TB Drug Candidates Examined for Use against Other Neglected Diseases
The TB Alliance is committed to maximizing our impact on global health. We had a chance to extend our reach beyond TB in 2010, when the TB Alliance announced a unique royalty-free license agreement with the Drugs for Neglected Diseases initiative (DNDi) to speed progress toward markedly improved therapy of multiple neglected diseases.
The TB Alliance granted rights to DNDi to develop a class of potential anti-TB compounds that also show significant promise for treating other neglected diseases that largely affect the world’s poor. Under the agreement, DNDi receives rights to develop a series of compounds from the nitroimidazole class for use against many neglected tropical diseases, including visceral leishmaniasis, HAT or sleeping sickness, and Chagas disease. The TB Alliance will also share its scientific expertise and specific knowledge of the drug class, as gained through ongoing work with these compounds. This agreement conserves donors’ funds and enables a promising candidate to advance quickly through the pipeline to treat neglected diseases.
This agreement highlights exemplifies the potential for increased efficiency and synergy across PDPs, and how investment in PDPs is producing a robust and diverse pipeline of tools to treat a wide variety of neglected diseases.
Gaining Efficiencies through the Global Health Clinical Consortium (GHCC)
A small group of contract research organizations (CROs) handle a significant portion of PDP research efforts. Under the GHCC initiative, a group of PDPs completed a process to identify preferred CROs—offering an opportunity to streamline providers and to gain efficiencies. This benefits both the PDPs and their business partners. The PDPs are now able to negotiate discounted rates based on higher volumes of work offered to these CROs. Performance is carefully monitored and active participation in the evaluation process will allow PDPs to jointly track and manage the performance of preferred CROs and either add or remove preferred CROs from the GHCC as determined by the collective needs of the PDPs. At the same time, the CROs are able to develop relationships with core, like-intentioned organizations, augment their expertise in related fields of research, and grow their businesses based on quality services.
Shared lab audits and site trainings
Each PDP needs to audit their lab network and conduct basic site trainings (primarily around GCP, but also on the topics of quality management, safety, and role-based training). PDPs often perform similar audits and trainings in the same cities. Taking advantage of a clear opportunity to collaborate on these efforts, organizations have acknowledged the potential value in running joint audits and trainings and the ability to drive quality consistency across global health research efforts.
An in-kind donation given as part of the GHCC preferred provider program, helped launch these pilots, while additional support from the Bill & Melinda Gates Foundation will facilitate these efforts. Pilot locations (Johannesburg and Bangkok) have been selected for two trainings and two lab audits (KEMRI Kilifi Lab in Kenya and Makerere University Lab in Kampala, Uganda), which will benefit the maximum number of PDPs.
Implementing shared site trainings and lab audits would allow PDPs to share costs and maximize the value of the donation. This will also enhance the quality of trainings and audits by aligning on and implementing consistent standards across the PDP network. This initiative will serve to develop capacity, and as an opportunity for PDPs and clinical trial staff to get together and share information, ideas, and expertise.
Clinical trial site opportunity assessment
High-quality clinical trial sites in the developing world are scarce, requiring organizations’ investment to build and maintain site infrastructure and capabilities. While some site support is protocol-specific, opportunities exist for PDPs to jointly invest in basic infrastructure and non-protocol specific capabilities. PDPs have recognized collaboration as a possible solution to ensuring optimal levels of investment and utilization at sites, free flow of information regarding site performances, capabilities, and increased standardization of operating and administrative procedures across sites and PDPs.
Potential benefits to the PDPs include more efficient allocation of clinical operations spend and easier coordination of activities across sites. In addition, PDPs may improve the long-term sustainability of some of their preferred sites as well as ensure consistent quality standards across locations. This will become increasingly important as the PDP pipeline bears additional large multi-site Phase III trials. The sites selected for cross-PDP collaboration may also receive significant benefits, including access to resources.
Streamlining the path to patients with regulatory expertise
As PDP pipelines expand and mature, PDPs need increased regulatory resources to support more clinical trials and additional products moving to review and licensure. Greater access to regulatory expertise is crucial for global health products to get to market expeditiously. Improvement of regulatory strategies resulting from increased access to knowledge and expertise would allow PDPs to deliver products to patients faster, reducing time delays and costs often associated with the regulatory process. In 2010, the Global Health Technologies Coalition (GHTC), housed at PATH, was selected as the secretariat for the “Global Health Regulatory Team,” with the goal to convene PDPs and provide access to regulatory resources. The Regulatory Team's mandate includes three activities:
· Establish a network of PDP regulatory stakeholders with regular interaction to increase communication and coordination between the PDPs
· Establish an online global health regulatory resource to improve the flow of information between PDPs
· Explore the creation of a network of experts to provide a resource for PDPs to access expertise and guidance on regulatory topics
The first two activities are active and have shown early promise. The group continues to explore the third topic to determine how this might be beneficial.
Activities to assess internal regulatory resources will allow PDPs to leverage existing resources better by helping them to identify and consult with regulatory staff members in other PDPs who have relevant expertise. Development of a mechanism that provides access to external experts will fill identified gaps in order to give PDPs the resources they need to make robust, informed decisions about regulatory strategy.