Interview with Andrew Fish, Executive Director, AdvaMedDx, and Chief Strategy Officer at AdvaMed.

In this Slone Partners’ interview, we talk to Andy Fish about changes in the diagnostics industry and his forecast for the near future.

Slone Partners: In your opinion, what is the most pressing issue in diagnostics in 2016/17?

Andy Fish: Right now, regulation of laboratory developed tests, or LDTs, is a hot topic. Certainly, this is a priority issue for our industry, and AdvaMedDx has long advocated for the Food and Drug Administration to enforce its regulations with respect to LDTs, under a risk-based approach, to help ensure patient safety. FDA has been working since 2010 to develop an implementation approach to LDT oversight, issued a draft guidance in 2014, and announced its intentions to issue a final guidance by the end of 2016. Following the election, however, FDA announced that it would not take further action on the guidance at this time. AdvaMedDx has been working closely with key congressional committees and stakeholders on the development of a legislative approach to diagnostics regulatory reforms, including LDT oversight. We are hopeful the next Congress will enact reforms that are positive both for patients and innovation. In the longer term, however, I believe the greatest challenge for all test developers and providers is assuring best practices in test utilization and securing diagnostic payment rates that are better aligned with their real value in driving more effective care. AdvaMedDx is developing a diagnostics value framework to help test developers and stakeholders better understand and assess the total value of diagnostics, and we believe this will be helpful in driving our message that diagnostics are not a cost to be minimized, but a value to be maximized.

Slone Partners: What are the most exciting areas of diagnostics for you at the moment and why?

Andy Fish: The pace and promise of scientific research and technology development are tremendously exciting for diagnostics. In precision medicine, our knowledge of the genomic underpinnings of health conditions is growing steadily. Molecular diagnostics are quickly becoming essential tools at every stage of the healthcare continuum, from discovery to R&D to diagnosis and prognosis, to treatment selection, and to effective patient monitoring. We’re also seeing very interesting developments in technology and convergence with digital health. With advances in sensors, wearables, in vivo diagnostics, wireless, and other areas, I believe will unlock tremendous patient and commercial value by generating much more real-time data and providing tools for patients and doctors that will make that data actionable.

Slone Partners: What are the most important industry changes for companies to be aware of at this time? Why are they important?

Andy Fish: Test developers need to be keenly aware of the growing pressure from payers, as well as other stakeholders, for compelling evidence that tests deliver information that not only is accurate and relevant, but that also makes a measurable and meaningful difference in patient care. There also is a lot of inconsistency in specific evidence expectations among payers, and companies need to incorporate a sophisticated understanding of these marketplace dynamics. As companies make early stage decisions about what technologies and tests to bring to market they must also determine what evidence they will need in hand early in that process to help ensure success not just with regulators but also with payers and providers.

Slone Partners: If you could change one area of diagnostics legislation, what would your priority be?

Andy Fish: You might check back after the Medicare diagnostics payment reforms in the 2014 Protecting Access to Medicare Act (PAMA) have been fully implemented! But in the immediate term, in addition to the regulatory reforms I mentioned earlier, AdvaMedDx supports a number of provisions in the 21st Century Cures legislation that would improve the FDA regulatory process for test developers and we’d like to see those enacted. AdvaMed has been closely engaged in the development of this legislation and we’re very pleased that congressional action on this legislation is scheduled this week.

Slone Partners: What’s your opinion of the Cancer Moonshot 2020? Why will it be different than current approaches to fighting cancer?

Andy Fish: We applaud the aims of the Cancer Moonshot but the overall goal is to make system changes, which will take time, and the effort really just in the early stages of formulating recommendations. However, the initial recommendations of the Blue Ribbon Panel were encouraging and underscore the critical role of diagnostic testing as a cornerstone of cancer care and the enabler of precision medicine. Many of the panel’s recommended activities will be driven by the use of diagnostics and contribute to the continued development of advanced diagnostic technologies and tests, including retrospective biospecimen analysis, networked data sharing, therapeutic target identification, and screening and early detection. One of the key themes of the Moonshot that is intended to distinguish it from other approaches in fighting cancer is the identification of areas where private and public initiatives can be joined and aligned to accelerate progress and break down existing barriers to collaboration. It should be noted that appropriate public policies – especially with regard to regulation and reimbursement, as well as access to biospecimens – are essential to ensuring robust progress in the research, development, commercialization, and utilization of advanced diagnostic technologies.

Slone Partners: Diagnostics and medical devices have seen a recent decline in VC funding. What is your outlook on investment in the Dx space moving forward?

Andy Fish: I don’t provide investment guidance but I will say that I am very bullish on diagnostics overall. I think investors in general are concerned about constraints on reimbursement, and incrementally better technologies may struggle to get traction, but investors always will be motivated to fund innovations that are positioned to make a real difference. As I’ve already referenced, the growing convergence of advanced diagnostics – both in vitro and in vivo – with digital health tools is going to generate tremendous value. When these technologies can be deployed in ways that make a difference in patient outcomes, efficiency of care delivery, and patient quality of life, I believe investors will recognize their value and invest in them.

Slone Partners: Where do you see the most growth in diagnostics over the next five years?

Andy Fish: Again, look elsewhere for specific investment guidance, but molecular diagnostics should continue to grow strongly, especially those in precision medicine that enable therapeutic discovery and treatment selection. Point of care should be another area of growth, as there is a lot of potential value in providing test results more quickly, both by moving tests out of the laboratory and closer to the patient care setting and by developing tests that have shorter time to result. Informatics is an area of diagnostics that is not yet as fully developed but that will be increasingly important as diagnostic companies move beyond generating test results and climb the value chain into collecting, managing, and deriving value from data. This will have applications everywhere from biopharmaceutical discovery to remote patient monitoring and population health management, ranging all the way from the clinic or individual hospital to national public health applications. Diagnostic companies that successfully integrate core diagnostic capabilities with broader informatics and digital heath functions should do well as our healthcare system moves steadily to value-based care.

Slone Partners:Why should companies join AdvaMedDx?

Andy Fish: AdvaMedDx is instrumental in shaping critical policy issues that influence the business environment for diagnostics in the United States and in key global markets. As the trade association for diagnostics manufacturers, AdvaMedDx promotes the value of diagnostics and supports the diagnostics industry’s interests on regulatory, payment, and health care delivery issues through a strong advocacy and external affairs program. We are a member-driven association, meaning that member companies have deep access to and influence on AdvaMedDx activities through participation in a wide variety of work groups through which companies shape AdvaMedDx activities and policies and gain access to and influence with key government agencies and stakeholders. The association also is a robust platform for information sharing and networking among industry peers. AdvaMedDx also is an active member of the Global Diagnostics Alliance, a collaboration of leading diagnostics associations that currently includes the U.S., Europe, Japan, Brazil, Australia, and Canada. Member companies benefit not only from AdvaMedDx’s dedicated focus on diagnostics, but also from AdvaMed’s advocacy on all key regulatory, payment, tax, and other issues.

About Andrew Fish

Andrew Fish is the first Executive Director of AdvaMedDx, the U.S. trade association representing leading manufacturers of medical diagnostic tests. AdvaMedDx was founded in 2010 as a division of AdvaMed, the medical technology manufacturers association, where Mr. Fish also serves as Chief Strategy Officer. Mr. Fish reports to the AdvaMedDx Board of Directors. Mr. Fish has extensive experience navigating the complex intersections of business, science, media, law, regulation, and politics. Earlier in Mr. Fish’s career, he served in the Senate-confirmed post of Assistant Secretary of Agriculture for Congressional and Intergovernmental Affairs. Prior to that position, he worked twice for the U.S. Senate Agriculture Committee, first as a professional staff member and later as deputy chief counsel. Prior to joining AdvaMedDx, Mr. Fish was Senior Vice President of Legal and Government Affairs, General Counsel, and Secretary for the Consumer Healthcare Products Association (CHPA), representing manufacturers of non-prescription medicines. Mr. Fish also led the American Cancer Society’s federal lobbying team as the Senior Director of Federal Government Relations. In his legal practice, Mr. Fish focused on biotechnology regulation, as well as on a wide range of food, drug and agriculture issues. Mr. Fish is a graduate of Yale University and Stanford Law School.

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