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Optical Biosensors Incubator Meeting Day 2

John Goertz

Commercialization of Optical Biosensors

The conversation on market pathways of biosensing technologies began with a presentation by Ruth Shuman of the National Science Foundation, offering an administrative overview as well as a grantor’s perspective on the potential for federal support of translational research to close the gaps between scientist, company, and consumer. Specifically focusing on the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which have recently seen increased overall and per-grant funding, Dr. Shuman highlighted the Foundation’s commitment to expediency in responding to applications in an average of five months, ahead of the federally mandated six. Dr. Shuman outlined the preferred process for seeking pre-deadline guidance on program submissions, namely communicating with a one- to two-page summary via email after the solicitation has been announced, and stressed the NSF’s emphasis on confidentiality and preservation of intellectual property throughout the submission process. Prior to discussion on the topic, Dr. David Nolte offered his insight to the research to venture funding to market lifecycle from his own experience spinning out numerous companies from his scientific efforts.

The subsequent panel focused on many common concerns regarding foundation of a company, from funding and FDA approval to the impacts of media and personal considerations. Several professors admitted it was personally difficult to maintain University appointments while getting a new company off the ground, and the differences in various University policies regarding such ventures was discussed, but many found it to be ultimately rewarding. Finally, attendees talked about the pros and cons of federal funding which allows founders to maintain full company ownership as compared to private funding which typically entails a dilution of equity, and pointed to recent high-profile cautionary tales in regulatory and media mismanagement regarding novel medical platforms.

The Future of Optical Biosensors for Point-of-Care Applications

In the final portion of the Incubator, participants were asked to consider the potential of optical biosensors for affording clinical insight quickly, easily, and as near the patient as possible. UC Santa Cruz’s Holger Schmidt presented his work in optofluidic systems for digital detection of rare analytes such as Ebola DNA or whole influenza virions. Gerard Coté from Texas A&M University emphasized “Engineering for Impact” in global health during his presentation, describing smartphone-based methods for malaria detection as well as minimally and non-invasive optical methods for glucose monitoring developed in his lab. Coming from the NIH’s National Cancer Institute, Avi Rasooly described increased interest in point-of-care technologies as healthcare paradigms shift to greater centralization and Physician Assistants and Nurse Practitioners play an increasingly vital role, and his colleague from the National Institute of BioImaging and Bioengineering, Dr. Richard Conroy, hinted at policy shifts within the NIH which emphasize greater rigor and reproducibility in research and pointed to numerous NIH, Trans-Agency, and White House initiatives available. As the penultimate presentation before the final panel discussion, Ian White from the University of Maryland gave an overview of his work in integrating clinical sample preparation into biosensing devices, such as performing PCR directly off of chitosan beads used to capture and purify DNA from cells and utilizing paper substrates for facile collection and SERS analysis of chemicals.

Dr. White also challenged the field to be wary of deluding itself with overly broad definitions of “point-of-care.” While it is not uncommon for any assay involving microfluidics, a small sensor, or low-cost materials to be labeled as point-of-care, he emphasized that the true metric must be utility in a low-resource, near-patient, or at-home setting, and offered as a universal definition those assays which would be eligible for a waiver from CLIA restrictions on commercial use. UCLA’s Aydogan Ozcan subsequently led the discussion by asking participants’ opinion of this definition. While responses were generally affirmative, Dr. Coté pointed out that many published systems may not fit each CLIA-waiver requirement yet may still be amenable to convenient use in the case of a remote emergency or at a hospital bedside. Dr. Ozcan then encouraged the community to be critically honest with itself, constructively, asking the attendees to state which clinical targets or analytical techniques optical biosensing will likely to fail to provide the optimal solution. Dr. Rasooly proffered invasive methods of blood glucose measurements, Dr. Coté reiterated his belief that, while noninvasive, infrared measurement of blood glucose through the skin is unlikely to succeed, and Dr. White predicted that SERS analytics of biological samples will fail to find clinical utility. Similarly, a discussion over the true need for very rapid and digital or single-molecule detection schemes suggested that these exquisitely sensitive approaches will be best suited to specific targets and settings. As a final note, Dr. Ozcan asked participants to state where they believe optical biosensing will realistically find its ideal application by the year 2025. Drs. Rasooly and Coté believed that cardiac health and event monitoring has high potential, and NC State University’s Michael Daniele suggested, to the assertion of several, that distributed environmental monitoring is another promising niche.

As the Optical Biosensing Incubator drew to a close, many attendees continued in small groups the challenging discussions held over the previous two days. The Incubator gathered many different perspectives together to provide a range of technical insights and the unconventional structure allowed the participants to have frank conversation and confront difficult questions facing the field as a whole. While larger venues often discourage or drown out controversial topics, participants here were urged to share potentially unpopular opinions, allowing the community to hold constructive dialogues and focus the field as it moves forward. The Optical Biosensing Incubator demonstrated that, despite several challenges, there are many promising avenues for the discipline to have significant humanitarian impacts.


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