Our coverage of World Immunisation Week continues, with an interview with Rene Coppens of TBVI, a Europe-based organisation working to advance the development of the next generation of TB vaccines. For more information on the series click here!
DSW: Can you tell our readers a little about TBVI? What is the organisation’s goal?
Rene Coppens: The TuBerculosis Vaccine Initiative (TBVI) is a non-profit foundation that facilitates the discovery and development of new, safe and effective TB vaccines that are accessible and affordable for all people.
What kind of approach does TBVI take to vaccine development, and to the broader global health R&D field?
As a Product Development Partnership (PDP), TBVI integrates, translates and prioritises R&D efforts to discover and develop new TB vaccines and biomarkers for global use. TBVI has evolved into an unique non-profit Product Development Partnership (PDP) that consists of two parts:
- – The TBVI R&D partners, which include more than 50 partners from academia, research institutes and private industry in the TB vaccine field from about 20 countries in Europe, North America, Africa, Asia and Australia.
- – The TBVI organisation (Dutch Foundation) that acts as a support structure to R&D partners providing a range of key services to these partners.
The TBVI organisation provide essential services that support the R&D efforts of its R&D partners. These services include: technical advice and support for product and clinical development; knowledge development, exchange and networking; resource mobilisation; project identification, design and development; and, project management.
How is TBVI working towards new and more effective TB vaccines?
TBVI works in a consortium approach with over 50 R&D partners from a wide range of academia, research institutes and private industry in the TB vaccine field. This allows for concept and idea generation; knowledge development, exchange and collaborative research between diverse partners all of which are essential to innovate and diversify the TB vaccine and biomarker pipeline. It supports the development of, and participates in global networks and partnerships and global initiatives such as the Global TB Vaccine Partnership (GTBVP). TBVI remains open to working with new partners and ideas.
TBVI uses a portfolio management approach based on established stage gating and priority setting criteria to is evaluate and prioritise the entry of candidates into the pipeline and the up – selection of candidates for support for preclinical and early clinical development. We work with its partners to refine the portfolio management criteria and build consensus and coordinates with stakeholders to expand the use of its portfolio management process in a global context.
TBVI, through pooling of the best ideas from its research community in the areas of discovery, preclinical and early clinical development of vaccines and the development and validation of biomarkers, fosters new ideas across the whole spectrum of TB vaccine R&D and contributes to the de-risking of vaccine development. The model deliberately does not direct the science, which allows for a broad portfolio of R&D activities to be developed in an environment of mutual trust and constructive collaboration among the partners. It does not have a pre-submission focus on research ideas from its R&D partners allowing for the TBVI model to be flexible and able to quickly incorporate new research opportunities and ideas in the context of an up to date R&D strategy. A rigorous internal selection process by experts from TBVI’s advisory committee and from its product and clinical development team assures funders that the best projects are selected and supported.
Our business model has contributed in a major way to maintain European excellence and leadership in the TB vaccine R&D field and in establishing a European network that is innovating and diversifying the TB vaccine pipeline. About half of the candidates in pre-clinical and clinical development have resulted from the collaborative efforts of TBVI and its R&D partners working within this business model.
In vaccine development, particularly when dealing with diseases for which the vaccines could disproportionately benefit people living in extreme poverty, intellectual property rights can be a difficult issue. How does TBVI approach this?
TBVI does not have its own commercial interests. Ownership of vaccine candidates and biomarkers and intellectual property rights stay with researchers and vaccine developers. We support individual research organisations and developers to manage IP issues in accordance with their strategic interests but includes upstream agreements with research partners and vaccine developers to promote acceptability, access and affordability of the vaccine for the end user.
What does the vaccine pipeline look like at the moment? Given we are working with an aged and ineffective vaccine, can we expect something new on the horizon?
Over the past decade there has been significant scientific progress as a result of investment in TB vaccine R&D. From only a single candidate in 2000, 16 candidate vaccines have moved forward into clinical studies in the last 10 years. There is now a robust global portfolio comprised of more than 25 early stage discovery leads and preclinical vaccine candidates, and more than a dozen candidates for which clinical are trials underway. The current pipeline includes vaccines: designed to replace the BCG (prime vaccines); vaccines to improve limited immunity conferred by BCG (prime-boost vaccines); and vaccines to shorten TB chemotherapy (immunotherapeutic vaccines).
In addition, advanced TB vaccine programmes now exist among major multi-national pharmaceutical companies, biotechs, Indian and Chinese public and private organisations, and a myriad of academic and public institutions.
In the aim to eliminate TB, multiple vaccine strategies will be needed and are being pursued to either prevent infection, prevent disease, or prevent recurrence.
How about the funding of TB vaccine development?
Despite almost 30,000 people each week dying of the disease, TB can still be considered a “neglected disease” from the perspective of funding for R&D for treatment, diagnostics and prevention.
Although WHO made the decisive statement in 2014 that ”R&D is the key to controlling and eventually eliminating TB: without discovery, development and uptake of new drugs, diagnostics and vaccines the world will never be free of the threat of TB,” funding for TB R&D is not keeping up with these goals. TB research and development is still severely underfunded compared to vaccine funding for HIV and malaria, and although the malaria vaccine funding level may reflect the cost of the current phase III trials, the difference is striking. Moreover, the TB funding levels overall have remained fairly static since 2009 and in particular, TB vaccine R&D funding is showing a downward trend from 2009 – 2015 and received only 16% of the total TB R&D funding in 2014.
The G-Finder 2015 data show that out of a total of $3,377 million spend on R&D for neglected disease, $589 million was spent on TB R&D. Of this:
R&D for TB drugs – $ 243 million
Basic research on TB – $143 million
R&D for preventative vaccines $112 million
R&D on TB diagnostics- $64 million
R&D for therapeutic vaccines $0.5 million
Rene Coppens is the Director Resource Mobilisation at TuBerculosis Vaccine Initiative (TBVI). Further information on the TB vaccine pipeline can be found on our website: http://www.tbvi.eu/what-we-do/pipeline-of-vaccines/
Photos courtesy of TBVI