Feb 28, 2010
A novel approach to creating sustainable technology platforms for the developing world through profit / non-profit partnerships.
A sick child wanders through a village somewhere in sub-Saharan Africa holding his mother’s hand. Years ago this mother and child walked for days to get to a hospital for a diagnosis, but today they travel only to the other side of town where, on a small piece of paper a square patch of color tells the mother that her child will be well. Elsewhere in the world, George M. Whitesides presents an idea in a room on MIT’s campus. He’s like other highly esteemed and well-respected academics, but it isn’t his curriculum vitae that distinguishes him from his peers; it’s the approach he has taken towards the industrial translation of technologies that his research has spawned. By creating two independent companies, one non-profit and one commercial, Whitesides has struck a balance in an attempt to optimize licensing, product development, and unmitigated distribution.
Founded in 2008, Diagnostics for All (DFA)1 is a government-recognized (501c3), non-profit corporation with research facilities in Cambridge, MA, a fitting locale given that its business plan won both the MIT 100K and Harvard Business School business plan competitions. DFA is striving to design diagnostic tests for infectious and parasitic diseases ideal for use in the developing world. They do so using biotechnology and microfluidic techniques invented in the Whitesides laboratories. In July of 2009, DFA signed an agreement with Harvard University’s Office of Technology Development (OTD)2 granting DFA exclusive licensing rights to the laboratory’s technology. Remarkably, the rights were granted free of royalty payments, permitting DFA to operate in the technological space and work towards even more innovative technologies to expand their intellectual property holdings.
DFA was co-founded by Whitesides and he chairs its scientific advisory board. Of the DFA mission, he says “[DFA is] working on engineering and design of diagnostic tools that can then be licensed for commercial applications in non-competitive areas.” Conversely, Paper Diagnostics is a for-profit company, still in the nucleating stages, aimed at marketing and potentially manufacturing alternative applications of the DFA technology, paying license fees and royalties in return. Ideally, the success of paper-based diagnostic technologies in commercial markets will lead to supplemental revenue for DFA, which when combined with organizational and donor funding will allow them to engineer more diagnostic tools for the developing world.
DFA is currently engineering microfluidic paper-based analytical devices (µPADs) with properties optimized for application in the developing world. These devices take advantage of the low cost and wicking power of paper. Colorimetric assays have been developed for glucose, protein, pH, and alkaline phosphatase, which are useful for urinalysis3. The assays show characteristic color intensity in response to solutions containing different concentrations of an analyte. Also, Martinez et al. have demonstrated the capability to generate three-dimensional μPADs. By alternately layering paper and tape with periodic gaps, solutions can be wicked between layers, permitting channels to cross over one another. In three dimensions, increasingly complex geometries and patterns can be achieved, allowing for increased numbers of assays per patient sample. The simplicity of this technology accommodates manufacturing practices nearly anywhere in the world. Limitations may arise from the conditions of the desired assay, given the dependence upon protein-based substrates and refrigeration requirements. Some proteins require more stabilizing storage conditions to reduce exposure to heat and dehydration, which may reduce their activity required for a particular assay. For validation studies, manufacturing will be conducted in the DFA labs.
Una Ryan, CEO of DFA, commented on the nature of this model by emphasizing the key hurdle in the process: “It’s not practical trying to get Mass[achussetts] General [Hospital] into Swaziland.” By focusing on simplified solutions rather than trying to squeeze down costs, DFA can be more innovative and less restricted. Current research in the DFA labs is focused on pushing liver function tests on paper towards market. Patients taking certain drugs for HIV/AIDS and tuberculosis have a significant risk of side effects, including liver toxicities. In some developing world countries, patients are denied these drugs because there is no diagnostic capability for monitoring such side effects. In response, DFA is working on blood-based assays for two key liver toxicity markers. These products are expected to be moved into field testing by the end of the year.
The payers for developing world diagnostics and therapeutics are typically developing nations themselves or charitable organizations; as a result, the return on investment for highly specialized diagnostic devices is limited in those settings. Consequently, diagnostics for diseases specific to these areas may never be studied because of economic considerations. Thanks to organizations like the Bill and Melinda Gates Foundation, which presently supports research in the Whitesides group and DFA as a subcontractor, the technology necessary to design new diagnostics can be developed. Once validated in the lab, and patented by the university, the technology has to be licensed. In this case, Harvard was willing to license the technology royalty-free, because it was going to a non-profit company focused on developing world applications. Harvard still has to recoup its patent costs from DFA, but has made other allowances to try to help DFA become sustainable. DFA has the power to relicense the intellectual property as they see fit to try to make secondary royalties, and Harvard OTD has agreed to take a smaller fraction of those sub-licensing royalties than it would otherwise.
As the technology moves forward through continued research in both DFA and the Whitesides lab, it will be interesting to see how the ownership of new intellectual property is handled. It’s likely that Harvard will push to retain IP ownership but continue to espouse the ideals of the medical technologies dissemination statement they signed last year4. The extent of revenue return and continuing support for DFA through sub-licensing will depend on the voracity of the Harvard OTD and legal counsel and their interest in siphoning off some of that revenue. The DFA model, which combines philanthropic funding with sub-licensing opportunities, appears to be a promising one that we can only hope will be allowed to flourish and extended to other applications.
Diagnostics for All : www.dfa.org.
Harvard Office of Technology Development.
Martinez, AW. Phillips, ST. Whitesides, GM. (2010) Diagnostics for the developing world: microfluidic paper-based analytical devices. Analytical Chemistry 82, 3-10.
Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies: