From invention to clinical product: The commercialization of scientific findings requires specific knowledge and skill sets, e.g. a solid understanding of the targeted markets, the competitive landscape, intellectual property rights, technical and clinical product development, regulatory requirements, quality management, financing strategies, and many others. This workshop will cover the most important topics that scientists must be aware of when considering to translate the results of their research into clinically relevant and commercially viable products.
Dr. Klaus Weinberger (Weinberger & Weinberger Life Sciences Consulting)
Dr. Hubert Müller (Ascenion GmbH)
- Introduction of speakers and participants. Presentation of agenda. Hurdles for translation of scientific results into clinical (and commercial) practice.
- Intellectual Property: From idea to first results: Evaluation of an innovation according to novelty. Inventive step and industrial applicability. Patenting. Exploitation of the innovation.
- Preclinical and clinical development of Therapeutics: Regulatory framework, prerequisites, processes, and milestones (IND, clinical trials, dossier, approval).
- Preclinical and clinical development of Diagnostics: Regulatory framework, prerequisites, processes, and milestones (new MDR & IVDR, quality and risk management, clinical validation, assessment of diagnostic performance).
- First steps towards commercialization: Licensing or spin-off? Business Plan, market research, competitive analysis.
- Use cases from therapeutic and diagnostic product development. Summary and lessons learnt.
We invite early career scientists of the German Centers for Health Research (DZG): DZD, DZL, DZHK, DZIF, DKTK, DZNE.
Ideally, the participants already have some initial contact with the topic, e.g. an invention for which a patent is being considered.
Free of costs for DZG Scientists (DZD, DZL, DZHK, DZIF, DKTK, DZNE).
Application by February 5.
Brigitte Fröhlich (DZD)
Klaus Weinberger is a biomedical scientist and entrepreneur with more than 20 years of experience in clinical research and both diagnostic and pharmaceutical product development. His scientific work covers basic and clinical hepatitis virology, vaccine vectors, and metabolic biomarkers in diabetology, nephrology, and other indications. Klaus made pioneering contributions to diagnostic innovations based on real-time PCR (viral load testing for Hepatitis B Virus) and mass spectrometry (targeted metabolomics platform and kits), and co-founded and managed successful biotech, data analytics, and consulting companies.
Hubert Müller is a biologist (virology, immunology, molecular biology) by training and holds a PhD in virology from Tübingen University. Hubert has an experience of almost 15 years of life science commercialization with a strong background in European and US business development and patent law. Aside the commercial activities in technology transfer Hubert provides training of researchers and technology transfer officials from research institutes in questions regarding inventions, IP management and commercialization. Prior to his commitment in technology transfer Hubert served as Director Project Management of two biotechnology companies in Düsseldorf and Martinsried.