The KidneyX Summit continued today, April 30, 2019, with congressional perspectives; the role of NIH, FDA, and payors; and the nephrology investment landscape all addressed during the second day of the event.

Following are remarks by the day’s speakers:

Congressional Perspective

Congresswoman Suzan DelBene (D-WA), Congressional Kidney Caucus Co-Chair

In conjunction with the other Co-Chair, Representative Buchson (R-IN), Representative DelBene and the Kidney Caucus drafted a letter to Congress to fund KidneyX along with 56 congressional co-signers and as was announced yesterday, $10 million has been included in the House appropriations FY 2020 funding bill.

“The current care model is bankrupting Medicare and is providing painfully poor outcomes for patients… I’m hopeful that KidneyX will be the spark that spurs meaningful innovation in the kidney space, delivering better care for patients and allow for the continuing stability of Medicare,” closed Representative DelBene.

Congressman Larry Buchson, MD (R-IN), Congressional Kidney Caucus Co-Chair

“In recent years, Congress has had some success. We’ve done much to promote research, innovation, and new treatments and cures by dramatically increasing the NIH budget and passing legislation called the 21^st Century CURES Act.  There are a number of areas we still need additional focus, particularly with chronic kidney disease and ESRD as they are a major driver of the cost of Medicare. We need to improve patient outcomes and patient care, while reducing cost to the system as a whole… We can, should, and must do better.” stated Representative Buchson.

Congressman Brian Babin, D.D.S (R-TX)

Congressman Babin joined the KidneyX Summit by recorded video.

“We cannot stand idly by for a minute longer, simply resting on the heels of treatments that were developed decades ago. It is long past time that we invest in innovation… [and] the status quo is simply not enough,” said Congressman Babin. “I also want to recognize the patients and caretakers in this room. Please know that I’m working hard with my colleagues, on both sides of the aisle in Congress, to make sure that each of you has more options when it comes to care, because you deserve better,” said Congressman Babin.

Industry Perpective

Larry Soler, JD, Founding Partner, Convergency

Mr. Soler’s presentation focused on the story of the artificial pancreas and the corollaries between the lack of innovation in insulin pumps for the past 30 years and dialysis. The press reported the Juvenile Diabetes Research Foundation (JDRF) was making a risky bet by shooting for an artificial pancreas when they weren’t sure whether industry, researchers, and patients would support it, whether the FDA would approve it, or whether insurance companies would reimbursement its use.

JDRF understood that if they weren’t willing to take on the risk, then it most likely wouldn’t otherwise happen. As long as they de-risked the private companies’ input by putting in money of their own, JDRF could get them to do things they wouldn’t otherwise take on.

It took about 10 years of collaboration and guidance from the FDA, but the final product was well accepted by all stakeholders.
 

Emily Levy, Former Head, Fresenius Medical Care Ventures

There is a database that tracks venture funding deals and unfortunately there has not been a lot of activity in the nephrology life sciences investment space. “One notable thing that stands out – private equity, which is the later money when you’re getting ready to commercialize is virtually absent,” stated Ms. Levy, which will make it difficult for private companies to raise funds. However, she foresees hope as there is a lot of room for growth.

Leslie Trigg, MBA, CEO, Outset Medical

Leslie Trigg, MBA tackled the question of “what is needed to move forward in the industry sphere for new nephrology developments”?

1. A mindset shift from dialysis as a destination to dialysis as a state. This would mean patients being in charge of their own care, transitional care programs focused on transiting patients to self-care whether in-clinic or at home, and expansion of where, when, and how dialysis can be delivered.
2. Capital flow. $9.8 billion flowed into life sciences and healthcare innovation, but nephrology didn’t crack the top 8 fields. So what do we need to do?
   - Success begets success – we need to show investors a trend of success to instill a fear of missing out
   - Customer willingness to adopt to adapt and we need early adopters
    
3. New entrepreneurs means more education, fundraising, commercial adoption. Upending the status quo
    

Closing remarks

Dr. John Sedor, ASN Chair, KidneyX Steering Committee, gave some final thoughts on all topics discussed and the inaugural KidneyX Summit with a phrase that spoke to the true reason behind all of this effort and innovation, “the patients are waiting”. Patients are waiting for new developments that can dramatically improve their lifestyles and ultimately save their lives. He hoped that as everyone moves forward in their innovative pursuits, this be in the forefront of their mind.

Stay tuned to Kidney News Online for more to come on the regulatory perspective from National Institutes of Health (NIH) representative, Jill Heemskerk, PhD, The Food & Drug Administration (FDA) representative, Jeffrey Shuren, MD, JD, and from Adam Boehler, Deputy Administrator and Director, Center for Medicare and Medicaid Innovation (CMMI).