Co-chairs of WGND, Mel Spigelmen and Bill Bishai opened the annual meeting by welcoming the attendees and briefly reviewing the agenda for the meeting. There were several guest speakers that presented on various topics including the website, community engagement, open source drug discovery for neglected diseases, TB R&D Initiatives at the NIH/NIAID and key updates from the Global Plan to Stop TB 2011-2015.
Below are brief synopses of these presentations. There was also an informative panel discussion that followed which we will detail in the next blog post. Please check out the photos from the WGND Annual Meeting in the Photo Gallery. To view a recap of the panel presentations and audience Q&A, as well as to download those presentations, please click here.
Clicking the presenter’s name will download a .pdf of of their individual presentation.
The Website and State-of-the-Art Pipeline
John-Michael Maas, Darby Films, continues to work very closely with the WGND to increase the global virtual online presence of the WGND. He presented an update on the continued evolution of the global pipeline and enhanced features of the WGND www.newtbdrugs.org website. Some drugs on the global pipeline in 2010 have been discontinued whereas several drugs have been added, and a few have progressed to another phase of development. The pipeline saw a net gain of nine projects in 2010 bringing the total to 39 active compounds. John-Michael also highlighted the growth and impact of the WGND blog since its inception in February 2010. The newtbdrugs.org website also has a resource tab for TB researchers and the community, and a TB Grant finding tool will come on-line soon with the goal of adding increased value to the TB community.
The Importance of Community Engagement
Albert Makone, one of the WGND community representatives gave a presentation on what is Community Engagement and why it is important. He discussed the value of engaging HIV groups to talk about TB, because HIV/TB co-morbidity is a significant issue. One group who is active in this area is the Treatment Action Group (TAG) who works closely with community reps to:
- Build capacity
- Engage TB researchers
- Advocate for early access and accelerated approval of drugs
In addition, the TB Alliance community advisory board (CAB) efforts are helpful in promoting community engagement.
One of the continuing challenges facing communities is “stock outs”, which is having no drugs available for patients. This is a serious issue that needs to be addressed now in advance of new drugs coming into the market. Albert emphasized that community reps try to raise awareness of TB as a global issue and that it is not just as issue for the poor in developing countries.
How can community engagement help? Community reps have been educating the community at large about the importance of treatment adherence. These education efforts will help when the new drugs arrive to stave off resistance. When we empower communities, we encourage compliance! Community reps play a necessary role in working to reduce stigma associated with diagnosis. They also function to enable resource mobilization. An example of how the work that community reps do has had significant impact is the case in Zimbabwe where there are food shortages and some patients have no appetite while others have an overactive appetite—the community has been engaged to provide food for patients and allocate resources as needed.
The community rep slogan is: Nothing About Us, Without Us. We cannot innovate for someone without involving them.
GSK’s Open Source Drug Discovery for Neglected Diseases
Martin Pan from GlaxoSmithKline (GSK) shared about GSK’s efforts for open source drug discovery for neglected diseases. The Tres Cantos Open Lab is where these efforts are being pursued. Martin discussed the challenges faced in different regions. In Africa, the disease burden is 24% and there are only 3% of health workers available to meet the need. The reality is that 46 countries spend only $12-$35 per capita where the minimum required is $34. In high income countries, the amount spent per capita is $2,000.
GSK is contributing all along the drug development chain to advance the discovery of drugs against diseases such as TB, malaria and other neglected diseases. There are 120 scientists at Tres Cantos. Tres Cantos is increasing its global makeup of scientists with new people coming from US and South Africa. Their vision is to be the leading organization to develop medicines for the diseases that affect the developing world. GSK desires to be the first port of call for partners looking to work on these neglected diseases with a reported pipeline of transformational medicines for malaria, resistant TB and other neglected diseases. The platform is “Open Innovation”, with $8M seed funding. It was announced earlier in the year that 13,500 malaria compounds are freely available and there are plans to do the same for TB compounds in the next few years. Martin noted that GSK is being more flexible with intellectual property and is enabling access to resources in an open lab format.
New TB R&D Initiatives at the NIH/NIAID
Christine Sizemore, Chief of TB, Leprosy, and Other Mycobacterial Disease Section at the National Institute for Allergy and Infectious Diseases (NIAID), indicated the agency’s support of science globally through grants and a partial mandate to move basic knowledge into translational science and product development. The NIH/NIAID is strongly committed to supporting TB Research and allocated $189M in fiscal year 2009, $195M in fiscal year 2010, and $199M in fiscal year 2011.
There is money available to fund the work of researchers through peer-reviewed applications for solicited grants for basic science. Researchers are encouraged to go to the NIAID website (http://www.niaid.nih.gov) for resources and information on funding. To find information on funding related to TB, researchers should not search by individual pathogen but search under Clinical Biodefense category. In addition to information on funding, there are resources related to preclinical research and R&D tools and technologies. The NIH/NIAID does not want to duplicate the efforts of Pharma but to reduce the risks involved, particularly in pre-clinical research. Researchers can contact NIH/NIAID and the agency can discuss ways that their research can be positioned within the NIH/NIAID pipeline. Several options exist including cooperative agreements (i.e., AIDS networks), contracts (i.e., vaccine phase I trial, TB Research Unit, TB Clinical Diagnostic Research Consortium), and grants.
TB is a high priority infectious disease at the NIH/NIAID with several efforts underway including:
- Expanding AIDS clinical networks to co-morbidities such as TB
- Building capacity of Clinical Trial Units to conduct trials not just for HIV/AIDS, but for TB and other infectious diseases
- Conducting Leadership Groups in areas such as HIV, Therapeutics, Pediatrics and Maternal, and Non-AIDS Infectious Diseases
- Bringing TB and HIV communities together
There will be Leadership Group Awards in 2013-2014 which will involve multiple solicitation and awards given to help facilitate these efforts.
Updates from the Global Plan to Stop TB 2011-2015
Christian Lienhardt, the Senior Scientific Advisor of the WHO Stop TB Partnership, presented key updates from the new Global Plan to Stop TB 2011-2015 released in October 2010. Currently, there are 9.4 million active cases of TB each year, with 440,000 cases of Multi-Drug Resistant (MDR) TB and 1.4 million cases of HIV/AIDS co-infection around the world.
The goal of the STOP TB Partnership is to achieve:
- 50% reduction of prevalence and deaths of TB by 2015
- Elimination of TB (meaning
To reach the Global Plan’s targets, $56 billion will be needed over the next 10 years. In the previous version of the Global Plan, 1 to 2 drugs were expected to be registered by 2010 and treatment times were expected to be reduced to 3-4 months. This was not realized so targets were reassessed timelines and $9.8 billion will be needed.
There is a new initiative called the Critical Path to TB Drug Regimens (CPTR) that is spearheaded by the TB Alliance. The initiative is expected to achieve the following:
- 4-month regimen by 2015
- A regimen that is recommended by the WHO and available
- 2 new drugs for drug-sensitive TB will be approved
- At least 1 new drug for drug-resistant TB will be approved
- 9-month regimen for drug-resistant TB
- A better regimen for pediatric TB patients
- Higher efficacy for latent TB infection treatment
The CPTR will work to increase discovery research, build and maintain trial site capacity and develop shorter regimens that can be used with antiretroviral therapy. The initiative want to ensure there are clear and efficient regulatory guidelines in place and ensure there is adoption at the country level.
There are very large funding gaps. There are questions of whether the funding expectations for TB are unreasonable. TAG has helped to show that there was a 71% increase in R&D over the last 5 years. Drugs are receiving the most funding. To overcome challenges, the large gaps in funding must be addressed. Also, the TB community needs to better engage political leaders. A Roadmap for International Research is in development that may be of great value.
New Tools and Approaches for TB
Elizabeth Gardiner from the TB Alliance discussed presented an overview of the purpose and activities of the subgroup Introducing New Tools and Approaches (INAT). The INAT works to promote new tools and approaches to TB through various means including sharing of information, working with other TB groups to ensure training and technical assistance is available, tracks and monitors progress of implementation and expansion of new tools and approaches.