Product Development Unit
From target discovery to approval of new drugs, 95% or more get stuck in the ‘valley of death’ and fail to reach clinical phase. All too often, this is not because of shortcomings with the innovative product, but rather due to an inadequate translational development process. The mission of the Product Development Unit (PDU) is to bridge the translational gap and to catalyze and regulate the rapid transformation of research discoveries into products, their preclinical development, manufacture and initiation of a first-in-man clinical trial.
To achieve the successful transfer of promising innovations and technologies developed in the DZIF partner sites – and beyond – into clinical practice, certain supporting structures will be established:
- Identification and assessment of technologies
- Product development planning and project management support
- Scientific and regulatory advice
The skills and expertise of DZIF-PDU will direct DZIF to follow the rules of successful translational research and development DZIF-PDU will ensure a tight integration of technology identification, clear and transparent exploitation plans and support for translational research and development.
DZIF-PDU has two offices; the DZIF Office for Scientific and Regulatory Advice (DZIF-OSRA) that handles regulatory aspects, and the DZIF Translational Project Management Office (DZIF-TPMO) that advises on commercial product development, elaborates corresponding project plans and supports the product development process.
Klaus Cichutek, Paul-Ehrlich-Institut
Thomas Hesterkamp, Helmholtz Centre for Infection Research
Christoph Conrad, Paul-Ehrlich-Institut