Head, Translational Medicine, Immunology Therapeutic Area
Janssen Research & Development, LLC
United States of America
Translational medicine, both the mindset and the practical approach, is an important if not essential element of today's successful pharmaceutical development. It deals with building the bridge between the science of the emerging preclinical portfolio and the early development space where molecules are studied in humans for the first time. It ensures that the right translational work is done in the immediate preclinical phase and is continued into early clinical studies. Translational medicine thinking also applies to many later clinical studies. For this reason, many larger pharmaceutical companies have dedicated a part of their research and development organization to translational medicine. Often, the same group may also be responsible for the conduct of early clinical trials.
Last but not least, another essential collaborator and eventual customer for the work of immunology translational medicine is the clinical development team who run Phase II and III trials. Success requires a team effort in which the clinical development colleagues are involved with planning and decisionmaking at every step. This ensures alignment within the plan and delivery of the best package of data when the molecule leaves early development and plans for Phase II are underway. Coordinating and integrating all of these activities can be challenging, so, within Janssen Immunology, a group called the Experimental Medicine Working Group serves as a forum where members of all of these functions meet regularly to discuss strategies and specific projects.