Dr. Hanna is the President and Chief Executive Officer of Ribomed Biotechnologies, Inc. (formerly Designer Genes, Inc.). She received her B.S. in Chemistry from Arizona State University and her Ph.D. in Chemistry from the University of California, Davis. Dr. Hanna completed postdoctoral work in Biochemistry as an American Cancer Society (ACS) Postdoctoral Fellow at the University of California, Berkeley. She was an Assistant Professor of Biological Chemistry at the University of California-Irvine College of Medicine, where she received an ACS Junior Faculty Research Award. She was a tenured Associate Professor in the Department of Chemistry and Biochemistry at the University of Oklahoma until August 1999 and is now an Adjunct Professor of Chemistry and Biochemistry at Arizona State University and an Associate Member of the University of Arizona Cancer Center.

Dr. Michelle Hanna

F&S: There are many promising biological detection technologies under development. How were you able to convince the Department of Homeland Security and the Defense Advanced Research Projects Agency to support the development of RiboMaker to detect bio-agents to the tune of $1 million and $3 million, respectively?

Dr. Hanna: There are many unique aspects to Ribomed’s detection technology that are desirable for use in detection devices. The RiboMaker® Detection System is based on a proprietary abscription® process that is isothermal and PCR free. The RiboMaker® Detection System can be used to detect both nucleic acid and protein biomarkers, which few other technologies can claim. The RiboMaker® is amenable to the simultaneous detection of multiple pathogen biomarkers—this can be harnessed for either increased specificity in detection of a single pathogen or the detection of multiple pathogens simultaneously. The abscription® process is also robust in the presence of blood components that inhibit PCR reactions, giving Ribomed’s technology an edge over the PCR-based detection technologies that currently dominate the molecular detection market.

F&S: At what stage is the technology and what remains to be done?

Dr. Hanna: The RiboMaker® Detection System is being adapted for a number of applications in both clinical diagnostics and biodefense. Ribomed’s technology has the capacity to detect RNA, DNA, and protein biomarkers as well as DNA signatures such as SNPs and CpG methylation. The Company is currently focused on RNA and protein detection, and thus its technology is more advanced on these fronts. Tests for both RNA and the protein toxin SEB were completed in December 2004. Ribomed has received its second phase of funding from DARPA for the HISSS (Handheld Isothermal Silver Standard Sensor) project to adapt its RNA and protein detection in a pathogen detection device for first responders. We have also begun developing new tests for other proteins, including biomarkers for disease diagnostics and monitoring.

Ribomed is in a position to customize its RiboPRO (protein detection) and RiboRNA (RNA detection) for customer-specific biomarker detection and to employ a number of other strategies to market its products. Such strategies may include the license of its Abscription® technology to other companies for incorporation into their detection devices and partnering with device manufacturers to develop its own point-of-care diagnostic devices. In addition, we are now selling the novel ribonucleotide analogs (Ribologs) that are used in our Abscription assays.

F&S: What have you learned thus far that can be used in biological detection applications beyond Homeland Security, for example, in developing pharmaceuticals?

Dr. Hanna: As already mentioned, Ribomed is interested in using its detection technology for both clinical and biodefense applications. Its biodefense work is directly portable to the development of clinical diagnostic kits. In particular, Ribomed plans to target its RNA detection capabilities to the development of blood bank screening tests for RNA viruses. This same type of testing could be used to assess viral load in patients in the presence of drugs—and thus allow screening for anti-viral agents to combat infection. Partnership with a vaccine development company may be a future avenue for Ribomed to explore.

The ability to do high level multiplexing with Abscription makes it very useful for molecular profiling. In a single device, multiple types of biomarkers can be detected and quantified. This will make abscription very useful for drug development.

F&S: What should the developers of biological detections systems do, and avoid, in order to design successful technologies for Homeland Defense?

Dr. Hanna: Among the greatest challenges facing developers of biological detection technologies is the need to avoid both false positive and false negative results.

A false negative has obvious undesirable consequences: the presence of undetected pathogens can lead to exposure that could otherwise have been prevented and/or infection that goes undetected. One of the first lines of defense in response to a bioterrorist attack with a biological agent is quarantine of individuals in order to limit exposure to the site of release. A false negative result could lead to widespread contamination.

False positives have their own repercussions. Entire facilities - airports, post offices, schools, other government buildings--can be shutdown unnecessarily, something that can have significant economic consequences with loss of revenue for both employees and employers. The occurrence of too many false positives is also likely to cause people will lose faith in the device or technology. In a manner reminiscent of ‘the boy who cried wolf,’ too many false positives can also result in unnecessary exposure and a delayed or complacent response in the case of a true positive. Minimization of both false positives and false negatives is critical for a successful biological detection device.

F&S: What do you think are the greatest biological threats facing the United States?

Dr. Hanna: The greatest biological threats facing the United States are the emerging RNA viruses and perhaps engineered biowarfare agents. Highly lethal and contagious RNA viruses, such as the Avian flu, have the potential to cause many deaths. We need a way to rapidly screen for these viruses in the environment and in our blood supply. During the cold war, the United States and the Soviet Union engaged in significant research and development of biological weapons. The result of these bioweapons programs was new strains and varieties of pathogenic organisms that humanity had not been exposed to before. These include antibiotic resistant strains of microbes, more virulent strains of viral pathogens, and ‘weaponized’ versions of microbes that are much more infective relative to ‘wild-type’ varieties. In the case of the engineered bioweapon, existing treatments may be ineffective, and the development of new therapies would be time consuming and costly at time when the need for treatment is most urgent. In the event of an attack with such an engineered bioweapon, early detection and quarantine of the affected area will be critical to containment. In the absence of early detection, thousands-perhaps millions-of unnecessary exposures will occur.

F&S: Where do you think authorities should concentrate their efforts in biological detection?

Dr. Hanna: Authorities should concentrate their biological detection efforts in areas with high population density, and in areas related to travel, i.e.: airports, train stations, bus stations, etc. Concentrating on areas with high population density is likely to aid in the prevention of person-to-person transmission as much as is possible. Provided a biological agent is detected quickly, an area can be rapidly quarantined, and exposed individuals can be promptly isolated and the appropriate treatment administered.

Concentrating on areas related to travel is essential for the same reasons. In the event of a biological attack at an airport, train or bus station, early detection and identification of the pathogen is essential. Early detection can prevent the potential spread of a biowarfare agent away from the site of release. In the case of pathogens that can be passed from person-to-person, identifying all individuals exposed at the site of release will be critical to containment.