I had the opportunity to attend the Congressional Science and Technology Subcommittee’s hearing review of The National Nanotechnology Initiative (NNI). At the NNI hearing, Nanotechnology Icon, Dr. Clayton Teague http://www.tappi.org/content/events/08nano/teague.pdf, informed the Subcommittee he was leaving his post as the Director of the National Nanotechnology Coordination Office (NNCO), a position he has held since April 2003. Dr. Teague has served America in various positions in the US Government for the last 39 years.
Now, for the review of Thursday, April 14th.
House Subcommittee Holds Hearing on NNI Oversight
On April 14, 2011, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled “Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses included:
– Dr. Clayton Teague, Director, National Nanotechnology Coordination Office (NNCO);
– Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
– Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
– Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
– Mr. William Moffitt, President and Chief Executive Officer, Nanosphere, Inc.
The witnesses emphasized the need for Congress to continue robust funding for the National Nanotechnology Initiative (NNI) to ensure that the US remains the global leader in nanotechnology. Other countries, such as Japan, China, and South Korea have increased their investment in nanotechnology and are showing corresponding increases in publication and patent rates. Dr. Teague noted that by current estimates, the 2010 nanotechnology funding for the European Community totaled $2.6B US, exceeding the NNI total of $1.9B. The witnesses encouraged the Subcommittee to continue supporting basic research while also directly promoting technology transfer, for example through expanded use of public-private partnerships. The speakers from industry noted that NNI investments in their companies have generated handsome returns on investment in the form of private follow-on funding, job creation, and cost-saving product or process improvements.
Representative Mo Brooks (R-AL), Chair of the Subcommittee, thanked Dr. Teague for his eight years of service as Director of the NNCO. Dr Teague’s last day as Director was April 15, 2011.
I have attended four of these types of hearings during the last 10 years. This review was very focused with the witnesses explaining how a variety of products developed through the Science of Nanotechnology have impacted America.
The 2011 NanoBusiness NYC Conference began with a reception Wednesday evening (April 6th) co-hosted with our friends from the New York Biotechnology Association http://www.nyba.org/.
The technical sessions began the following morning at 9:00am with introductory remarks by NanoBCA Executive Director Vincent Caprio. Next, Dr. AJ Malshe, Founder, Executive Vice President and Chief Technology Officer of NanoMech http://www.nanomech.biz/, discussed his company’s philosophy and pipeline. NanoMech has received considerable media attention recently, due in part to a well-publicized visit by treasury Secretary Timothy Geithner. NanoMech is currently pursuing product lines based on 4 technologies, each of which is “making atoms work harder and smarter”. TuffTek is a cubic boron nitride (BN) coating which increases the life of machine tooling and saw blades. BN is extremely hard and long-wearing and, unlike diamond, is chemically compatible with steel. AJ showed data indicating that TuffTek-coated tool inserts last 10 times as long as conventional cutters, and at least twice as long as competitive titanium-aluminum-nitride-coated inserts, with which they are cost-competitive. Other NanoMech technologies include Nanoglide, a line of lubricant products which can save energy use in heavy machinery by reducing friction while enhancing durability; the polymer-based antibacterial Nguard line; and ElementX, a proprietary method for forming nanoparticles from evaporable elements or alloys. Nanoglide is being used in a major Department of Energy-sponsored wind turbine improvement program, as recently featured on the General Electric’s Edison Desk http://ge.geglobalresearch.com/blog/making-machines-tick-longer-with-nanolubrication/ blog. ElementX technology was originally developed in Canada and recently acquired by NanoMech. AJ emphasized that NanoMech has not rushed to market but has built its product lines slowly and carefully. A key strategy has been developing materials and processes for integration with existing high-volume manufacturing equipment. He also gave substantial credit to support from local, Arkansas-based businesses and individuals, including his current CEO, James Phillips, who began as an investor.
Longtime nanotechnology advocate, NanoBCA co-founder, and Lux Capital http://luxcapital.com/ Managing Partner, Josh Wolfe, described his investment philosophy and gave us an update on the Lux portfolio. Lux invests in core technologies with broad market applications, biomedical technologies, and materials for the energy market. In all three areas, it looks to differentiate itself by identifying special situations or identifying and investing in outstanding people. The company takes a contrarian perspective when they have a strong thesis suggesting that the herd is wrong—in energy, for example, Lux is staying out of the crowded solar field and sees biofuels as a regressive approach based on an outdated agrarian model. On the other hand, they have been looking carefully at nuclear energy for a decade. One of their portfolio companies, Kurion http://www.kurion.com/, has been developing technologies for safely handling nuclear waste and for cleaning up contaminated sites like Hanford, WA. Their technologies are now being evaluated for use at the earthquake-damaged Fukushima Daiichi plant in Japan. Another investment Lux recently unveiled, along with heavy hitters Google Ventures and Kleiner Perkins, is Transphorm. It is the latest company from UCSB Professor and serial entrepreneur Umesh Mishra. Transphorm technology uses gallium nitride semiconducting devices to increase the efficiency of voltage converters, with potential applications all along the electricity chain from power plants to wall warts. As our electric grid becomes ever more complex, the opportunities for employing this energy-conserving technology will only grow. Those of you who missed our recent interview http://www.vincentcaprio.org/nanobusiness-interview-josh-wolfe-co-founder-managing-partner-lux-capital-management with Josh can read it online for more information about Lux’s nanotech investments.
We then moved on to a series of presentations on nanomedicine, chaired by Livingston Securities’ health care guru Mostafa Analoui. First, Mostafa introduced Anil Diwan, Chairman and President of NanoViricides http://nanoviricide.com/. NanoViricides is a publicly traded company whose nanoparticle technology attacks a wide variety of virus particles. A distinguishing characteristic is a flexible component that spreads out on the lipid-based exterior of virus particles, disrupting their structure and ultimately causing them to fall apart. In laboratory tests, the current generation NanoViricides shows about an eightfold improvement in performance compared to its predecessor. In mouse studies of H1N1 influenza, for example, the occurrence of lung lesions was reduced 15 to 30 times compared to untreated subjects. While NanoViricides’ most promising results so far are with HIV and influenza viruses, the technology is also appropriate for fighting Ebola, rabies, and even Dengue fever. Dengue is particularly difficult to treat due to its unusual ability to be more virulent on a second exposure, a phenomenon known as antibody-dependent enhancement. Anil noted that pharmaceutical development costs remain a difficult obstacle, and reported that his company’s analysis indicated that it would be less expensive for them to proceed with private funding than to devote substantial resources to obtaining and managing grants.
Next, Edith Mathiowitz of Perosphere and Brown University discussed her work with polymers that are engineered to adhere to tissue. By increasing bioadhesion and decreasing particle size, Edith noted that the long-standing quest to deliver more medications orally has often been frustrated by a simple fact: the human body is designed to absorb only certain biologic compounds, and to reject most others. By dispersing biologics in sticky biopolymers and taking advantage of the high surface area of nanoparticles, Perosphere believes they can overcome this obstacle. Preliminary results for orally administered insulin are promising.
Frank Bedu-Addo of PDS Biotechnology http://www.pdsbiotech.com/ described Versamune, a nano-based immunotherapy technology. Immunotherapies, which fight disease by activating the body’s own defender T cells, are only now starting to deliver on their promise; Dendreon’s Provenge received the industry’s first FDA approval last year. Most immunotherapies exhibit low potency, so adjuvants have traditionally been used to enhance their effectiveness. But available adjuvants have poor safety profiles, and the added complexity approaches with separate adjuvants increases cost. In contrast, Versamune safely acts as an adjutant activator itself, has higher potency, and is a simpler system. They have completed preliminary animal trials incorporating a protein which targets human papilloma virus. These trials showed striking remission of HPV-associated head and neck tumors. PDS plans to enter clinical trials with this drug candidate within a year, followed by a related compound targeting melanoma in 2013. They have raised $11M in capital to date with minimal dilution, and have received $5M in-kind service contributions from NIH.
We shifted from therapeutic drugs to diagnostic testing with Moritz Beckmann, CEO of XinRay Systems http://www.xinraysystems.com/. XinRay, a joint venture of UNC-spinout Xintek and diagnostic powerhouse Siemens, uses carbon nanotubes to build X-ray emitters. The compact, rugged CNT-based sources allow XinRay to build imaging systems that are not practical with traditional X-ray generators, which Beckmann compared to incandescent light bulbs in their sophistication and fragility. XinRay designs use an array of emitters, so the X-ray beam can be steered electrically instead of swinging a single source mechanically. Medical applications in development range from mammography to image-guided radiotherapy (in which rapid 3-D imaging is used to help surgeons place radioactive implants precisely in diseased tissue). Future possibilities include dental imaging systems. This 3-D imaging approach, called tomosynthesis, is a variant of computer-aided tomographic (CT) scanning. It trades off some resolution for speed, reduced X-ray exposure, and low cost. Non-medical applications include airport baggage screening (in development) and non-destructive testing of structural materials (future).
Joel Friedman described his work building a nanobiotechnology center at Albert Einstein Medical College. They are striving to create the kind of open, collaborative research environment that once thrived at Bell Laboratories, with a “bench to bedside and back” mission – start with basic research on nanoparticles, develop technologies to deliver diagnostics or therapies based on these particles, and apply them in focused healthcare situations. Then take the results right back to the basic research and iterate. They presently have two technology thrusts, each with multiple healthcare applications. The first is hybrid materials combining hydrogels with glassy nanoparticle; the second is gadolinium oxide nanoparticles and techniques for coating them with various substances.
Tony Green, Director of The Nanotechnology Institute, closed out the nanomedicine panel with a description of NTI’s relationship with Ben Franklin Technology Partners. As one of four independent regional entities in the Ben Franklin model, NTI has been a leader in developing multi-institutional IP agreements and moving university-developed IP into companies. They work with many partner companies in Southeastern Pennsylvania and beyond, with restrictions in place to keep most of the money in state. In the past few years the State has shifted more emphasis to funding clean energy, following a very similar model, while cutting back somewhat on their nanobio and other life science investments.
We rejoined our NanoBCA colleagues for lunch, which included a keynote presentation from PhARMA CEO John Castellani. The nano track continued afterward with Jeff Rosedale of Woodcock Washburn surveying the nanomedicine intellectual property landscape. To get a big picture of the situation, Jeff compared the U.S. Patent and Trademark Office’s Nanotechnology Cross-reference Class (Class 977) with the A1 international class for medical patents. He came up with 2,900 patents, 2,300 of them independent, in both classes. Three out of four describe compositions of nanomaterials or methods for making them. Diagnostic devices, imaging devices, bandages, and stents were also common. The largest patenters, not surprisingly, are big corporations – Proctor and Gamble, L’Oreal, and Elan. The University of California is fourth. Jeff used a few just-issued patents to illustrate the true state of the art. Last Tuesday’s new announcement included the following:
from the University of Kentucky and Hebrew University respectively. The UK patent is a variation on an 80-year-old idea for altering metabolism, with applications from weight loss to healing brain injuries. While the basic mechanism is demonstrated, it has been very difficult to control. As in many other similar applications, the inventors believe nanotechnology will give them the ability to fine-tune the process safely. Jeff continued that major pharma manufacturers do have nano patent portfolios, including AstraZeneca’s supercritical process for dispersing protein particles; Bristol-Myers Squibb’s conjugated MRI contrast agents; Ethicon’s fluorescent markers to aid surgeons; and Abbott’s stent which eludes nanoparticles that are both bioactive and contrast-enhancing, so standard imaging techniques can see when the medicine has all eluted. GE, as might be expected, has many nano patents throughout the biomedical imaging field. But with all this activity only one set of patents has made it into the FDA orange book, which lists patents of composition or method that are generally recognized as safe and effective. That’s Elan’s TriCor portfolio, which is based on ball milling- far from a modern technology! Moving on to patenting strategies, Jeff suggested that inventors should generally focus more on “what” and less on “how”, since competitors can often find a different way to make something. Claim what they need to take (steal) from you. And claim something that is verifiable – i.e., that you can measure. Rosedale reminded us that trademarks, trade secrets, and agreements can be just as important as patents. Small companies in particular should be very sure that employees and consultants have proper agreements assigning rights to the company. One good basic strategy for balancing these components is to patent your basic compositions, consumables, devices, and tests, while keeping non-critical details and improvements as trade secrets. When conflicting or overlapping IP claims appear, what should a company do? A good way to start is by asking a patent attorney for a freedom to operate study. Their recommendations may range from licensing to requesting re-examination of patents based on new-found prior art to seeking a declaratory judgment invalidating a patent to, as a last (and expensive) resort, doing battle in court.
Our good friend Scott Livingston http://www.livingstonsecurities.com/about.php followed Jeff with an update on the investment outlook. Scott had just been in Boston for the annual meeting of the National Venture Capital Association, which he said was the hottest in several years. He met with leading partners from 20 major VC firms – they are all looking to get their money working again in companies, and IPOs are regaining favor. The political landscape is also promising. Scott noted President Obama’s emphasis on innovation in the State of the Union address, Secretary Geithner’s recent travels to high tech companies including NanoMech, and plenty of interest in innovation on the other side of the aisle – he reminded us that the re-emergent Newt Gingrich has a long history as a champion of innovation (and friend of the NanoBCA). Livingston Securities http://www.livingstonsecurities.com/ expects to continue to be in upcoming quality IPO deals, hoping to following on recent successes like Neophotonics and Gevo. But business as usual on Wall Street is a risk. The big investment firms are not focused on the needs of high tech companies and are pushing them too hard. It is especially bad in healthcare. Biotech deals are getting canceled or requiring companies to give up too many shares at too low a price, leaving them underfunded and unhealthy. He described Tesla’s much talked about 2010 offering as a different model. Sentiment was strong and highly mixed. By offering “friends and family” deals to owners of their first generation Roadster or people on the waiting list, they had 1/3 of their deal done, with engaged investors, before going to the big banks. Scott sees small investment banks like Livingston Securities as playing a similar role for nanotech companies. About 2,500 people are participating in Scott’s investor network. He is looking for more, and more active, members who will add to the group’s collective smarts, proselytize for innovation, and increase its attractiveness to IPO dealmakers. Scott has been hosting state-level webinars around the country, pushing regional connections. Eventually, he would like to move his company up from being the #3,4, or 5 firm on $100M dollar deals to leading $30M deals. Governors, senators, and Presidential hopefuls will be cutting ribbons around the country for the next 18 months, so Scott says get in now.
Harris and Harris http://www.tinytechvc.com/ Chairman and CEO Doug Jamison gave us the VC perspective on the investment landscape. While Doug continues to see some disarray in the community, he is optimistic about the direction in which things are moving. H&H believes that, as a publicly traded VC firm, it offers investors a unique combination of liquidity, transparency, and multi-industry exposure. There are now 32 companies in the portfolio, principally in cleantech, electronics, and healthcare. H&H is able to be more patient than traditional firms since it has permanent capital; some exits are pushing 8, 9, and even 10 years. But the successes are starting to come. BioVex was recently acquired by Amgen for $425M plus up to $575 in future performance payments. Neophotonics completed a successful IPO in February. A third exit is expected soon. Harris and Harris’ portfolio has pipelines of early, middle, and late stage companies, so this is just the beginning. Doug agrees with Scott that smaller IPOs make sense for a lot of companies, though in some fields (healthcare, for example) there is the opposite problem – the current median size for mergers and acquisitions, < 100M, is not sufficient. But he is not sure the NVCA really understands this or has a clue what to do about it. H&H’s attitude is that you want to know who you are selling to – when they make a Series A investment, they already know who they would like to have involved in Series B. Finally, Doug reminded us that nanotechnology is succeeding, with lots of product wins and plenty of interest in the business press. Two examples Doug highlighted which you can buy now are Contour long life lithium carbon fluoride batteries and Sephora’s Algenist skin cream utilizing alguronic acid from biofuel innovator Solazyme. Algenist sold out in 8 minutes in its debut on QVC.
Sam Brauer of Nanotech Plus http://www.nanotechplus.net/ brought the meeting in to the home stretch with his talk on the state of cancer diagnostics. Sam pointed out that diagnostics are less than successful in today’s approach to cancer, nor are therapies successful for many cancers. In fact, the major advance against cancer in the last 50 years has been prevention, most notably by reducing smoking. Consider four of the most highly used screening diagnostics – the pap smear, mammogram, prostate-specific antigen test, and colonoscopy. Too often, Pap smears come back negative when diseased cells are present. Skilled clinicians seem to have lower false negative rates, but this variability is a major problem. PSA tests have the opposite problem – antigen levels are often elevated even though no cancer is present. Mammography also has a high false positive rate. Among these common tests, only colonoscopy is generally considered to have good accuracy and sensitivity – but it is expensive and invasive. Testing overall is about a $4.3B market. We spend almost 10 times that much on chemotherapy drugs. And about 80% if cancer deaths are from metastases, which are not really addressed by the major diagnostic screens. Can we do better by using targeted molecular diagnostics instead of broad screens? The science supporting this approach has been developing for more than 30 years, but may still be inadequate. Over 400 genes are already known to be involved in malignancy, and many researchers believe that all cancer-related genes will be identified within 10 years. But the pattern of gene expression in individual cancers is highly variable – Dr. James Heath, for example, found nearly as many expression patterns as he had patients in a study of the brain tumor known as glioblastoma. Heath’s conclusion is that we need protein screens rather than gene screens. But this is a much less developed area. In colon cancer, for example, only 3 proteins have been identified and none of them seems to be a driving force in the development of the disease. There are particular areas where the path forward seems a little clearer, such as leukemia, where Sam cited a recent paper on resistance to the drug Gleevec that many researchers think provides a roadmap to understanding how the disease progresses. But overall, the field faces scientific obstacles and a challenging business environment. Pharmaceutical companies show little interest in diagnostics, which they see as less profitable than therapeutics. They are also skeptical about providing diagnostics when appropriate companion therapies are not available. While GE’s Jeffrey Immelt foresees a shift of $250B from treatment to diagnosis over the next decade, he seems to be in the minority among healthcare experts. To make real progress, business issues such as research for funding and payment models must be addressed along with technology issues such as the identification of reliable DNA-based (genetic) or protein-based disease markers and the development of inexpensive, robust instruments for measuring them.
Our session closed with a summary dialogue between NanoBCA board members Steve Waite and Philip Lippel. Steve reminded us that nanotechnology is built on scientific discoveries dating back to the early twentieth century, with individual scientists and investors playing critical roles in turning research into innovative products. Phil noted that some of the hype (both positive and negative) around nanotechnology seems to be in decline. He expressed the hope that we are entering a phase where all stakeholders acknowledge that new technology development involves both benefits and risks and attempt to assess both realistically.
In this month’s interview, we talk to William Moffitt, President and Chief Executive Officer of Nanosphere. Mr. Moffitt became president and CEO of Nanosphere in 2004. Moffitt is a 30+ year veteran of the diagnostics and medical device industry, having spent the last 20 years developing novel technologies into products and solutions that have helped shape the industry and generate significant shareholder value. Prior to Nanosphere, he served as President and CEO of i-STAT Corporation, a developer, manufacturer and marketer of diagnostic products that pioneered the point-of-care blood analysis market. Moffitt led i-STAT from an early stage private company through commercialization, an IPO in 1992 and its acquisition by Abbott Laboratories in 2003. Prior to i-STAT, Moffitt held increasingly responsible executive positions from 1973 through 1989 with Baxter Healthcare Corporation, a $7 billion manufacturer and distributor of healthcare products, and American Hospital Supply Corporation, a $3.5 billion diversified manufacturer and distributor of healthcare products, which Baxter acquired in 1985. Mr. Moffitt earned a B.S. in zoology from Duke University.
In our interview, we discuss Nanosphere’s diagnostics technology and the impact of nanotechnology on health care diagnostics. We hope you enjoy the interview. -Steve Waite
SW: Thanks for taking time to speak with us today, Bill. I thought we would begin by discussing the current state of diagnostics technology. What types of advances in diagnostics technology have we seen over the past decade?
WM: We have seen three significant advances in diagnostics in recent years and with them the potential for real, measurable improvements in patient treatment. First, continued discovery of new biomarkers for disease including genetic markers and gene expression ranging from RNA to protein markers. These new biomarker discoveries help advance diagnostics and provide physicians and patients with clinically actionable information that can lead to better outcomes.
Second, although the term personalized medicine created a significant degree of hype and early expectations, there is great progress being made in understanding the mechanisms of action and genetic implications for various therapeutic agents. This will result in a new era for the treatment and prevention of disease using therapies that are more appropriately targeted to an individual. To paraphrase William Osler, a father of modern medicine, “it is more important to know what patient a disease has than what disease a patient has.”
Third, new technologies have emerged that enable complex genetic and protein tests to be performed in virtually any health care setting, thus enabling these new advances to be incorporated into mainstream medicine on a practical and cost effective basis.
SW: What role is nanotechnology playing in advancing diagnostics in health care?
WM: Breakthroughs in nanotechnology have enabled Nanosphere to develop a testing platform – the Verigene System – that can perform both nucleic acid and ultra-sensitive protein assays in a very simple and cost-effective format; and, one that can put molecular diagnostics into any health care setting. Nanotechnology eliminates the complexity and high cost of testing found with other technologies when performing genetic assays for human disease or infectious disease. Moreover, nanotechnology provides a level of sensitivity for protein biomarkers not found in other technologies, which in turn leads to earlier detection of disease. For example, we have in development a test for cardiovascular disease which has already proven to be far more sensitive in detecting heart attacks and acute coronary syndromes. Recent data also suggest that this assay has great value in monitoring patients with chronic heart failure to more appropriately adjust therapy for this life threatening condition. We have also demonstrated the ability to detect recurrent prostate cancer following radical prostatectomy months and years earlier than tests available today. Most oncologist would agree, today the best weapon medicine has to fight cancer is early detection.
SW: Tell us more about your Verigene System and how it is being used today by customers.
WM: The heart of the Verigene System is the nanoparticle probe, which due to its selectivity enables us to format assays on a microarray. The microarray printed on a simple glass slide is incorporated into a unit-use disposable test cartridge that contains the reagents necessary to perform a test. Three very important characteristics arise. First, the microarray gives us the ability to probe for dozens of biological targets in a single test at one time. This makes it possible to perform very complex panels of tests such as an infectious disease assay where any number of bacteria or viruses may be the underlying cause. Second, the unit-use disposable cartridge format makes it economically feasible to run one patient sample at the place and time the physician requests the test. Other technologies rely on batch processing many patient samples at one time in order to lower the cost of any single test. This is not conducive to providing critical patient information when and where it is required. Third, operation of the system is so simple that it can be used in virtually any health care setting. After the user inserts a sample, the Verigene System performs all functions required to provide a test result. The system also incorporates an on-board quality control system to ensure accurate results.
SW: Nanosphere is pioneering the use of gold nanoparticles in diagnostics technology. Why gold?
WM: We functionalize the surface of gold nanoparticles with oligonucleotides or antibodies to create probes for genetic and protein assays. On the nanoscale, gold exhibits the perfect properties for creating high selectivity and sensitivity in biological probes, two attributes critical for the development of assays that must detect the smallest quantities of biological materials. Moreover, the catalytic properties of gold enable rapid amplification schemes, which in our case is the attachment of silver to the particle in the detection phase of the assay. This enlarges the particle and increases its light scattering properties. Gold’s stability at the nanoscale enables us to create reagents with a long shelf life, a property that is important in commercializing products for global distribution.
SW: Who are the primary customers for your nano-enabled diagnostics technology and what kind of feedback are you getting from the market?
WM: Our primary customers are hospital-based clinical laboratories, regional reference laboratories and other professional health care settings. Feedback has been very encouraging as our customers are excited about the ability to perform complex genetic and infectious disease tests when and where they are needed and in a format that is very simple to operate. The Verigene System is enabling testing in locations that could otherwise not perform such diagnostic tests.
SW: What kinds of efficiencies and cost savings are you able to deliver to the market today and how might that evolve in the foreseeable future?
WM: One of the greatest efficiencies delivered to the market is speed to patient diagnosis. Enabling tests to be performed at the point of care and as requested by the physician generates critical diagnostic information when and where it is required. The high cost and complexity of genetic tests has been eliminated through nanotechnology. Nanotechnology has enabled the development of a molecular diagnostics platform that operates in a very simple format thus eliminating the need for highly specialized labor. Moreover, the underlying cost of the consumable test cartridge is very inexpensive, which allows for pricing that is in line with any number of other routine diagnostic tests – tens of dollars as opposed to hundreds or thousands.
SW: We are seeing a tremendous decline in the cost of mapping human genomes. What kind of impact will this have on the diagnostics landscape and how do you see it impacting your company in the future?
WM: Genetic research will continue to advance the discovery of genetic biomarkers for disease and the metabolic pathways of various drugs. Medicine will continue to march toward true personalization. The effect on Nanosphere is very positive as such research programs provide the content for our business. As new genetic markers are discovered, we can incorporate them into our testing platform and rapidly and broadly disseminate the use of these new diagnostic tests.
SW: How do you see the regulatory climate evolving with respect to nanotech in diagnostics?
WM: As with any new science or technology, it will take time for the various regulatory agencies to fully understand the implications of products based on nanotechnology. As nanotechnology replaces the underlying technologies of diagnostic tests, it will be important for the regulatory agencies to develop a better understanding of this new science, which in many instances may eliminate problems associated with other older technologies.
SW: If you look out over the next decade, what kind of impact do you think nanotechnology overall will have on health care?
WM: Nanotechnology will impact both diagnostics and therapeutics. Nanoparticles are powerful constructs for the conveyance of biological substances, whether those substances are to probe for a particular target, as in the case of a diagnostic assay, or block the expression of a particular gene within a cell as a therapeutic agent. The best way to look at what nanotechnology can do is to consider the fact that these particles, which exhibit different functional characteristics on the nanoscale than on the macroscale, operate on the same size scale as the biology. Matching these nanoscale properties to the biology will lead to new discoveries in both diagnostics and therapeutics.
SW: Last question for you today, Bill. What do you think are the major risks for nanotech innovation in diagnostics and health care in general?
WM: Nanotech is having and will continue to have a significant impact on many aspects of medicine and on many established technologies and businesses. One risk is simply the adoption curve and how quickly new technologies are accepted in health care. The process can often be daunting, from clinical trials to the demonstration of not only medical efficacy but also economic sense.
For in vivo applications, manufacturers and developers are going to have to understand the biological and environmental impact and provide data to support safety, but this is really not different from proving the safety of any therapeutic drug or device.
SW: Thanks again for your time, Bill. We wish you and your colleagues at Nanosphere all the best in the future.
Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”
NanoBusiness Commercialization Association
203-733-1949 email@example.com www.nanobca.org