In the development of new drugs, many potential pharmaceutical products fail long before the first clinical trial, often because there is a lack of professional support for research projects. Therefore, experts from the Product Development Unit (PDU) at the DZIF support scientists from the project idea through to the first clinical trials. The PDU works closely with the various DZIF researchers in order to identify appropriate approaches to new vaccines or therapeutic agents early-on. The goal is to support the development of innovative concepts until the pharmaceutical industry can potentially take over and further develop the product. In this partnership-based model, biotechnology or pharmaceutical companies take over the downstream development phases all the way up to the approval and marketing of the product.
The Office for Scientific and Regulatory Advice (OSRA) is part of the Product Development Unit (PDU). It is located at the Paul-Ehrlich-lnstitut (PEI) and at the Federal Institute for Drugs and Medical Devices (BfArM). The PDU also includes the Translational Project Management Office (TPMO) at the Helmholtz Centre for Infection Research (HZI) in Braunschweig, Germany.
- The advice in the TPMO is primarily aimed at the project manager, and sometimes the TPMO takes over management in selected projects
- Support for the preparation of regulatory documents, e.g. for scientific consultation or application for clinical trial
- Frequently, the TPMO provides support for budgeting and milestone planning of projects, contractual matters, and implementing projects; it also assists in identifying partners and contractors
- The TPMO coordinates DZIF's technology transfer activities with the relevant DZIF member institutions; presentation of selected
projects at public events, such as Biovaria; search for cooperation partners
- Organisation of consortia and partnerships for collaborative project work
- Preparation of subsidy and grant applications with internal and external partners
- OSRA assists in clarifying regulatory and technical issues within scientific discussion and consulting procedures:
- production and quality of clinical trial vaccines, investigational medicinal products and new adjuvants
- Suitable models for preclinical proof-of-concept studies
- Preclinical safety
- Early clinical development
- OSRA arranges workshops that focus on a specific, current topic, e.g.
- the new clinical trial regulation
- First-in-man study
- PK/PD modelling, regulatory framework conditions and associated consequences for project and product development.
Currently, the PDU is working intensively with scientists in eight DZIF projects. The TPMO and OSRA jointly support preclinical and early-clinical projects.
Information about Regulatory Advice:
Antibody and vaccine development
A successful example in this area is the development of a vaccine against the MERS coronavirus:
The DZIF recently became one of ten partners worldwide to support CARB-X in the fight against antibiotic-resistant bacteria. CARB-X supports biotechnology and pharmaceutical companies in their efforts to develop drugs against antibiotic-resistant bacteria.