Strengthening research capacity where it’s needed most
Through the TDR Career Development Fellowship Programme, scientists from disease endemic countries have a unique opportunity to learn both the product development and full registration processes by taking part at every stage, training in the some of the world’s most advanced labs. Three different partnerships are profiled in Viet Nam, Tanzania and Democratic Republic of Congo.
Field experience with a product development partnership
To date, 27 Fellows from 13 countries have participated in the programme, and with the latest round, TDR and partners decided to pilot a new approach: pairing a Fellow with both a pharmaceutical company and a product development partnership (PDP). Last year, Dr Wilfried Mutombo Kalonji of the National Programme to Fight Human African Trypanosomiasis (HAT) in the Democratic Republic of the Congo (DRC), became the first fellow to do this.
Like Dat, Kalonji spent the first six months of his fellowship in Paris, where, as a trainee at Sanofi Aventis, he learned the theoretical underpinnings of clinical trials – everything from protocol development and site set up to Good Clinical Practice and regulatory approval. But whereas Dat continued on his fellowship with Sanofi Pasteur, Kalonji spent his second six months with the not-for-profit Drugs for Neglected Disease Initiative (DNDi).
Started by Doctors Without Borders in 2003, DNDi initiates and coordinates drug R&D for tropical diseases in collaboration with a host of public and private partners. And in partnering with the group, TDR took the programme in a promising new direction. “We had heard during our alumni meetings that some Fellows were having difficulty reintegrating with their home institutions,” says Dr Pascal Launois, who as manager of individual training in TDR’s research capability strengthening unit oversees the CDF. “And that got us thinking that it would be great to select researchers who were already involved in a clinical trial.”
With the new approach, says Launois, Fellows get a firm grounding in the theoretical basis for a clinical trial at a pharmaceutical company before putting those lessons into practice. And over the past year, Kalonji has done just that, assisting DNDi investigators on a pivotal Phase II/III study of the safety and ease of using a new combination therapy for HAT, otherwise known as sleeping sickness, in his native DRC, where more than two thirds of all reported cases occur. “The development of drugs for HAT has many steps,” says Kalonji. “And when you consider them in theory, you can be very far from reality,” especially, he says, when that “reality” is a rural village in the DRC. “Most of the people don’t have education, so the way you prepare them, it’s very important.”
“It’s having an impact. These Fellows have been building teams and producing data of internationally accepted quality, and that data is being used. ”
Dr Fabio Zicker
TDR Research Coordinator
“The reality is the medical reality, the political reality, the environmental reality,” says DNDi Medical Director Dr Nathalie Strub Wourgaft, who selected Kalonji to be the clinical coordinator of the trial for the duration of his fellowship. “Wilfried really helped us understand how to conduct the best possible study, and how to accommodate our GCP needs in light of the local constraints.” Part of DNDi’s mission, Wourgaft adds, is to strengthen countries’ capacity in clinical research, and Kalonji’s training surely contributes to that. But she stresses that DNDi, too, has learned from the experience. “By understanding where the patients are, the complexity of their treatment, their nutrition, their whole medical setting – a lot of the things we need to take into account to build a study that works.”
Kalonji, for his part, can hardly wait to get started on the next project. “We have so many things to do and I have many ideas,” he says. “It will take time to start doing local projects. But that’s my dream. I hope that I will reach it.”
“Wilfried really helped us understand how to conduct the best possible study, and how to accomodate our good clinical practice needs in light of the local constraints. ”
Dr Nathalie Strub Wourgaft
Drugs for Neglected Diseases initiative