In the context of developing a vaccine for human use, BiosYnth's business model is structured through
various consecutive phases, from scientific discovery to Research and Development after the successful
completion of pre-clinical tests.
Here's how the process can be outlined:
1. Pathology : The first phase involves identifying a specific infectious disease that requires a vaccine based on epidemiological reports released by the WHO. This could be a new infectious disease or a known disease for which there is no effective vaccine yet, an emerging disease, or a disease for which existing vaccines could be improved. The selection of the disease thus guides the direction of basic research and subsequent development.
2. Research : The research phase focuses on understanding the pathogen responsible for the disease, such as viruses or bacteria, and how the human immune system responds to it. This includes the identification of phenotype-specific antigens that can be used to provoke a protective immune response in the host organism (body).
3. Pre-clinical : During the pre-clinical phase, vaccine candidates are tested in vitro and in animal models to assess their safety and ability to induce a specific and potentially effective immune response. These studies are crucial to determine which formulations to advance to the next phase of clinical trials.
4. Intellectual Property : Protecting discoveries through patents is essential for the developed know-how including antigens, adjuvants, vaccine production methods, and formulations resulting from pre-clinical indications. This protection allows BiosYnth to maintain a competitive edge and attract investments from industrial and commercial partners.
5. R&D (Research and Development) : R&D continues through all phases of vaccine development on a pilot scale, including the optimization of the vaccine formulation and improvement of production methods.
6. Clinical Trial: Given the complexity and high cost of clinical studies, finding strategic partners is crucial. These can be large pharmaceutical companies, national governments, or public and private institutions. These partners can provide funding, research infrastructure, and organized access to clinical study populations.
7. Market : After successfully completing clinical studies and obtaining regulatory approval from the relevant authorities (Marketing Authorization), the next step is the commercialization of the vaccine. In collaboration with partners, existing distribution channels structured from previous experiences in the vaccine market are used, along with appropriate marketing strategies to reach a wide audience that can benefit. This phase also includes activities such as large-scale production, cold chain management (for vaccines requiring refrigeration and controlled temperature), and post-marketing surveillance programs to evaluate the long-term effectiveness and safety of the vaccine.