Product Development
The ‘Product Development’ infrastructure is the first point of contact for DZIF scientists who want to research and develop new products. The experts provide support from the project idea and translation into clinical trials through to commercialisation opportunities and spin-offs.
When developing new vaccines and therapeutics, many fail in the early stages due to a lack of professional support for researchers to develop a market-ready product. In order to close this gap, the experts in the DZIF's Product Development Unit (PDU) as a centre for translation and exploitation support and advise DZIF scientists in all phases of product development.
The PDU is made up of three teams, the Translational Project Management Office (TPMO), the Office for Scientific and Regulatory Advice (OSRA) and the Clinical Trial Office (CTO). All PDU teams are involved in the assessment of FlexFunds funding applications.
Translational Project Management Office (TPMO)
The TPMO is divided into two departments with different areas of specialisation. Thomas Hesterkamp's Drug Development team supports and advises all projects that deal with small molecules. Klaus Schwamborn and his Vaccine Development team supervise all vaccine and biologics projects at the DZIF. Hesterkamp and Schwamborn have many years of industrial experience and also advise on commercialisation opportunities and spin-offs.
The TPMO experts advise in particular on all operational aspects of preclinical projects and the transition to the clinic. This includes the production of preclinical and clinical test samples, pharmacology, toxicology and safety pharmacology, but also the selection of the best vaccine platform for a given candidate - to name just a few examples. In addition, the TPMO advises on FlexFunds applications.
The TPMO works closely with external consultants on questions relating to product development for microbiota products, phages, gene and cell therapies and diagnostics.
Office for Scientific and Regulatory Advice (OSRA)
The OSRA experts are based at the Paul Ehrlich Institute (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM), the higher federal authorities responsible for the authorisation of new medicinal products. This enables them to provide ideal support in clarifying regulatory issues, e.g. the manufacture and quality of investigational medicinal products, pharmaceutical characterisation or requirements for preclinical and clinical studies. OSRA also organises workshops that deal with fundamental or current topics in the field of product development in a targeted manner.
Nadine Kirsch-Stefan's team at the PEI supports projects in the areas of vaccines, monoclonal antibodies, cell and gene therapeutics, while Nils Lilienthal's team at the BfArM supports projects in the areas of small molecules, microbiota products and phages.
Clinical Trial Office (CTO)
The CTO supports DZIF researchers in the planning of clinical trials at all stages of development, both for medicinal products and medical devices. The majority of these are phase 1 and 2 clinical trials, with a particular focus on RCTs (randomised clinical trials). The CTO experts advise on the design, operational planning and implementation of clinical trials, as well as on the calculation of budgets and recruitment strategies.
In addition, the CTO advises on non-interventional clinical trials, which explicitly includes prospective cohort studies and registries.
The CTO advisory service is open to clinical projects before applying for FlexFunds funding, but also explicitly to any other clinical project. The CTO team is available to DZIF researchers at all times, be it with the initial study idea, the study synopsis for the FlexFunds funding application or many other hurdles that need to be overcome in the course of the project.
Furthermore, the CTO supervises the 12 DZIF-Clinical Trial Units (CTU) as a coordinating office until the end of 2025.
Further involvement
The PDU works closely with INCATE - Incubator for Antibacterial Therapies in Europe. Together with partners from industry and other organisations such as the DZIF, the consortium ensures that the pipeline for new antibiotics is filled and further expanded. Expert advice, networking and financial support are the three tools with which INCATE pursues this goal.
The PDU is also involved in CARB-X, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator. CARB-X accelerates projects worldwide to develop new drugs and diagnostics in the fight against antibiotic-resistant germs. The DZIF has been a partner in the CARB-X Global Accelerator Network since the beginning of 2019. The network contributes to the acceleration of funding activities and supports innovative projects worldwide.
