IAVI develops vaccine candidates and other biomedical innovations and manages clinical research with partners in academic, biotechnology, pharmaceutical, and government institutions. IAVI also provides translational research services and support to other organizations in the field, assisting them with the complex process of transitioning innovations from the laboratory into clinical trials. This includes providing assistance with process development, Current Good Manufacturing Practice (cGMP) manufacturing, clinical development and regulatory filings.
In 2013, the Bill & Melinda Gates Foundation (BMGF) awarded a grant to IAVI to create the Vaccine Product Development Center (VxPDC) to assist investigators affiliated with BMGF’s Collaboration for AIDS Vaccine Discovery with the complex process of transitioning vaccine candidates from the laboratory to the clinic. Subsequently, IAVI expanded the Product Development Center (PDC) in recognition of efforts beyond vaccines and extending this translational expertise to other partners — whether academic, nonprofit, government, or industry — that are advancing new biomedical interventions. The PDC fills a critical gap in the development process for new vaccines and other biomedical innovations. Today, investigators from the U.S. National Institutes of Health and European funding partners are among those who utilize IAVI’s PDC.
The PDC provides:
- A team of pharmaceutical development experts who collectively have advanced hundreds of projects through global regulatory agencies.
- An extensive network of Contract Research Organizations, Contract Manufacturing Organizations, and technology partners to accelerate development and minimize risk.
- Access to clinical research networks around the world, including in Africa and India.
- Over 20 years of HIV vaccine development experience from projects using a wide range of technology platforms.
Recent accomplishments include:
- Assisting an academic team with the development of a broadly neutralizing antibody discovered by IAVI. The antibody was scaled up and manufactured with PDC guidance and has entered Phase I clinical trials.
- Advising investigators at IAVI’s Neutralizing Antibody Center on a program to develop an engineered vaccine candidate designed to trigger the production of antibodies. The PDC managed preclinical activities, performed process and analytical development for the candidate, oversaw the clinical grade manufacture of the product, and made the regulatory filings, which is now in a Phase I clinical trial.
- Providing manufacturing, clinical, and regulatory expertise to university scientists in preparation for an efficacy study of two broadly neutralizing antibodies.