Nanotechnology might not be immediately evident in a small, isolated village in India, but Steve Walsh says such a place offers an important example of what drives nanobiomedical innovation.
Residents there don’t have access to major testing labs, nor do they have the financial means for expensive care. But they can now take advantage of the latest in AIDS testing technology. They just need to blot a drop of blood on a piece of paper. Biotechnology combines with microfluidics to make a chemical indicator that looks like nothing more than a postage stamp-sized piece of paper. The result is a diagnostic test that is both accurate and cheap — two criteria necessary for making testing for AIDS and other diseases globally accessible.
This paper AIDS test didn’t come from big pharma. It was developed at Harvard University and spun out as Diagnostics For All, a nonprofit company aimed at making point-of-care diagnostics accessible in the developing world. Walsh, founder and past president of the Micro and Nanotechnology Commercialization Education Foundation, a global nanotechnology group more commonly known as MANCEF, uses the example of the paper AIDS test technology to make two points. One, nanotechnology innovation is being driven by needs from all over the world. And second, biomedical innovations need to come from a new model that brings knowledge and expertise from outside the medical field.
“Big pharma doesn’t have all of it,” Walsh said. “They have to work with others.”
Walsh spoke with MedCity News during the Commercialization of Micro-Nano Systems conference, a global nanotechnology conference that this year was held in Greensboro, North Carolina. While nanotechnology is not new, it is a new player in the healthcare realm. Until recently, the U.S. Food and Drug Administration did not have a definition of nanotechnology, nor any guidance for companies on the matter.
MANCEF has been working on nanotechnology guidance for several years. The guidance will provide a road map for any stakeholder whose work touches on the developing nanotechnology and microtechnology landscape. A finished document isn’t expected for another six months, but Walsh did offer some insight into the draft.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Walsh says the world faces five major challenges in the 21st century: healthcare, food, the environment, energy and water. Nanotechnology will be part of the solutions addressing those problems. Pharmaceutical companies will be part of those solutions, too, but not in the same way that they’ve been operating. The pharma model for developing new products has focused on biology and chemistry operating within a pharma company’s silo, Walsh said. But innovation will force them to look to other disciplines and to also partner with other kinds of companies. Products that incorporate nanotechnology will require monomer and polymer chemistry, biology and bio-nanotechnology, and computational sciences. Walsh offers a simple definition of this convergence: using more than one technology to solve a problem. That’s what Harvard chemistry professor George Whiteside did in developing the technology that formed the basis for Diagnostics for All.
(A Bloomberg News report on Diagnostics For All)
Even an effort that focuses on a single condition, such as malaria, must cull from multiple areas to deliver innovative approaches. Walsh offers Research Triangle Park-based nanobiomedical company Liquidia Technologies as an example. Liquidia’s technology can form nanoparticles of particular sizes and shapes to optimize the delivery of a therapeutic to cells of the human body. That technology developed from the convergence of disciplines including chemistry, biology and computational science.
Liquidia’s technology offers an additional example of how the old model of bringing new products to market is changing. The company is collaborating with the PATH Malaria Vaccine Initiative, an international nonprofit that was started through a grant from the Bill & Melinda Gates Foundation. The initiative is working to make vaccines accessible in the developing world.
Nanobiotechnology products won’t necessarily take the same commercialization path that traditional small molecule drugs have traveled. In some cases, the latest innovations will be commercialized in the developing world well before they’re available in the West. It’s a shift in thinking for biomedical innovation and commercialization and Walsh concedes that not everyone will be comfortable with the change. Pharma companies have naturally pursued the U.S. market because it’s the largest market in the world. With nanotechnology, companies can take a different approach — delivering new products that help the largest number of people in the world.
