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Personalized Medicine: The Promise, Our Challenge, Its Future | Recap of panel discussion, held April 30 | By Jeremy Blum

WBBA hosted a forward-thinking panel discussion entitled “Personalized Medicine: The Promise, Our Challenge, Its Future”.  Moderated by Chris Rivera, President and CEO of the WBBA, the panel engaged a stimulating discussion on the challenges and opportunities faced by their respective organizations in the emerging practice of precision medicine.  The expert panelists included Hans Bishop (CEO and Co-Founder of Juno Therapeutics), Heather Franklin (President and CEO of Blaze Bioscience), Brad Gray (President and CEO of NanoString Technologies), Chad Robins (Founder and CEO of Adaptive Biotechnologies), and Andrew Scharenberg (Principal Investigator at Seattle Children’s Research Institute, Center for Immunity and Immunotherapies).

Early in the discussion, Heather Franklin, reframed the terminology from “personalized medicine” to “precision medicine”, which more accurately encompassed the breadth of the technologies represented by the panelists’ organizations.  The NIH defines precision medicine as “an approach to treatment and prevention that takes individual’s gene variability, environment, and lifestyle.”  The emerging technologies represented by the panelists included procedural reagents, diagnostics, and cell and gene therapies; the discussed applications of these technologies were for genetic diseases and cancer.  

Rivera inquired of the panelists of their biggest challenges or “What keeps them up at night?”.  Gray shared that despite the versatility of NanoString’s diagnostic platform, it was (and continues to be) critical for the company to be focused on selecting the appropriate disease targets for developing the technology’s applications. Scharenberg spoke to the importance of young investigators to drive innovation within academia and the challenge for these individuals within the current funding environment.  Bishop pointed to the challenge of learning at an incredibly fast rate in these pioneering and highly competitive environments.

The panelists also discussed the challenges of the regulatory and reimbursement landscapes for precision medicine.  Gray mentioned NanoString’s ProSigna diagnostic for breast cancer indication was successful in receiving USFDA approval, but a more daunting environment would be navigating the bureaucratic process of reimbursement from CMS.  Other panelists echoed Gray’s sentiments about the uncertainties of reimbursement.  Scharenberg also brought up the complexity of regulating a gene therapy intervention, where the process may be standard, but the reagents would be unique, to each patient.
A question from the audience fostered discussion around patient advocacy.  Robins brought up the value of precision medicine in improving quality of life for patients by providing the example of how emerging diagnostics would be able to reduce invasive and painful procedures to a simple blood draw for oncology patients.  Gray added that the vision of NanoString’s diagnostic platform was to be closer to the patient, noting that instruments were positioned to serve low to middle income countries.  All panelists agreed that the patients provided inspiration for their organizational mission and advocacy would be critical to adoption into the healthcare system.    

The panelists spoke to the opportunity of integrating precision diagnostics with precision therapies.  Robins described a new paradigm in which diagnostics would dictate therapeutic intervention and these diagnoses could be part of routine doctor visits. With time, the healthcare community will be able to leverage the mega database that is currently being generated to support precision medicine interventions.  Bishop indicated that the good companies are already thinking and planning for precision medicine for healthcare interventions.

Overall, the enlightening discussion provided the audience with an optimistic glimpse of how precision medicine may cure patients with cancer and genetic diseases, while balancing its current and potential challenges. Throughout the discussion, it was clear that Seattle was well-positioned to be a leader in precision medicine through the innovation and collaboration of local companies and institutions.


Personalized Medicine: The Promise, Our Challenge, Its Future | Recap of panel discussion, held April 30 | By Stephanie Ginger, Stratos Product Development

The WBBA’s recent event titled “Personalized Medicine: The Promise, Our Challenge, Its Future” was held at Seattle Children’s Research Institute and included leaders in the field of next generation therapeutics and diagnostics. Moderated by Chris E. Rivera, President and Chief Executive Officer of the WBBA, the panel included Hans Bishop, Chief Executive Officer and Co-Founder of Juno Therapeutics; Brad Gray, President and Chief Executive Officer or NanoString Technologies; Heather Franklin, President and Chief Executive Officer of Blaze Bioscience, Andrew Scharenberg, MD, Principal Investigator at Seattle Children’s Research Institute, Center for Immunity and Immunotherapies; and Chad Robins, Founder and Chief Executive Officer of Adaptive Biotechnologies.


Each panelist brought a unique perspective to the discussion, but there was a distinct common thread – as one panelist put it, “personalized medicine is not a thing, it’s THE thing.”  And another said, “not using these technologies is like an accountant using an abacus instead of Excel.” If companies and research institutions aren’t thinking about personalized medicine, they are headed in the wrong direction.


The goal of these innovators is to get patients effective and affordable treatment; personalized medicine can do that in a way that isn’t just a little bit better, it is a lot better. Pinpointing tumors so that only the tumor is removed – no more, no less; developing advanced immunosequencing tools that can detect diseases early, or using a patient’s own immune system or genetic information to not just treat a disease, but actually cure it  - that’s the promise of personalized medicine.


As the panelists expressed, this field is certainly not without its difficulties. Our current regulatory landscape is not conducive to new technologies and is a significant barrier to getting these new tools and treatments to patients.


For instance, a treatment may have FDA approval, but not approval from the Centers for Medicare & Medicaid Services. Without that clear path to reimbursement, it often isn’t financially feasible to commercialize a new, much needed treatment. In the case of a patient specific genetic disease that requires each person to receive a completely unique therapy, our system of clinical trials simply doesn’t make sense. In the clinical world, regulatory hurdles are forcing tough decisions where one treatment or tool will be developed over another simply because the approval process is so uncertain and onerous.


As several panelists pointed out, our healthcare system is also going to have to change to embrace these new immunotherapies. It’s critical that we have a system to encourage development of new treatments that have the potential to completely change the way we fight disease. Instead of being evaluated relative to the cost of existing therapies, we should consider the lifetime benefit of these new tools and consider all future treatments that will no longer be required.


The good news, however, greatly outweighs the bad. The science is remarkable and Seattle is at the forefront. Our region has proved to be collaborative and open to new partnerships - both public and private - not just in personalized therapeutic and diagnostic tools, but for all kinds of new technologies. The science of personalized medicine is moving fast and some of the world’s greatest minds are propelling it forward right here in the Pacific Northwest. For these and other enterprises that are focused on innovations in personalized medicine, it’s a bigger task than any one group can tackle alone. Exciting opportunities for convergence in diagnostics and therapeutics are here. The time for a revolution in medical diagnosis and treatment is now.


Bio on the Vine


It was an overcast evening but the stars were out in full force at our kick off social event of the year – Bio on the Vine at the Space Needle.  Our largest Bio on the Vine to date, we had 160 people register to attend!  With wine flowing from Washington’s original winery, Chateau Ste. Michelle, and a 360-degree view of Seattle, the event was buzzing and alive with conversation and networking!    If you missed out, we’re planning on a repeat at the Needle next year!  Our next social event will be April 9 at The District Lounge at the Hotel Decca.  Please join me in thanking our sponsors:  Wells Fargo Insurance Services, MPI Research, & ZymoGenetics


Succeeding in Today's Medical Device Environment | Recap of panel discussion, held February 26, 2015 | By Carly Holstein

WBBA hosted a timely and rich panel discussion entitled “Succeeding in Today’s Medical Device Environment.” Moderated by Joe Hage, leader of the Medical Devices Group on LinkedIn, the panel engaged in thoughtful, and at times oppositional, discussion about the realities of operating in the medical device industry amidst current political and financial challenges. The expert panelists included Tom Clement (CEO of Aqueduct Critical Care, Inc.), Sean MacLeod (President of Stratos Product Development), Val Veitengruber (VP of Clinical Economics, Policy & Reimbursement at FUJIFILM SonoSite), and Joe Gifford (CEO of the Providence Swedish Health Alliance).


The discussion began with a heavy dose of criticism of the medical device tax enacted by the Affordable Care Act (ACA), also known as “Obamacare,” in 2012. Clement, MacLeod, and Veitengruber shared frustration regarding the tax and its impact on medical device manufacturers. Citing examples of decreased profit margins, increased cuts to workforce and R&D, and decreased investor activity, Veitengruber stated that the “medical device tax has been very impactful in our industry and not in a good way.” Hage added a compelling example from a member of his medical device group, who explained that, for his 50-person company, the medical device tax is equivalent to hiring 7 people who don’t do anything. Veitengruber is actively involved in lobbying efforts in Washington D.C., where medical device supporters are gaining bipartisan support to repeal the medical device tax. However, without a proposed solution for replacing the associated $29B tax revenue in the federal budget, the bill to repeal the tax is not likely to garner widespread Democratic support or a signature from President Obama.


Gifford turned the tables on this discussion, highlighting the benefits of the ACA and the improvements in cost and quality of care that hospitals have realized because of it. While Veitengruber criticized the ACA for not generating increased usage of imaging services—as might be expected for the increase in the number of insured Americans that has resulted from the ACA—Gifford clearly yet playfully pointed out that “we (hospitals) are trying to use your (imaging) services less,” not more. This excellent and honest discussion among the panelists underscored the obvious tension in this industry between device developers and healthcare systems and payers. Despite this current tension, Gifford highlighted the opportunity for technologists to embrace healthcare innovation and ultimately be the ones who truly fix the healthcare system. MacLeod agreed with this standpoint, adding that healthcare must shift to a “wellness management system,” and that Stratos and many of its clients are already working toward this goal.


Bringing the discussion to a more a local focus, the panel also talked about the impact of the WA state R&D tax credit that was recently repealed after 20 years of serving as a strong incentive for high-tech companies to set up shop in this state. Veitengruber stated that this repeal majorly affects SonoSite, which manufactures its products locally in Bothell, WA. Patti Tenney, Senior Director of Public Affairs at WBBA, described her organization’s efforts to work with state legislators and the governor to reinstate the incentive. To this end, House Bill 1769 has been proposed to reenact the R&D tax credit. Tenney and the WBBA highly encourage all players in the industry to contact state legislators and share their stories of the impact of this tax credit on their businesses.


The discussion ended with a recap of the superb array of resources available to medical device companies in this region. Clement pointed out that the University of Washington serves as a great research foundation, explaining that the technology for his company was exclusively licensed from UW through CoMotion (formerly C4C). Clement also mentioned that Aqueduct Critical Care benefited tremendously from a seed grant from the Life Sciences Discovery Fund (LSDF), which funded the development of their initial prototype. The panel also pointed out other resources, such as the Washington Research Foundation (WRF) and local angel investor groups, especially WINGS, which is specifically focused on medical technology. MacLeod also highlighted the importance of the Venture Investing & Partnering (VIP) forums hosted by WBBA, which bring national investors to Seattle to increase the visibility of our companies, hopefully mitigating the “out of sight, out of mind” problem that local companies often face.


Overall, the panel served as a great opportunity to learn from the insights of local medical device experts. While the medical device and healthcare industries are complex—and the intersection of them even more challenging—the panelists all echoed the same enthusiasm for improving health that unites us all in this field and propels us forward.


“From Washington to the World: Developing and Deploying Diagnostics” | Recap of panel discussion, held March 26, 2015, at IDRI | By Koji Abe

WBBA hosted an informative presentation and panel discussion regarding new and innovative global health diagnostics in development in Washington, entitled “From Washington to the World: Developing and Deploying Diagnostics”. Moderated by Christine Rousseau, Senior Program Officer at the Bill & Melinda Gates Foundation, the discussion focused on best practices and the lessons learned while developing a diagnostic; especially for low-resource environments. The expert panelists included Steve Reed (Founder, President, & Chief Scientific Officer of the Infectious Disease Research Institute (IDRI)), Tony Gades (Clinical Scientist of Philips Ultrasound), Malcolm Duthie (Senior Scientist & Principal Investigator of IDRI), and Wallace White (Director of Point-of-Care Diagnostics, Stratos Product Development).


The presentations began with the reveal of the Gates Foundation philosophy, “begin with the end in mind”, by Rousseau. She shared some strategies the Gates Foundation employs to improve global health markets, making an example of the VCT rapid test process. She emphasized how important it was to consider the size of market, taskforce, policy, technical solutions, and payers when setting priorities in diagnostic development.


Reed shared another example of a disease target, leishmaniasis, which would cause patients to display different symptoms, which in turn made it difficult to diagnosis and prescribe effective treatments. As a solution to this challenge, the k39 RDT, produced at IDRI, is a fabulous example of a sensitive and fast disease diagnostic that results in better options for treatment.


Gades showed another example of mobile diagnostic tools and Philips’ low-cost, low-power, and high-performing ultrasound. Their Ultra Mobile line, including VISIQ and NUVIS, has a huge potential to offer sophisticated, quick “yes/no” clinical answers even in low-resource settings.


Duthie next illustrated the challenges of leprosy, which traditionally requires a very long diagnostic process. To achieve an ideal scenario for leprosy with active detection and earlier diagnosis, specific antibodies have been investigated for clinical use. As a tool for leprosy control, a lateral flow test format was developed; it is simple to perform, easy to integrate, and good for objective results. Serosurveillance for case detection in China was given as another example.


White shared his experiences of visiting local clinics and health center labs in developing countries. A collaboration with the Gates Foundation, PanDx was developed as a multi-technology diagnostic tool for health centers worldwide. This technology is flexible for test types (e.g. nucleic acids, immunoassay, etc.) and easy to use (just add the sample, and results are available within an hour, no biosafety cabinet needed, and no computer required).


During the panel discussion, audience members asked several questions. One query focused on how to fix and maintain devices after their transfer overseas; often times the technology is goes unused, due to a lack of a supportive environmental infrastructure. Gades pointed out that it is not easy even for big companies to guarantee good services for local end users. He stated that reducing the number of parts and simplifying the diagnostic hardware/software is a possible solution. Rousseau mentioned that making this technology more disposable would be another approach to limiting the need for its maintenance.


Another question concerned the challenges inherent in training local health workers to utilize these practices throughout their varied cultures. Reed shared his experiences with the complex dialects of Brazil as an example of potential challenges. White added that minimizing the need for long-term training is important in an environment that cannot support it.  As an alternative approach, Rousseau stated that cloud computing could be a good way to remotely manage health workers’ training and device maintenance.


Overall, this was an informative event where audience members benefited from the insights of WBBA’s expert panelists. It was also a valuable opportunity to consider efficient/practical developmental diagnostic processes for low-resource settings.


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