By Michael Greeley
December 15, 2003 | THE SUCCESS OF COMBINATION products such as pacemakers and drug-coated stents is generating enthusiasm among investors focused on converging bio-IT opportunities. Parallel advances in drug formulation and microprocessing and other manufacturing technologies are creating new products and services as these industries start to intersect.
"One of the Holy Grails of drug delivery is to have a device with intelligence that can respond automatically to the body's changing conditions," observes Robert Langer, a professor of chemistry and biomedical engineering at MIT and holder of nearly 500 issued or pending patents. A number of disparate technical advances allow us to envision an approach to patient management that includes a complete biofeedback loop, where certain conditions can be identified, monitored, and treated remotely and automatically.
According to John Santini, founder and chief scientific officer of MicroCHIPS, which is developing microfabricated devices for innovative drug delivery and biosensing, "Current drug delivery systems are plagued by the needs of continuous and frequent user intervention to ensure patient adherence to drug therapies." (It must be noted that my fund is an investor in MicroCHIPS, and I am on its board.) Additionally, compelling software algorithms are being created to provide intelligence in these kinds of microdevices. Such bio-IT developments promise to modify the practice of medicine.
| Insider: MicroCHIPS' implantable device can deliver drugs held in tiny reservoirs or house microfabricated biosensors.
Information technologies have been automating every industry for the past 50 years. Today many entrepreneurs and potential corporate partners are exploring the "preprogrammed-diagnosis-to-therapy loop." There are enormous benefits, including reducing hospital stays and doctor visits. A good example: the many technologies that serve as an "artificial pancreas" for real-time glucose monitoring coupled to insulin pumps. "There are technologies and devices increasingly finding applications in the body," Santini notes, "from orthopedic implants to systems to help pace the heart to advanced drug delivery systems."
Coincident with these technology advances, there is a perception that large pharmaceutical companies are defining their roles to be more than drug developers and are adopting a broader perspective on more comprehensive therapies. This revised definition is taking into account other elements such as diagnosis, delivery, and issues around patient acceptance and understanding.
Amir Tehrani, founder of Inspiration Medical, a startup therapeutic device company, and formerly a senior manager of Guidant's Compass Group, observes: "Life science companies are seeing that the convergence of information, medical, and pharmaceutical technologies paves the path for a new healthcare paradigm to continuously monitor patients with chronic diseases, predicting event onsets, and providing accurate and timely information to the physicians." Tehrani states that rather than replacing the physician, these devices serve as "intelligence gatherers," which should lead to more effective treatment.
The Body Is the Network
Hezi Himelfarb, CEO of Remon Medical Technologies, an Israel-based developer of wireless implantable communication devices, envisions a "future intrabody communication" network that will send data wirelessly to external devices or to other implanted devices. "As devices get smarter, the markets will be expanded for pharma when closed information loops are established, as pharma will be able to deliver personalized treatments to patients," Himelfarb says.
Centralized systems may coordinate pacemakers, defibrillators, and insulin pumps as well as other biosensing devices. Santini envisions implanted devices with telemetry capabilities so that they can be checked or reprogrammed noninvasively. While these developments may have a modest impact on the bio-IT field today, Tehrani concludes that data being delivered from these devices "will accelerate the advent of designer drugs and personalized treatments."
Santini adds that the "bioinformatics piece of the equation will be the critical element of these types of therapies" because the algorithms create the intelligence in these new devices. The issues around compound formulation are not trivial and may best be dealt with by utilizing the powerful bioinformatics tools now available.
These new devices will also allow for large molecules to be delivered on a targeted basis and possibly enable new delivery mechanisms for compound candidates that would otherwise be eliminated from the pipeline.
Arguably, the promises of the biotech and pharmaceutical industries have not been fully realized because the device platforms have been inadequate. With the growing acceptance by the FDA of combination products, expect to see great innovation at the intersection of these industries. The venture capital community is beginning to focus on these opportunities. There is ample evidence that large corporate partners are interested; they are making equity investments in these types of emerging growth companies, many of which will not generate revenue for years. This is all rather new and exciting.
Michael A. Greeley is the managing general partner of IDG Ventures, a global family of venture capital funds operating in North America, Europe, and Asia, with approximately $600 million under management. Reach him at firstname.lastname@example.org.
PHOTO OF CHIP BY SAM BALDWIN. COURTESY MICROCHIPS.