Jean-Marie Préaud brings together people working on different stages of vaccine development. Photo: PATH.
To make vaccines affordable, it pays to build relationships
Though his expertise is in pharmaceutical operations, much of Jean-Marie Préaud’s work involves building relationships. As a senior technical officer at PATH, Jean-Marie is responsible for managing the transfer of vaccine technologies from manufacturers and laboratories, often in the United States or Europe, to manufacturers in developing countries. This allows vaccines to be produced at prices that poorer countries can afford.
“My role is to put together all the actors of the vaccine development,” Jean-Marie explains.
From one partner to another
To ensure vaccines are available to countries at an affordable price, we form creative partnerships between the public and private sectors to share intellectual property and make it available for public health benefit. When the Meningitis Vaccine Project (MVP)—a partnership between PATH and the World Health Organization—set out to create an affordable vaccine against meningococcal A meningitis to halt deadly epidemics in Africa, for example, Préaud led the transfer of vaccine science and materials through an innovative alliance.
The MenAfriVac® vaccine could end epidemic meningitis in Africa. Watch the video. Photo: PATH.
The US Food and Drug Administration (FDA) provided the technological process to boost the vaccine's effectiveness, a step called conjugation. The Serum Institute of India Ltd. and Synco BioPartners in Amsterdam supplied the raw materials, and the Serum Institute found a way to manufacture the vaccine at a low cost. Through this product development plan, MVP and its partners developed the vaccine MenAfriVac® at a cost of less than US$0.50 per dose. In December 2010, the new vaccine began reaching millions of people in Africa’s meningitis belt.
Préaud has completed nine technology transfers in his career, but no two are alike. He connects the dots between raw materials, production processes, manufacturing facilities, and regulatory issues to ensure the smooth transfer of scientific know-how from one partner to another.
All together now
Jean-Marie talks about what it takes to successfully transfer vaccine technology:
“My role is to put together all the actors of the vaccine development.”
What is exciting about technology transfer is to put all the people together from different cultures—they may be American, Dutch, Indian, Brazilian, Indonesian, or Chinese. But one of the challenges is the cultural obstacles due to language or due to differences in scientific backgrounds. It takes a long time to make sure that one group understands what the other group is talking about. This is exactly why we need to be with the people at the very beginning and frequently make sure all the messages are well understood.
It is very important to spend a lot of time with different groups to make sure that, first, we listen to them and try to understand where the obstacles are. Then it takes a long time to build confidence and to nurture a good relationship between the groups, to break the ice. We need to develop a very good climate of confidence and collaboration. It’s necessary to be with the people, to know the group, to know the technology, to be able to assist the people not only on the scientific point of view but also with the daily, very simple problems.
Learning the technology
Careful coordination and communication are critical to a successful technology transfer, Jean-Marie continues:
When we do a technology transfer, the first step is to bring the receiver of the technology transfer to the donor team to learn the technology. Then the receiver brings the technology home to try to develop it in-house.
For the meningitis vaccine, two scientists from the Serum Institute went to the Center for Biologics Evaluation and Research at the FDA for three weeks so they could learn all the technology of the conjugation method. We went into the lab to watch the scientists demonstrate the conjugation technology, then invited the trainees to do it by themselves. At the end of each day we had a wrap-up. We documented all of the questions and answers that came up to make sure this information was not lost. Every single activity must be well-documented. When the scientists go back home, they need to be able to do this on their own. Later, two scientists from the FDA traveled to the Serum Institute in Pune, India to answer questions and polish the technical details of the transfer.
Technology transfer can take one week or it can take three or four years. It depends if you have only one or two people to train or 200 people. It also depends on the scope. If you have a complete manufacturing technology transfer with production, quality control, quality assurance, engineering, and packaging, it can take much longer. It’s like if you build a house or you build a campus—it’s not the same. The experience is as technically and culturally challenging as it is rewarding. You just need communication, communication, and more communication.
MenAfriVac is a registered trademark of Serum Institute of India Ltd.