Development of vaccines, monoclonal antibodies or small molecule compounds is a complex process.
Based on extensive industry and academic experience, VaxxCellence offers expert, hands-on advice for the different development stages, ranging from Discovery, to Target Product Profile (TPP), Clinical Development Program (CDP) and biomarker strategy development as well as post-licensure commitments.
To support this, services are offered in the following areas:
Please contact us for more information and to initiate a discussion on your specific needs in drug & vaccine development
From concept to product: translating scientific concepts into Target Product Profiles. A roadmap is required that covers Discovery, Clinical Development Plans and the associated studies, to formulating a view on benefit/risk and cost/benefit assessments. Collectively, this supports early-stage strategic decision making.
Generating the optimal immunological data is critical throughout development because it is the key portal to interpret outcomes, de-risk next steps and inform the entire portfolio. A proper biomarker strategy is adapted to the stage of development and finds the right balance between exploratory work and data generated in a regulatory environment.
Supported by a sound academic background, a strong publication track record and 16 years of hands-on industry experience in Discovery, Clinical Development, safety evaluation and post-licensure work, VaxxCellence can support your project(s) at multiple levels.
Advice on pre-clinical research and toxicological studies
Advice on clinical development
Advice on developing a Target Product Profile (TPP)
Advice on safety evaluation of vaccines