By Anna Laura Ross, Françoise Barré-Sinoussi, David Margolis, Guido Silvestri and Stephen Mason
We like to think of researchers as being able to dive straight into their lab experiments immediately following a ‘eureka’ moment of inspiration. If only that were true; unfortunately, researchers, like professionals in many other fields, often confront some substantial administrative, legal and paperwork challenges in completing their daily tasks – in this case, in transforming hypotheses into experiments, and experiments into potential remission strategies for HIV.
Investigators in all domains, including HIV cure and remission studies, have faced the reality of legal restrictions and piles of paperwork that can stand between them and the compounds they need to conduct their studies. Such restrictions are a particular problem for studies, like those of many of the most promising strategies in HIV remission research, that involve therapies from multiple companies. Each pharmaceutical company has their own individual legal framework for making their drugs available, and unique restrictions on how those drugs can be combined in research studies with those from other companies, meaning that some promising remission studies have been delayed by months, or even years.
With thousands of people becoming newly infected with HIV every day, such obstacles have been a sobering reality for researchers...a reality that has slowed the pursuit of some of the most promising avenues of HIV remission research.
Now, however, thanks to an unprecedented new agreement with five leading pharmaceutical companies -- negotiated by the International AIDS Society (IAS) Towards an HIV Cure Industry Collaboration Group (ICG) -- those days, and delays, are finally over. The new pact, known as a Common Material Transfer Agreement, (cMTA), eliminates a maze of legal restrictions on the use of drugs in cure research studies, clears some major bottlenecks for investigators, and provides a critical boost to efforts to develop new remission or cure strategies for HIV.
By providing a simplified, unified process for the donation and use of drugs in HIV cure and remission studies, the new cMTA clears the way for faster, more effective approaches to achieving full viral suppression of SIV in non-human primate models. Those approaches, if proven effective, could one day lead to a new generation of HIV cure or remission studies in people.
Five industry leaders in HIV research – Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck, and ViiV Healthcare – participated in three years of IAS-led negotiations to achieve this groundbreaking agreement. The cMTA is the result of an exceptional spirit of openness and partnership between industry representatives, researchers and advocates involved in the negotiations – the same spirit of collaboration we will need moving forward to overcome the scientific challenges to achieving HIV remission.
The cMTA comes at a key time in HIV cure research as NHP models now allow researchers to investigate strategies in animal models on ARV’s. Such models are highlighted in the 2016 Global Scientific Strategy: Towards an HIV Cure, developed by a multi-disciplinary International Scientific Working Group, under the guidance of the IAS, as a key priority in the research agenda.
As successful cure or remission strategies will likely require the use of multiple therapies, the cMTA also allows investigators to combine antiretroviral drugs from different companies in research studies, something that previously required the negotiation of multiple agreements. And, with an eye toward the future, the cMTA also requires research institutions that take advantage of its provisions to provide non-exclusive licenses for potential cure breakthroughs to all parties who request them -- setting a framework for even greater advances in collaborative research in the future.
Developing shared solutions to research problems has been at the center of the work of the IAS Towards an HIV Cure Industry Collaboration Group. Our members believe that HIV cure and remission research present scientific challenges that can only be met through approaches that speed research and break down divides between geographic boundaries, areas of scientific discipline, and the public and private sectors.
The road to HIV cure or remission will be long and full of scientific obstacles. We want to free investigators to focus on overcoming those scientific hurdles, without spending excessive time grappling with legal challenges and corporate paperwork. With the new cMTA in place, we have every reason to believe that the long road to achieving an HIV cure just became a bit shorter.
For more information on the common Material Transfer Agreement, please visit the IAS Towards an HIV Cure website.
Download the Common Material Transfer Agreement (cMTA)