DNDi and the International AIDS Society-Industry Liaison Forum (IAS-ILF) symposium
Sunday July 22, 13:30-15:00
Catching Children Before They Fall: Addressing Urgent Needs in Developing Drugs for Young Children Living with HIV
The objective of the satellite was to highlight the oft-neglected drug development needs of children with HIV, with a focus on the challenges of and potential solutions for developing appropriate drug formulations that meet the particular needs of infants and young children with HIV/AIDS in resource-limited settings.
Co-chairs: Bernard Pécoul, Executive Director of DNDi, and Celia Christie-Samuels, of IAS-ILF and the University of the West Indies.
Keynote address: “Paediatric HIV – a neglected disease?” by Stephen Lewis, Co-Director of AIDS-Free World
He opened the session with a dynamic keynote address asking if pediatric HIV is a neglected disease. His emphatic answer was “Yes.” Given the theme of this year’s International AIDS Conference, “Turning the Tide Together”, Mr. Lewis proclaimed about HIV/AIDS in children, “This is a tide we know how to turn.”
“A dream formulation for HIV-positive infants in the developing world? A paediatrician’s experience” by Adeodata Kekitiinwa-Rukyalekere, of Mulago Hospital in Kampala, Uganda
“We need a formulation that can deal with all issues,” said Dr. Kekitiinwa-Rukyalekere, referring to simplified administration, convenient delivery, and effective in all age groups and body weights.
The pharmaceutical industry’s point of view on pediatric drug development was provided by Karen Thompson of Merck, and Martin Gartland of ViiV Healthcare.
“Addressing the drug development needs of infants and young children: DNDi‘s Paediatric HIV Programme” by Shing Chang, Scientific Advisor and former R&D Director of DNDi
Dr. Chang presented DNDi’s strategy for developing a “4-in-1” antiretroviral drug combination therapy adapted for the treatment needs of infants and young children living with HIV/AIDS. Dr. Chang described DNDi’s non-profit R&D efforts like that of an “orchestra”, where good partners are like good musicians, led by a dynamic conductor.
The session then proceeded with two panel discussions: the first on how to tackle the technical challenges of pediatric formulation development, and the second on how to accelerate the production and availability of new pediatric HIV treatments.
Both panels were moderated by Polly Clayden of HIV i-Base and Lynne Mofenson of the US National Institutes of Health (NIH).
Technical pediatric drug development issues were addressed by Jaideep Gogtay, Head of Medical Services of Cipla, the Indian drug manufacturer and development partner with DNDi. Regarding technical challenges, Lynne Mofenson asked about how to utilize true innovative technologies in drug delivery, such as dissolvable films (as is used with breath mints) or “lollipops”. The pharmaceutical industry representatives answered that such strategies are technologically difficult, costly, and time-consuming.
In terms of accelerating pediatric HIV drug development, Diana Gibb of the UK’s Medical Research Council remarked that clinical studies can be sped up and time saved through the combination of drug-formulation product acceptability by the patients with pharmacokinetics and other evaluations.
Shaffiq Essajee of the Clinton Health Access Initiative commented that young children should be included early in clinical trials, remarking, “We want no child left without treatment.”
The Honorable Minister of Health of Swaziland, Dr Benedict Xaba, explained how fixed-dose combination drugs were helping HIV+ patient populations in his country, where all antiretrovirals are paid for by the country’s health budget. He said clinical trials were welcome in his country. “We still need to look at our health systems,” said Dr. Xaba. “We need political commitment for the quality of life of our children,” he added. In Swazi, all arvs come from country budget.
Polly Clayden summarized the panel discussions by commenting, “Poor people in poor countries cannot afford expensive drugs.”
Drs Christie-Samuels and Pécoul closed the satellite session with an emphasis on highlighting partnerships. “We need to be innovative with our partnerships,” said Dr. Christie-Samuels. She added, “We must be close to communities”, taking into consideration the “needs of mothers, children, [and] families.”