Especially in the initial phase of a project, start-ups and biotechs need support in making strategic decisions that often determine the success or failure of a project. Many companies offer services of varying quality in the drug development process. I accompany companies, help to classify the necessary development components, and arrange contacts to high quality service providers.
Due diligence as critical assessment of novel assets in drug research and corresponding translational strategies supports investors such as VC Funds with identification of valuable projects and risk minimization. Asking the right questions in the beginning of a project can generate added value in the long run.
The transferability of preclinical effects to clinical effects in patients, the so-called translational value, is a major challenge, especially in pain research. Time and again, new approaches that show promising data in rodents fail in patients. A steadily growing number of different pain indications meet the question of a precisely fitting treatment. I provide pharmaceutical companies with the expertise I have acquired over decades in pain research. I assess complex data sets, question strategic decisions and recommend tailor-made translational approaches.
Drug development is a highly regulated process subject to multiple constraints. Taking these requirements into account in the development strategy and at the same time integrating success factors such as a sound patent strategy or the “drugability” of a substance require sound and broad experience. I accompany companies and support them in regulatory issues along the entire value chain of drug development. The spectrum ranges from patent strategies to environmental toxicological expert opinions to market support for new products.
The drug development process is complex, interactive and integrates many specialized disciplines. Pharmacology contributes from early research to the approval and marketing of new drugs. Decades of work in a wide variety of projects form the basis for my network of experienced specialists from pharma and biotech. Thus, complex issues can be solved quickly and efficiently.