase 0 trials and microdosing studies will learn what needs to be considered before they get started.

Why Join?

• Get different perspectives of what is meant by “phase 0 trials” and how the methodology can be used across different therapeutic areas
• Hear real-life examples and lessons from those pioneering the phase 0 scene
• Find out where the regulators and ethics committees stand on phase 0 trials and how to plan accordingly
• Discover how a well designed phase 0 trial can remove wasteful steps in phase I and phase II trials
• Understand if and how undertaking phase 0 trials can speed products to the market and reduce risk

Who will benefit?

Managers involved in clinical and in-vivo pharmacology, early drug development, exploratory and translational medicine, biomarker validation, toxicology, modeling & simulation, pharmacometrics, experimental medicine, clinical development and optimization, phase I clinical trials and drug discovery. As well as medical directors, study coordinators, Heads of R&D, and CSOs.

A more detailed list of speakers’ names is available on the downloadable agenda. Please „request event agenda“ below. 

Invited and Confirmed Speakers Include: